chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-404656 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Vaccinated after the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Vaccinated after the excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Vaccinated after the excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Vaccinated after the excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-403721 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Moderna vaccine  3 months after a Johnson and Johnson vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Moderna vaccine  3 months after a Johnson and Johnson vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Moderna vaccine  3 months after a Johnson and Johnson vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Moderna vaccine  3 months after a Johnson and Johnson vaccine) had resolved.            No concomitant medications provided.  No treatment medications provided.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR. At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Pruritus, Pyrexia, Vaccination site pain
Clinical narrative: Had a covid arm; Redness; Itchiness; 100 degree fever; soreness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Had a covid arm), ERYTHEMA (Redness), PRURITUS (Itchiness), PYREXIA (100 degree fever) and VACCINATION SITE PAIN (soreness at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04262A and 003A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, AMLODIPINE, LEVOTHYROXINE, ALENDRONATE SODIUM (ALENDRONATE), BUSPIRONE and BACLOFEN for an unknown indication.   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 an unknown date, the patient experienced VACCINATION SITE REACTION (Had a covid arm), ERYTHEMA (Redness), PRURITUS (Itchiness), PYREXIA (100 degree fever) and VACCINATION SITE PAIN (soreness at injection site). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Had a covid arm), ERYTHEMA (Redness), PRURITUS (Itchiness), PYREXIA (100 degree fever) and VACCINATION SITE PAIN (soreness at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degree fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other treatment medication included Steroid cream, for Adverse event.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Had a covid arm; Redness; Itchiness; 100 degree fever; soreness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Had a covid arm), ERYTHEMA (Redness), PRURITUS (Itchiness), PYREXIA (100 degree fever) and VACCINATION SITE PAIN (soreness at injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04262A and 003A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, AMLODIPINE, LEVOTHYROXINE, ALENDRONATE SODIUM (ALENDRONATE), BUSPIRONE and BACLOFEN for an unknown indication.   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 an unknown date, the patient experienced VACCINATION SITE REACTION (Had a covid arm), ERYTHEMA (Redness), PRURITUS (Itchiness), PYREXIA (100 degree fever) and VACCINATION SITE PAIN (soreness at injection site). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Had a covid arm), ERYTHEMA (Redness), PRURITUS (Itchiness), PYREXIA (100 degree fever) and VACCINATION SITE PAIN (soreness at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degree fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other treatment medication included Steroid cream, for Adverse event.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Arm is sore on her left; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Arm is sore on her left) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 044A21A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 03-Dec-2021, the patient experienced VACCINATION SITE PAIN (Arm is sore on her left). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 02-Dec-2021, PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm is sore on her left) 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.  The patient was worried that ever since she had her 1st and 2nd shots, she keeps on having the pain on both arms where she had her shots.   This case was linked to MOD-2021-404746, MOD-2021-404747 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccinated after the excursion; Product storage error; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) and PRODUCT STORAGE ERROR (Product storage error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-403721 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia
Clinical narrative: slight fever overnight; lethargic for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever overnight) and LETHARGY (lethargic for 24 hours) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included IMIPRAMINE 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 03-Mar-2021, the patient experienced PYREXIA (slight fever overnight) and LETHARGY (lethargic for 24 hours). The patient was treated with PREDNISONE for Adverse event, at a dose of 2 days of 50 mg; PREDNISONE for Adverse event, at a dose of 2 days of 40mg; PREDNISONE for Adverse event, at a dose of 1 day of 30mg and HYDROXYZINE HCL for Adverse event, at a dose of 10mg at night. On 04-Mar-2021, LETHARGY (lethargic for 24 hours) had resolved. At the time of the report, PYREXIA (slight fever overnight) 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.   This case was linked to MOD-2021-404689, MOD-2021-404690 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain). At the time of the report, PAIN IN EXTREMITY (leg pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Doses given after 20 minutes temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after 20 minutes temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after 20 minutes temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses given after 20 minutes temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment medications were not provided.  The vial had a 20 minute excursion in the freezer.   This case was linked to MOD-2021-403721, MOD-2021-404722 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Feeling dizzy). At the time of the report, DIZZINESS (Feeling dizzy) outcome was unknown.            Concomitant product use was not provider by the reporter.  Treatment information was not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 029L20A and 077C21B) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, SARS-CoV-2 antibody test: 189.0 u/ml (High) SARS-COV-2 antibody level equal to 189.0 U/ml.         No Concomitant and treatment medication were reported.   This case was linked to MOD-2021-404590, MOD-2021-404658 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Feeling abnormal, Gait disturbance, Gastrooesophageal reflux disease
Clinical narrative: throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this; Can hardly walk; Going to die; Pale; Sweating; Acid reflux; Cant lay down/couldnt life head; Cough; Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DYSPNOEA (Difficulty breathing), INFECTION (throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this), GAIT DISTURBANCE (Can hardly walk) and FEELING ABNORMAL (Going to die) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040821A and 002821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced COUGH (Cough) and DYSPNOEA (Difficulty breathing). On an unknown date, the patient experienced INFECTION (throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this), GAIT DISTURBANCE (Can hardly walk), FEELING ABNORMAL (Going to die), PALLOR (Pale), HYPERHIDROSIS (Sweating), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and IMPAIRED QUALITY OF LIFE (Cant lay down/couldnt life head). The patient was treated with CODEINE for Cough, at an unspecified dose and frequency. At the time of the report, COUGH (Cough) had not resolved and DYSPNOEA (Difficulty breathing), INFECTION (throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this), GAIT DISTURBANCE (Can hardly walk), FEELING ABNORMAL (Going to die), PALLOR (Pale), HYPERHIDROSIS (Sweating), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and IMPAIRED QUALITY OF LIFE (Cant lay down/couldnt life head) outcome was unknown.            Concomitant product information not provided. Treatment medications also include antibiotics, allergy pills, used inhalers, spray for nose.  Patient stated in June the coughing went down and on July 8th it came back. Now the coughing is ongoing. Patient states she was told to quarantine for 14 days, when she went for her second dose. Consumer states she was not tested for COVID. Consumer also states she had COVID, as far as she known. Patient administered Pfizer booster dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Impaired quality of life, Infection, Pallor
Clinical narrative: throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this; Can hardly walk; Going to die; Pale; Sweating; Acid reflux; Cant lay down/couldnt life head; Cough; Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DYSPNOEA (Difficulty breathing), INFECTION (throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this), GAIT DISTURBANCE (Can hardly walk) and FEELING ABNORMAL (Going to die) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040821A and 002821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced COUGH (Cough) and DYSPNOEA (Difficulty breathing). On an unknown date, the patient experienced INFECTION (throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this), GAIT DISTURBANCE (Can hardly walk), FEELING ABNORMAL (Going to die), PALLOR (Pale), HYPERHIDROSIS (Sweating), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and IMPAIRED QUALITY OF LIFE (Cant lay down/couldnt life head). The patient was treated with CODEINE for Cough, at an unspecified dose and frequency. At the time of the report, COUGH (Cough) had not resolved and DYSPNOEA (Difficulty breathing), INFECTION (throat with a scope, and it was full of mucus. The doctor took much of it out as he could and said he had never seen any infection like this), GAIT DISTURBANCE (Can hardly walk), FEELING ABNORMAL (Going to die), PALLOR (Pale), HYPERHIDROSIS (Sweating), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and IMPAIRED QUALITY OF LIFE (Cant lay down/couldnt life head) outcome was unknown.            Concomitant product information not provided. Treatment medications also include antibiotics, allergy pills, used inhalers, spray for nose.  Patient stated in June the coughing went down and on July 8th it came back. Now the coughing is ongoing. Patient states she was told to quarantine for 14 days, when she went for her second dose. Consumer states she was not tested for COVID. Consumer also states she had COVID, as far as she known. Patient administered Pfizer booster dose.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: pain in the arm; Fatigue; Head ache; body ache; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), FATIGUE (Fatigue), HEADACHE (Head ache), MYALGIA (body ache) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-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 PAIN IN EXTREMITY (pain in the arm), FATIGUE (Fatigue), HEADACHE (Head ache), MYALGIA (body ache), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (pain in the arm), FATIGUE (Fatigue), HEADACHE (Head ache), MYALGIA (body ache), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.            Concomitant medications includes thyroid medications Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-404565 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pain in the arm; Fatigue; Head ache; body ache; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), FATIGUE (Fatigue), HEADACHE (Head ache), MYALGIA (body ache) and PYREXIA (low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-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 PAIN IN EXTREMITY (pain in the arm), FATIGUE (Fatigue), HEADACHE (Head ache), MYALGIA (body ache), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (pain in the arm), FATIGUE (Fatigue), HEADACHE (Head ache), MYALGIA (body ache), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown.            Concomitant medications includes thyroid medications Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-404565 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy
Clinical narrative: felt off; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL and LETHARGY in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A, 029A21A, and 939906) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included IMIPRAMINE 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 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 31-Mar-2021, the patient experienced FEELING ABNORMAL and LETHARGY. The patient was treated with PREDNISONE for Adverse event, at a dose of 2 days of 50 mg; PREDNISONE for Adverse event, at a dose of 2 days of 40mg; PREDNISONE for Adverse event, at a dose of 1 day of 30mg and HYDROXYZINE HCL for Adverse event, at a dose of 10mg at night. On 01-Apr-2021, FEELING ABNORMAL and LETHARGY had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-404634, MOD-2021-404690 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: This spontaneous case was reported by a respiratory therapist and describes the occurrence of SWELLING (swelling from armpit to beginning of breast tissue) 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 01-Dec-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling from armpit to beginning of breast tissue). At the time of the report, SWELLING (swelling from armpit to beginning of breast tissue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Potential expired dose given; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potential expired dose given) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potential expired dose given). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Potential expired dose given) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore right arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 024M20A) for COVID-19 immunization. No medical history reported. On Feb 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore right arm). At the time of the report, pain in extremity (sore right arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-404586, MOD-2021-404698 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Report adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report adverse event). At the time of the report, VACCINATION COMPLICATION (Report adverse event) 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 medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: having, it seem like side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having, it seem like side effects) 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 28-Nov-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 COMPLICATION (having, it seem like side effects). At the time of the report, VACCINATION COMPLICATION (having, it seem like side effects) 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 provided.   This case was linked to MOD-2021-404727 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Pain in extremity, Pruritus, Pustule
Clinical narrative: Developed pustules on arm that formed and burst; Have trouble raising arm; scratchy itchy red sore around arm; scratchy itchy red sore around arm; scratchy itchy red sore around arm; symptoms improved after receiving a booster dose; This spontaneous case was reported by a physician and describes the occurrence of PUSTULE (Developed pustules on arm that formed and burst), LIMB DISCOMFORT (Have trouble raising arm), ERYTHEMA (scratchy itchy red sore around arm), PRURITUS (scratchy itchy red sore around arm) and PAIN IN EXTREMITY (scratchy itchy red sore around arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 013M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included LOSARTAN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-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 PUSTULE (Developed pustules on arm that formed and burst), LIMB DISCOMFORT (Have trouble raising arm), ERYTHEMA (scratchy itchy red sore around arm), PRURITUS (scratchy itchy red sore around arm), PAIN IN EXTREMITY (scratchy itchy red sore around arm) and THERAPEUTIC RESPONSE UNEXPECTED (symptoms improved after receiving a booster dose). At the time of the report, PUSTULE (Developed pustules on arm that formed and burst), LIMB DISCOMFORT (Have trouble raising arm), ERYTHEMA (scratchy itchy red sore around arm), PRURITUS (scratchy itchy red sore around arm) and PAIN IN EXTREMITY (scratchy itchy red sore around arm) was resolving and THERAPEUTIC RESPONSE UNEXPECTED (symptoms improved after receiving a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-034126, MOD-2021-059296 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Developed pustules on arm that formed and burst; Have trouble raising arm; scratchy itchy red sore around arm; scratchy itchy red sore around arm; scratchy itchy red sore around arm; symptoms improved after receiving a booster dose; This spontaneous case was reported by a physician and describes the occurrence of PUSTULE (Developed pustules on arm that formed and burst), LIMB DISCOMFORT (Have trouble raising arm), ERYTHEMA (scratchy itchy red sore around arm), PRURITUS (scratchy itchy red sore around arm) and PAIN IN EXTREMITY (scratchy itchy red sore around arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 013M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included LOSARTAN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-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 PUSTULE (Developed pustules on arm that formed and burst), LIMB DISCOMFORT (Have trouble raising arm), ERYTHEMA (scratchy itchy red sore around arm), PRURITUS (scratchy itchy red sore around arm), PAIN IN EXTREMITY (scratchy itchy red sore around arm) and THERAPEUTIC RESPONSE UNEXPECTED (symptoms improved after receiving a booster dose). At the time of the report, PUSTULE (Developed pustules on arm that formed and burst), LIMB DISCOMFORT (Have trouble raising arm), ERYTHEMA (scratchy itchy red sore around arm), PRURITUS (scratchy itchy red sore around arm) and PAIN IN EXTREMITY (scratchy itchy red sore around arm) was resolving and THERAPEUTIC RESPONSE UNEXPECTED (symptoms improved after receiving a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-034126, MOD-2021-059296 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Caller stated that unlike the other times, she has been having very strong effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Caller stated that unlike the other times, she has been having very strong effects) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Caller stated that unlike the other times, she has been having very strong effects). At the time of the report, VACCINATION COMPLICATION (Caller stated that unlike the other times, she has been having very strong effects) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were given. No treatment information were given.   This case was linked to MOD-2021-404313, MOD-2021-404716 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination complication
Clinical narrative: Unlike the other times, she has been having very strong effects; First dose received on 07-Apr-2021 and second dose on 03-Oct-2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unlike the other times, she has been having very strong effects) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 07-Apr-2021 and second dose on 03-Oct-2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 002B21A and 012H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 07-Apr-2021 and second dose on 03-Oct-2021). On an unknown date, the patient experienced VACCINATION COMPLICATION (Unlike the other times, she has been having very strong effects). On 03-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 07-Apr-2021 and second dose on 03-Oct-2021) had resolved. At the time of the report, VACCINATION COMPLICATION (Unlike the other times, she has been having very strong effects) outcome was unknown.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-404313, MOD-2021-404712 (Patient Link).
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information were reported. patient states that SARSCOV2 VAC 50MCG/0.5ML IM, Moderna 3rd dose.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; Product storage error; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches all over, neck, back, etc.; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (Body aches all over, neck, back, etc.) 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.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches all over, neck, back, etc.). At the time of the report, MYALGIA (Body aches all over, neck, back, etc.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses given after temperature excursion; The vials had 20 mins of temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion). In 2021, EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; The vials had 20 mins of temperature excursion; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion). In 2021, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The facility had 20 minutes of excursion in the freezer with the Moderna COVID-19 stored vials. The excursion was on Sunday and the other health care professional was not informed until the doses were vaccinated.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: It seem like side effects; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (It seem like side effects) 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 28-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Nov-2021, the patient experienced VACCINATION COMPLICATION (It seem like side effects). At the time of the report, VACCINATION COMPLICATION (It seem like side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses given after temperature excursion; doses given after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (doses given after temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (doses given after temperature excursion). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion). On 28-Nov-2021, PRODUCT STORAGE ERROR (doses given after temperature excursion) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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.