chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: sweating bad; feels hot and cold; shakes like she was nervous; hoarse; nauseated; throwing up; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating bad), FEELING OF BODY TEMPERATURE CHANGE (feels hot and cold), TREMOR (shakes like she was nervous), DYSPHONIA (hoarse) and NAUSEA (nauseated) in a 52-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 Shellfish allergy, Seafood allergy, Penicillin allergy, Iodine allergy, Drug allergy (Phenergan.) and Blood pressure high. Concomitant products included AMLODIPINE, FLUOXETINE and GABAPENTIN for an unknown indication.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced HYPERHIDROSIS (sweating bad), FEELING OF BODY TEMPERATURE CHANGE (feels hot and cold), TREMOR (shakes like she was nervous), DYSPHONIA (hoarse), NAUSEA (nauseated), VOMITING (throwing up) and HEADACHE (headache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating bad), FEELING OF BODY TEMPERATURE CHANGE (feels hot and cold), TREMOR (shakes like she was nervous), DYSPHONIA (hoarse), NAUSEA (nauseated), VOMITING (throwing up) and HEADACHE (headache) outcome was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: fatigue; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN and AMLODIPINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, MYALGIA (muscle pain) had resolved. At the time of the report, FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications include airborne vitamins.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Malaise, Myalgia, Nausea
Clinical narrative: irritation rather than a real cough; dry cough, cough is lingering; feels like I am at the end of a cold; little bit queasy; fatigued; muscle pain, felt like someone punch me in the arm twice; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT IRRITATION (irritation rather than a real cough), COUGH (dry cough, cough is lingering), MALAISE (feels like I am at the end of a cold), MYALGIA (muscle pain, felt like someone punch me in the arm twice) and NAUSEA (little bit queasy) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Feb-2021, the patient experienced MYALGIA (muscle pain, felt like someone punch me in the arm twice). On 25-Feb-2021, the patient experienced NAUSEA (little bit queasy) and FATIGUE (fatigued).  On 26-Feb-2021, the patient experienced THROAT IRRITATION (irritation rather than a real cough), COUGH (dry cough, cough is lingering) and MALAISE (feels like I am at the end of a cold). On 26-Feb-2021, NAUSEA (little bit queasy) and FATIGUE (fatigued) had resolved.   On 27-Feb-2021, MYALGIA (muscle pain, felt like someone punch me in the arm twice) had resolved. At the time of the report, THROAT IRRITATION (irritation rather than a real cough), COUGH (dry cough, cough is lingering) and MALAISE (feels like I am at the end of a cold) had not resolved.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-034373 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: irritation rather than a real cough; dry cough, cough is lingering; feels like I am at the end of a cold; little bit queasy; fatigued; muscle pain, felt like someone punch me in the arm twice; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROAT IRRITATION (irritation rather than a real cough), COUGH (dry cough, cough is lingering), MALAISE (feels like I am at the end of a cold), MYALGIA (muscle pain, felt like someone punch me in the arm twice) and NAUSEA (little bit queasy) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 24-Feb-2021, the patient experienced MYALGIA (muscle pain, felt like someone punch me in the arm twice). On 25-Feb-2021, the patient experienced NAUSEA (little bit queasy) and FATIGUE (fatigued).  On 26-Feb-2021, the patient experienced THROAT IRRITATION (irritation rather than a real cough), COUGH (dry cough, cough is lingering) and MALAISE (feels like I am at the end of a cold). On 26-Feb-2021, NAUSEA (little bit queasy) and FATIGUE (fatigued) had resolved.   On 27-Feb-2021, MYALGIA (muscle pain, felt like someone punch me in the arm twice) had resolved. At the time of the report, THROAT IRRITATION (irritation rather than a real cough), COUGH (dry cough, cough is lingering) and MALAISE (feels like I am at the end of a cold) had not resolved.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-034373 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Rash on Palm; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on Palm), HEADACHE (Headache) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 28-Feb-2021, the patient experienced RASH (Rash on Palm), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, RASH (Rash on Palm), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.   No treatment related information has been reported
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-031654 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever; fatigue; Headache; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M10A and 030L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included VITAMIN and LISINOPRIL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 02-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches).   The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   At the time of the report, PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 101 f (High) Patient had fever of 101 F.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; fatigue; Headache; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M10A and 030L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included VITAMIN and LISINOPRIL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 02-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches).   The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency.   At the time of the report, PYREXIA (Fever), FATIGUE (fatigue), HEADACHE (Headache), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 101 f (High) Patient had fever of 101 F.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchiness below the injection site/spreading; redness below the injection site; muscle pain on my neck; This spontaneous case was reported by a health care professional and describes the occurrence of NECK PAIN (muscle pain on my neck), VACCINATION SITE PRURITUS (itchiness below the injection site/spreading) and VACCINATION SITE ERYTHEMA (redness below the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy. Concomitant products included CALCIUM, FISH OIL and ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, MALPIGHIA GLABRA, ROSA CANINA, RUTOSIDE (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Feb-2021, the patient experienced NECK PAIN (muscle pain on my neck). On 03-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness below the injection site/spreading) and VACCINATION SITE ERYTHEMA (redness below the injection site).   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency.   At the time of the report, NECK PAIN (muscle pain on my neck), VACCINATION SITE PRURITUS (itchiness below the injection site/spreading) and VACCINATION SITE ERYTHEMA (redness below the injection site) 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.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI updated for 1st dose of Vaccine
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Myalgia, Product dose omission issue, Pyrexia
Clinical narrative: 36 days since the first dose; Flu-like symptoms; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (36 days since the first dose), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever) and MYALGIA (Body aches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included THYROID for Thyroid disorder NOS, CLOPIDOGREL BISULFATE (PLAVIX) and ATENOLOL for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever) and MYALGIA (Body aches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (36 days since the first dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRODUCT DOSE OMISSION ISSUE (36 days since the first dose) outcome was unknown and INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever) and MYALGIA (Body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 100.0 (High) Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio fluctuation
Clinical narrative: Fluctuating INR; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO FLUCTUATION (Fluctuating INR) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DULAGLUTIDE (TRULICITY), INSULIN, METFORMIN, GLIPIZIDE, METOPROLOL, WARFARIN, WARFARIN and LOSARTAN.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INTERNATIONAL NORMALISED RATIO FLUCTUATION (Fluctuating INR). At the time of the report, INTERNATIONAL NORMALISED RATIO FLUCTUATION (Fluctuating INR) 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.   Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Headache, Malaise, Pyrexia
Clinical narrative: did not feel well; dry heaves; bedridden; fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well), RETCHING (dry heaves), BEDRIDDEN (bedridden), PYREXIA (fever) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Mar-2021, the patient experienced MALAISE (did not feel well), RETCHING (dry heaves), BEDRIDDEN (bedridden), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills).   At the time of the report, MALAISE (did not feel well), RETCHING (dry heaves), BEDRIDDEN (bedridden), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-034401 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: did not feel well; dry heaves; bedridden; fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well), RETCHING (dry heaves), BEDRIDDEN (bedridden), PYREXIA (fever) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Mar-2021, the patient experienced MALAISE (did not feel well), RETCHING (dry heaves), BEDRIDDEN (bedridden), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills).   At the time of the report, MALAISE (did not feel well), RETCHING (dry heaves), BEDRIDDEN (bedridden), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-034401 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular, Illness, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm is so huge and so swollen), HEART RATE INCREASED (heart started acting up/beating erratic like) and HEART RATE IRREGULAR (beating erratic-like) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Patient is allergic to dairy products) and Allergy to chemicals (Patient is allergic to Bactrim). Concomitant products included ZINC for an unknown indication.  On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm is so huge and so swollen), HEART RATE INCREASED (heart started acting up/beating erratic like) and HEART RATE IRREGULAR (beating erratic-like).   On 01-Mar-2021, HEART RATE INCREASED (heart started acting up/beating erratic like) and HEART RATE IRREGULAR (beating erratic-like) had resolved. At the time of the report, VACCINATION SITE SWELLING (arm is so huge and so swollen) 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's treatment medication included Heart pill taken half a pill to make sure that heart beats right and hot compress on the injection site.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Patient sick, declined further FU
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Swelling face
Clinical narrative: Blisters in mouth and throat; swelling on face; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters in mouth and throat) and SWELLING FACE (swelling on face) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Penicillin allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 01-Mar-2021, the patient experienced BLISTER (Blisters in mouth and throat) and SWELLING FACE (swelling on face). At the time of the report, BLISTER (Blisters in mouth and throat) and SWELLING FACE (swelling on face) outcome was unknown.      Patient stated that she takes many medications but could not provide details of them. No treatment information was provided.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A little tenderness at the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A little tenderness at the arm of the injection) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (A little tenderness at the arm of the injection). At the time of the report, VACCINATION SITE PAIN (A little tenderness at the arm of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications provided by the reporter included blood pressure medication, heart medication, diabetes medication and some other medications which the reporter was not able to remember. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: The event outcome was updated to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Neck pain prior to getting vaccinated and after the vaccination was administered the pain had worsened; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain prior to getting vaccinated and after the vaccination was administered the pain had worsened) 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 NECK PAIN (Neck pain prior to getting vaccinated and after the vaccination was administered the pain had worsened). At the time of the report, NECK PAIN (Neck pain prior to getting vaccinated and after the vaccination was administered the pain had worsened) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient inquired about contraindications of OTC pain medications and the vaccine. Treatment information was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Musculoskeletal chest pain
Clinical narrative: Brain fog; Feels like a broken rib on her left side; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), MUSCULOSKELETAL CHEST PAIN (Feels like a broken rib on her left side) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog), MUSCULOSKELETAL CHEST PAIN (Feels like a broken rib on her left side) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Brain fog), MUSCULOSKELETAL CHEST PAIN (Feels like a broken rib on her left side) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported. No treatment related information has been reported.    This case was linked to MOD-2021-055108 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: 11 doses administered from a cracked vial; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (11 doses administered from a cracked vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 22M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (11 doses administered from a cracked vial). On 03-Mar-2021, POOR QUALITY PRODUCT ADMINISTERED (11 doses administered from a cracked vial) 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.   Report concerns 11 patients (age and gender unspecified). No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: The reporter confirmed that no patient identifiers could be provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Lump at injection site; Itchiness at injection site; Redness at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE MASS (Lump at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment details were not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Bloodshot eyes; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Bloodshot eyes) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced OCULAR HYPERAEMIA (Bloodshot eyes). At the time of the report, OCULAR HYPERAEMIA (Bloodshot eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was really sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore) 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 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was really sore). At the time of the report, PAIN IN EXTREMITY (arm was really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment details not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: brain fog; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to the company on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026620A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included GABAPENTIN, MELOXICAM, ESCITALOPRAM OXALATE (LEXAPRO) and VITAMINS NOS for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, FEELING ABNORMAL (brain fog) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Retching, Vomiting
Clinical narrative: pain; dry heaving; vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), RETCHING (dry heaving) and VOMITING (vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (pain), RETCHING (dry heaving) and VOMITING (vomiting). On 08-Feb-2021, PAIN (pain), RETCHING (dry heaving) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment details were not provided. The patient wanted to confirm if her scheduled steroid shot in the following days would interfere with the second dose of her vaccine or not.  Follow-up information on 03-May-2021 included: The patient believed that her symptoms that she was experiencing after her first vaccination were actually caused by extreme back pain due to a herniated disc that happened later on the same day of her injection. She agreed with that, did not have any adverse effects after her second vaccination (details not provided), and therefore did not feel she had any adverse reaction to either vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 04-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            Concomitant medication provided was medication for diabetes NOS. No treatment information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: underneath the injection arm it is puffy and appears fat and swollen; injection site itches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (underneath the injection arm it is puffy and appears fat and swollen) and VACCINATION SITE PRURITUS (injection site itches) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE SWELLING (underneath the injection arm it is puffy and appears fat and swollen) and VACCINATION SITE PRURITUS (injection site itches). At the time of the report, VACCINATION SITE SWELLING (underneath the injection arm it is puffy and appears fat and swollen) and VACCINATION SITE PRURITUS (injection site itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was taking unspecified medications for high blood pressure and high cholesterol. Treatment details were not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling hot, Vaccination site warmth
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Very warm on arm), BACK PAIN (Painful in her waist to turn over to other side) and FEELING HOT (Whole body felt warm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Seizures.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Very warm on arm), BACK PAIN (Painful in her waist to turn over to other side) and FEELING HOT (Whole body felt warm). At the time of the report, VACCINATION SITE WARMTH (Very warm on arm), BACK PAIN (Painful in her waist to turn over to other side) and FEELING HOT (Whole body felt warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received unspecified medications for seizures. Treatment details were not reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Urticaria
Clinical narrative: hot; "a weird rash" that looks like hives; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot) and URTICARIA ("a weird rash" that looks like hives) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced FEELING HOT (hot) and URTICARIA ("a weird rash" that looks like hives). At the time of the report, FEELING HOT (hot) had resolved and URTICARIA ("a weird rash" that looks like hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included Claritin, Steroid cream and Benadryl. Concomitant medications also included birth control pill .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: warm to the touch circle at the site of injection; sore circle at the site of injection; Red circle at the site of injection; Itchy circle at the site of injection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch circle at the site of injection), VACCINATION SITE PAIN (sore circle at the site of injection), VACCINATION SITE ERYTHEMA (Red circle at the site of injection) and VACCINATION SITE PRURITUS (Itchy circle at the site of injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch circle at the site of injection), VACCINATION SITE PAIN (sore circle at the site of injection), VACCINATION SITE ERYTHEMA (Red circle at the site of injection) and VACCINATION SITE PRURITUS (Itchy circle at the site of injection). At the time of the report, VACCINATION SITE WARMTH (warm to the touch circle at the site of injection), VACCINATION SITE PAIN (sore circle at the site of injection), VACCINATION SITE ERYTHEMA (Red circle at the site of injection) and VACCINATION SITE PRURITUS (Itchy circle at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not provided
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest discomfort, Feeling abnormal, Malaise, Rash
Clinical narrative: chest is fluttering; my whole body is on flames; rash on her entire body (hives all over body); not feeling well, doesn't feel right since then; feels like something is crawling down her skin; rash on her entire body (hives all over body) that are very painful; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest is fluttering), BURNING SENSATION (my whole body is on flames), URTICARIA (rash on her entire body (hives all over body)), MALAISE (not feeling well, doesn't feel right since then) and FEELING ABNORMAL (feels like something is crawling down her skin) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CHEST DISCOMFORT (chest is fluttering), BURNING SENSATION (my whole body is on flames), URTICARIA (rash on her entire body (hives all over body)), MALAISE (not feeling well, doesn't feel right since then), FEELING ABNORMAL (feels like something is crawling down her skin) and RASH (rash on her entire body (hives all over body) that are very painful). At the time of the report, CHEST DISCOMFORT (chest is fluttering), BURNING SENSATION (my whole body is on flames), URTICARIA (rash on her entire body (hives all over body)), MALAISE (not feeling well, doesn't feel right since then), FEELING ABNORMAL (feels like something is crawling down her skin) and RASH (rash on her entire body (hives all over body) that are very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking high blood pressure pills.  Treatment reported was Benadryl but patient could not take it.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: chest is fluttering; my whole body is on flames; rash on her entire body (hives all over body); not feeling well, doesn't feel right since then; feels like something is crawling down her skin; rash on her entire body (hives all over body) that are very painful; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest is fluttering), BURNING SENSATION (my whole body is on flames), URTICARIA (rash on her entire body (hives all over body)), MALAISE (not feeling well, doesn't feel right since then) and FEELING ABNORMAL (feels like something is crawling down her skin) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CHEST DISCOMFORT (chest is fluttering), BURNING SENSATION (my whole body is on flames), URTICARIA (rash on her entire body (hives all over body)), MALAISE (not feeling well, doesn't feel right since then), FEELING ABNORMAL (feels like something is crawling down her skin) and RASH (rash on her entire body (hives all over body) that are very painful). At the time of the report, CHEST DISCOMFORT (chest is fluttering), BURNING SENSATION (my whole body is on flames), URTICARIA (rash on her entire body (hives all over body)), MALAISE (not feeling well, doesn't feel right since then), FEELING ABNORMAL (feels like something is crawling down her skin) and RASH (rash on her entire body (hives all over body) that are very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking high blood pressure pills.  Treatment reported was Benadryl but patient could not take it.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Oropharyngeal pain
Clinical narrative: sore throat; eyes were crying; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and LACRIMATION INCREASED (eyes were crying) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 OROPHARYNGEAL PAIN (sore throat) and LACRIMATION INCREASED (eyes were crying). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and LACRIMATION INCREASED (eyes were crying) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment related information was reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of lymph node; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swelling of lymph node) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LYMPHADENOPATHY (swelling of lymph node). At the time of the report, LYMPHADENOPATHY (swelling of lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.Concomitant medications was not provided by the reporter.  The patient received developed lymphadenopathy under his right arm. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Consumer gave consent for follow up