chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Oropharyngeal pain, Pulmonary pain
Clinical narrative: body aches similar like the flu; sore throat; lungs hurt when she takes a deep breath; body aches similar like the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu) 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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu). At the time of the report, INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported.   This case was linked to MOD-2021-106524 (E2B Linked Report).; Sender's Comments:  MOD-2021-106524:second dose
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Induration, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Itchy; Redness; Warm; Hard; Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff; Then a bump showed up and it's the size of a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ERYTHEMA (Redness), FEELING HOT (Warm), INDURATION (Hard) and MUSCULOSKELETAL STIFFNESS (Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-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 PRURITUS (Itchy), ERYTHEMA (Redness), FEELING HOT (Warm), INDURATION (Hard), MUSCULOSKELETAL STIFFNESS (Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff) and JOINT SWELLING (Then a bump showed up and it's the size of a golf ball). At the time of the report, PRURITUS (Itchy), ERYTHEMA (Redness), FEELING HOT (Warm), INDURATION (Hard), MUSCULOSKELETAL STIFFNESS (Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff) and JOINT SWELLING (Then a bump showed up and it's the size of a golf ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy; Redness; Warm; Hard; Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff; Then a bump showed up and it's the size of a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ERYTHEMA (Redness), FEELING HOT (Warm), INDURATION (Hard) and MUSCULOSKELETAL STIFFNESS (Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Apr-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 PRURITUS (Itchy), ERYTHEMA (Redness), FEELING HOT (Warm), INDURATION (Hard), MUSCULOSKELETAL STIFFNESS (Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff) and JOINT SWELLING (Then a bump showed up and it's the size of a golf ball). At the time of the report, PRURITUS (Itchy), ERYTHEMA (Redness), FEELING HOT (Warm), INDURATION (Hard), MUSCULOSKELETAL STIFFNESS (Arm was stiff for the first couple of days after the shot but then it stopped / makes her arm feel stiff) and JOINT SWELLING (Then a bump showed up and it's the size of a golf ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: weakness; chills; high fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (chills), PYREXIA (high fever) and HEADACHE (headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, BETA VULGARIS ROOT, IRON AMINO ACID CHELATE, ROSA CANINA FRUIT, RUBUS IDAEUS LEAF (IRON SUPPLEMENT WITH VIT C & HERBS) for an unknown indication.   On 02-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), CHILLS (chills), PYREXIA (high fever) and HEADACHE (headache). At the time of the report, ASTHENIA (weakness), CHILLS (chills), PYREXIA (high fever) and HEADACHE (headache) outcome was unknown.            This case was linked to MOD-2021-106689 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: tenderness; Injection arm sore; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness) and PAIN IN EXTREMITY (Injection arm sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concomitant products included preser vision for Product used for unknown indication, OXYBUTYNIN, METOPROLOL, CYANOCOBALAMIN, FOLIC ACID (VITAMIN B12 & FOLIC ACID) and PARACETAMOL (TYLENOL) for an unknown indication, BUPROPION, VITAMIN D3 and IRON.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced TENDERNESS (tenderness) and PAIN IN EXTREMITY (Injection arm sore). On 29-Apr-2021, TENDERNESS (tenderness) and PAIN IN EXTREMITY (Injection arm sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-106520 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106520:Daughter case
Sex: M
Vaccine: COVID19
Symptoms: Limb deformity, Peripheral swelling
Clinical narrative: Swelling; Distorted arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling) and LIMB DEFORMITY (Distorted arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 04-May-2021, the patient experienced PERIPHERAL SWELLING (Swelling) and LIMB DEFORMITY (Distorted arm). At the time of the report, PERIPHERAL SWELLING (Swelling) and LIMB DEFORMITY (Distorted arm) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste of tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste of tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced DYSGEUSIA (metallic taste of tongue). At the time of the report, DYSGEUSIA (metallic taste of tongue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Cannot lift the left arm; Pain in the entire left  arm; pain in the left arm has become worst; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the entire left  arm), PAIN IN EXTREMITY (pain in the left arm has become worst) and LIMB DISCOMFORT (Cannot lift the left arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the entire left  arm) and PAIN IN EXTREMITY (pain in the left arm has become worst). On 03-May-2021, the patient experienced LIMB DISCOMFORT (Cannot lift the left arm). At the time of the report, PAIN IN EXTREMITY (pain in the left arm has become worst) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-106708 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106708:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: incidental off-label use (adolescent); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incidental off-label use (adolescent)) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incidental off-label use (adolescent)). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (incidental off-label use (adolescent)) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Energy increased, Oropharyngeal discomfort, Palpitations
Clinical narrative: dizziness/little light-headed; little tickle in my throat; heart was also racing, maybe to 90; pizza did not taste like a pizza, it tasted like steel; felt a boost of energy/like very hyper; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (little tickle in my throat), PALPITATIONS (heart was also racing, maybe to 90), DYSGEUSIA (pizza did not taste like a pizza, it tasted like steel), ENERGY INCREASED (felt a boost of energy/like very hyper) and DIZZINESS (dizziness/little light-headed) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B12A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (little tickle in my throat), PALPITATIONS (heart was also racing, maybe to 90), DYSGEUSIA (pizza did not taste like a pizza, it tasted like steel) and ENERGY INCREASED (felt a boost of energy/like very hyper). On an unknown date, the patient experienced DIZZINESS (dizziness/little light-headed). On 03-Apr-2021, OROPHARYNGEAL DISCOMFORT (little tickle in my throat) and PALPITATIONS (heart was also racing, maybe to 90) had resolved. At the time of the report, DYSGEUSIA (pizza did not taste like a pizza, it tasted like steel), ENERGY INCREASED (felt a boost of energy/like very hyper) and DIZZINESS (dizziness/little light-headed) 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.   Concomitant medications also include Blood pressure pill for Blood Pressure Management and Cholesterol pill for Cholesterol Management. No Treatment information was  provided.
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: left ring finger swelling; left lower extremity pain; tightness; swelling; decreased range of motion in finger; decreased strength in finger; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (left ring finger swelling), PAIN IN EXTREMITY (left lower extremity pain), MUSCULOSKELETAL STIFFNESS (tightness), PERIPHERAL SWELLING (swelling) and MOBILITY DECREASED (decreased range of motion in finger) 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.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (left ring finger swelling), PAIN IN EXTREMITY (left lower extremity pain), MUSCULOSKELETAL STIFFNESS (tightness), PERIPHERAL SWELLING (swelling), MOBILITY DECREASED (decreased range of motion in finger) and MUSCULAR WEAKNESS (decreased strength in finger). At the time of the report, PERIPHERAL SWELLING (left ring finger swelling), PAIN IN EXTREMITY (left lower extremity pain), MUSCULOSKELETAL STIFFNESS (tightness), PERIPHERAL SWELLING (swelling), MOBILITY DECREASED (decreased range of motion in finger) and MUSCULAR WEAKNESS (decreased strength in finger) outcome was unknown. Not Provided   Treatment information was provided i.e., steroids     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.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: 3 drops of the dose ran down the patient's right arm; Drops came out from the hub of the needle; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (3 drops of the dose ran down the patient's right arm) and DEVICE CONNECTION ISSUE (Drops came out from the hub of the needle) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (3 drops of the dose ran down the patient's right arm) and DEVICE CONNECTION ISSUE (Drops came out from the hub of the needle). At the time of the report, UNDERDOSE (3 drops of the dose ran down the patient's right arm) and DEVICE CONNECTION ISSUE (Drops came out from the hub of the needle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Mark on leg; flat, round, half an inch in size and like strawberry color; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Mark on leg) and ERYTHEMA (flat, round, half an inch in size and like strawberry color) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced RASH (Mark on leg) and ERYTHEMA (flat, round, half an inch in size and like strawberry color). At the time of the report, RASH (Mark on leg) and ERYTHEMA (flat, round, half an inch in size and like strawberry color) outcome was unknown. Not Provided          The patient is on concomitant medications. No treatment information was provided.  The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-106672 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106672:HUSBAND CASE
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Redness and warmth of the injection site; Itching at injection site; Redness and warmth of the injection site; Rash on back; Swelling on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on left arm), VACCINATION SITE WARMTH (Redness and warmth of the injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness and warmth of the injection site) and RASH (Rash on back) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling on left arm). 23-Apr-2021, the patient experienced RASH (Rash on back). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Redness and warmth of the injection site), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness and warmth of the injection site). At the time of the report, PERIPHERAL SWELLING (Swelling on left arm), VACCINATION SITE WARMTH (Redness and warmth of the injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Redness and warmth of the injection site) and RASH (Rash on back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitants and treatments were not reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Cough, Dyspnoea
Clinical narrative: malaise; lack of energy; cough; difficulty breathing; tight chest; is expectorating a green mucous and sometimes with blood; headache rarely; 100.9 fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), ASTHENIA (lack of energy), COUGH (cough), DYSPNOEA (difficulty breathing) and CHEST DISCOMFORT (tight chest) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, ENALAPRIL, LEVOTHYROXINE, SIMVASTATIN, LINAGLIPTIN (TRADJENTA) and TAMSULOSIN for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MALAISE (malaise), ASTHENIA (lack of energy), COUGH (cough), DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (tight chest), HAEMOPTYSIS (is expectorating a green mucous and sometimes with blood), HEADACHE (headache rarely), PYREXIA (100.9 fever) and CHILLS (chills). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and GUAIFENESIN (MUCUS) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (malaise), ASTHENIA (lack of energy), COUGH (cough), DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (tight chest), HAEMOPTYSIS (is expectorating a green mucous and sometimes with blood), HEADACHE (headache rarely), PYREXIA (100.9 fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Headache, Malaise, Pyrexia
Clinical narrative: malaise; lack of energy; cough; difficulty breathing; tight chest; is expectorating a green mucous and sometimes with blood; headache rarely; 100.9 fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), ASTHENIA (lack of energy), COUGH (cough), DYSPNOEA (difficulty breathing) and CHEST DISCOMFORT (tight chest) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, ENALAPRIL, LEVOTHYROXINE, SIMVASTATIN, LINAGLIPTIN (TRADJENTA) and TAMSULOSIN for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced MALAISE (malaise), ASTHENIA (lack of energy), COUGH (cough), DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (tight chest), HAEMOPTYSIS (is expectorating a green mucous and sometimes with blood), HEADACHE (headache rarely), PYREXIA (100.9 fever) and CHILLS (chills). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and GUAIFENESIN (MUCUS) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (malaise), ASTHENIA (lack of energy), COUGH (cough), DYSPNOEA (difficulty breathing), CHEST DISCOMFORT (tight chest), HAEMOPTYSIS (is expectorating a green mucous and sometimes with blood), HEADACHE (headache rarely), PYREXIA (100.9 fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Migraine, Pyrexia, Vomiting
Clinical narrative: I had severe migraine.; yesterday, vomiting every 10 mins and non stop; I felt like someone has taken a bat to hit my head; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (I had severe migraine.), VOMITING (yesterday, vomiting every 10 mins and non stop), HEADACHE (I felt like someone has taken a bat to hit my head), PYREXIA (fever) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0457321A and 039AZIA OR 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 04-May-2021, the patient experienced MIGRAINE (I had severe migraine.), VOMITING (yesterday, vomiting every 10 mins and non stop) and HEADACHE (I felt like someone has taken a bat to hit my head). At the time of the report, MIGRAINE (I had severe migraine.), VOMITING (yesterday, vomiting every 10 mins and non stop), HEADACHE (I felt like someone has taken a bat to hit my head), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-106518 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Two patients were given temp excursion vaccine vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Two patients were given temp excursion vaccine vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Two patients were given temp excursion vaccine vial). At the time of the report, PRODUCT STORAGE ERROR (Two patients were given temp excursion vaccine vial) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   2 patients were given each a dose of excursion vials.  No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-156255 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-156255:
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain
Clinical narrative: welts on her back; vaccination site burning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welts on her back) and VACCINATION SITE PAIN (vaccination site burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (welts on her back) and VACCINATION SITE PAIN (vaccination site burning). At the time of the report, URTICARIA (welts on her back) and VACCINATION SITE PAIN (vaccination site burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling abnormal, Gait inability, Pain
Clinical narrative: Could barely walk; Back and legs aching; Back and legs hurt really bad; Feels like she pulled a muscle; Pain returns with exertion; little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little tired), GAIT INABILITY (Could barely walk), BACK PAIN (Back and legs aching), PAIN IN EXTREMITY (Back and legs hurt really bad) and FEELING ABNORMAL (Feels like she pulled a muscle) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE, MIRTAZAPINE (MIRTAZEPINE TEVA), ZOLPIDEM, SERTRALINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), ONDANSETRON and ACETYLSALICYLIC ACID, CARISOPRODOL (SOMA CMPD) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (little tired). On 01-May-2021, the patient experienced GAIT INABILITY (Could barely walk), BACK PAIN (Back and legs aching), PAIN IN EXTREMITY (Back and legs hurt really bad), FEELING ABNORMAL (Feels like she pulled a muscle) and PAIN (Pain returns with exertion). At the time of the report, FATIGUE (little tired), GAIT INABILITY (Could barely walk), BACK PAIN (Back and legs aching), PAIN IN EXTREMITY (Back and legs hurt really bad), FEELING ABNORMAL (Feels like she pulled a muscle) and PAIN (Pain returns with exertion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-106692 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Could barely walk; Back and legs aching; Back and legs hurt really bad; Feels like she pulled a muscle; Pain returns with exertion; little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little tired), GAIT INABILITY (Could barely walk), BACK PAIN (Back and legs aching), PAIN IN EXTREMITY (Back and legs hurt really bad) and FEELING ABNORMAL (Feels like she pulled a muscle) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE, MIRTAZAPINE (MIRTAZEPINE TEVA), ZOLPIDEM, SERTRALINE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), ONDANSETRON and ACETYLSALICYLIC ACID, CARISOPRODOL (SOMA CMPD) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (little tired). On 01-May-2021, the patient experienced GAIT INABILITY (Could barely walk), BACK PAIN (Back and legs aching), PAIN IN EXTREMITY (Back and legs hurt really bad), FEELING ABNORMAL (Feels like she pulled a muscle) and PAIN (Pain returns with exertion). At the time of the report, FATIGUE (little tired), GAIT INABILITY (Could barely walk), BACK PAIN (Back and legs aching), PAIN IN EXTREMITY (Back and legs hurt really bad), FEELING ABNORMAL (Feels like she pulled a muscle) and PAIN (Pain returns with exertion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-106692 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Migraine, Neck pain, Peripheral swelling
Clinical narrative: started itching,  itching was like poison ivy; neck swollen; arm swollen, fingertips were all swollen; neck hurt; had bad migraine; back and shoulders were hurting so bad; shoulders were hurting so bad; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started itching,  itching was like poison ivy), SWELLING (neck swollen), PERIPHERAL SWELLING (arm swollen, fingertips were all swollen), NECK PAIN (neck hurt) and MIGRAINE (had bad migraine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LARIN FE), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VENLAFAXINE, LANSOPRAZOLE, TIZANIDINE HCL, BUSPIRONE, POTASSIUM, MAGNESIUM, ZINC, DUPILUMAB (DUPIXENT), VITAMIN D NOS and VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (started itching,  itching was like poison ivy), SWELLING (neck swollen), PERIPHERAL SWELLING (arm swollen, fingertips were all swollen), NECK PAIN (neck hurt), MIGRAINE (had bad migraine), BACK PAIN (back and shoulders were hurting so bad) and ARTHRALGIA (shoulders were hurting so bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. At the time of the report, PRURITUS (started itching,  itching was like poison ivy), SWELLING (neck swollen), PERIPHERAL SWELLING (arm swollen, fingertips were all swollen), NECK PAIN (neck hurt), MIGRAINE (had bad migraine), BACK PAIN (back and shoulders were hurting so bad) and ARTHRALGIA (shoulders were hurting so bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment with Pepcid ,Benadryl  and Nauzene  were taken pertained to the events, as provided by the patient. Concomitant medication includes Butterbur.   This case was linked to MOD-2021-106731 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: started itching,  itching was like poison ivy; neck swollen; arm swollen, fingertips were all swollen; neck hurt; had bad migraine; back and shoulders were hurting so bad; shoulders were hurting so bad; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started itching,  itching was like poison ivy), SWELLING (neck swollen), PERIPHERAL SWELLING (arm swollen, fingertips were all swollen), NECK PAIN (neck hurt) and MIGRAINE (had bad migraine) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LARIN FE), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VENLAFAXINE, LANSOPRAZOLE, TIZANIDINE HCL, BUSPIRONE, POTASSIUM, MAGNESIUM, ZINC, DUPILUMAB (DUPIXENT), VITAMIN D NOS and VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRURITUS (started itching,  itching was like poison ivy), SWELLING (neck swollen), PERIPHERAL SWELLING (arm swollen, fingertips were all swollen), NECK PAIN (neck hurt), MIGRAINE (had bad migraine), BACK PAIN (back and shoulders were hurting so bad) and ARTHRALGIA (shoulders were hurting so bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. At the time of the report, PRURITUS (started itching,  itching was like poison ivy), SWELLING (neck swollen), PERIPHERAL SWELLING (arm swollen, fingertips were all swollen), NECK PAIN (neck hurt), MIGRAINE (had bad migraine), BACK PAIN (back and shoulders were hurting so bad) and ARTHRALGIA (shoulders were hurting so bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment with Pepcid ,Benadryl  and Nauzene  were taken pertained to the events, as provided by the patient. Concomitant medication includes Butterbur.   This case was linked to MOD-2021-106731 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Muscle spasms, Pain in extremity, Paraesthesia
Clinical narrative: muscle spasms/along with cramps in upper and lower; severe pain in hands and feet; tingling that migrates all over my body; Numbness hands/ feet/losing feeling in my hands and feet; Numbness tongue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness hands/ feet/losing feeling in my hands and feet), HYPOAESTHESIA ORAL (Numbness tongue), MUSCLE SPASMS (muscle spasms/along with cramps in upper and lower), PAIN IN EXTREMITY (severe pain in hands and feet) and PARAESTHESIA (tingling that migrates all over my body) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness hands/ feet/losing feeling in my hands and feet) and HYPOAESTHESIA ORAL (Numbness tongue). On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasms/along with cramps in upper and lower), PAIN IN EXTREMITY (severe pain in hands and feet) and PARAESTHESIA (tingling that migrates all over my body). At the time of the report, HYPOAESTHESIA (Numbness hands/ feet/losing feeling in my hands and feet) and HYPOAESTHESIA ORAL (Numbness tongue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Magnetic resonance imaging, Paraesthesia, Peripheral swelling
Clinical narrative: left arm fell asleep/left side of her body became numb/shoulder and back numb; Did not receive the second dose; right shoulder still hurts; tingling from head to toe that progressed with a month of first dose; swelling in right arm; immediate feeling of itchiness as soon as shot went in her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (left arm fell asleep/left side of her body became numb/shoulder and back numb), PARAESTHESIA (tingling from head to toe that progressed with a month of first dose), PERIPHERAL SWELLING (swelling in right arm), PRURITUS (immediate feeling of itchiness as soon as shot went in her arm) and PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL and OMEPRAZOLE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling from head to toe that progressed with a month of first dose), PERIPHERAL SWELLING (swelling in right arm) and PRURITUS (immediate feeling of itchiness as soon as shot went in her arm). On an unknown date, the patient experienced HYPOAESTHESIA (left arm fell asleep/left side of her body became numb/shoulder and back numb), PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose) and ARTHRALGIA (right shoulder still hurts). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (left arm fell asleep/left side of her body became numb/shoulder and back numb), PARAESTHESIA (tingling from head to toe that progressed with a month of first dose), PERIPHERAL SWELLING (swelling in right arm), PRURITUS (immediate feeling of itchiness as soon as shot went in her arm) and PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose) outcome was unknown and ARTHRALGIA (right shoulder still hurts) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Magnetic resonance imaging: No results provided..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was scheduled for nerve conduction and had appointment with neurologist. No treatment was prescribed because doctors were not sure of the cause of the symptoms. Doctor advised the patient to hold off on second dose. The reporter mentioned that the treatment included Ibuprofen.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus
Clinical narrative: left arm fell asleep/left side of her body became numb/shoulder and back numb; Did not receive the second dose; right shoulder still hurts; tingling from head to toe that progressed with a month of first dose; swelling in right arm; immediate feeling of itchiness as soon as shot went in her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (left arm fell asleep/left side of her body became numb/shoulder and back numb), PARAESTHESIA (tingling from head to toe that progressed with a month of first dose), PERIPHERAL SWELLING (swelling in right arm), PRURITUS (immediate feeling of itchiness as soon as shot went in her arm) and PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL and OMEPRAZOLE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling from head to toe that progressed with a month of first dose), PERIPHERAL SWELLING (swelling in right arm) and PRURITUS (immediate feeling of itchiness as soon as shot went in her arm). On an unknown date, the patient experienced HYPOAESTHESIA (left arm fell asleep/left side of her body became numb/shoulder and back numb), PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose) and ARTHRALGIA (right shoulder still hurts). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (left arm fell asleep/left side of her body became numb/shoulder and back numb), PARAESTHESIA (tingling from head to toe that progressed with a month of first dose), PERIPHERAL SWELLING (swelling in right arm), PRURITUS (immediate feeling of itchiness as soon as shot went in her arm) and PRODUCT DOSE OMISSION ISSUE (Did not receive the second dose) outcome was unknown and ARTHRALGIA (right shoulder still hurts) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Magnetic resonance imaging: No results provided..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was scheduled for nerve conduction and had appointment with neurologist. No treatment was prescribed because doctors were not sure of the cause of the symptoms. Doctor advised the patient to hold off on second dose. The reporter mentioned that the treatment included Ibuprofen.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site mass, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: vaccination site bump/huge like a baseball/visible; warm and hot; painful when bump tried to move; vaccination site swollen; minor fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (vaccination site bump/huge like a baseball/visible), VACCINATION SITE WARMTH (warm and hot), VACCINATION SITE PAIN (painful when bump tried to move), VACCINATION SITE SWELLING (vaccination site swollen) and PYREXIA (minor fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No medical history information was reported.     On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site swollen) and PYREXIA (minor fever). On an unknown date, the patient experienced VACCINATION SITE MASS (vaccination site bump/huge like a baseball/visible), VACCINATION SITE WARMTH (warm and hot) and VACCINATION SITE PAIN (painful when bump tried to move). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (vaccination site bump/huge like a baseball/visible), VACCINATION SITE WARMTH (warm and hot), VACCINATION SITE PAIN (painful when bump tried to move), VACCINATION SITE SWELLING (vaccination site swollen) and PYREXIA (minor fever) 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.   Patient was reported to take birth control as concomitant medication.