chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Feeling hot, Gait disturbance, Impaired work ability, Inflammation
Clinical narrative: couldn't go to work; couldn't walk; red and swollen legs from the knee to her buttock; could not even stand up to go to the bathroom; joints of her toes, of her ankle, she was sore; as if they were inflamed; Did not want to take second shot; flesh of his legs felt like "snoring"; hands swollen; hands hot; hands hard; she is bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands swollen), FEELING HOT (hands hot), MUSCULOSKELETAL STIFFNESS (hands hard), MALAISE (she is bad) and IMPAIRED WORK ABILITY (couldn't go to work) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (hands swollen), FEELING HOT (hands hot), MUSCULOSKELETAL STIFFNESS (hands hard) and MALAISE (she is bad). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (couldn't go to work), GAIT DISTURBANCE (couldn't walk), PERIPHERAL SWELLING (red and swollen legs from the knee to her buttock), DYSSTASIA (could not even stand up to go to the bathroom), PAIN (joints of her toes, of her ankle, she was sore), INFLAMMATION (as if they were inflamed), INTENTIONAL DOSE OMISSION (Did not want to take second shot) and MYALGIA (flesh of his legs felt like "snoring"). At the time of the report, PERIPHERAL SWELLING (hands swollen), FEELING HOT (hands hot), MUSCULOSKELETAL STIFFNESS (hands hard), MALAISE (she is bad), IMPAIRED WORK ABILITY (couldn't go to work), GAIT DISTURBANCE (couldn't walk), PERIPHERAL SWELLING (red and swollen legs from the knee to her buttock), DYSSTASIA (could not even stand up to go to the bathroom), PAIN (joints of her toes, of her ankle, she was sore), INFLAMMATION (as if they were inflamed), INTENTIONAL DOSE OMISSION (Did not want to take second shot) and MYALGIA (flesh of his legs felt like "snoring") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) She has been tested 8 times for COVID-19 and was negative every time.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: TCR added, new event added and patient denied follow up
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Malaise, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: couldn't go to work; couldn't walk; red and swollen legs from the knee to her buttock; could not even stand up to go to the bathroom; joints of her toes, of her ankle, she was sore; as if they were inflamed; Did not want to take second shot; flesh of his legs felt like "snoring"; hands swollen; hands hot; hands hard; she is bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands swollen), FEELING HOT (hands hot), MUSCULOSKELETAL STIFFNESS (hands hard), MALAISE (she is bad) and IMPAIRED WORK ABILITY (couldn't go to work) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (hands swollen), FEELING HOT (hands hot), MUSCULOSKELETAL STIFFNESS (hands hard) and MALAISE (she is bad). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (couldn't go to work), GAIT DISTURBANCE (couldn't walk), PERIPHERAL SWELLING (red and swollen legs from the knee to her buttock), DYSSTASIA (could not even stand up to go to the bathroom), PAIN (joints of her toes, of her ankle, she was sore), INFLAMMATION (as if they were inflamed), INTENTIONAL DOSE OMISSION (Did not want to take second shot) and MYALGIA (flesh of his legs felt like "snoring"). At the time of the report, PERIPHERAL SWELLING (hands swollen), FEELING HOT (hands hot), MUSCULOSKELETAL STIFFNESS (hands hard), MALAISE (she is bad), IMPAIRED WORK ABILITY (couldn't go to work), GAIT DISTURBANCE (couldn't walk), PERIPHERAL SWELLING (red and swollen legs from the knee to her buttock), DYSSTASIA (could not even stand up to go to the bathroom), PAIN (joints of her toes, of her ankle, she was sore), INFLAMMATION (as if they were inflamed), INTENTIONAL DOSE OMISSION (Did not want to take second shot) and MYALGIA (flesh of his legs felt like "snoring") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) She has been tested 8 times for COVID-19 and was negative every time.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: TCR added, new event added and patient denied follow up
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test
Clinical narrative: couldn't go to work; couldn't walk; red and swollen legs from the knee to her buttock; could not even stand up to go to the bathroom; joints of her toes, of her ankle, she was sore; as if they were inflamed; Did not want to take second shot; flesh of his legs felt like "snoring"; hands swollen; hands hot; hands hard; she is bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands swollen), FEELING HOT (hands hot), MUSCULOSKELETAL STIFFNESS (hands hard), MALAISE (she is bad) and IMPAIRED WORK ABILITY (couldn't go to work) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (hands swollen), FEELING HOT (hands hot), MUSCULOSKELETAL STIFFNESS (hands hard) and MALAISE (she is bad). On an unknown date, the patient experienced IMPAIRED WORK ABILITY (couldn't go to work), GAIT DISTURBANCE (couldn't walk), PERIPHERAL SWELLING (red and swollen legs from the knee to her buttock), DYSSTASIA (could not even stand up to go to the bathroom), PAIN (joints of her toes, of her ankle, she was sore), INFLAMMATION (as if they were inflamed), INTENTIONAL DOSE OMISSION (Did not want to take second shot) and MYALGIA (flesh of his legs felt like "snoring"). At the time of the report, PERIPHERAL SWELLING (hands swollen), FEELING HOT (hands hot), MUSCULOSKELETAL STIFFNESS (hands hard), MALAISE (she is bad), IMPAIRED WORK ABILITY (couldn't go to work), GAIT DISTURBANCE (couldn't walk), PERIPHERAL SWELLING (red and swollen legs from the knee to her buttock), DYSSTASIA (could not even stand up to go to the bathroom), PAIN (joints of her toes, of her ankle, she was sore), INFLAMMATION (as if they were inflamed), INTENTIONAL DOSE OMISSION (Did not want to take second shot) and MYALGIA (flesh of his legs felt like "snoring") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) She has been tested 8 times for COVID-19 and was negative every time.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: TCR added, new event added and patient denied follow up
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Inappropriate schedule of product administration, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Injection arm still painful when laying down; Mismanagement of dose, received 2nd Vaccination 43 days after 1st Vaccination; Injection arm, shoulder and back painful; Injection arm, shoulder and back painful; Injection arm, shoulder and back painful; Injection arm, shoulder and back became stiff; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Injection arm, shoulder and back painful), BACK PAIN (Injection arm, shoulder and back painful), MUSCULOSKELETAL STIFFNESS (Injection arm, shoulder and back became stiff), PAIN IN EXTREMITY (Injection arm still painful when laying down) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mismanagement of dose, received 2nd Vaccination 43 days after 1st Vaccination) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Injection arm, shoulder and back painful), BACK PAIN (Injection arm, shoulder and back painful), MUSCULOSKELETAL STIFFNESS (Injection arm, shoulder and back became stiff), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mismanagement of dose, received 2nd Vaccination 43 days after 1st Vaccination) and ARTHRALGIA (Injection arm, shoulder and back painful). On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Injection arm still painful when laying down). The patient was treated with OXYCODONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Injection arm, shoulder and back painful), BACK PAIN (Injection arm, shoulder and back painful), MUSCULOSKELETAL STIFFNESS (Injection arm, shoulder and back became stiff), PAIN IN EXTREMITY (Injection arm still painful when laying down) and ARTHRALGIA (Injection arm, shoulder and back painful) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mismanagement of dose, received 2nd Vaccination 43 days after 1st Vaccination) had resolved. Not Provided          No concomitant medication was reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fatigue, Nausea, Pain in extremity
Clinical narrative: Dizziness; Exhaustion; Nausea; Arm pain; Lack of balance; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (Exhaustion), NAUSEA (Nausea), PAIN IN EXTREMITY (Arm pain) and BALANCE DISORDER (Lack of balance) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), FATIGUE (Exhaustion), NAUSEA (Nausea), PAIN IN EXTREMITY (Arm pain) and BALANCE DISORDER (Lack of balance). At the time of the report, DIZZINESS (Dizziness), FATIGUE (Exhaustion), NAUSEA (Nausea), PAIN IN EXTREMITY (Arm pain) and BALANCE DISORDER (Lack of balance) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site rash
Clinical narrative: lymph node swelling and a small rash at the site of her Moderna injection; lymph node swelling and a small rash at the site of her Moderna injection; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (lymph node swelling and a small rash at the site of her Moderna injection) and VACCINATION SITE RASH (lymph node swelling and a small rash at the site of her Moderna injection) 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 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph node swelling and a small rash at the site of her Moderna injection) and VACCINATION SITE RASH (lymph node swelling and a small rash at the site of her Moderna injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph node swelling and a small rash at the site of her Moderna injection) and VACCINATION SITE RASH (lymph node swelling and a small rash at the site of her Moderna injection) 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 Treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-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 COVID-19 (Positive COVID-19). At the time of the report, COVID-19 (Positive COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On 19-Mar-2021, the patient experienced COVID- like symptoms such as coughing and low grade fever. Later, the patient had lost of taste and experienced loss of appetite.; Sender's Comments: Based on the mechanism of action of mRNA 1273 and etiology of event Covid 19, the event is unlikely related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site warmth
Clinical narrative: Lumpy area at the injection site; Warm to touch at injection site; Red area at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lumpy area at the injection site), VACCINATION SITE WARMTH (Warm to touch at injection site) and VACCINATION SITE ERYTHEMA (Red area at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE MASS (Lumpy area at the injection site), VACCINATION SITE WARMTH (Warm to touch at injection site) and VACCINATION SITE ERYTHEMA (Red area at the injection site). At the time of the report, VACCINATION SITE MASS (Lumpy area at the injection site), VACCINATION SITE WARMTH (Warm to touch at injection site) and VACCINATION SITE ERYTHEMA (Red area at the injection site) 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: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (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 02-Mar-2021, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) outcome was unknown.            No concomitant medication was provided. Treatment medication included Aleve.   This case was linked to MOD-2021-060448 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Pain, Urinary tract infection
Clinical narrative: Urinary tract infection; body aches; felt like couldn't breath; chills; pain in the arm; head ache; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), PAIN (body aches), DYSPNOEA (felt like couldn't breath), CHILLS (chills) and VACCINATION SITE PAIN (pain in the arm) in a male 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.     The patient's past medical history included No adverse event.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection), PAIN (body aches), DYSPNOEA (felt like couldn't breath), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm) and HEADACHE (head ache). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), PAIN (body aches), DYSPNOEA (felt like couldn't breath), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm) and HEADACHE (head ache) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included alieve.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Urinary tract infection; body aches; felt like couldn't breath; chills; pain in the arm; head ache; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), PAIN (body aches), DYSPNOEA (felt like couldn't breath), CHILLS (chills) and VACCINATION SITE PAIN (pain in the arm) in a male 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.     The patient's past medical history included No adverse event.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection), PAIN (body aches), DYSPNOEA (felt like couldn't breath), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm) and HEADACHE (head ache). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), PAIN (body aches), DYSPNOEA (felt like couldn't breath), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm) and HEADACHE (head ache) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included alieve.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain in extremity
Clinical narrative: diarrhea; shaky; vomiting; chills; runny nose; nausea; sore arm; swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), SWELLING (swelling), DIARRHOEA (diarrhea) and TREMOR (shaky) in a 56-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 27-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 PAIN IN EXTREMITY (sore arm), SWELLING (swelling) and HEADACHE (headache). On 28-Mar-2021, the patient experienced RHINORRHOEA (runny nose), DIARRHOEA (diarrhea), TREMOR (shaky), VOMITING (vomiting), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), SWELLING (swelling), DIARRHOEA (diarrhea), TREMOR (shaky), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up was received on 07 July 2021 - Events outcome added.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Swelling, Tremor, Vomiting
Clinical narrative: diarrhea; shaky; vomiting; chills; runny nose; nausea; sore arm; swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), SWELLING (swelling), DIARRHOEA (diarrhea) and TREMOR (shaky) in a 56-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 27-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 PAIN IN EXTREMITY (sore arm), SWELLING (swelling) and HEADACHE (headache). On 28-Mar-2021, the patient experienced RHINORRHOEA (runny nose), DIARRHOEA (diarrhea), TREMOR (shaky), VOMITING (vomiting), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), SWELLING (swelling), DIARRHOEA (diarrhea), TREMOR (shaky), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up was received on 07 July 2021 - Events outcome added.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Scintillating scotoma
Clinical narrative: really bad Migraine headache (really bad headache); (Scintillating Scotomas) visual disturbances, (saw lights were shimmering and wavy lines); Periodic chills, like the chills you get with flu or virus, but she doesn't have any fevers; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (really bad Migraine headache (really bad headache)), SCINTILLATING SCOTOMA ((Scintillating Scotomas) visual disturbances, (saw lights were shimmering and wavy lines)) and CHILLS (Periodic chills, like the chills you get with flu or virus, but she doesn't have any fevers) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21 and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Platelet disorder (platelet disorder that's inherited, doesn't get better or worse.).   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced MIGRAINE (really bad Migraine headache (really bad headache)). 01-Mar-2021, the patient experienced SCINTILLATING SCOTOMA ((Scintillating Scotomas) visual disturbances, (saw lights were shimmering and wavy lines)) and CHILLS (Periodic chills, like the chills you get with flu or virus, but she doesn't have any fevers). The patient was treated with PARACETAMOL (TYLENOL) on 01-Mar-2021 for Migraine, at a dose of two 650mg tylenol for 2 days. On 03-Mar-2021, MIGRAINE (really bad Migraine headache (really bad headache)) and SCINTILLATING SCOTOMA ((Scintillating Scotomas) visual disturbances, (saw lights were shimmering and wavy lines)) had resolved. At the time of the report, CHILLS (Periodic chills, like the chills you get with flu or virus, but she doesn't have any fevers) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-051822 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Wrong product administered
Clinical narrative: Swelling of lips; Face swelling; received the Johnson and Johnson vaccine for the second dose; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of lips), SWELLING FACE (Face swelling) and WRONG PRODUCT ADMINISTERED (received the Johnson and Johnson vaccine for the second dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced WRONG PRODUCT ADMINISTERED (received the Johnson and Johnson vaccine for the second dose). On an unknown date, the patient experienced LIP SWELLING (Swelling of lips) and SWELLING FACE (Face swelling). At the time of the report, LIP SWELLING (Swelling of lips), SWELLING FACE (Face swelling) and WRONG PRODUCT ADMINISTERED (received the Johnson and Johnson vaccine for the second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient took Benadryl as treatment medication.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: LENVIMA (Patient was not currently taking Lenvima 12 mg at the moment and reported that she went to the ER for chest pain and increased blood pressure on 15 Feb 2021, healthcare suspected that it was caused by Lenvima and put her on a hold. Due to the event caused by vaccination and her healthcare provider decided to keep her off of Lenvima for a little while longer.) on 16-Jan-2021. Concurrent medical conditions included Endometrial cancer (Endometrial Cancer C54.1). Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown. Not Provided          Plan was to have a CT scan today (18 Mar 2021)  and possibly resume lenvatinib mesilate at a lower dosage on 23 Mar 2021. No treatment information was provided.Her healthcare provider decided to keep her off of  lenvatinib mesilate for a little while longer due to the event caused by vaccination. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Limb discomfort, Nausea, Skin discolouration
Clinical narrative: Excruciatingly Painful headache; nausea; face is "white as a sheet"; Feeling very hot and cold; hands "curled in on themselves"; soreness at the injection sight; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection sight), HEADACHE (Slight Headache), HEADACHE (Excruciatingly Painful headache), NAUSEA (nausea) and SKIN DISCOLOURATION (face is "white as a sheet") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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 VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    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 VACCINATION SITE PAIN (soreness at the injection sight) and HEADACHE (Slight Headache). On 29-Mar-2021, the patient experienced HEADACHE (Excruciatingly Painful headache), NAUSEA (nausea), SKIN DISCOLOURATION (face is "white as a sheet"), FEELING OF BODY TEMPERATURE CHANGE (Feeling very hot and cold) and LIMB DISCOMFORT (hands "curled in on themselves"). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at the injection sight), HEADACHE (Slight Headache), HEADACHE (Excruciatingly Painful headache), NAUSEA (nausea), SKIN DISCOLOURATION (face is "white as a sheet"), FEELING OF BODY TEMPERATURE CHANGE (Feeling very hot and cold) and LIMB DISCOMFORT (hands "curled in on themselves") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Excruciatingly Painful headache; nausea; face is "white as a sheet"; Feeling very hot and cold; hands "curled in on themselves"; soreness at the injection sight; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection sight), HEADACHE (Slight Headache), HEADACHE (Excruciatingly Painful headache), NAUSEA (nausea) and SKIN DISCOLOURATION (face is "white as a sheet") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 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 VITAMINS NOS (DAILY VITAMINS) for an unknown indication.    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 VACCINATION SITE PAIN (soreness at the injection sight) and HEADACHE (Slight Headache). On 29-Mar-2021, the patient experienced HEADACHE (Excruciatingly Painful headache), NAUSEA (nausea), SKIN DISCOLOURATION (face is "white as a sheet"), FEELING OF BODY TEMPERATURE CHANGE (Feeling very hot and cold) and LIMB DISCOMFORT (hands "curled in on themselves"). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at the injection sight), HEADACHE (Slight Headache), HEADACHE (Excruciatingly Painful headache), NAUSEA (nausea), SKIN DISCOLOURATION (face is "white as a sheet"), FEELING OF BODY TEMPERATURE CHANGE (Feeling very hot and cold) and LIMB DISCOMFORT (hands "curled in on themselves") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Oropharyngeal pain
Clinical narrative: sore throat; dizziness; weakness; achy joint; vomiting; chills; flashing; continuation of movement of light - like watching film and advancing it, (there are) different frames in there; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (flashing), VISUAL IMPAIRMENT (continuation of movement of light - like watching film and advancing it, (there are) different frames in there), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness) and ASTHENIA (weakness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PHOTOPSIA (flashing) and VISUAL IMPAIRMENT (continuation of movement of light - like watching film and advancing it, (there are) different frames in there). On 29-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), ASTHENIA (weakness), ARTHRALGIA (achy joint), VOMITING (vomiting) and CHILLS (chills). At the time of the report, PHOTOPSIA (flashing), VISUAL IMPAIRMENT (continuation of movement of light - like watching film and advancing it, (there are) different frames in there), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), ASTHENIA (weakness), ARTHRALGIA (achy joint), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Photopsia, Visual impairment, Vomiting
Clinical narrative: sore throat; dizziness; weakness; achy joint; vomiting; chills; flashing; continuation of movement of light - like watching film and advancing it, (there are) different frames in there; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (flashing), VISUAL IMPAIRMENT (continuation of movement of light - like watching film and advancing it, (there are) different frames in there), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness) and ASTHENIA (weakness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PHOTOPSIA (flashing) and VISUAL IMPAIRMENT (continuation of movement of light - like watching film and advancing it, (there are) different frames in there). On 29-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), ASTHENIA (weakness), ARTHRALGIA (achy joint), VOMITING (vomiting) and CHILLS (chills). At the time of the report, PHOTOPSIA (flashing), VISUAL IMPAIRMENT (continuation of movement of light - like watching film and advancing it, (there are) different frames in there), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizziness), ASTHENIA (weakness), ARTHRALGIA (achy joint), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: dark, orange colored urine.; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (dark, orange colored urine.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced CHROMATURIA (dark, orange colored urine.). At the time of the report, CHROMATURIA (dark, orange colored urine.) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Chills, Fatigue, Headache
Clinical narrative: concerned about having Covid; runny nose; weak; chills; severe headache; fatigue; bloated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), ABDOMINAL DISTENSION (bloated), RHINORRHOEA (runny nose), TENSION (concerned about having Covid) and CHILLS (chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced ABDOMINAL DISTENSION (bloated). On 27-Mar-2021, the patient experienced CHILLS (chills), HEADACHE (severe headache) and FATIGUE (fatigue). On 28-Mar-2021, the patient experienced ASTHENIA (weak). On 29-Mar-2021, the patient experienced RHINORRHOEA (runny nose). On an unknown date, the patient experienced TENSION (concerned about having Covid). At the time of the report, ASTHENIA (weak), ABDOMINAL DISTENSION (bloated), RHINORRHOEA (runny nose), TENSION (concerned about having Covid), CHILLS (chills), HEADACHE (severe headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Tension
Clinical narrative: concerned about having Covid; runny nose; weak; chills; severe headache; fatigue; bloated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), ABDOMINAL DISTENSION (bloated), RHINORRHOEA (runny nose), TENSION (concerned about having Covid) and CHILLS (chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced ABDOMINAL DISTENSION (bloated). On 27-Mar-2021, the patient experienced CHILLS (chills), HEADACHE (severe headache) and FATIGUE (fatigue). On 28-Mar-2021, the patient experienced ASTHENIA (weak). On 29-Mar-2021, the patient experienced RHINORRHOEA (runny nose). On an unknown date, the patient experienced TENSION (concerned about having Covid). At the time of the report, ASTHENIA (weak), ABDOMINAL DISTENSION (bloated), RHINORRHOEA (runny nose), TENSION (concerned about having Covid), CHILLS (chills), HEADACHE (severe headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose 17 days after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 17 days after the first dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 17 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose 17 days after the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hot flush, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: received second dose early; Burning up really bad, hot flashes; arm pain; felt dizzy; headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose early), HOT FLUSH (Burning up really bad, hot flashes), PAIN IN EXTREMITY (arm pain), DIZZINESS (felt dizzy) and HEADACHE (headache) in a 26-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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose early), HOT FLUSH (Burning up really bad, hot flashes), PAIN IN EXTREMITY (arm pain), DIZZINESS (felt dizzy) and HEADACHE (headache). On 08-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose early) had resolved. At the time of the report, HOT FLUSH (Burning up really bad, hot flashes), PAIN IN EXTREMITY (arm pain), DIZZINESS (felt dizzy) and HEADACHE (headache) outcome was unknown.            Patient did not take any concomitant medications.  Patient did not take any treatment medication for the symptoms.    This case was linked to MOD-2021-038163 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash, Vaccination site swelling
Clinical narrative: Itching; Area turning very red; Swelling at the injection site; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), PRURITUS (Itching), RASH (Area turning very red) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included HCTZ for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 23-Mar-2021, the patient experienced PAIN (Soreness) and VACCINATION SITE SWELLING (Swelling at the injection site). On 26-Mar-2021, the patient experienced PRURITUS (Itching) and RASH (Area turning very red). On 24-Mar-2021, PAIN (Soreness) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. On 28-Mar-2021, RASH (Area turning very red) had resolved. At the time of the report, PRURITUS (Itching) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Pain
Clinical narrative: feels throbbing pain in her ear; feels throbbing pain in her ear; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feels throbbing pain in her ear) and EAR PAIN (feels throbbing pain in her ear) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN (feels throbbing pain in her ear) and EAR PAIN (feels throbbing pain in her ear). At the time of the report, PAIN (feels throbbing pain in her ear) and EAR PAIN (feels throbbing pain in her ear) outcome was unknown.            No Concomitant medications was reported. Action taken with mRNA-1273 in response to the event was not applicable Treatment information was not provided