chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vaccination site pain
Clinical narrative: Anomia; Elevated heart rate/felt like it got to over 100; Tachycardia; Paroxysmal atrial tachycardia (PAT); Uncomfortable feeling on the nervous system, like it's overactivated; Adrenaline feeling/hormonal or neuorchemical feeling; Brain fog; Tingling in the mouth; Feel so tired, and is having a hard time sleeping; Feel so tired, and is having a hard time sleeping; Arm sore; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of APHASIA (Anomia), HEART RATE INCREASED (Elevated heart rate/felt like it got to over 100), TACHYCARDIA (Tachycardia), ATRIAL TACHYCARDIA (Paroxysmal atrial tachycardia (PAT)) and NERVOUS SYSTEM DISORDER (Uncomfortable feeling on the nervous system, like it's overactivated) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced APHASIA (Anomia), HEART RATE INCREASED (Elevated heart rate/felt like it got to over 100), TACHYCARDIA (Tachycardia), ATRIAL TACHYCARDIA (Paroxysmal atrial tachycardia (PAT)), NERVOUS SYSTEM DISORDER (Uncomfortable feeling on the nervous system, like it's overactivated), FEELING ABNORMAL (Adrenaline feeling/hormonal or neuorchemical feeling), FEELING ABNORMAL (Brain fog), PARAESTHESIA ORAL (Tingling in the mouth), INSOMNIA (Feel so tired, and is having a hard time sleeping), FATIGUE (Feel so tired, and is having a hard time sleeping) and VACCINATION SITE PAIN (Arm sore). At the time of the report, APHASIA (Anomia), HEART RATE INCREASED (Elevated heart rate/felt like it got to over 100), TACHYCARDIA (Tachycardia), ATRIAL TACHYCARDIA (Paroxysmal atrial tachycardia (PAT)), NERVOUS SYSTEM DISORDER (Uncomfortable feeling on the nervous system, like it's overactivated), FEELING ABNORMAL (Adrenaline feeling/hormonal or neuorchemical feeling), FEELING ABNORMAL (Brain fog), PARAESTHESIA ORAL (Tingling in the mouth), INSOMNIA (Feel so tired, and is having a hard time sleeping), FATIGUE (Feel so tired, and is having a hard time sleeping) and VACCINATION SITE PAIN (Arm sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Heart rate: 125 (High) heart rate was 125 bpm. On 27-Feb-2021, Antinuclear antibody: positive (High) Positive ANA so high, highest possible..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes Cold showers, Compression stocking, Fluid intake.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration joint, Joint swelling
Clinical narrative: Right elbow swelling; about 25cc of fluid was withdrawn form the swelling; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right elbow swelling) and ASPIRATION JOINT (about 25cc of fluid was withdrawn form the swelling) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Right elbow swelling) and ASPIRATION JOINT (about 25cc of fluid was withdrawn form the swelling). At the time of the report, JOINT SWELLING (Right elbow swelling) and ASPIRATION JOINT (about 25cc of fluid was withdrawn form the swelling) outcome was unknown.            patient has visited his MD 5 times. No concomitant information was provided No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: mild fever 100.3 now 100; chills; body aches; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever 100.3 now 100), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (joint pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL from 18-Mar-2021 to an unknown date for an unknown indication.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PYREXIA (mild fever 100.3 now 100), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (joint pain). At the time of the report, PYREXIA (mild fever 100.3 now 100), CHILLS (chills), MYALGIA (body aches) and ARTHRALGIA (joint pain) outcome was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: no taste; lost of appetite; congestion; Headaches; Chills; achy body; throwing up; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no taste), DECREASED APPETITE (lost of appetite), NASAL CONGESTION (congestion), HEADACHE (Headaches) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 02-Jan-2021. Concomitant products included ASCORBIC ACID (VIT C) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    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 AGEUSIA (no taste), DECREASED APPETITE (lost of appetite), NASAL CONGESTION (congestion), HEADACHE (Headaches), CHILLS (Chills), MYALGIA (achy body), VOMITING (throwing up) and FATIGUE (exhausted). The patient was treated with ZINC at a dose of 50 milligram, for 5 days and MELATONIN for Booster, at a dose of for 5 days. At the time of the report, AGEUSIA (no taste), DECREASED APPETITE (lost of appetite), NASAL CONGESTION (congestion), HEADACHE (Headaches), CHILLS (Chills), MYALGIA (achy body), VOMITING (throwing up) and FATIGUE (exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: No new information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, SARS-CoV-2 test, Vomiting
Clinical narrative: no taste; lost of appetite; congestion; Headaches; Chills; achy body; throwing up; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (no taste), DECREASED APPETITE (lost of appetite), NASAL CONGESTION (congestion), HEADACHE (Headaches) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 02-Jan-2021. Concomitant products included ASCORBIC ACID (VIT C) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    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 AGEUSIA (no taste), DECREASED APPETITE (lost of appetite), NASAL CONGESTION (congestion), HEADACHE (Headaches), CHILLS (Chills), MYALGIA (achy body), VOMITING (throwing up) and FATIGUE (exhausted). The patient was treated with ZINC at a dose of 50 milligram, for 5 days and MELATONIN for Booster, at a dose of for 5 days. At the time of the report, AGEUSIA (no taste), DECREASED APPETITE (lost of appetite), NASAL CONGESTION (congestion), HEADACHE (Headaches), CHILLS (Chills), MYALGIA (achy body), VOMITING (throwing up) and FATIGUE (exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: No new information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Arm cannot lift; pain is spreading to her arm; pain is spreading in the lower part of her neck; pain is spreading at the back of her shoulder; sharp and stabbing pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm cannot lift), PAIN (pain is spreading to her arm), NECK PAIN (pain is spreading in the lower part of her neck), ARTHRALGIA (pain is spreading at the back of her shoulder) and VACCINATION SITE PAIN (sharp and stabbing pain in the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and COPD. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (sharp and stabbing pain in the injection site). On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm cannot lift), PAIN (pain is spreading to her arm), NECK PAIN (pain is spreading in the lower part of her neck) and ARTHRALGIA (pain is spreading at the back of her shoulder). At the time of the report, PAIN IN EXTREMITY (Arm cannot lift), PAIN (pain is spreading to her arm), NECK PAIN (pain is spreading in the lower part of her neck), ARTHRALGIA (pain is spreading at the back of her shoulder) and VACCINATION SITE PAIN (sharp and stabbing pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Disorientation, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: Disorientation that lasted 5 min; Feels out of synch with himself; Very tired; Achy; Sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping a lot), DISORIENTATION (Disorientation that lasted 5 min), FEELING ABNORMAL (Feels out of synch with himself), FATIGUE (Very tired) and PAIN (Achy) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (to yellowjackets). Concurrent medical conditions included Thyroid disorder NOS.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HYPERSOMNIA (Sleeping a lot), FEELING ABNORMAL (Feels out of synch with himself), FATIGUE (Very tired) and PAIN (Achy). On 14-Mar-2021, the patient experienced DISORIENTATION (Disorientation that lasted 5 min). On 14-Mar-2021, DISORIENTATION (Disorientation that lasted 5 min) had resolved. At the time of the report, HYPERSOMNIA (Sleeping a lot), FEELING ABNORMAL (Feels out of synch with himself), FATIGUE (Very tired) and PAIN (Achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) normal. In March 2021, Electrocardiogram: normal (normal) normal.         No concomitant medication was reported.  No treatment medication was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Pain
Clinical narrative: Disorientation that lasted 5 min; Feels out of synch with himself; Very tired; Achy; Sleeping a lot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping a lot), DISORIENTATION (Disorientation that lasted 5 min), FEELING ABNORMAL (Feels out of synch with himself), FATIGUE (Very tired) and PAIN (Achy) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic reaction (to yellowjackets). Concurrent medical conditions included Thyroid disorder NOS.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HYPERSOMNIA (Sleeping a lot), FEELING ABNORMAL (Feels out of synch with himself), FATIGUE (Very tired) and PAIN (Achy). On 14-Mar-2021, the patient experienced DISORIENTATION (Disorientation that lasted 5 min). On 14-Mar-2021, DISORIENTATION (Disorientation that lasted 5 min) had resolved. At the time of the report, HYPERSOMNIA (Sleeping a lot), FEELING ABNORMAL (Feels out of synch with himself), FATIGUE (Very tired) and PAIN (Achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) normal. In March 2021, Electrocardiogram: normal (normal) normal.         No concomitant medication was reported.  No treatment medication was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling hot
Clinical narrative: burning sensation inside her chest; warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (burning sensation inside her chest) and FEELING HOT (warm to touch) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041A21A or 047FR1A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE, VALPROATE SEMISODIUM (DIVALPROEX), AMLODIPINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced CHEST PAIN (burning sensation inside her chest) and FEELING HOT (warm to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (burning sensation inside her chest) and FEELING HOT (warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: No doses were administered/ never actually gave the patient the shot.; give to a patient 25 days after first; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Mar-2021. The most recent information was received on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (give to a patient 25 days after first) and PRODUCT DOSE OMISSION ISSUE (No doses were administered/ never actually gave the patient the shot.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (give to a patient 25 days after first). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (No doses were administered/ never actually gave the patient the shot.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (give to a patient 25 days after first) and PRODUCT DOSE OMISSION ISSUE (No doses were administered/ never actually gave the patient the shot.) 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.   No concomitant medications were reported.  No treatment information was provided..   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant follow up received on 04-AUG-2021 contain new event information.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Product dose omission issue, SARS-CoV-2 test, Viral infection
Clinical narrative: She didn't get the second shot; Viral Syndrome; Cough; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Viral Syndrome), COUGH (Cough) and PRODUCT DOSE OMISSION ISSUE (She didn't get the second shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The medical history was not reported by the reporter.  Concomitant products included ZIPRASIDONE, RISPERIDONE, ARIPIPRAZOLE (ABILIFY) and METOPROLOL for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VIRAL INFECTION (Viral Syndrome) and COUGH (Cough). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She didn't get the second shot). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (ROBITUSSIN DM COUGH CONTROL) for Cough, at a dose of 1 dosage form. At the time of the report, VIRAL INFECTION (Viral Syndrome), COUGH (Cough) and PRODUCT DOSE OMISSION ISSUE (She didn't get the second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Initial additional significant Follow-up received on 28 July 2021 included Adverse Event  out come updated and patient didn't get the second shot.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm Soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (Headache) 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 PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment was provided.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Insomnia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), DIZZINESS (dizziness) and PAIN (body aches) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Environmental allergy (patient is under Flonase and Zyrtec). Concomitant products included Multivitamins                                                  for supplemental purposes, Fisoil                                                         for supplemental purposes, Zyrtec                                                         for environmental allergy and Biotin                                                         for supplemental purposes for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INSOMNIA (couldn't sleep), ASTHENIA (weakness), PAIN (body aches), PYREXIA (fever), FATIGUE (tiredness) and CHILLS (chills). On 14-Mar-2021, the patient experienced DIZZINESS (lightheadedness), DIZZINESS (dizziness) and NAUSEA (extreme nausea). The patient was treated with PARACETAMOL (TYLENOL) for Pain relief, at a dose of 1 dosage form and IBUPROFEN for Pain relief, at a dose of 1 dosage form. On 15-Mar-2021, INSOMNIA (couldn't sleep), ASTHENIA (weakness), PAIN (body aches), PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (tiredness) and CHILLS (chills) had resolved. At the time of the report, DIZZINESS (lightheadedness) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), DIZZINESS (dizziness) and PAIN (body aches) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Environmental allergy (patient is under Flonase and Zyrtec). Concomitant products included Multivitamins                                                  for supplemental purposes, Fisoil                                                         for supplemental purposes, Zyrtec                                                         for environmental allergy and Biotin                                                         for supplemental purposes for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INSOMNIA (couldn't sleep), ASTHENIA (weakness), PAIN (body aches), PYREXIA (fever), FATIGUE (tiredness) and CHILLS (chills). On 14-Mar-2021, the patient experienced DIZZINESS (lightheadedness), DIZZINESS (dizziness) and NAUSEA (extreme nausea). The patient was treated with PARACETAMOL (TYLENOL) for Pain relief, at a dose of 1 dosage form and IBUPROFEN for Pain relief, at a dose of 1 dosage form. On 15-Mar-2021, INSOMNIA (couldn't sleep), ASTHENIA (weakness), PAIN (body aches), PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (tiredness) and CHILLS (chills) had resolved. At the time of the report, DIZZINESS (lightheadedness) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Hand was hot to touch; Hand swell; Hand was red; Hand was red; Hand swell; Hand was hot to touch; This spontaneous case was reported by a patient and describes the occurrence of the first episode of ERYTHEMA (Hand was red), the first episode of PERIPHERAL SWELLING (Hand swell), the first episode of FEELING HOT (Hand was hot to touch), the second episode of FEELING HOT (Hand was hot to touch) and the second episode of PERIPHERAL SWELLING (Hand swell) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Thyroid disorder NOS. Concomitant products included LISINOPRIL, NIFEDIPINE and ATORVASTATIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced the first episode of ERYTHEMA (Hand was red), the first episode of PERIPHERAL SWELLING (Hand swell) and the first episode of FEELING HOT (Hand was hot to touch). On 19-Mar-2021, the patient experienced the second episode of FEELING HOT (Hand was hot to touch), the second episode of PERIPHERAL SWELLING (Hand swell) and the second episode of ERYTHEMA (Hand was red). At the time of the report, last episode of FEELING HOT (Hand was hot to touch), the last episode of PERIPHERAL SWELLING (Hand swell) and the last episode of ERYTHEMA (Hand was red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified medicines for blood pressure and thyroid.  Patient had the symptoms on11-MAR-2021 which went away but returned again on 19-MAR-2021.  The patient did not receive any treatment.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Myalgia, Pyrexia
Clinical narrative: 101.5F fever; Arm soreness; injection site hardness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm soreness), INJECTION SITE DISCOMFORT (injection site hardness) and PYREXIA (101.5F fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21B) for COVID-19 vaccination. Concomitant products included VITAMIN D3 for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced MYALGIA (Arm soreness) and INJECTION SITE DISCOMFORT (injection site hardness). On 21-Mar-2021, the patient experienced PYREXIA (101.5F fever). At the time of the report, MYALGIA (Arm soreness), INJECTION SITE DISCOMFORT (injection site hardness) and PYREXIA (101.5F fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment was provided. Reporter did not allow further contact.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nasal Congestion) and PAIN IN EXTREMITY (Arm was sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0U5A21A) for COVID-19 vaccination. Concomitant products included USTEKINUMAB (STELARA) and TOPIRAMATE (TOPAMAX) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced NASAL CONGESTION (Nasal Congestion) and PAIN IN EXTREMITY (Arm was sore). At the time of the report, NASAL CONGESTION (Nasal Congestion) and PAIN IN EXTREMITY (Arm was sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy/Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy/Exposure during pregnancy) in a 37-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 25-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-Jun-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy/Exposure during pregnancy). The delivery occurred on an unknown date. For neonate 1, estimated due date: 20-Jun-2021 there has been no  complications or acute illnesses during this pregnancy to date. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy/Exposure during pregnancy) outcome was unknown.            Caller would like to register for pregnancy registry - was talking to someone but got disconnected No details below of prenatal testing/investigations during pregnancy to date (ultrasounds, amniocentesis, glucose tolerance, etc.) were provided, also the details concerning the patient's chronic or long-standing health conditions (diabetes, seizure disorder, hypertension, mental health disorders, asthma, etc.) were not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: initially the patient called on 19-Mar-2021 but the call got disconnected thereby the follow up was generated the patient reported her details on 26-Mar-2021
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Rash; itching; Red; swollen; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 NOS for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced RASH (Rash), PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH (Rash), PRURITUS (itching), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: arm itching; rash on arm /rash under both arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itching) and RASH (rash on arm /rash under both arms) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (COZAAR), CARVEDILOL (COREG), ATORVASTATIN and VITAMINS NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PRURITUS (arm itching) and RASH (rash on arm /rash under both arms). At the time of the report, PRURITUS (arm itching) and RASH (rash on arm /rash under both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment details include cold cloth
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Gait disturbance, Headache
Clinical narrative: very stiff and painful in my legs,sore arm; pain in back of neck; "I could barely walk"; very stiff and painful in my legs; real sleepy , very fatigue; no appetite; very very bad headache; Experienced severe chills/unbelievable chills; real sleepy , very fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very stiff and painful in my legs,sore arm), NECK PAIN (pain in back of neck), GAIT DISTURBANCE ("I could barely walk"), MUSCULOSKELETAL STIFFNESS (very stiff and painful in my legs) and SOMNOLENCE (real sleepy , very fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (very stiff and painful in my legs,sore arm), NECK PAIN (pain in back of neck), GAIT DISTURBANCE ("I could barely walk"), MUSCULOSKELETAL STIFFNESS (very stiff and painful in my legs), SOMNOLENCE (real sleepy , very fatigue), DECREASED APPETITE (no appetite), HEADACHE (very very bad headache), CHILLS (Experienced severe chills/unbelievable chills) and FATIGUE (real sleepy , very fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, PAIN IN EXTREMITY (very stiff and painful in my legs,sore arm), NECK PAIN (pain in back of neck), GAIT DISTURBANCE ("I could barely walk"), MUSCULOSKELETAL STIFFNESS (very stiff and painful in my legs), SOMNOLENCE (real sleepy , very fatigue), DECREASED APPETITE (no appetite), HEADACHE (very very bad headache), CHILLS (Experienced severe chills/unbelievable chills) and FATIGUE (real sleepy , very fatigue) had resolved.            No concomitant medication reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity, Somnolence
Clinical narrative: very stiff and painful in my legs,sore arm; pain in back of neck; "I could barely walk"; very stiff and painful in my legs; real sleepy , very fatigue; no appetite; very very bad headache; Experienced severe chills/unbelievable chills; real sleepy , very fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very stiff and painful in my legs,sore arm), NECK PAIN (pain in back of neck), GAIT DISTURBANCE ("I could barely walk"), MUSCULOSKELETAL STIFFNESS (very stiff and painful in my legs) and SOMNOLENCE (real sleepy , very fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (very stiff and painful in my legs,sore arm), NECK PAIN (pain in back of neck), GAIT DISTURBANCE ("I could barely walk"), MUSCULOSKELETAL STIFFNESS (very stiff and painful in my legs), SOMNOLENCE (real sleepy , very fatigue), DECREASED APPETITE (no appetite), HEADACHE (very very bad headache), CHILLS (Experienced severe chills/unbelievable chills) and FATIGUE (real sleepy , very fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Mar-2021, PAIN IN EXTREMITY (very stiff and painful in my legs,sore arm), NECK PAIN (pain in back of neck), GAIT DISTURBANCE ("I could barely walk"), MUSCULOSKELETAL STIFFNESS (very stiff and painful in my legs), SOMNOLENCE (real sleepy , very fatigue), DECREASED APPETITE (no appetite), HEADACHE (very very bad headache), CHILLS (Experienced severe chills/unbelievable chills) and FATIGUE (real sleepy , very fatigue) had resolved.            No concomitant medication reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Temperature of 99.6-99.7 F which is high for the patient.; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 99.6-99.7 F which is high for the patient.) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 625ALIA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PYREXIA (Temperature of 99.6-99.7 F which is high for the patient.) and CHILLS (Chills). At the time of the report, PYREXIA (Temperature of 99.6-99.7 F which is high for the patient.) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 99.6-99.7 (High) Temperature of 99.6-99.7 F which is high for the patient..         Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red dot size of quarter, its little bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red dot size of quarter, its little bigger) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011AZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter .  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and RETINOL ACETATE (VITAMIN A [RETINOL ACETATE]) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (red dot size of quarter, its little bigger). At the time of the report, VACCINATION SITE ERYTHEMA (red dot size of quarter, its little bigger) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used Cetirizine Hydrochloride as treatment
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Chills, Cough, Pain
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of decreased body temperature (cold temperature), cough, pain (body aches) and chills in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 09L20A) for COVID-19 immunization. Medical history not provided. On Feb 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Feb 3, 2021, patient experienced decreased body temperature (cold temperature), cough, pain (body aches) and chills. February 2021, decreased body temperature (cold temperature), cough, pain (body aches) and chills resolved. The reporter did not provide any causality assessments, concomitant product use or treatment information. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Dizziness, Pyrexia
Clinical narrative: Faintness on Standing; Back Ache; Fever 100.2 F; Chills; Sore Injection Site; A spontaneous report was received from a Nurse concerning a 52-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced events Faintness on Standing/Dizziness, Fever 100.2 F/ Pyrexia, Chills, Back Aches/ Back pain, Sore Injection Site/ Vaccination site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: Unknown), via an unknown route for prophylaxis of COVID-19 infection.  On 03 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot/Batch number: 029L20A) via intramuscularly in the Deltoid Muscle for prophylaxis of COVID-19 infection.   On 03 Feb 2021, the patient had Fever 100.2 F, Chills, Back Aches, Faintness on Standing, Sore Injection Site. Treatment information for the events was not reported.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events, Fever 100.2 F, Chills, Back Aches, Faintness on Standing, Sore Injection Site, was unknown in Feb 2021 at the time of this report.; Reporter'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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Faintness on Standing; Back Ache; Fever 100.2 F; Chills; Sore Injection Site; A spontaneous report was received from a Nurse concerning a 52-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced events Faintness on Standing/Dizziness, Fever 100.2 F/ Pyrexia, Chills, Back Aches/ Back pain, Sore Injection Site/ Vaccination site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: Unknown), via an unknown route for prophylaxis of COVID-19 infection.  On 03 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot/Batch number: 029L20A) via intramuscularly in the Deltoid Muscle for prophylaxis of COVID-19 infection.   On 03 Feb 2021, the patient had Fever 100.2 F, Chills, Back Aches, Faintness on Standing, Sore Injection Site. Treatment information for the events was not reported.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   The outcome of the events, Fever 100.2 F, Chills, Back Aches, Faintness on Standing, Sore Injection Site, was unknown in Feb 2021 at the time of this report.; Reporter'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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pain, Pruritus
Clinical narrative: itchiness; rash over the injection site, 4"x6"; swelling; mild aches; redness 2" x 4"; headaches; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (swelling), PAIN (mild aches), PRURITUS (itchiness), ERYTHEMA (redness 2" x 4") and HEADACHE (headaches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SWELLING (swelling), PAIN (mild aches), ERYTHEMA (redness 2" x 4"), HEADACHE (headaches) and FATIGUE (fatigue). On 12-Mar-2021, the patient experienced PRURITUS (itchiness) and VACCINATION SITE RASH (rash over the injection site, 4"x6"). On 09-Mar-2021, SWELLING (swelling) had not resolved, ERYTHEMA (redness 2" x 4") had resolved. On 10-Mar-2021, PAIN (mild aches), HEADACHE (headaches) and FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (itchiness) and VACCINATION SITE RASH (rash over the injection site, 4"x6") 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.   Concomitant medication not reported.  Treatment medication not reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site rash
Clinical narrative: itchiness; rash over the injection site, 4"x6"; swelling; mild aches; redness 2" x 4"; headaches; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (swelling), PAIN (mild aches), PRURITUS (itchiness), ERYTHEMA (redness 2" x 4") and HEADACHE (headaches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SWELLING (swelling), PAIN (mild aches), ERYTHEMA (redness 2" x 4"), HEADACHE (headaches) and FATIGUE (fatigue). On 12-Mar-2021, the patient experienced PRURITUS (itchiness) and VACCINATION SITE RASH (rash over the injection site, 4"x6"). On 09-Mar-2021, SWELLING (swelling) had not resolved, ERYTHEMA (redness 2" x 4") had resolved. On 10-Mar-2021, PAIN (mild aches), HEADACHE (headaches) and FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (itchiness) and VACCINATION SITE RASH (rash over the injection site, 4"x6") 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.   Concomitant medication not reported.  Treatment medication not reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Vaccination site pain
Clinical narrative: his arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (his arm was sore) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included METOPROLOL, AMLODIPINE and SIMVASTATIN for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (his arm was sore). At the time of the report, VACCINATION SITE PAIN (his arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood pressure measurement: (High) started going up, it's been elevated ever since 160/170/180. On an unknown date, Blood pressure measurement: 190/90 (High) ER his pressure was 190/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events not provided.   This case was linked to MOD-2021-052656, MOD-2021-052656 (Patient Link).