chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Hyperhidrosis
Clinical narrative: Dizzy really bad; Sweating; Back was hurting, that day was terrible / soreness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy really bad), HYPERHIDROSIS (Sweating) and BACK PAIN (Back was hurting, that day was terrible / soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 016M20A) for COVID-19 vaccination. The patient's past medical history included Back surgery (Several years ago.).Concurrent medical conditions included Blood pressure high. Concomitant products included FOLIC ACID, GABAPENTIN, TIZANIDINE and IBUPROFEN for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy really bad), HYPERHIDROSIS (Sweating) and BACK PAIN (Back was hurting, that day was terrible / soreness). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Back pain, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy really bad) and HYPERHIDROSIS (Sweating) outcome was unknown and BACK PAIN (Back was hurting, that day was terrible / soreness) had resolved. Other concomitant product use included medications for high blood pressure.This case was linked to MOD-2021-385885 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Dehydration, Dry mouth
Clinical narrative: muscle cramps in my hand and then my right foot/muscles and joints were cramping; feeling cold; lips felt a little tingly; heart was beating very fast; mouth was dry; felt very weak; cold; completely dehydrated; short of breath; blood pressure was 146/84; temperature at 100.6; finger tips started to feel tingly; very bad headache; full blown chills; very tired suddenly; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Nov-2021 and was forwarded to Moderna on 12-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired suddenly), FEELING COLD (feeling cold), CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping) and PARAESTHESIA ORAL (lips felt a little tingly) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced FATIGUE (very tired suddenly), FEELING COLD (feeling cold), CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping), PARAESTHESIA ORAL (lips felt a little tingly), PALPITATIONS (heart was beating very fast), DRY MOUTH (mouth was dry), ASTHENIA (felt very weak), NASOPHARYNGITIS (cold), DEHYDRATION (completely dehydrated), DYSPNOEA (short of breath), HEADACHE (very bad headache), HYPERTENSION (blood pressure was 146/84), BODY TEMPERATURE INCREASED (temperature at 100.6) and PARAESTHESIA (finger tips started to feel tingly). On 30-Oct-2021, FATIGUE (very tired suddenly), FEELING COLD (feeling cold), PARAESTHESIA ORAL (lips felt a little tingly), PALPITATIONS (heart was beating very fast), DRY MOUTH (mouth was dry), ASTHENIA (felt very weak), DEHYDRATION (completely dehydrated), DYSPNOEA (short of breath), HYPERTENSION (blood pressure was 146/84), BODY TEMPERATURE INCREASED (temperature at 100.6) and PARAESTHESIA (finger tips started to feel tingly) had resolved, CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping) and NASOPHARYNGITIS (cold) outcome was unknown. On 01-Nov-2021, HEADACHE (very bad headache) 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 medication was reported NO treatment medication was reported
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling cold, Headache, Hypertension
Clinical narrative: muscle cramps in my hand and then my right foot/muscles and joints were cramping; feeling cold; lips felt a little tingly; heart was beating very fast; mouth was dry; felt very weak; cold; completely dehydrated; short of breath; blood pressure was 146/84; temperature at 100.6; finger tips started to feel tingly; very bad headache; full blown chills; very tired suddenly; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Nov-2021 and was forwarded to Moderna on 12-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired suddenly), FEELING COLD (feeling cold), CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping) and PARAESTHESIA ORAL (lips felt a little tingly) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced FATIGUE (very tired suddenly), FEELING COLD (feeling cold), CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping), PARAESTHESIA ORAL (lips felt a little tingly), PALPITATIONS (heart was beating very fast), DRY MOUTH (mouth was dry), ASTHENIA (felt very weak), NASOPHARYNGITIS (cold), DEHYDRATION (completely dehydrated), DYSPNOEA (short of breath), HEADACHE (very bad headache), HYPERTENSION (blood pressure was 146/84), BODY TEMPERATURE INCREASED (temperature at 100.6) and PARAESTHESIA (finger tips started to feel tingly). On 30-Oct-2021, FATIGUE (very tired suddenly), FEELING COLD (feeling cold), PARAESTHESIA ORAL (lips felt a little tingly), PALPITATIONS (heart was beating very fast), DRY MOUTH (mouth was dry), ASTHENIA (felt very weak), DEHYDRATION (completely dehydrated), DYSPNOEA (short of breath), HYPERTENSION (blood pressure was 146/84), BODY TEMPERATURE INCREASED (temperature at 100.6) and PARAESTHESIA (finger tips started to feel tingly) had resolved, CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping) and NASOPHARYNGITIS (cold) outcome was unknown. On 01-Nov-2021, HEADACHE (very bad headache) 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 medication was reported NO treatment medication was reported
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nasopharyngitis, Palpitations, Paraesthesia, Paraesthesia oral
Clinical narrative: muscle cramps in my hand and then my right foot/muscles and joints were cramping; feeling cold; lips felt a little tingly; heart was beating very fast; mouth was dry; felt very weak; cold; completely dehydrated; short of breath; blood pressure was 146/84; temperature at 100.6; finger tips started to feel tingly; very bad headache; full blown chills; very tired suddenly; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Nov-2021 and was forwarded to Moderna on 12-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired suddenly), FEELING COLD (feeling cold), CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping) and PARAESTHESIA ORAL (lips felt a little tingly) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced FATIGUE (very tired suddenly), FEELING COLD (feeling cold), CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping), PARAESTHESIA ORAL (lips felt a little tingly), PALPITATIONS (heart was beating very fast), DRY MOUTH (mouth was dry), ASTHENIA (felt very weak), NASOPHARYNGITIS (cold), DEHYDRATION (completely dehydrated), DYSPNOEA (short of breath), HEADACHE (very bad headache), HYPERTENSION (blood pressure was 146/84), BODY TEMPERATURE INCREASED (temperature at 100.6) and PARAESTHESIA (finger tips started to feel tingly). On 30-Oct-2021, FATIGUE (very tired suddenly), FEELING COLD (feeling cold), PARAESTHESIA ORAL (lips felt a little tingly), PALPITATIONS (heart was beating very fast), DRY MOUTH (mouth was dry), ASTHENIA (felt very weak), DEHYDRATION (completely dehydrated), DYSPNOEA (short of breath), HYPERTENSION (blood pressure was 146/84), BODY TEMPERATURE INCREASED (temperature at 100.6) and PARAESTHESIA (finger tips started to feel tingly) had resolved, CHILLS (full blown chills), MUSCLE SPASMS (muscle cramps in my hand and then my right foot/muscles and joints were cramping) and NASOPHARYNGITIS (cold) outcome was unknown. On 01-Nov-2021, HEADACHE (very bad headache) 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 medication was reported NO treatment medication was reported
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: lymph nodes are swollen on left side; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes are swollen on left side) and VACCINATION SITE PAIN (soreness at the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 002B21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced LYMPHADENOPATHY (lymph nodes are swollen on left side). 11-Nov-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, LYMPHADENOPATHY (lymph nodes are swollen on left side) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.            No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-385895 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Chills after 2nd shot; Low Grade Fever after 2nd shot; Tired after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after 2nd shot), PYREXIA (Low Grade Fever after 2nd shot) and FATIGUE (Tired after 2nd shot) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 015M20A) for COVID-19 vaccination. The patient's past medical history included Pulmonary fibrosis. Concurrent medical conditions included Scoliosis and Hypertension. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (Chills after 2nd shot), PYREXIA (Low Grade Fever after 2nd shot) and FATIGUE (Tired after 2nd shot). On 08-Mar-2021, CHILLS (Chills after 2nd shot), PYREXIA (Low Grade Fever after 2nd shot) and FATIGUE (Tired after 2nd shot) had resolved. No Concomitant medications were provided by the reporter.No Treatment information was reported. This case was linked to MOD-2021-385943 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Nurse gave 24 Moderna booster doses out of 1 vial, So 4 patients received a booster dose after vial was needle punctured 20 times. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Nurse gave 24 Moderna booster doses out of 1 vial, So 4 patients received a booster dose after vial was needle punctured 20 times.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Nurse gave 24 Moderna booster doses out of 1 vial, So 4 patients received a booster dose after vial was needle punctured 20 times.). On 10-Nov-2021, ACCIDENTAL UNDERDOSE (Nurse gave 24 Moderna booster doses out of 1 vial, So 4 patients received a booster dose after vial was needle punctured 20 times.) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No Concomitant product use was reported.No treatment information was provided.The reporter informed that 4 patients received a booster dose after vial was needle punctured 20 times. Doses were injected into deltoid muscle.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Should have received the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Should have received the full dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A, 046B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Should have received the full dose). On 10-Nov-2021, ACCIDENTAL UNDERDOSE (Should have received the full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Expired product administered, Headache, Hypertension
Clinical narrative: elevated blood pressure; I got a severe headache, it was really bad; Expired vaccine used; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (elevated blood pressure), HEADACHE (I got a severe headache, it was really bad) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 028L20A and 012L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included HYDRALAZINE and AMLODIPINE for an unknown indication.On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced HYPERTENSION (elevated blood pressure) and HEADACHE (I got a severe headache, it was really bad). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, HYPERTENSION (elevated blood pressure) and HEADACHE (I got a severe headache, it was really bad) was resolving.DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Blood pressure measurement: 157-105 (High) 157-105 (high lowest was 139-94).For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Syncope
Clinical narrative: Psyncopy 2; Myocarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of SYNCOPE (Psyncopy 2) and MYOCARDITIS (Myocarditis) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Psyncopy 2) (seriousness criterion medically significant) and MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Psyncopy 2) and MYOCARDITIS (Myocarditis) 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 concomitant product use was provided by the reporter. No treatment medication was provided.  The patient experienced myocarditis and psyncopy 2 days after vaccine.  Company comment: This case concerns a  patient with unknown age and gender with no relevant medical history, who experienced the unexpected serious event of Syncope and the expected serious event of Myocarditis. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  patient with unknown age and gender with no relevant medical history, who experienced the unexpected serious event of Syncope and the expected serious event of Myocarditis. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypoacusis, Oropharyngeal pain, Rhinitis allergic, Throat irritation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (bit of hearing loss), URINARY TRACT INFECTION (possible urinary tract infection), RHINITIS ALLERGIC (nasal allergy/nasal rhinitis), COUGH (she has been coughing a little bit/if she drinks water she starts coughing) and THROAT IRRITATION (her throat feels irritated from time to time/it's slightly irritated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Nasal allergy (Patient has had rhinitis since she was three years old).On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (bit of hearing loss), URINARY TRACT INFECTION (possible urinary tract infection), RHINITIS ALLERGIC (nasal allergy/nasal rhinitis), COUGH (she has been coughing a little bit/if she drinks water she starts coughing), THROAT IRRITATION (her throat feels irritated from time to time/it's slightly irritated) and OROPHARYNGEAL PAIN (it's not very sore/they are a little worse now). At the time of the report, HYPOACUSIS (bit of hearing loss), URINARY TRACT INFECTION (possible urinary tract infection), RHINITIS ALLERGIC (nasal allergy/nasal rhinitis), COUGH (she has been coughing a little bit/if she drinks water she starts coughing), THROAT IRRITATION (her throat feels irritated from time to time/it's slightly irritated) and OROPHARYNGEAL PAIN (it's not very sore/they are a little worse now) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 11-Nov-2021, Urine analysis: possible urinary tract infection (abnormal) It indicates a possible urinary tract infection.Patient's urine analysis was made last night and got the results this morning. It indicates a possible urinary tract infection (UTI). She has had rhinitis since she was 3 years old, and she had these symptoms with the first two doses, but they are a little worse now. Patient had got a bit of hearing loss, it could not be clarified if this was after or before the Moderna Covid19 Vaccination. On 11-Nov-2021, blood test was done result unknown. Her doctor also ordered a culture.No concomitant medications were provided.Treatment medications included unspecified antibiotics, used for possible UTI.This case was linked to MOD-2021-385962 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Urine analysis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (bit of hearing loss), URINARY TRACT INFECTION (possible urinary tract infection), RHINITIS ALLERGIC (nasal allergy/nasal rhinitis), COUGH (she has been coughing a little bit/if she drinks water she starts coughing) and THROAT IRRITATION (her throat feels irritated from time to time/it's slightly irritated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Nasal allergy (Patient has had rhinitis since she was three years old).On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (bit of hearing loss), URINARY TRACT INFECTION (possible urinary tract infection), RHINITIS ALLERGIC (nasal allergy/nasal rhinitis), COUGH (she has been coughing a little bit/if she drinks water she starts coughing), THROAT IRRITATION (her throat feels irritated from time to time/it's slightly irritated) and OROPHARYNGEAL PAIN (it's not very sore/they are a little worse now). At the time of the report, HYPOACUSIS (bit of hearing loss), URINARY TRACT INFECTION (possible urinary tract infection), RHINITIS ALLERGIC (nasal allergy/nasal rhinitis), COUGH (she has been coughing a little bit/if she drinks water she starts coughing), THROAT IRRITATION (her throat feels irritated from time to time/it's slightly irritated) and OROPHARYNGEAL PAIN (it's not very sore/they are a little worse now) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 11-Nov-2021, Urine analysis: possible urinary tract infection (abnormal) It indicates a possible urinary tract infection.Patient's urine analysis was made last night and got the results this morning. It indicates a possible urinary tract infection (UTI). She has had rhinitis since she was 3 years old, and she had these symptoms with the first two doses, but they are a little worse now. Patient had got a bit of hearing loss, it could not be clarified if this was after or before the Moderna Covid19 Vaccination. On 11-Nov-2021, blood test was done result unknown. Her doctor also ordered a culture.No concomitant medications were provided.Treatment medications included unspecified antibiotics, used for possible UTI.This case was linked to MOD-2021-385962 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Intestinal obstruction
Clinical narrative: experiencing a bowel obstruction, not a complete one, but a partial bowel obstruction; This spontaneous case was reported by a consumer and describes the occurrence of INTESTINAL OBSTRUCTION (experiencing a bowel obstruction, not a complete one, but a partial bowel obstruction) 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 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced INTESTINAL OBSTRUCTION (experiencing a bowel obstruction, not a complete one, but a partial bowel obstruction) (seriousness criterion medically significant). At the time of the report, INTESTINAL OBSTRUCTION (experiencing a bowel obstruction, not a complete one, but a partial bowel obstruction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter.  No treatment medications provided by the reporter.  Company Comment: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Intestinal Obstruction. The event occurred approximately 1-2 days after receiving an unknown dose number of mRNA-1273 Vaccine with unknown outcome. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the unexpected event of Intestinal Obstruction. The event occurred approximately 1-2 days after receiving an unknown dose number of mRNA-1273 Vaccine with unknown outcome. The rechallenge was not applicable since no information about the dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Myalgia, Pain, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (My lower back is killing me), FEELING ABNORMAL (Not feeling great), PAIN (Achiness), URTICARIA (Hives on arm, trunk and rest of the body) and MYALGIA (Muscle pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 017B21A and 010A21A) 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) (unknown route) 1 dosage form.On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (My lower back is killing me), FEELING ABNORMAL (Not feeling great), PAIN (Achiness), URTICARIA (Hives on arm, trunk and rest of the body) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (My lower back is killing me), FEELING ABNORMAL (Not feeling great), PAIN (Achiness), URTICARIA (Hives on arm, trunk and rest of the body) and MYALGIA (Muscle pain) had not resolved. No concomitant medication was reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The nurse stated she reconstituted the 5 to 11-year-old  Pfizer COVID-19 vaccine with 1.8mL of 0.9% of normal saline instead of 1.3mL.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Muscular weakness, Pyrexia
Clinical narrative: This was the booster 0.25ml of Moderna  vaccine given 10 months after second dose. I experienced worse side effects than with 2nd dose. They were similar to 2nd dose SED chills, fever 101, severe headache, muscle weakness. Started 12 hrs after administration of booster. These lasted about 24 hours. But reason reporting is I experienced COVID arm, which came up about 72 hrs after administration. Large ,big red round circle on vaccinated arm, very warm to touch. Has lasted about 4-5 days. I experience this with the first dose and reported it. I expected the SED that were similar to 2nd dose but much worse and half of dose of vaccine given. This is just for your information. I am fine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vaccination site reaction
Clinical narrative: This was the booster 0.25ml of Moderna  vaccine given 10 months after second dose. I experienced worse side effects than with 2nd dose. They were similar to 2nd dose SED chills, fever 101, severe headache, muscle weakness. Started 12 hrs after administration of booster. These lasted about 24 hours. But reason reporting is I experienced COVID arm, which came up about 72 hrs after administration. Large ,big red round circle on vaccinated arm, very warm to touch. Has lasted about 4-5 days. I experience this with the first dose and reported it. I expected the SED that were similar to 2nd dose but much worse and half of dose of vaccine given. This is just for your information. I am fine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Flushing, Gaze palsy, Headache, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: About 2 minutes after the 1st dose pfizer vaccine, pt reported throbbing feeling on Right cheek & slight swollen showed on Right cheek; we applied Ice for patient & patient felt better. Pt also reported light headache level 1-2; we gave Tylenol 10ml, 1 dose and pt felt better. Pt also reported Sweaty. We monitored pt for total about 45 minutes. Pt reported recovered, no more reaction and left with parents. Parents reported they took kid to Urgent Care after AE incident & pt's fine
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Mouth swelling, Pain, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Additional Details: About 2 minutes after the 1st dose pfizer vaccine, pt reported throbbing feeling on Right cheek & slight swollen showed on Right cheek; we applied Ice for patient & patient felt better. Pt also reported light headache level 1-2; we gave Tylenol 10ml, 1 dose and pt felt better. Pt also reported Sweaty. We monitored pt for total about 45 minutes. Pt reported recovered, no more reaction and left with parents. Parents reported they took kid to Urgent Care after AE incident & pt's fine
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt s/p IM vaccine laughing walking around while sister being vaccinated pt fainted while standing, pt was responsive immediately afterwards mother informed this nurse afterwards of Hx of dizziness with flu vaccine. pt was cryting s/p vaccine mom holding pt. No cervical spine or para spine tenderness. pt A&Ox3 clear speech no Hx of blood thinners. Mother ED nurse agreeable to watch pt for any issues and bring pt to ED for any issues. BP prior to leaving 114/75 LA sitting and HR 102 Regular
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia
Clinical narrative: High heart rate, numbness in fingers and toes
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Hypertension, Injection site swelling, Lymphadenopathy
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Hypertension-Severe, Systemic: Lymph Node Swelling-Severe
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Throat tightness
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Hypertension-Severe, Systemic: Lymph Node Swelling-Severe
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinusitis, Swelling face, Vaccination site reaction
Clinical narrative: sinus infection; really bad cold; right side of the face was swollen; COVID arm,/oval shaped in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen) and VACCINATION SITE REACTION (COVID arm,/oval shaped in the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen) and VACCINATION SITE REACTION (COVID arm,/oval shaped in the arm). The patient was treated with AMOXICILLIN for Sinus infection, at an unspecified dose and frequency. At the time of the report, SINUSITIS (sinus infection), NASOPHARYNGITIS (really bad cold), SWELLING FACE (right side of the face was swollen) and VACCINATION SITE REACTION (COVID arm,/oval shaped in the arm) outcome was unknown.            No Concomitant use were reported She went to an oral surgeon and was advised to continue with the antibiotics.   This case was linked to MOD-2021-386034 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: General fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (General fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Goiter and Radioactive iodine therapy (For goiter). Concurrent medical conditions included Latex allergy, Drug allergy (Zantac) and Penicillin allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL and LISINOPRIL for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced FATIGUE (General fatigue). At the time of the report, FATIGUE (General fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. After receiving two injections , the patient cannot keep thyroid level normal. Patient  had an x-ray of right hand and an ENG (Electronystagmography)was done - ENG showed carpal tunnel the tests were ordered by her primary care physician. she was referred to a neurologist.   This case was linked to MOD-2021-386040 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm after second dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm after second dose of Moderna Covid-19 vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045821A and 031821A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm after second dose of Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm after second dose of Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medications were reported   This case was linked to MOD-2021-386038 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant follow up appended-HCP details added
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Depressed mood, Malaise, Nausea
Clinical narrative: today seriously sick; feels down; Hasn´t eat anything; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (today seriously sick), DEPRESSED MOOD (feels down), DECREASED APPETITE (Hasn´t eat anything) and NAUSEA (Nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Dialysis (Patient is on dialysis) since an unknown date.On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced MALAISE (today seriously sick), DEPRESSED MOOD (feels down), DECREASED APPETITE (Hasn´t eat anything) and NAUSEA (Nauseous). At the time of the report, MALAISE (today seriously sick), DEPRESSED MOOD (feels down), DECREASED APPETITE (Hasn´t eat anything) and NAUSEA (Nauseous) outcome was unknown. No concomitant medication was reported.No treatment medication was reported. Company comment- This case concerns a male patient, unknown age, with medical history of undergoing dialysis, who experienced the non-serious, unexpected events of malaise, depressed mood, decreased appetite and non-serious expected event of nausea. The events occurred  one day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report. Sender's Comments: This case concerns a male patient, unknown age, with medical history of undergoing dialysis, who experienced the non-serious, unexpected events of malaise, depressed mood, decreased appetite and non-serious expected event of nausea. The events occurred  one day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Faeces discoloured, Illness, Nausea
Clinical narrative: had diarrhea; my stool turned bile colored; I was sick for months; I had left shoulder pain for 6 months; I had joint pain; My arm sore was sore at the injection site; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (had diarrhea), FAECES DISCOLOURED (my stool turned bile colored), ILLNESS (I was sick for months), ARTHRALGIA (I had left shoulder pain for 6 months) and ARTHRALGIA (I had joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced DIARRHOEA (had diarrhea), ILLNESS (I was sick for months), ARTHRALGIA (I had left shoulder pain for 6 months), ARTHRALGIA (I had joint pain) and NAUSEA (nauseated). 29-Mar-2021, the patient experienced FAECES DISCOLOURED (my stool turned bile colored) and VACCINATION SITE PAIN (My arm sore was sore at the injection site). In September 2021, ARTHRALGIA (I had left shoulder pain for 6 months) had resolved. At the time of the report, DIARRHOEA (had diarrhea), FAECES DISCOLOURED (my stool turned bile colored), ILLNESS (I was sick for months), ARTHRALGIA (I had joint pain), VACCINATION SITE PAIN (My arm sore was sore at the injection site) and NAUSEA (nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-386019, MOD-2021-386089 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had diarrhea; my stool turned bile colored; I was sick for months; I had left shoulder pain for 6 months; I had joint pain; My arm sore was sore at the injection site; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (had diarrhea), FAECES DISCOLOURED (my stool turned bile colored), ILLNESS (I was sick for months), ARTHRALGIA (I had left shoulder pain for 6 months) and ARTHRALGIA (I had joint pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced DIARRHOEA (had diarrhea), ILLNESS (I was sick for months), ARTHRALGIA (I had left shoulder pain for 6 months), ARTHRALGIA (I had joint pain) and NAUSEA (nauseated). 29-Mar-2021, the patient experienced FAECES DISCOLOURED (my stool turned bile colored) and VACCINATION SITE PAIN (My arm sore was sore at the injection site). In September 2021, ARTHRALGIA (I had left shoulder pain for 6 months) had resolved. At the time of the report, DIARRHOEA (had diarrhea), FAECES DISCOLOURED (my stool turned bile colored), ILLNESS (I was sick for months), ARTHRALGIA (I had joint pain), VACCINATION SITE PAIN (My arm sore was sore at the injection site) and NAUSEA (nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-386019, MOD-2021-386089 (Patient Link).