chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Numbness; Redness/ red arm; inflamed (swollen) arm; Pain in her arm; Fever; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPOAESTHESIA (Numbness), ERYTHEMA (Redness/ red arm), SWELLING (inflamed (swollen) arm) and VACCINATION SITE PAIN (Pain in her arm) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-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 DIZZINESS (Dizziness), VACCINATION SITE PAIN (Pain in her arm) and PYREXIA (Fever). On 03-May-2021, the patient experienced HYPOAESTHESIA (Numbness), ERYTHEMA (Redness/ red arm) and SWELLING (inflamed (swollen) arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), HYPOAESTHESIA (Numbness), ERYTHEMA (Redness/ red arm), SWELLING (inflamed (swollen) arm), VACCINATION SITE PAIN (Pain in her arm) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included birth control patch Paracetamol had helped with fever but not for the pain.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: she had "just a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she had "just a sore arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-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 MYALGIA (she had "just a sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (she had "just a sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use included "Noutral .5".
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: The vaccine leaked during administration/She is unsure how much the patient received; She had a defective needle; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The vaccine leaked during administration/She is unsure how much the patient received) and DEVICE CONNECTION ISSUE (She had a defective needle) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-May-2021, the patient experienced UNDERDOSE (The vaccine leaked during administration/She is unsure how much the patient received) and DEVICE CONNECTION ISSUE (She had a defective needle). On 03-May-2021, UNDERDOSE (The vaccine leaked during administration/She is unsure how much the patient received) and DEVICE CONNECTION ISSUE (She had a defective needle) 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 relevant concomitant medications were reported. No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: 108 days passed since first dose given; Covid Infection; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid Infection) and PRODUCT DOSE OMISSION ISSUE (108 days passed since first dose given) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced COVID-19 (Covid Infection). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (108 days passed since first dose given). At the time of the report, COVID-19 (Covid Infection) and PRODUCT DOSE OMISSION ISSUE (108 days passed since first dose given) 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.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Feeling hot, Pain in extremity, Somnolence
Clinical narrative: feels real cold; feels lousy; her head feels hot; been sleeping pretty much all day; Soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on arm), FEELING COLD (feels real cold), FEELING ABNORMAL (feels lousy), FEELING HOT (her head feels hot) and SOMNOLENCE (been sleeping pretty much all day) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SB21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness on arm). On 01-May-2021, the patient experienced FEELING COLD (feels real cold), FEELING ABNORMAL (feels lousy), FEELING HOT (her head feels hot) and SOMNOLENCE (been sleeping pretty much all day). At the time of the report, PAIN IN EXTREMITY (Soreness on arm), FEELING COLD (feels real cold), FEELING ABNORMAL (feels lousy), FEELING HOT (her head feels hot) and SOMNOLENCE (been sleeping pretty much all day) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-101577 (Patient Link).   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm  felt dead; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  felt dead) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included H.pylori gastrointestinal disease, Fracture (Patient fractured her neck vertebrae in her 20's.), Carpal tunnel syndrome (carpal tunnel in both hands), Trigger finger (Trigger finger in her left thumb) and Foggy feeling in head. Previously administered products included for Product used for unknown indication: flu. Past adverse reactions to the above products included Adverse event with flu. Concurrent medical conditions included Chronic obstructive pulmonary disease, Diabetes, Fibromyalgia, Irritable bowel syndrome and Osteoarthritis. Concomitant products included OXYBUTYNIN, ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, TRAZODONE, OMEPRAZOLE, GABAPENTIN, METFORMIN, IBUPROFEN and DULOXETINE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm  felt dead). On 02-Apr-2021, PAIN IN EXTREMITY (Arm  felt dead) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to Trigger finger (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Dyspnoea, Gait disturbance
Clinical narrative: broken out in hives; having a pretty bad allergic reaction; hands and feet swollen; chills; muscle spasms; hard to breathe; front of my chest was sore; dizziness; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms), DYSPNEA (hard to breathe), CHEST PAIN (front of my chest was sore), DIZZINESS (dizziness) and GAIT DISTURBANCE (could not walk) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 038A21A,) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DOMPERIDONE, RANITIDINE HYDROCHLORIDE (NEUTRAL [DOMPERIDONE;RANITIDINE HYDROCHLORIDE]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 30-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasms), DYSPNEA (hard to breathe), CHEST PAIN (front of my chest was sore), DIZZINESS (dizziness), GAIT DISTURBANCE (could not walk) and CHILLS (chills). On 01-May-2021, the patient experienced URTICARIA (broken out in hives), HYPERSENSITIVITY (having a pretty bad allergic reaction) and PERIPHERAL SWELLING (hands and feet swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, MUSCLE SPASMS (muscle spasms), DYSPNEA (hard to breathe), CHEST PAIN (front of my chest was sore), DIZZINESS (dizziness), GAIT DISTURBANCE (could not walk), URTICARIA (broken out in hives), HYPERSENSITIVITY (having a pretty bad allergic reaction), PERIPHERAL SWELLING (hands and feet swollen) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-101581 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Muscle spasms, Peripheral swelling, Urticaria
Clinical narrative: broken out in hives; having a pretty bad allergic reaction; hands and feet swollen; chills; muscle spasms; hard to breathe; front of my chest was sore; dizziness; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle spasms), DYSPNEA (hard to breathe), CHEST PAIN (front of my chest was sore), DIZZINESS (dizziness) and GAIT DISTURBANCE (could not walk) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 038A21A,) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DOMPERIDONE, RANITIDINE HYDROCHLORIDE (NEUTRAL [DOMPERIDONE;RANITIDINE HYDROCHLORIDE]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 30-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasms), DYSPNEA (hard to breathe), CHEST PAIN (front of my chest was sore), DIZZINESS (dizziness), GAIT DISTURBANCE (could not walk) and CHILLS (chills). On 01-May-2021, the patient experienced URTICARIA (broken out in hives), HYPERSENSITIVITY (having a pretty bad allergic reaction) and PERIPHERAL SWELLING (hands and feet swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, MUSCLE SPASMS (muscle spasms), DYSPNEA (hard to breathe), CHEST PAIN (front of my chest was sore), DIZZINESS (dizziness), GAIT DISTURBANCE (could not walk), URTICARIA (broken out in hives), HYPERSENSITIVITY (having a pretty bad allergic reaction), PERIPHERAL SWELLING (hands and feet swollen) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-101581 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Myalgia, Vaccination site pain
Clinical narrative: bleeding from nose; dizziness; myalgia; pain at the site of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (bleeding from nose), DIZZINESS (dizziness), MYALGIA (myalgia) and VACCINATION SITE PAIN (pain at the site of vaccination) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (bleeding from nose), DIZZINESS (dizziness), MYALGIA (myalgia) and VACCINATION SITE PAIN (pain at the site of vaccination). At the time of the report, EPISTAXIS (bleeding from nose) had not resolved and DIZZINESS (dizziness), MYALGIA (myalgia) and VACCINATION SITE PAIN (pain at the site of vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: off label use; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (off label use) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (off label use). At the time of the report, OFF LABEL USE (off label use) had resolved. 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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: knife come up under her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (knife come up under her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO RELEVANT HISTORY PROVIDED.).    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 PAIN IN EXTREMITY (knife come up under her arm). At the time of the report, PAIN IN EXTREMITY (knife come up under her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration
Clinical narrative: When she would breathe a really sharp pain; Painful respiration; This spontaneous case was reported by a consumer and describes the occurrence of PAINFUL RESPIRATION (When she would breathe a really sharp pain) and PAINFUL RESPIRATION (Painful respiration) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Depression and Allergy (Contrast dye ). Concomitant products included FLUOXETINE for an unknown indication.   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, 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 experienced PAINFUL RESPIRATION (When she would breathe a really sharp pain) and PAINFUL RESPIRATION (Painful respiration). At the time of the report, PAINFUL RESPIRATION (When she would breathe a really sharp pain) had resolved and PAINFUL RESPIRATION (Painful respiration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include Birth control pills.  3May2021, the pain has come back again.  No treatment drugs were reported.   This case was linked to MOD-2021-216259 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Updated concomitant medication.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: sore arm; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ASTHENIA (felt weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus systemic and Drug allergy. Concomitant products included HYDROCHLOROTHIAZIDE, OMEPRAZOLE, HYDROXYCHLOROQUINE (HYDROXYCHLOROQUIN) and AZATHIOPRINE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and ASTHENIA (felt weak). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and ASTHENIA (felt weak) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-101606 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Muscular weakness, Myalgia
Clinical narrative: headache; joint pain; weakness in both hands to the extent I could not pick up a coffee cup; chills; fever; pain at injection site; Entire body aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in both hands to the extent I could not pick up a coffee cup), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Metabolic acidosis. Concurrent medical conditions included Type 2 diabetes mellitus since 01-Mar-2005 and Blood pressure. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid-base balance, LISINOPRIL (LISINOPRIL AL) for Blood pressure, METFORMIN from 06-Mar-2005 to an unknown date and EMPAGLIFLOZIN (JARDIANCE) for Diabetes.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (pain at injection site) and MYALGIA (Entire body aches). On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness in both hands to the extent I could not pick up a coffee cup), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, MUSCULAR WEAKNESS (weakness in both hands to the extent I could not pick up a coffee cup), CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown and PYREXIA (fever) and MYALGIA (Entire body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2020, SARS-CoV-2 test: positive (Positive) Nasal Test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-101598 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up Received on 04-JUN-2021,Received Significant Information. Added Patient Demographics, Medical History, Lab data, Suspect Drug Information, Concomitant Product Information.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: headache; joint pain; weakness in both hands to the extent I could not pick up a coffee cup; chills; fever; pain at injection site; Entire body aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in both hands to the extent I could not pick up a coffee cup), CHILLS (chills), PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Metabolic acidosis. Concurrent medical conditions included Type 2 diabetes mellitus since 01-Mar-2005 and Blood pressure. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Acid-base balance, LISINOPRIL (LISINOPRIL AL) for Blood pressure, METFORMIN from 06-Mar-2005 to an unknown date and EMPAGLIFLOZIN (JARDIANCE) for Diabetes.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (fever), VACCINATION SITE PAIN (pain at injection site) and MYALGIA (Entire body aches). On an unknown date, the patient experienced MUSCULAR WEAKNESS (weakness in both hands to the extent I could not pick up a coffee cup), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (joint pain). At the time of the report, MUSCULAR WEAKNESS (weakness in both hands to the extent I could not pick up a coffee cup), CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown and PYREXIA (fever) and MYALGIA (Entire body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2020, SARS-CoV-2 test: positive (Positive) Nasal Test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-101598 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up Received on 04-JUN-2021,Received Significant Information. Added Patient Demographics, Medical History, Lab data, Suspect Drug Information, Concomitant Product Information.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (she will have double mastectomy.).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced RASH (rash on the arm). At the time of the report, RASH (rash on the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Dysgeusia, Hypoaesthesia oral, Salivary hypersecretion
Clinical narrative: bitter metallic taste; lost appetite; numb on tongue; felt more thirsty; loss of taste; there is saliva though; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bitter metallic taste), DECREASED APPETITE (lost appetite), HYPOAESTHESIA ORAL (numb on tongue), THIRST (felt more thirsty) and AGEUSIA (loss of taste) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), MULTIVITAMIN [VITAMINS NOS] and EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) 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 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced DYSGEUSIA (bitter metallic taste), DECREASED APPETITE (lost appetite), HYPOAESTHESIA ORAL (numb on tongue), THIRST (felt more thirsty), AGEUSIA (loss of taste) and SALIVARY HYPERSECRETION (there is saliva though). At the time of the report, DYSGEUSIA (bitter metallic taste), DECREASED APPETITE (lost appetite), HYPOAESTHESIA ORAL (numb on tongue), THIRST (felt more thirsty), AGEUSIA (loss of taste) and SALIVARY HYPERSECRETION (there is saliva though) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported by reporter.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: bitter metallic taste; lost appetite; numb on tongue; felt more thirsty; loss of taste; there is saliva though; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bitter metallic taste), DECREASED APPETITE (lost appetite), HYPOAESTHESIA ORAL (numb on tongue), THIRST (felt more thirsty) and AGEUSIA (loss of taste) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), MULTIVITAMIN [VITAMINS NOS] and EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) 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 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced DYSGEUSIA (bitter metallic taste), DECREASED APPETITE (lost appetite), HYPOAESTHESIA ORAL (numb on tongue), THIRST (felt more thirsty), AGEUSIA (loss of taste) and SALIVARY HYPERSECRETION (there is saliva though). At the time of the report, DYSGEUSIA (bitter metallic taste), DECREASED APPETITE (lost appetite), HYPOAESTHESIA ORAL (numb on tongue), THIRST (felt more thirsty), AGEUSIA (loss of taste) and SALIVARY HYPERSECRETION (there is saliva though) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported by reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site pain
Clinical narrative: joint pain; muscle pain; injection arm soreness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (injection arm soreness), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, WARFARIN and LISINOPRIL for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (injection arm soreness). On 22-Apr-2021, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 18-Apr-2021, VACCINATION SITE PAIN (injection arm soreness) had not resolved. At the time of the report, ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Gastritis, Myalgia, Pruritus, Pyrexia
Clinical narrative: her Hashimoto's disease had gone; allergic reactions like hives; allergic reactions like itching; Sometimes she also experience rapid heartbeat; Her gastritis is getting worst; muscle pain; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of CONDITION AGGRAVATED (her Hashimoto's disease had gone), URTICARIA (allergic reactions like hives), PRURITUS (allergic reactions like itching), TACHYCARDIA (Sometimes she also experience rapid heartbeat) and GASTRITIS (Her gastritis is getting worst) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's disease.    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 CONDITION AGGRAVATED (her Hashimoto's disease had gone), URTICARIA (allergic reactions like hives), PRURITUS (allergic reactions like itching), TACHYCARDIA (Sometimes she also experience rapid heartbeat), GASTRITIS (Her gastritis is getting worst), MYALGIA (muscle pain) and PYREXIA (Fever). At the time of the report, CONDITION AGGRAVATED (her Hashimoto's disease had gone), URTICARIA (allergic reactions like hives), PRURITUS (allergic reactions like itching), TACHYCARDIA (Sometimes she also experience rapid heartbeat), GASTRITIS (Her gastritis is getting worst), MYALGIA (muscle pain) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Urticaria
Clinical narrative: her Hashimoto's disease had gone; allergic reactions like hives; allergic reactions like itching; Sometimes she also experience rapid heartbeat; Her gastritis is getting worst; muscle pain; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of CONDITION AGGRAVATED (her Hashimoto's disease had gone), URTICARIA (allergic reactions like hives), PRURITUS (allergic reactions like itching), TACHYCARDIA (Sometimes she also experience rapid heartbeat) and GASTRITIS (Her gastritis is getting worst) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hashimoto's disease.    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 CONDITION AGGRAVATED (her Hashimoto's disease had gone), URTICARIA (allergic reactions like hives), PRURITUS (allergic reactions like itching), TACHYCARDIA (Sometimes she also experience rapid heartbeat), GASTRITIS (Her gastritis is getting worst), MYALGIA (muscle pain) and PYREXIA (Fever). At the time of the report, CONDITION AGGRAVATED (her Hashimoto's disease had gone), URTICARIA (allergic reactions like hives), PRURITUS (allergic reactions like itching), TACHYCARDIA (Sometimes she also experience rapid heartbeat), GASTRITIS (Her gastritis is getting worst), MYALGIA (muscle pain) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: itchiness; allergy issues; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and HYPERSENSITIVITY (allergy issues) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Brain tumor and Depression. Concomitant products included TAMSULOSINE [TAMSULOSIN], ATORVASTATIN, SERTRALINE, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), VITAMIN D3 and PARACETAMOL (TYLENOL) 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 PRURITUS (itchiness) and HYPERSENSITIVITY (allergy issues). At the time of the report, PRURITUS (itchiness) and HYPERSENSITIVITY (allergy issues) outcome was unknown. 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.   Other concomitant medications also included riveltectim (sic). No treatment information was provided.   This case was linked to MOD-2021-101600 (Patient Link).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Migraine, Pruritus
Clinical narrative: migraine; significant itchiness; bumpiness on skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (significant itchiness), MASS (bumpiness on skin) and MIGRAINE (migraine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Brain tumor and Depression. Concomitant products included TAMSULOSINE [TAMSULOSIN], ATORVASTATIN, SERTRALINE, FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), VITAMIN D3 and PARACETAMOL (TYLENOL) 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 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 27-Apr-2021, the patient experienced PRURITUS (significant itchiness) and MASS (bumpiness on skin). On an unknown date, the patient experienced MIGRAINE (migraine). At the time of the report, PRURITUS (significant itchiness), MASS (bumpiness on skin) and MIGRAINE (migraine) had not resolved. Unknown          Concomitant medications also included riveltectim (sic). Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-101599 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: NNI
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching at the back of head, arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching at the back of head, arms and legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PRURITUS (Itching at the back of head, arms and legs). At the time of the report, PRURITUS (Itching at the back of head, arms and legs) outcome was unknown. Not Provided          Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Product dose omission issue
Clinical narrative: coughing; did not get second dose yet (more than 36 days have passed since first dose); Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PRODUCT DOSE OMISSION ISSUE (did not get second dose yet (more than 36 days have passed since first dose)) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-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 INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced COUGH (coughing) and PRODUCT DOSE OMISSION ISSUE (did not get second dose yet (more than 36 days have passed since first dose)). At the time of the report, COUGH (coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PRODUCT DOSE OMISSION ISSUE (did not get second dose yet (more than 36 days have passed since first dose)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose outside of allowed time window; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside of allowed time window) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 03-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside of allowed time window). On 03-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside of allowed time window) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles outbreak) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles outbreak). At the time of the report, HERPES ZOSTER (Shingles outbreak) had not resolved.            No relevant concomitant medications were provided. Patient was on 3 months worth of antiviral treatment. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-014652 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose fluctuation
Clinical narrative: blood sugar is out of control/like a roller coaster/blood sugar fluctuates from 50-300mg/dL/has chosen not to get the second dose because of blood sugar issues; This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE FLUCTUATION (blood sugar is out of control/like a roller coaster/blood sugar fluctuates from 50-300mg/dL/has chosen not to get the second dose because of blood sugar issues) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER) for Diabetes, LISINOPRIL, AMLODIPINE, INSULIN DEGLUDEC (TRESIBA), VITAMIN D [VITAMIN D NOS], ZINC, VITAMIN C [ASCORBIC ACID], FISH OIL and VITAMINS NOS (MULTIPLE VITAMIN) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced BLOOD GLUCOSE FLUCTUATION (blood sugar is out of control/like a roller coaster/blood sugar fluctuates from 50-300mg/dL/has chosen not to get the second dose because of blood sugar issues). At the time of the report, BLOOD GLUCOSE FLUCTUATION (blood sugar is out of control/like a roller coaster/blood sugar fluctuates from 50-300mg/dL/has chosen not to get the second dose because of blood sugar issues) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: TCR added
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Migraine, Myalgia, Pyrexia, Vision blurred
Clinical narrative: trouble with vision; body aches; joint pain; fever; Lingering migrane headache which she describes as full spectrum headache in the frontal lobe; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Lingering migrane headache which she describes as full spectrum headache in the frontal lobe), VISION BLURRED (trouble with vision), PYREXIA (fever), MYALGIA (body aches) and ARTHRALGIA (joint pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047821A and 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for Sleeplessness.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MIGRAINE (Lingering migrane headache which she describes as full spectrum headache in the frontal lobe). On 28-Apr-2021, the patient experienced PYREXIA (fever). On 29-Apr-2021, the patient experienced VISION BLURRED (trouble with vision), MYALGIA (body aches) and ARTHRALGIA (joint pain). On 29-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, MIGRAINE (Lingering migrane headache which she describes as full spectrum headache in the frontal lobe), VISION BLURRED (trouble with vision), MYALGIA (body aches) and ARTHRALGIA (joint pain) outcome was unknown.            Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-100435 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fear, Feeling abnormal, Heart rate, Illness, Palpitations
Clinical narrative: Heart palpitations; Scared; Sick as a dog; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), FEELING ABNORMAL (Feeling bad), ILLNESS (Sick as a dog) and FEAR (Scared) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-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 29-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad). On 30-Apr-2021, the patient experienced ILLNESS (Sick as a dog). On 01-May-2021, the patient experienced PALPITATIONS (Heart palpitations) and FEAR (Scared). At the time of the report, PALPITATIONS (Heart palpitations), FEELING ABNORMAL (Feeling bad), ILLNESS (Sick as a dog) and FEAR (Scared) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: irregular (abnormal) Irregular.         No relevant concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-101771 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101771:Son's wife Case
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pruritus, Vaccination site discolouration, Vaccination site swelling
Clinical narrative: Had some discomfort after the first dose; Had an itchy scalp and forehead; It started to look like a black and blue mark.; she has a small about 1/8 inch circle at the top of her injection arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Had some discomfort after the first dose), PRURITUS (Had an itchy scalp and forehead), VACCINATION SITE DISCOLOURATION (It started to look like a black and blue mark.) and VACCINATION SITE SWELLING (she has a small about 1/8 inch circle at the top of her injection arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DISCOMFORT (Had some discomfort after the first dose), PRURITUS (Had an itchy scalp and forehead), VACCINATION SITE DISCOLOURATION (It started to look like a black and blue mark.) and VACCINATION SITE SWELLING (she has a small about 1/8 inch circle at the top of her injection arm). At the time of the report, DISCOMFORT (Had some discomfort after the first dose), PRURITUS (Had an itchy scalp and forehead), VACCINATION SITE DISCOLOURATION (It started to look like a black and blue mark.) and VACCINATION SITE SWELLING (she has a small about 1/8 inch circle at the top of her injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-101554 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101554: