chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (contracted COVID-19) and product dose omission issue (unable to receive her 2nd dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045A21A) for COVID-19 immunization. No medical history reported. On Mar 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 13, 2021, patient experienced COVID-19 (contracted COVID-19). On an unknown date, patient experienced product dose omission issue (unable to receive her 2nd dose). At the time of the report, COVID-19 (contracted COVID-19) and product dose omission issue (unable to receive her 2nd dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. Most recent follow-up information incorporated: On Jul 12, 2021: Follow-up received on Jul 12, 2021 contains non-significant information. Patient identifier (patient initials) added.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Ocular hyperaemia
Clinical narrative: lot of fatigue; Woke up with her left eye swollen; Woke up with her left eye red; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Woke up with her left eye swollen), OCULAR HYPERAEMIA (Woke up with her left eye red) and FATIGUE (lot of fatigue) 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 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced EYE SWELLING (Woke up with her left eye swollen) and OCULAR HYPERAEMIA (Woke up with her left eye red). On an unknown date, the patient experienced FATIGUE (lot of fatigue). At the time of the report, EYE SWELLING (Woke up with her left eye swollen), OCULAR HYPERAEMIA (Woke up with her left eye red) and FATIGUE (lot of fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder muscle; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder muscle) 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 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced ARTHRALGIA (Sore shoulder muscle). At the time of the report, ARTHRALGIA (Sore shoulder muscle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medication was provided.   Reporter did not allow further contact
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: dizzy; flu like symptoms; headache; Fever; pain in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), PYREXIA (Fever) and PAIN IN EXTREMITY (pain in arm) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), PYREXIA (Fever) and PAIN IN EXTREMITY (pain in arm). At the time of the report, DIZZINESS (dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (headache), PYREXIA (Fever) and PAIN IN EXTREMITY (pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD21-089861, US-MODERNATX, INC.-MOD-2021-127829, US-MODERNATX, INC.-MOD-2021-127871 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-089861:Same reporter, different patient US-MODERNATX, INC.-MOD-2021-127871:Husband case US-MODERNATX, INC.-MOD-2021-127829:Husband case
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: allergy in the arm; it got very very hot; itchy; my arm swelled; it got really read; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (allergy in the arm), VACCINATION SITE WARMTH (it got very very hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (my arm swelled) and VACCINATION SITE ERYTHEMA (it got really read) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE REACTION (allergy in the arm), VACCINATION SITE WARMTH (it got very very hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (my arm swelled) and VACCINATION SITE ERYTHEMA (it got really read). At the time of the report, VACCINATION SITE REACTION (allergy in the arm), VACCINATION SITE WARMTH (it got very very hot), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (my arm swelled) and VACCINATION SITE ERYTHEMA (it got really read) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided    Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included centrum, vitamin D, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (felt bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-127450 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Having chest pains; Having difficulty breathing; Had back aches, body aches; Have headaches; Had back aches, body aches; Felt pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Had back aches, body aches), FEELING ABNORMAL (Felt pretty bad), CHEST PAIN (Having chest pains), DYSPNOEA (Having difficulty breathing) and MYALGIA (Had back aches, body aches) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to sulfa products).   On 11-May-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 12-May-2021, the patient experienced BACK PAIN (Had back aches, body aches), FEELING ABNORMAL (Felt pretty bad), MYALGIA (Had back aches, body aches) and HEADACHE (Have headaches). On 13-May-2021, the patient experienced CHEST PAIN (Having chest pains) and DYSPNOEA (Having difficulty breathing). On 13-May-2021, BACK PAIN (Had back aches, body aches) and MYALGIA (Had back aches, body aches) had resolved. At the time of the report, FEELING ABNORMAL (Felt pretty bad), CHEST PAIN (Having chest pains), DYSPNOEA (Having difficulty breathing) and HEADACHE (Have headaches) had not resolved.            Concomitant medications were not reported. Treatment information was not reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Having chest pains; Having difficulty breathing; Had back aches, body aches; Have headaches; Had back aches, body aches; Felt pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Had back aches, body aches), FEELING ABNORMAL (Felt pretty bad), CHEST PAIN (Having chest pains), DYSPNOEA (Having difficulty breathing) and MYALGIA (Had back aches, body aches) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to sulfa products).   On 11-May-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 12-May-2021, the patient experienced BACK PAIN (Had back aches, body aches), FEELING ABNORMAL (Felt pretty bad), MYALGIA (Had back aches, body aches) and HEADACHE (Have headaches). On 13-May-2021, the patient experienced CHEST PAIN (Having chest pains) and DYSPNOEA (Having difficulty breathing). On 13-May-2021, BACK PAIN (Had back aches, body aches) and MYALGIA (Had back aches, body aches) had resolved. At the time of the report, FEELING ABNORMAL (Felt pretty bad), CHEST PAIN (Having chest pains), DYSPNOEA (Having difficulty breathing) and HEADACHE (Have headaches) had not resolved.            Concomitant medications were not reported. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash under arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (rash under 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 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced RASH (rash under arm). At the time of the report, RASH (rash under arm) outcome was unknown.            Concomitant medication was not reported.  Treatment medication was not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Fatigue, Hypoaesthesia, Myalgia, Paraesthesia oral
Clinical narrative: Tired; Achy; Little bit of reaction; Tingling in my mouth and lips; Facial numbness; Tongue swelling; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Little bit of reaction), PARAESTHESIA ORAL (Tingling in my mouth and lips), HYPOAESTHESIA (Facial numbness), SWOLLEN TONGUE (Tongue swelling) and FATIGUE (Tired) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced ADVERSE REACTION (Little bit of reaction), PARAESTHESIA ORAL (Tingling in my mouth and lips), HYPOAESTHESIA (Facial numbness) and SWOLLEN TONGUE (Tongue swelling). On an unknown date, the patient experienced FATIGUE (Tired) and MYALGIA (Achy). On 16-Apr-2021, ADVERSE REACTION (Little bit of reaction), PARAESTHESIA ORAL (Tingling in my mouth and lips), HYPOAESTHESIA (Facial numbness) and SWOLLEN TONGUE (Tongue swelling) had resolved. At the time of the report, FATIGUE (Tired) and MYALGIA (Achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information were provided.  Treatment information was not reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Tired; Achy; Little bit of reaction; Tingling in my mouth and lips; Facial numbness; Tongue swelling; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Little bit of reaction), PARAESTHESIA ORAL (Tingling in my mouth and lips), HYPOAESTHESIA (Facial numbness), SWOLLEN TONGUE (Tongue swelling) and FATIGUE (Tired) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced ADVERSE REACTION (Little bit of reaction), PARAESTHESIA ORAL (Tingling in my mouth and lips), HYPOAESTHESIA (Facial numbness) and SWOLLEN TONGUE (Tongue swelling). On an unknown date, the patient experienced FATIGUE (Tired) and MYALGIA (Achy). On 16-Apr-2021, ADVERSE REACTION (Little bit of reaction), PARAESTHESIA ORAL (Tingling in my mouth and lips), HYPOAESTHESIA (Facial numbness) and SWOLLEN TONGUE (Tongue swelling) had resolved. At the time of the report, FATIGUE (Tired) and MYALGIA (Achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information were provided.  Treatment information was not reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site reaction, Paraesthesia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), PARAESTHESIA (Arm is tingling from the injection site to the elbow), HYPOAESTHESIA (Arm is numb), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (A little bit of swelling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced INJECTION SITE REACTION (Injection site reaction), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (A little bit of swelling). On 13-May-2021, the patient experienced PARAESTHESIA (Arm is tingling from the injection site to the elbow) and HYPOAESTHESIA (Arm is numb). At the time of the report, INJECTION SITE REACTION (Injection site reaction), PARAESTHESIA (Arm is tingling from the injection site to the elbow), HYPOAESTHESIA (Arm is numb), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (A little bit of swelling) was resolving. 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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Dyspnoea, Fatigue, Feeling hot
Clinical narrative: Pain in her bones \ bones ache in an impressive way; Pain in her skin (she fell it as hot); Back is hot; Headache; Chills; As if she had a fever; Arm is hard; Arm is swollen; Like she couldn't breathe.; Arm is in pain; Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), BONE PAIN (Pain in her bones \ bones ache in an impressive way) and PAIN OF SKIN (Pain in her skin (she fell it as hot)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025c21a and 04b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CENTRUM ACTIVE, VITAMIN D NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), MYALGIA (Arm is in pain) and FATIGUE (Felt fatigue). On 13-May-2021, the patient experienced BONE PAIN (Pain in her bones \ bones ache in an impressive way), PAIN OF SKIN (Pain in her skin (she fell it as hot)), FEELING HOT (Back is hot), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (As if she had a fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, q6h. At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), BONE PAIN (Pain in her bones \ bones ache in an impressive way), PAIN OF SKIN (Pain in her skin (she fell it as hot)), FEELING HOT (Back is hot), MYALGIA (Arm is in pain), FATIGUE (Felt fatigue), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (As if she had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pain of skin, Peripheral swelling
Clinical narrative: Pain in her bones \ bones ache in an impressive way; Pain in her skin (she fell it as hot); Back is hot; Headache; Chills; As if she had a fever; Arm is hard; Arm is swollen; Like she couldn't breathe.; Arm is in pain; Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), BONE PAIN (Pain in her bones \ bones ache in an impressive way) and PAIN OF SKIN (Pain in her skin (she fell it as hot)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025c21a and 04b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CENTRUM ACTIVE, VITAMIN D NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), MYALGIA (Arm is in pain) and FATIGUE (Felt fatigue). On 13-May-2021, the patient experienced BONE PAIN (Pain in her bones \ bones ache in an impressive way), PAIN OF SKIN (Pain in her skin (she fell it as hot)), FEELING HOT (Back is hot), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (As if she had a fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, q6h. At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), BONE PAIN (Pain in her bones \ bones ache in an impressive way), PAIN OF SKIN (Pain in her skin (she fell it as hot)), FEELING HOT (Back is hot), MYALGIA (Arm is in pain), FATIGUE (Felt fatigue), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (As if she had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain in her bones \ bones ache in an impressive way; Pain in her skin (she fell it as hot); Back is hot; Headache; Chills; As if she had a fever; Arm is hard; Arm is swollen; Like she couldn't breathe.; Arm is in pain; Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), BONE PAIN (Pain in her bones \ bones ache in an impressive way) and PAIN OF SKIN (Pain in her skin (she fell it as hot)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025c21a and 04b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included CENTRUM ACTIVE, VITAMIN D NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), MYALGIA (Arm is in pain) and FATIGUE (Felt fatigue). On 13-May-2021, the patient experienced BONE PAIN (Pain in her bones \ bones ache in an impressive way), PAIN OF SKIN (Pain in her skin (she fell it as hot)), FEELING HOT (Back is hot), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (As if she had a fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, q6h. At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm is hard), PERIPHERAL SWELLING (Arm is swollen), DYSPNOEA (Like she couldn't breathe.), BONE PAIN (Pain in her bones \ bones ache in an impressive way), PAIN OF SKIN (Pain in her skin (she fell it as hot)), FEELING HOT (Back is hot), MYALGIA (Arm is in pain), FATIGUE (Felt fatigue), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (As if she had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyskinesia, Leukocytosis, Pyrexia
Clinical narrative: Leukocytosis; Chills; Febrile; Dyskinesia; This spontaneous case was reported by a consumer and describes the occurrence of LEUKOCYTOSIS (Leukocytosis), DYSKINESIA (Dyskinesia), CHILLS (Chills) and PYREXIA (Febrile) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplant (Patient had 2 operations within 10 days of each other.) on 01-Jan-1998. Concurrent medical conditions included Wilson's disease since 01-Jan-1998, Blood pressure high, Cholesterol high and Anxiety. Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Antiviral treatment, DIAZEPAM for Anxiety, VALSARTAN (DIOVAN) for Blood pressure abnormal, EZETIMIBE (ZETIA) and PRAVASTATIN for Cholesterol total abnormal NOS, CYCLOSPORINE, SIROLIMUS and SIROLIMUS for Immunosuppressant drug therapy, CLOPIDOGREL BISULFATE (PLAVIX) for Platelets abnormal, ESZOPICLONE (LUNESTA) for Sleep disorder NOS, GLYCOPYRROLATE for an unknown indication.   On 26-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 LEUKOCYTOSIS (Leukocytosis), CHILLS (Chills) and PYREXIA (Febrile). On an unknown date, the patient experienced DYSKINESIA (Dyskinesia). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Mar-2021, LEUKOCYTOSIS (Leukocytosis), CHILLS (Chills) and PYREXIA (Febrile) had resolved. At the time of the report, DYSKINESIA (Dyskinesia) had resolved.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Headache, Heart rate irregular
Clinical narrative: irregular heartbeat ( it slows down and comes up.); uncomfortable feeling; headache; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE IRREGULAR (irregular heartbeat ( it slows down and comes up.)), DISCOMFORT (uncomfortable feeling) and HEADACHE (headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Anxiety. Concurrent medical conditions included Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeat ( it slows down and comes up.)), DISCOMFORT (uncomfortable feeling) and HEADACHE (headache). At the time of the report, HEART RATE IRREGULAR (irregular heartbeat ( it slows down and comes up.)), DISCOMFORT (uncomfortable feeling) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Anxiety medications and Blood pressure medications.  No treatment medications were provided by reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: sharp pain near injection site when I tried to raise my left arm; Injection arm soreness; pain in left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Injection arm soreness), MYALGIA (pain in left arm) and VACCINATION SITE PAIN (sharp pain near injection site when I tried to raise my left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination.     The patient's past medical history included Movement disorder, Pain in arm and Muscle strain (right arm). Concurrent medical conditions included Fibromyalgia since 01-Jan-2000, Depression since 01-Jan-1980, Egg allergy, Food allergy (Allergy to whey), Seasonal allergy, Allergy to chemicals (Allergy to perfumes), Allergy to chemicals (Allergy to scents) and Allergy to chemicals (Allergy to Harsh chemicals). Concomitant products included FISH OIL from 01-Jan-2016 to an unknown date for Inflammation, MULTIVITAMINS [VITAMINS NOS] from 01-Jan-2018 to an unknown date, HCL PLUS [AMMONIUM CHLORIDE;BETAINE HYDROCHLORIDE;GLUTAMIC ACID HYDROCHLORIDE;PEPSIN;PYRIDOXINE HYDROCHLORIDE] from 01-Jan-2008 to an unknown date, BIO B COMPLEX from 01-Jan-2008 to an unknown date and ASTRAGALUS MONGHOLICUS ROOT (ASTRAGALUS EXTRACT) from 01-Jan-2015 to an unknown date for an unknown indication.   On 24-Apr-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced MYALGIA (pain in left arm). On 06-May-2021, the patient experienced VACCINATION SITE PAIN (Injection arm soreness). On an unknown date, the patient experienced VACCINATION SITE PAIN (sharp pain near injection site when I tried to raise my left arm). On 20-May-2021, MYALGIA (pain in left arm) had resolved. At the time of the report, VACCINATION SITE PAIN (Injection arm soreness) and VACCINATION SITE PAIN (sharp pain near injection site when I tried to raise my left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Significant follow-up information received: Second dose information updated, Event outcome for pain in left arm was updated, Concomitant medications, ethnicity, race, height, weight, age at vaccination site, allergies, Primary Reporter's middle name, Vaccine facility information were updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Feeling hot, Induration, Limb discomfort
Clinical narrative: Hard to touch; Soreness is getting worse/redness was getting darker and darker; She started with sore left arm that evening; Heavy left arm that evening; She has a really big dark red spot on left arm that started at same night; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She started with sore left arm that evening), LIMB DISCOMFORT (Heavy left arm that evening), ERYTHEMA (She has a really big dark red spot on left arm that started at same night), FEELING HOT (Warm to touch) and INDURATION (Hard to touch) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN for an unknown indication.   On 06-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 06-May-2021, the patient experienced PAIN IN EXTREMITY (She started with sore left arm that evening), LIMB DISCOMFORT (Heavy left arm that evening), ERYTHEMA (She has a really big dark red spot on left arm that started at same night) and FEELING HOT (Warm to touch). On 13-May-2021, the patient experienced INDURATION (Hard to touch) and CONDITION AGGRAVATED (Soreness is getting worse/redness was getting darker and darker). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (She started with sore left arm that evening), ERYTHEMA (She has a really big dark red spot on left arm that started at same night), INDURATION (Hard to touch) and CONDITION AGGRAVATED (Soreness is getting worse/redness was getting darker and darker) had not resolved and LIMB DISCOMFORT (Heavy left arm that evening) and FEELING HOT (Warm to touch) outcome was unknown.            Concomitant medication also included blood pressure medication.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Hard to touch; Soreness is getting worse/redness was getting darker and darker; She started with sore left arm that evening; Heavy left arm that evening; She has a really big dark red spot on left arm that started at same night; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She started with sore left arm that evening), LIMB DISCOMFORT (Heavy left arm that evening), ERYTHEMA (She has a really big dark red spot on left arm that started at same night), FEELING HOT (Warm to touch) and INDURATION (Hard to touch) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN for an unknown indication.   On 06-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 06-May-2021, the patient experienced PAIN IN EXTREMITY (She started with sore left arm that evening), LIMB DISCOMFORT (Heavy left arm that evening), ERYTHEMA (She has a really big dark red spot on left arm that started at same night) and FEELING HOT (Warm to touch). On 13-May-2021, the patient experienced INDURATION (Hard to touch) and CONDITION AGGRAVATED (Soreness is getting worse/redness was getting darker and darker). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (She started with sore left arm that evening), ERYTHEMA (She has a really big dark red spot on left arm that started at same night), INDURATION (Hard to touch) and CONDITION AGGRAVATED (Soreness is getting worse/redness was getting darker and darker) had not resolved and LIMB DISCOMFORT (Heavy left arm that evening) and FEELING HOT (Warm to touch) outcome was unknown.            Concomitant medication also included blood pressure medication.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: sore throat;  sneezing;  lot of mucus; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN ( sore throat), SNEEZING (sneezing) and RHINORRHOEA ( lot of mucus) 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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN ( sore throat), SNEEZING (sneezing) and RHINORRHOEA ( lot of mucus). At the time of the report, OROPHARYNGEAL PAIN ( sore throat), SNEEZING (sneezing) and RHINORRHOEA ( lot of mucus) 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 provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040321A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 14-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information included shower and eating.   This case was linked to MOD-2021-127502 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness while lying down and moving to fast; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness while lying down and moving to fast) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1CC021-427 (?)) for COVID-19 immunisation.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced DIZZINESS (dizziness while lying down and moving to fast). At the time of the report, DIZZINESS (dizziness while lying down and moving to fast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drug information provided. No concomitant drug information provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Arm stiffness/ Legs are stiff and heavy/ muscle stiffness; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (caught COVID two other times) in November 2019 and Brain inflammation (Inflammation in the brain from COVID).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm stiffness/ Legs are stiff and heavy/ muscle stiffness) and ARTHRALGIA (Joint pain) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-127553 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up information was received on 13 May 2021 and included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127553:husband case
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of tremor (shaky hands), pyrexia (fever), chills/shivering, headache and myalgia (body ache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014C21A) for COVID-19 immunization. The patient's past medical history included COVID-19 on Apr 2, 2021. On Apr 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 29, 2021, patient experienced tremor (shaky hands), pyrexia (fever), chills/shivering, headache and myalgia (body ache). On May 6, 2021, tremor (shaky hands), pyrexia (fever), chills/shivering, headache and myalgia (body ache) resolved. Diagnostic results: On Apr 2, 2021, SARS-CoV-2 test: Positive. On Apr 29, 2021, body temperature: 102ºF (high) fever. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of tremor (shaky hands), pyrexia (fever), chills/shivering, headache and myalgia (body ache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014C21A) for COVID-19 immunization. The patient's past medical history included COVID-19 on Apr 2, 2021. On Apr 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 29, 2021, patient experienced tremor (shaky hands), pyrexia (fever), chills/shivering, headache and myalgia (body ache). On May 6, 2021, tremor (shaky hands), pyrexia (fever), chills/shivering, headache and myalgia (body ache) resolved. Diagnostic results: On Apr 2, 2021, SARS-CoV-2 test: Positive. On Apr 29, 2021, body temperature: 102ºF (high) fever. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Lump and soreness on the vaccination site; Very hot to touch; Lump and soreness on the vaccination site; Hardness in her arm; Swelling and hardness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump and soreness on the vaccination site), VACCINATION SITE WARMTH (Very hot to touch), VACCINATION SITE INDURATION (Hardness in her arm), VACCINATION SITE SWELLING (Swelling and hardness in her arm) and VACCINATION SITE PAIN (Lump and soreness on the vaccination site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 040321A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE INDURATION (Hardness in her arm) and VACCINATION SITE SWELLING (Swelling and hardness in her arm). On an unknown date, the patient experienced VACCINATION SITE MASS (Lump and soreness on the vaccination site), VACCINATION SITE WARMTH (Very hot to touch) and VACCINATION SITE PAIN (Lump and soreness on the vaccination site). On 12-May-2021, VACCINATION SITE INDURATION (Hardness in her arm) and VACCINATION SITE SWELLING (Swelling and hardness in her arm) had resolved. At the time of the report, VACCINATION SITE MASS (Lump and soreness on the vaccination site), VACCINATION SITE WARMTH (Very hot to touch) and VACCINATION SITE PAIN (Lump and soreness on the vaccination site) had resolved.            No concomitant medications were reported.  Patient reported shower and eating as treatment. She reported all the events went away after 2.5 days.   This case was linked to MOD-2021-127480 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Added events and duration of events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Decreased activity, Erythema, Malaise, Product dose omission issue
Clinical narrative: Not feeling well; Strong bone pain; Missed the appointment for the second dose; could not drive; felt like a hardness in my arm; I massaged my arm, it was red; Where I got the vaccine like it crystalized; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (I massaged my arm, it was red), MALAISE (Not feeling well), BONE PAIN (Strong bone pain), PRODUCT DOSE OMISSION ISSUE (Missed the appointment for the second dose) and VACCINATION SITE CALCIFICATION (Where I got the vaccine like it crystalized) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for Pain in leg, ATORVASTATIN, IRBESARTAN and Aspirin.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Apr-2021, the patient experienced ERYTHEMA (I massaged my arm, it was red), VACCINATION SITE CALCIFICATION (Where I got the vaccine like it crystalized) and VACCINATION SITE INDURATION (felt like a hardness in my arm). On 30-Apr-2021, the patient experienced MALAISE (Not feeling well), BONE PAIN (Strong bone pain), PRODUCT DOSE OMISSION ISSUE (Missed the appointment for the second dose) and DECREASED ACTIVITY (could not drive). At the time of the report, ERYTHEMA (I massaged my arm, it was red), MALAISE (Not feeling well), BONE PAIN (Strong bone pain), PRODUCT DOSE OMISSION ISSUE (Missed the appointment for the second dose), VACCINATION SITE CALCIFICATION (Where I got the vaccine like it crystalized), DECREASED ACTIVITY (could not drive) and VACCINATION SITE INDURATION (felt like a hardness in my arm) 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.   Treatment medication includes acetaminophen (Tylenol)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site calcification, Vaccination site induration
Clinical narrative: Not feeling well; Strong bone pain; Missed the appointment for the second dose; could not drive; felt like a hardness in my arm; I massaged my arm, it was red; Where I got the vaccine like it crystalized; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (I massaged my arm, it was red), MALAISE (Not feeling well), BONE PAIN (Strong bone pain), PRODUCT DOSE OMISSION ISSUE (Missed the appointment for the second dose) and VACCINATION SITE CALCIFICATION (Where I got the vaccine like it crystalized) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for Pain in leg, ATORVASTATIN, IRBESARTAN and Aspirin.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Apr-2021, the patient experienced ERYTHEMA (I massaged my arm, it was red), VACCINATION SITE CALCIFICATION (Where I got the vaccine like it crystalized) and VACCINATION SITE INDURATION (felt like a hardness in my arm). On 30-Apr-2021, the patient experienced MALAISE (Not feeling well), BONE PAIN (Strong bone pain), PRODUCT DOSE OMISSION ISSUE (Missed the appointment for the second dose) and DECREASED ACTIVITY (could not drive). At the time of the report, ERYTHEMA (I massaged my arm, it was red), MALAISE (Not feeling well), BONE PAIN (Strong bone pain), PRODUCT DOSE OMISSION ISSUE (Missed the appointment for the second dose), VACCINATION SITE CALCIFICATION (Where I got the vaccine like it crystalized), DECREASED ACTIVITY (could not drive) and VACCINATION SITE INDURATION (felt like a hardness in my arm) 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.   Treatment medication includes acetaminophen (Tylenol)