chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: I don't have smell; stiff neck; little cough; cold like symptoms; sore throat; I don't have smell or taste; injection arm bothered little bit; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), COUGH (little cough), NASOPHARYNGITIS (cold like symptoms), OROPHARYNGEAL PAIN (sore throat) and AGEUSIA (I don't have smell or taste) in a 79-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 LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE, ALENDRONATE SODIUM (FOSAMAX), COLECALCIFEROL (VITAMIN D3) and CELECOXIB for an unknown indication.    On 11-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 MUSCULOSKELETAL STIFFNESS (stiff neck), COUGH (little cough), NASOPHARYNGITIS (cold like symptoms), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (I don't have smell or taste) and PAIN IN EXTREMITY (injection arm bothered little bit). On an unknown date, the patient experienced ANOSMIA (I don't have smell). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-May-2021, PAIN IN EXTREMITY (injection arm bothered little bit) outcome was unknown. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), COUGH (little cough), NASOPHARYNGITIS (cold like symptoms), OROPHARYNGEAL PAIN (sore throat), AGEUSIA (I don't have smell or taste) and ANOSMIA (I don't have smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The action taken with the drug was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Polymenorrhoea
Clinical narrative: Brought a really heavy period; Shortened their menstrual cycle; Had an earlier period; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), POLYMENORRHOEA (Shortened their menstrual cycle) and MENSTRUATION IRREGULAR (Had an earlier period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), POLYMENORRHOEA (Shortened their menstrual cycle) and MENSTRUATION IRREGULAR (Had an earlier period). At the time of the report, HEAVY MENSTRUAL BLEEDING (Brought a really heavy period), POLYMENORRHOEA (Shortened their menstrual cycle) and MENSTRUATION IRREGULAR (Had an earlier period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-148424, US-MODERNATX, INC.-MOD-2021-148762, US-MODERNATX, INC.-MOD-2021-149413, US-MODERNATX, INC.-MOD-2021-149360 (E2B Linked Report). This case was linked to MOD-2021-149251 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148424:Reporter as a patient-1st dose US-MODERNATX, INC.-MOD-2021-148762:Reporter as a patient-2nd dose US-MODERNATX, INC.-MOD-2021-149413:Cluster case-2nd dose US-MODERNATX, INC.-MOD-2021-149360:Cluster case-1st dose
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in her armpit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in her armpit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash in her armpit). At the time of the report, RASH (Rash in her armpit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-098177 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm soreness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain in hip (Hip soreness), Hypothyroidism (low thyroid) since 1995, Drug allergy (Statins), Allergy to antibiotic (Arythamyacin) and Grass allergy (Fresh cut grass). Concomitant products included LEVOTHYROXINE for Hypothyroidism.    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 VACCINATION SITE PAIN (Injection arm soreness). At the time of the report, VACCINATION SITE PAIN (Injection arm soreness) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was allergic to super glue.  Treatment information was not provided.   This case was linked to MOD-2021-250499 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information included patient's demographics, allergy details, concomitant medications and medical history.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Coinfection, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Coinfection; Diarrhea; Light-headed; Headache; Fatigue; Sickness; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), COINFECTION (Coinfection), DIARRHOEA (Diarrhea), DIZZINESS (Light-headed) and HEADACHE (Headache) in a 65-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.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (Myalgia). On 12-May-2021, the patient experienced ILLNESS (Sickness). On 15-May-2021, the patient experienced COINFECTION (Coinfection), DIARRHOEA (Diarrhea), DIZZINESS (Light-headed), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Sickness), COINFECTION (Coinfection), DIARRHOEA (Diarrhea), DIZZINESS (Light-headed), HEADACHE (Headache), MYALGIA (Myalgia) and FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitants were reported. No treatment was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-148260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148260:Same Reporter
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia
Clinical narrative: Coinfection; Diarrhea; Light-headed; Headache; Fatigue; Sickness; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), COINFECTION (Coinfection), DIARRHOEA (Diarrhea), DIZZINESS (Light-headed) and HEADACHE (Headache) in a 65-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.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (Myalgia). On 12-May-2021, the patient experienced ILLNESS (Sickness). On 15-May-2021, the patient experienced COINFECTION (Coinfection), DIARRHOEA (Diarrhea), DIZZINESS (Light-headed), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Sickness), COINFECTION (Coinfection), DIARRHOEA (Diarrhea), DIZZINESS (Light-headed), HEADACHE (Headache), MYALGIA (Myalgia) and FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitants were reported. No treatment was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-148260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148260:Same Reporter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Dyspnoea, Fatigue
Clinical narrative: tongue swelled up on left side , completely; nausea; trouble breathing/very winded when I climbed the stairs; heavy chest; felt like I had been punched in chest; arm swelling; chills; headache; felt exhausted; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing/very winded when I climbed the stairs), CHEST DISCOMFORT (heavy chest), CHEST PAIN (felt like I had been punched in chest), SWOLLEN TONGUE (tongue swelled up on left side , completely) and PERIPHERAL SWELLING (arm swelling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DYSPNOEA (trouble breathing/very winded when I climbed the stairs), CHEST DISCOMFORT (heavy chest), CHEST PAIN (felt like I had been punched in chest), PERIPHERAL SWELLING (arm swelling), CHILLS (chills), HEADACHE (headache) and FATIGUE (felt exhausted). On 25-Apr-2021, the patient experienced NAUSEA (nausea). On 26-Apr-2021, the patient experienced SWOLLEN TONGUE (tongue swelled up on left side , completely). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 25-Apr-2021, HEADACHE (headache) had resolved. On 26-Apr-2021, PERIPHERAL SWELLING (arm swelling) had resolved. On 28-Apr-2021, SWOLLEN TONGUE (tongue swelled up on left side , completely) and NAUSEA (nausea) had resolved. On 30-Apr-2021, DYSPNOEA (trouble breathing/very winded when I climbed the stairs), CHEST DISCOMFORT (heavy chest), CHEST PAIN (felt like I had been punched in chest), CHILLS (chills) and FATIGUE (felt exhausted) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non-Significant followup Email Received- nonsafety info.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Peripheral swelling, Swollen tongue
Clinical narrative: tongue swelled up on left side , completely; nausea; trouble breathing/very winded when I climbed the stairs; heavy chest; felt like I had been punched in chest; arm swelling; chills; headache; felt exhausted; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (trouble breathing/very winded when I climbed the stairs), CHEST DISCOMFORT (heavy chest), CHEST PAIN (felt like I had been punched in chest), SWOLLEN TONGUE (tongue swelled up on left side , completely) and PERIPHERAL SWELLING (arm swelling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DYSPNOEA (trouble breathing/very winded when I climbed the stairs), CHEST DISCOMFORT (heavy chest), CHEST PAIN (felt like I had been punched in chest), PERIPHERAL SWELLING (arm swelling), CHILLS (chills), HEADACHE (headache) and FATIGUE (felt exhausted). On 25-Apr-2021, the patient experienced NAUSEA (nausea). On 26-Apr-2021, the patient experienced SWOLLEN TONGUE (tongue swelled up on left side , completely). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 25-Apr-2021, HEADACHE (headache) had resolved. On 26-Apr-2021, PERIPHERAL SWELLING (arm swelling) had resolved. On 28-Apr-2021, SWOLLEN TONGUE (tongue swelled up on left side , completely) and NAUSEA (nausea) had resolved. On 30-Apr-2021, DYSPNOEA (trouble breathing/very winded when I climbed the stairs), CHEST DISCOMFORT (heavy chest), CHEST PAIN (felt like I had been punched in chest), CHILLS (chills) and FATIGUE (felt exhausted) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non-Significant followup Email Received- nonsafety info.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in their armpit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in their armpit) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash in their armpit). At the time of the report, RASH (Rash in their armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided. The reporter stated that the symptom was a bad reaction.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Follow up information was received. Patient gender added.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Peripheral coldness, Pyrexia, Vaccination site pain
Clinical narrative: cold feet and hands; shortness of breath; Pain at injection site; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (cold feet and hands), DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (fever) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 031B21A) for COVID-19 vaccination.     The patient's past medical history included Industrial accident (In an airplane factory) in 2008 and Neck surgery (Three neck surgery). Concurrent medical conditions included Asthma, Fibromyalgia, Shoulder arthritis, Allergy to chemicals (A severe allergic reaction to "MPK chemical that manager her lungs), Lung disease (Caused by industrial accident ), Heart rate abnormal and Numbness of head. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and SALBUTAMOL (VENTOLINE [SALBUTAMOL]) for Asthma, OXYCODONE for Pain.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-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 PERIPHERAL COLDNESS (cold feet and hands), DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (fever) and CHILLS (chills). At the time of the report, PERIPHERAL COLDNESS (cold feet and hands), DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Lab data included MRI was completed with findings normal. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-148240, US-MODERNATX, INC.-MOD-2021-148380 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148240: US-MODERNATX, INC.-MOD-2021-148380:
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Influenza like illness
Clinical narrative: knocked on her rear end; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (knocked on her rear end) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced ADVERSE EVENT (knocked on her rear end) and INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, ADVERSE EVENT (knocked on her rear end) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Myalgia, Swelling
Clinical narrative: Swelling; muscle pain; Chills; "strong reaction"; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT ("strong reaction"), MYALGIA (Myalgia), MYALGIA (muscle pain), CHILLS (Chills) and SWELLING (Swelling) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    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 EVENT ("strong reaction") and MYALGIA (Myalgia). On 17-May-2021, the patient experienced MYALGIA (muscle pain) and CHILLS (Chills). On 18-May-2021, the patient experienced SWELLING (Swelling). On 18-Apr-2021, ADVERSE EVENT ("strong reaction") and MYALGIA (Myalgia) had resolved. On 18-May-2021, MYALGIA (muscle pain) and SWELLING (Swelling) had resolved and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Circumoral swelling, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMORAL SWELLING (face swelling located around eyes and mouth), CHILLS (chills), MYALGIA (muscle pain), MYALGIA (body aches) and ADVERSE REACTION ("strong reaction") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE for an unknown indication. 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 ("strong reaction"). On 17-May-2021, the patient experienced CHILLS (chills), MYALGIA (muscle pain) and MYALGIA (body aches). On 18-May-2021, the patient experienced CIRCUMORAL SWELLING (face swelling located around eyes and mouth). On 18-Apr-2021, ADVERSE REACTION ("strong reaction") had resolved. On 18-May-2021, CIRCUMORAL SWELLING (face swelling located around eyes and mouth), CHILLS (chills), MYALGIA (muscle pain) and MYALGIA (body aches) had resolved. Treatment information not provided. Action taken with mRNA-1273 in response to the event/s was not applicable.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: Soreness of the arm; Rash; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness of the arm) and RASH (Rash) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 040B21A) for COVID-19 vaccination.     The patient's past medical history included Colon cancer (Presently clear.). Concomitant products included INSULIN (NOVOLIN 30R [INSULIN]), CLOPIDOGREL BISULFATE (PLAVIX), PIOGLITAZONE, LISINOPRIL, ATENOLOL, AMLODIPINE BESYLATE, POTASSIUM CHLORIDE, FUROSEMIDE and ALLOPURINOL for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-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 MYALGIA (Soreness of the arm) and RASH (Rash). At the time of the report, MYALGIA (Soreness of the arm) and RASH (Rash) outcome was unknown.            No treatment medication was provided.  Action taken with the drug in response to events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; 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 VACCINATION SITE PAIN (Soreness at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 10-May-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment provided include antihistamines.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Bed rest, Constipation, Fatigue, Feeding disorder
Clinical narrative: Horrible reaction to the 2nd dose; In bed for a few days after 2nd dose; Soaking wet with sweat after the 2nd dose; Constipated after the 2nd dose; Sore arm after 2nd dose; Had to be spoon fed after 2nd dose; Tired after 2nd dose; Headache after 2nd dose; Had a fever after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Horrible reaction to the 2nd dose), BED REST (In bed for a few days after 2nd dose), HYPERHIDROSIS (Soaking wet with sweat after the 2nd dose), CONSTIPATION (Constipated after the 2nd dose) and PAIN IN EXTREMITY (Sore arm after 2nd dose) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027c21a and 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dementia.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, 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 ADVERSE DRUG REACTION (Horrible reaction to the 2nd dose), BED REST (In bed for a few days after 2nd dose), HYPERHIDROSIS (Soaking wet with sweat after the 2nd dose), CONSTIPATION (Constipated after the 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), FEEDING DISORDER (Had to be spoon fed after 2nd dose), FATIGUE (Tired after 2nd dose), HEADACHE (Headache after 2nd dose) and PYREXIA (Had a fever after the 2nd dose). At the time of the report, ADVERSE DRUG REACTION (Horrible reaction to the 2nd dose), BED REST (In bed for a few days after 2nd dose), HYPERHIDROSIS (Soaking wet with sweat after the 2nd dose), CONSTIPATION (Constipated after the 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), FEEDING DISORDER (Had to be spoon fed after 2nd dose), FATIGUE (Tired after 2nd dose), HEADACHE (Headache after 2nd dose) and PYREXIA (Had a fever after the 2nd dose) outcome was unknown.            No concomitant medication were provided. Treatment information were not provided.  Action taken with mRNA-1273 was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-148194 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148194:Son case
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Horrible reaction to the 2nd dose; In bed for a few days after 2nd dose; Soaking wet with sweat after the 2nd dose; Constipated after the 2nd dose; Sore arm after 2nd dose; Had to be spoon fed after 2nd dose; Tired after 2nd dose; Headache after 2nd dose; Had a fever after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Horrible reaction to the 2nd dose), BED REST (In bed for a few days after 2nd dose), HYPERHIDROSIS (Soaking wet with sweat after the 2nd dose), CONSTIPATION (Constipated after the 2nd dose) and PAIN IN EXTREMITY (Sore arm after 2nd dose) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027c21a and 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dementia.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, 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 ADVERSE DRUG REACTION (Horrible reaction to the 2nd dose), BED REST (In bed for a few days after 2nd dose), HYPERHIDROSIS (Soaking wet with sweat after the 2nd dose), CONSTIPATION (Constipated after the 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), FEEDING DISORDER (Had to be spoon fed after 2nd dose), FATIGUE (Tired after 2nd dose), HEADACHE (Headache after 2nd dose) and PYREXIA (Had a fever after the 2nd dose). At the time of the report, ADVERSE DRUG REACTION (Horrible reaction to the 2nd dose), BED REST (In bed for a few days after 2nd dose), HYPERHIDROSIS (Soaking wet with sweat after the 2nd dose), CONSTIPATION (Constipated after the 2nd dose), PAIN IN EXTREMITY (Sore arm after 2nd dose), FEEDING DISORDER (Had to be spoon fed after 2nd dose), FATIGUE (Tired after 2nd dose), HEADACHE (Headache after 2nd dose) and PYREXIA (Had a fever after the 2nd dose) outcome was unknown.            No concomitant medication were provided. Treatment information were not provided.  Action taken with mRNA-1273 was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-148194 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148194:Son case
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: vial punctured for 24 hours; This spontaneous case was reported by a health care professional and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial punctured for 24 hours) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044c21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial punctured for 24 hours). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (vial punctured for 24 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral, Peripheral swelling
Clinical narrative: Unilateral swelling; Emergency Room visit due to lower leg swelling that started to get bigger and bigger; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL (Unilateral swelling) and PERIPHERAL SWELLING (Emergency Room visit due to lower leg swelling that started to get bigger and bigger) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02AL20A and 026AZ114) for COVID-19 vaccination.     No medical history provided by the reporter.  The patient's past medical history included Acid dyspepsia, Sleep disorder NOS and Mood elevated. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), TRAZODONE for Sleep deficit, SIMVASTATIN and TEMAZEPAM (RESTORIL [TEMAZEPAM]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced OEDEMA PERIPHERAL (Unilateral swelling) and PERIPHERAL SWELLING (Emergency Room visit due to lower leg swelling that started to get bigger and bigger). The patient was treated with RIVAROXABAN (XARELTO) for Clot blood, at a dose of 15 mg. At the time of the report, OEDEMA PERIPHERAL (Unilateral swelling) and PERIPHERAL SWELLING (Emergency Room visit due to lower leg swelling that started to get bigger and bigger) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered OEDEMA PERIPHERAL (Unilateral swelling) and PERIPHERAL SWELLING (Emergency Room visit due to lower leg swelling that started to get bigger and bigger) to be possibly related.    This is a report regarding adverse events for the first dose of the vaccine.  At the time of the report, the patient neither described additional/new adverse events for the second dose, not worsening of the events related to the first dose.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the evenst, a causal relationship cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Erythema, Rash, Urticaria
Clinical narrative: hives on the upper arm, stomach, back and upper thighs/  red welts; red welts; skin drying; little bumps; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on the upper arm, stomach, back and upper thighs/  red welts), ERYTHEMA (red welts), DRY SKIN (skin drying) and RASH (little bumps) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Colon cancer since an unknown date. Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN 30/70), PIOGLITAZONE, LISINOPRIL, ATENOLOL, AMLODIPINE BESYLATE, POTASSIUM CHLORIDE, FUROSEMIDE, ALLOPURINOL and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 06-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 URTICARIA (hives on the upper arm, stomach, back and upper thighs/  red welts), ERYTHEMA (red welts), DRY SKIN (skin drying) and RASH (little bumps). At the time of the report, URTICARIA (hives on the upper arm, stomach, back and upper thighs/  red welts), ERYTHEMA (red welts), DRY SKIN (skin drying) and RASH (little bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treatment information was not provided.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received his first dose back in January (he has not received a second dose yet) More than 36 days have passed since first dose received; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received his first dose back in January (he has not received a second dose yet) More than 36 days have passed since first dose received) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received his first dose back in January (he has not received a second dose yet) More than 36 days have passed since first dose received). In January 2021, PRODUCT DOSE OMISSION ISSUE (Patient received his first dose back in January (he has not received a second dose yet) More than 36 days have passed since first dose received) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication history not provided. Treatment information was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Mobility decreased, Pain, Vaccination site haematoma
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE HAEMATOMA (Developed huge hematoma about 5 to 6 inches from the injection the site. The shape of the hematoma was a big square 5 inches by 3 inches then it went to an anchor shape, then it went to the shape of a question mark), CHEST PAIN (Chest pain), MOBILITY DECREASED (Couldn't turn bend or sit down), PAIN (Was in excruciating pain) and FEELING ABNORMAL (Felt like she was in a barrel) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The patient's past medical history included Guillain Barre syndrome (Patient never got the flu shot because of that.) in 1989 and Surgery (Microvalve replacement.). Concurrent medical conditions included Hypothyroidism. Concomitant products included CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) and LEVOTHYROXINE 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 11-Apr-2021, the patient experienced CHEST PAIN (Chest pain), MOBILITY DECREASED (Couldn't turn bend or sit down), PAIN (Was in excruciating pain) and FEELING ABNORMAL (Felt like she was in a barrel). On an unknown date, the patient experienced VACCINATION SITE HAEMATOMA (Developed huge hematoma about 5 to 6 inches from the injection the site. The shape of the hematoma was a big square 5 inches by 3 inches then it went to an anchor shape, then it went to the shape of a question mark). On 30-Apr-2021, CHEST PAIN (Chest pain), MOBILITY DECREASED (Couldn't turn bend or sit down), PAIN (Was in excruciating pain) and FEELING ABNORMAL (Felt like she was in a barrel) had resolved. At the time of the report, VACCINATION SITE HAEMATOMA (Developed huge hematoma about 5 to 6 inches from the injection the site. The shape of the hematoma was a big square 5 inches by 3 inches then it went to an anchor shape, then it went to the shape of a question mark) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included Presserarev 2. Events except vaccination site hematoma got worse for about 4 days and started to get better. Reporter states patient might have got the vaccine intravenous instead of intramuscular which might be the reason for huge hematoma. The second dose on the 06-MAY-2021 but could not get it and was rescheduled till  19-MAY-2021.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Inflammation, Nausea
Clinical narrative: Numb arm; Inflamed arm; Painful arm; Having headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb arm), INFLAMMATION (Inflamed arm), VACCINATION SITE PAIN (Painful arm), HEADACHE (Having headache) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numb arm), INFLAMMATION (Inflamed arm), VACCINATION SITE PAIN (Painful arm), HEADACHE (Having headache), NAUSEA (Nausea) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (Numb arm), INFLAMMATION (Inflamed arm), VACCINATION SITE PAIN (Painful arm), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved and HEADACHE (Having headache) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU: Added reporter email address and Changed outcome of the events from unknown to recovered expect for the event headache
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Numb arm; Inflamed arm; Painful arm; Having headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numb arm), INFLAMMATION (Inflamed arm), VACCINATION SITE PAIN (Painful arm), HEADACHE (Having headache) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numb arm), INFLAMMATION (Inflamed arm), VACCINATION SITE PAIN (Painful arm), HEADACHE (Having headache), NAUSEA (Nausea) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (Numb arm), INFLAMMATION (Inflamed arm), VACCINATION SITE PAIN (Painful arm), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved and HEADACHE (Having headache) had not resolved.            Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant FU: Added reporter email address and Changed outcome of the events from unknown to recovered expect for the event headache
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Product dose omission issue
Clinical narrative: She had an anxiety attack and this is why she missed her dose; I missed my 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (She had an anxiety attack and this is why she missed her dose) and PRODUCT DOSE OMISSION ISSUE (I missed my 2nd dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (She had an anxiety attack and this is why she missed her dose) and PRODUCT DOSE OMISSION ISSUE (I missed my 2nd dose). At the time of the report, ANXIETY (She had an anxiety attack and this is why she missed her dose) and PRODUCT DOSE OMISSION ISSUE (I missed my 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received on 1-July-2021.TCR added, contain No New Information
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered the first shot of Moderna Covid 19 Vaccine more than the recommended dose (1.65 ml) to a patient; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (administered the first shot of Moderna Covid 19 Vaccine more than the recommended dose (1.65 ml) to a patient) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1.65 ml. On 19-May-2021, the patient experienced ACCIDENTAL OVERDOSE (administered the first shot of Moderna Covid 19 Vaccine more than the recommended dose (1.65 ml) to a patient). On 19-May-2021, ACCIDENTAL OVERDOSE (administered the first shot of Moderna Covid 19 Vaccine more than the recommended dose (1.65 ml) to a patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug included unspecified  allergy medications.Treatment for the event was not reported. Reporter stated that patient was administered 1.65 mL of vaccine that was 4 (2+2) doses on alternative arms.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Added first dose start date,medical history and concomitant medication.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Impaired work ability, Malaise, Pain in extremity
Clinical narrative: not feeling well at all; body is killing me, like i got hit by a truck; bones are hurting; unable to work; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well at all), PAIN IN EXTREMITY (body is killing me, like i got hit by a truck), BONE PAIN (bones are hurting), IMPAIRED WORK ABILITY (unable to work) and FATIGUE (fatigued) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced MALAISE (not feeling well at all), PAIN IN EXTREMITY (body is killing me, like i got hit by a truck), BONE PAIN (bones are hurting), IMPAIRED WORK ABILITY (unable to work) and FATIGUE (fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well at all), PAIN IN EXTREMITY (body is killing me, like i got hit by a truck), BONE PAIN (bones are hurting), IMPAIRED WORK ABILITY (unable to work) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Vaccination site erythema, Vaccination site inflammation
Clinical narrative: her left arm was inflamed; cough; her left arm was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (her left arm was inflamed), COUGH (cough) and VACCINATION SITE ERYTHEMA (her left arm was red) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical history information was given by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and TIZANIDINE HYDROCHLORIDE (TIZAFLEX) for an unknown indication.    On 13-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 VACCINATION SITE INFLAMMATION (her left arm was inflamed), COUGH (cough) and VACCINATION SITE ERYTHEMA (her left arm was red). At the time of the report, VACCINATION SITE INFLAMMATION (her left arm was inflamed), COUGH (cough) and VACCINATION SITE ERYTHEMA (her left arm was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat tightness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and High cholesterol. Concomitant products included METFORMIN and GLIBENCLAMIDE (GLYBURIDE) for Diabetes, ATORVASTATIN for High cholesterol. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced THROAT TIGHTNESS (Throat tightness). At the time of the report, THROAT TIGHTNESS (Throat tightness) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Treatment medicines were not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-149672 (E2B Linked Report). This case was linked to MOD-2021-149408 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-149672:Crosslink case for family member.