chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received the first Moderna vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the first Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No medical history reported. ).    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the first Moderna vaccine). On 28-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the first Moderna vaccine) 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.   This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown, with no associated AEs.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle rigidity, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE RIGIDITY (the area where she got the injection is buffed), VACCINATION SITE WARMTH (the area where she got the injection is warm) and VACCINATION SITE SWELLING (the area where she got the injection is swollen) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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 27-Mar-2021, the patient experienced MUSCLE RIGIDITY (the area where she got the injection is buffed), VACCINATION SITE WARMTH (the area where she got the injection is warm) and VACCINATION SITE SWELLING (the area where she got the injection is swollen). At the time of the report, MUSCLE RIGIDITY (the area where she got the injection is buffed), VACCINATION SITE WARMTH (the area where she got the injection is warm) and VACCINATION SITE SWELLING (the area where she got the injection is swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Fatigue
Clinical narrative: lost voice; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (lost voice) and FATIGUE (extremely tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031A21A) for COVID-19 immunisation.     Concomitant products included LISINOPRIL, ZOLPIDEM TARTRATE (AMBIEN) and HYDROCODONE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced APHONIA (lost voice) and FATIGUE (extremely tired). On 04-Mar-2021, FATIGUE (extremely tired) had resolved. On 06-Mar-2021, APHONIA (lost voice) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       As reported patient was extremely tired for two days and lost voice for four days after first shot. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-065183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065183:2nd dose case
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Aphonia, Chills, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (lost voice), FATIGUE (extremely tired), INJECTION SITE PAIN (extreme sore in injection site), PYREXIA (102.2 degrees Fahrenheit fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, ZOLPIDEM TARTRATE (AMBIEN) and HYDROCODONE for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced APHONIA (lost voice) and FATIGUE (extremely tired). On 31-Mar-2021, the patient experienced INJECTION SITE PAIN (extreme sore in injection site), PYREXIA (102.2 degrees Fahrenheit fever), CHILLS (chills), ABDOMINAL PAIN (body aches), PYREXIA (shaking body) and HEADACHE (extreme headache). On 04-Mar-2021, FATIGUE (extremely tired) had resolved. On 06-Mar-2021, APHONIA (lost voice) had resolved. At the time of the report, INJECTION SITE PAIN (extreme sore in injection site), PYREXIA (102.2 degrees Fahrenheit fever), CHILLS (chills), ABDOMINAL PAIN (body aches), PYREXIA (shaking body) and HEADACHE (extreme headache) outcome was unknown. Treatment information was not provided. This case was linked to MOD-2021-065181 (E2B Linked Report).; Sender's Comments: MOD-2021-065181:1st dose case.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (lost voice), FATIGUE (extremely tired), INJECTION SITE PAIN (extreme sore in injection site), PYREXIA (102.2 degrees Fahrenheit fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, ZOLPIDEM TARTRATE (AMBIEN) and HYDROCODONE for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced APHONIA (lost voice) and FATIGUE (extremely tired). On 31-Mar-2021, the patient experienced INJECTION SITE PAIN (extreme sore in injection site), PYREXIA (102.2 degrees Fahrenheit fever), CHILLS (chills), ABDOMINAL PAIN (body aches), PYREXIA (shaking body) and HEADACHE (extreme headache). On 04-Mar-2021, FATIGUE (extremely tired) had resolved. On 06-Mar-2021, APHONIA (lost voice) had resolved. At the time of the report, INJECTION SITE PAIN (extreme sore in injection site), PYREXIA (102.2 degrees Fahrenheit fever), CHILLS (chills), ABDOMINAL PAIN (body aches), PYREXIA (shaking body) and HEADACHE (extreme headache) outcome was unknown. Treatment information was not provided. This case was linked to MOD-2021-065181 (E2B Linked Report).; Sender's Comments: MOD-2021-065181:1st dose case.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cluster headache, Face oedema, Peripheral swelling, Swelling
Clinical narrative: giant line from left side of her forehead to her eyebrow; whole left side swollen/could not get rings off; whole left side swollen; headache that was like burst in left side of her head kind of like a cluster; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (whole left side swollen/could not get rings off), FACE OEDEMA (giant line from left side of her forehead to her eyebrow), CLUSTER HEADACHE (headache that was like burst in left side of her head kind of like a cluster) and SWELLING (whole left side swollen) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced CLUSTER HEADACHE (headache that was like burst in left side of her head kind of like a cluster). On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (whole left side swollen/could not get rings off) and SWELLING (whole left side swollen). On 01-Apr-2021, the patient experienced FACE OEDEMA (giant line from left side of her forehead to her eyebrow). At the time of the report, PERIPHERAL SWELLING (whole left side swollen/could not get rings off), FACE OEDEMA (giant line from left side of her forehead to her eyebrow), CLUSTER HEADACHE (headache that was like burst in left side of her head kind of like a cluster) and SWELLING (whole left side swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site Itchy; swollen circle around the injection site/swollen circle around the injection site; red circle around the injection site; circle sized like a golf ball in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (circle sized like a golf ball in diameter), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE SWELLING (swollen circle around the injection site/swollen circle around the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) for Migraine.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE MASS (circle sized like a golf ball in diameter), VACCINATION SITE SWELLING (swollen circle around the injection site/swollen circle around the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site Itchy). At the time of the report, VACCINATION SITE MASS (circle sized like a golf ball in diameter), VACCINATION SITE PRURITUS (Injection site Itchy), VACCINATION SITE SWELLING (swollen circle around the injection site/swollen circle around the injection site) and VACCINATION SITE ERYTHEMA (red circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia
Clinical narrative: Coughing; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), HEADACHE (Headache) and MYALGIA (Body ache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COUGH (Coughing), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, COUGH (Coughing), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products was not provided.  Treatment medication was not reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose; Fever 101°F; Can hardly move; Body aches and pain; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), RHINORRHOEA (Runny nose), PAIN (Body aches and pain), PYREXIA (Fever 101°F) and FATIGUE (Can hardly move) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced COUGH (Coughing), PAIN (Body aches and pain) and FATIGUE (Can hardly move). On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and PYREXIA (Fever 101°F). At the time of the report, COUGH (Coughing), RHINORRHOEA (Runny nose), PAIN (Body aches and pain), PYREXIA (Fever 101°F) and FATIGUE (Can hardly move) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products was not provided/unknown.  Treatment medication was not reported/unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site rash
Clinical narrative: Itchy in the middle of the rash; Rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy in the middle of the rash) and VACCINATION SITE RASH (Rash around the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #003B21A) 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 RASH PRURITIC (Itchy in the middle of the rash) and VACCINATION SITE RASH (Rash around the injection site). At the time of the report, RASH PRURITIC (Itchy in the middle of the rash) and VACCINATION SITE RASH (Rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient was not provided.  Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Not feeling well; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced MALAISE (Not feeling well) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MALAISE (Not feeling well) and PYREXIA (Fever) 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Musculoskeletal stiffness, Pain
Clinical narrative: Pressure from neck to hip area; Vertigo; Body pain (stomach, chest, back) for 48 hours; Body pain (stomach, chest, back) for 48 hours; Body pain (stomach, chest, back) for 48 hours; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Pressure from neck to hip area), VERTIGO (Vertigo), PAIN (Body pain (stomach, chest, back) for 48 hours), ABDOMINAL PAIN UPPER (Body pain (stomach, chest, back) for 48 hours) and BACK PAIN (Body pain (stomach, chest, back) for 48 hours) in a 67-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.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Pressure from neck to hip area), VERTIGO (Vertigo), PAIN (Body pain (stomach, chest, back) for 48 hours), ABDOMINAL PAIN UPPER (Body pain (stomach, chest, back) for 48 hours), BACK PAIN (Body pain (stomach, chest, back) for 48 hours), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Pressure from neck to hip area), VERTIGO (Vertigo), PAIN (Body pain (stomach, chest, back) for 48 hours), ABDOMINAL PAIN UPPER (Body pain (stomach, chest, back) for 48 hours), BACK PAIN (Body pain (stomach, chest, back) for 48 hours), PYREXIA (Fever) and CHILLS (Chills) 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: Pressure from neck to hip area; Vertigo; Body pain (stomach, chest, back) for 48 hours; Body pain (stomach, chest, back) for 48 hours; Body pain (stomach, chest, back) for 48 hours; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Pressure from neck to hip area), VERTIGO (Vertigo), PAIN (Body pain (stomach, chest, back) for 48 hours), ABDOMINAL PAIN UPPER (Body pain (stomach, chest, back) for 48 hours) and BACK PAIN (Body pain (stomach, chest, back) for 48 hours) in a 67-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.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Pressure from neck to hip area), VERTIGO (Vertigo), PAIN (Body pain (stomach, chest, back) for 48 hours), ABDOMINAL PAIN UPPER (Body pain (stomach, chest, back) for 48 hours), BACK PAIN (Body pain (stomach, chest, back) for 48 hours), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (Pressure from neck to hip area), VERTIGO (Vertigo), PAIN (Body pain (stomach, chest, back) for 48 hours), ABDOMINAL PAIN UPPER (Body pain (stomach, chest, back) for 48 hours), BACK PAIN (Body pain (stomach, chest, back) for 48 hours), PYREXIA (Fever) and CHILLS (Chills) 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.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Hyperhidrosis, Myalgia, Rhinorrhoea
Clinical narrative: Joint ache; Muscle ache; Sneezing; Runny nose; Woke up twice very sweat; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold), HYPERHIDROSIS (Woke up twice very sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and ARTHRALGIA (Joint ache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included AFib. Concomitant products included VITAMIN D3 and FISH OIL for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced FEELING COLD (Felt cold). On 29-Mar-2021, the patient experienced HYPERHIDROSIS (Woke up twice very sweat). On 30-Mar-2021, the patient experienced SNEEZING (Sneezing) and RHINORRHOEA (Runny nose). On 31-Mar-2021, the patient experienced ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (Felt cold), HYPERHIDROSIS (Woke up twice very sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and ARTHRALGIA (Joint ache) outcome was unknown and MYALGIA (Muscle ache) was resolving. Not Provided          The patient reported that she has A fib, she cannot take Ibuprofen. Concomitant products includes blood thinner medication, blood pressure medication two every morning, pill for bones and stool softener.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Reporter declined further follow-up with the Treating doctor
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Joint ache; Muscle ache; Sneezing; Runny nose; Woke up twice very sweat; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt cold), HYPERHIDROSIS (Woke up twice very sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and ARTHRALGIA (Joint ache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included AFib. Concomitant products included VITAMIN D3 and FISH OIL for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced FEELING COLD (Felt cold). On 29-Mar-2021, the patient experienced HYPERHIDROSIS (Woke up twice very sweat). On 30-Mar-2021, the patient experienced SNEEZING (Sneezing) and RHINORRHOEA (Runny nose). On 31-Mar-2021, the patient experienced ARTHRALGIA (Joint ache) and MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, FEELING COLD (Felt cold), HYPERHIDROSIS (Woke up twice very sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and ARTHRALGIA (Joint ache) outcome was unknown and MYALGIA (Muscle ache) was resolving. Not Provided          The patient reported that she has A fib, she cannot take Ibuprofen. Concomitant products includes blood thinner medication, blood pressure medication two every morning, pill for bones and stool softener.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Reporter declined further follow-up with the Treating doctor
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Pain in extremity
Clinical narrative: Feeling crappy; Chills; Pain in joints; Arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore), FEELING ABNORMAL (Feeling crappy), CHILLS (Chills) and ARTHRALGIA (Pain in joints) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm was very sore). On 01-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling crappy), CHILLS (Chills) and ARTHRALGIA (Pain in joints). At the time of the report, PAIN IN EXTREMITY (Arm was very sore), FEELING ABNORMAL (Feeling crappy), CHILLS (Chills) and ARTHRALGIA (Pain in joints) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-065246 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065246:Husband case
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Scar
Clinical narrative: Numbness under right arm; Numbness on left side of mastectomy scar; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOAESTHESIA (Numbness under right arm) and SCAR (Numbness on left side of mastectomy scar) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Blood pressure.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE HYPOAESTHESIA (Numbness under right arm) and SCAR (Numbness on left side of mastectomy scar). At the time of the report, INJECTION SITE HYPOAESTHESIA (Numbness under right arm) and SCAR (Numbness on left side of mastectomy scar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported was blood pressure medication.  On 10 Mar 2021 the patient received the second dose of the Moderna covid-19 vaccine.  No treatment medication information was provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Twitching eye; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twitching eye) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MUSCLE TWITCHING (Twitching eye). On 31-Mar-2021, MUSCLE TWITCHING (Twitching eye) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD21-066986, MOD21-066987 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Disorientation, Feeling abnormal, Myalgia
Clinical narrative: Brain fog and feels disoriented; Diarrhea; brain fog and feels disoriented; Nausea; Severe chills; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Brain fog and feels disoriented), DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog and feels disoriented), NAUSEA (Nausea) and CHILLS (Severe chills) in a 77-year-old female patient 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 information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DISORIENTATION (Brain fog and feels disoriented), DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog and feels disoriented), NAUSEA (Nausea), CHILLS (Severe chills) and MYALGIA (Muscle aches). At the time of the report, DISORIENTATION (Brain fog and feels disoriented), DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog and feels disoriented), NAUSEA (Nausea), CHILLS (Severe chills) and MYALGIA (Muscle aches) 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.  Treatment information was not provided.  The patient is scared of the second dose and does not want to take it. She would like to know if she can take the second dose
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Brain fog and feels disoriented; Diarrhea; brain fog and feels disoriented; Nausea; Severe chills; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Brain fog and feels disoriented), DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog and feels disoriented), NAUSEA (Nausea) and CHILLS (Severe chills) in a 77-year-old female patient 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 information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DISORIENTATION (Brain fog and feels disoriented), DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog and feels disoriented), NAUSEA (Nausea), CHILLS (Severe chills) and MYALGIA (Muscle aches). At the time of the report, DISORIENTATION (Brain fog and feels disoriented), DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain fog and feels disoriented), NAUSEA (Nausea), CHILLS (Severe chills) and MYALGIA (Muscle aches) 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.  Treatment information was not provided.  The patient is scared of the second dose and does not want to take it. She would like to know if she can take the second dose
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant when receiving both doses of vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when receiving both doses of vaccine) in a 26-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 01-Jun-2021. On 05-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when receiving both doses of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 30-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant when receiving both doses of vaccine) had resolved. Not Provided          Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: Voice is hoarse; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice is hoarse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0037217 and 006M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPHONIA (Voice is hoarse). At the time of the report, DYSPHONIA (Voice is hoarse) outcome was unknown. Not Provided          Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.  No Medical History information was reported.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-059651 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick after receiving Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after receiving 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced ILLNESS (Sick after receiving Vaccine). At the time of the report, ILLNESS (Sick after receiving Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient never took her second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient never took her second dose of vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient never took her second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient never took her second dose of vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not experience any side effects after her first dose.  Concomitant medications were not reported.  Treatment information was not provided.  This report refers to a case of Product dose omission, for mRNA-1273, lot #  037K20A, with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product dose omission, for mRNA-1273, lot #  037K20A, with no associated AEs.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash on forearms; Red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and RASH (Rash on forearms) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Rash as a chil), Contrast media allergy (Delayed while body rash), Osteoporosis and Osteopenia. Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS and CALCIUM for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash). On an unknown date, the patient experienced RASH (Rash on forearms). At the time of the report, RASH ERYTHEMATOUS (Red rash) and RASH (Rash on forearms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  Patient took second dose on 19- Feb-2021 in left arm.   This case was linked to US-MODERNATX, INC.-MOD-2021-065221 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up updated on 28-Jun-2021, added patient demographics, relevant medical history, concomitant product details, new event-Rash on forearm.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065221:Dose 2
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: Small bump appeared on her face; Started getting bigger and red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Small bump appeared on her face) and SWELLING FACE (Started getting bigger and red) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-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 ERYTHEMA (Small bump appeared on her face) and SWELLING FACE (Started getting bigger and red). At the time of the report, ERYTHEMA (Small bump appeared on her face) and SWELLING FACE (Started getting bigger and red) outcome was unknown. Not Provided      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 was not provided.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-079727 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: follow-up received and does contain non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079727:Second dose
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Movement disorder, Pain in extremity, Sleep disorder
Clinical narrative: Inappropriate schedule of vaccine administered; Arm  was sore; Can't lift anything; Can't lay on it to sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  was sore), MOVEMENT DISORDER (Can't lift anything), SLEEP DISORDER (Can't lay on it to sleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Acid reflux (esophageal). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm  was sore), MOVEMENT DISORDER (Can't lift anything) and SLEEP DISORDER (Can't lay on it to sleep). On 25-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 25-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm  was sore), MOVEMENT DISORDER (Can't lift anything) and SLEEP DISORDER (Can't lay on it to sleep) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant medication also included cholesterol meds and acid reflux meds.  Treatment information was not provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Sore arm; Tired; 16 years old and received the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received the vaccine), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received the vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old and received the vaccine), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Arm was swollen for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm was swollen for a couple of days) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS. Concomitant products included OMEPRAZOLE, IRON (IRON ORAL) and BUPROPION for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Arm was swollen for a couple of days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Jan-2021, VACCINATION SITE SWELLING (Arm was swollen for a couple of days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment for the event included ice.   This case was linked to MOD-2021-065230 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling around the face and upper chin; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling around the face and upper chin) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced SWELLING FACE (Swelling around the face and upper chin). At the time of the report, SWELLING FACE (Swelling around the face and upper chin) 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.  Treatment information was not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Tenderness at the injection site right after receiving the vaccine; Small rash at the injection site; Rash has progressed as big as a cantaloupe at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness at the injection site right after receiving the vaccine), VACCINATION SITE RASH (Small rash at the injection site) and VACCINATION SITE RASH (Rash has progressed as big as a cantaloupe at the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at the injection site right after receiving the vaccine). In March 2021, the patient experienced VACCINATION SITE RASH (Small rash at the injection site) and VACCINATION SITE RASH (Rash has progressed as big as a cantaloupe at the injection site). At the time of the report, VACCINATION SITE PAIN (Tenderness at the injection site right after receiving the vaccine), VACCINATION SITE RASH (Small rash at the injection site) and VACCINATION SITE RASH (Rash has progressed as big as a cantaloupe at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Myalgia, Nausea
Clinical narrative: Felt hot; Chills; Nausea; Muscle pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt hot), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and FATIGUE (Tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING HOT (Felt hot), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and FATIGUE (Tiredness). At the time of the report, FEELING HOT (Felt hot), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle pain) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-079756 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079756:1 dose case.