chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: What do I do if I have administered an expired vaccine to a patient / an expired vaccine was given to up to 38 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (What do I do if I have administered an expired vaccine to a patient / an expired vaccine was given to up to 38 patients) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (What do I do if I have administered an expired vaccine to a patient / an expired vaccine was given to up to 38 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (What do I do if I have administered an expired vaccine to a patient / an expired vaccine was given to up to 38 patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not reported. No treatment medication was not reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up Document received on 15-JUN-2021 contains no significant information
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: popped blood vessel in the eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (popped blood vessel in the eye) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (popped blood vessel in the eye). At the time of the report, EYE SWELLING (popped blood vessel in the eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Muscular weakness
Clinical narrative: weakness in legs; some shortness of breath; This spontaneous case was reported by a nurse and describes the occurrence of MUSCULAR WEAKNESS (weakness in legs) and DYSPNOEA (some shortness of breath) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LISINOPRIL and FUROSEMIDE for an unknown indication.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs) and DYSPNOEA (some shortness of breath). At the time of the report, MUSCULAR WEAKNESS (weakness in legs) and DYSPNOEA (some shortness of breath) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-222370 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Whole body ache after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Whole body ache after 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 MYALGIA (Whole body ache after 2nd shot). At the time of the report, MYALGIA (Whole body ache after 2nd shot) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Product dose omission issue
Clinical narrative: missed the second dose of the Moderna COVID-19 vaccine; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and PRODUCT DOSE OMISSION ISSUE (missed the second dose of the Moderna COVID-19 vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose of the Moderna COVID-19 vaccine). At the time of the report, FATIGUE (fatigue) and PRODUCT DOSE OMISSION ISSUE (missed the second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient missed the second dose vaccine. The patient reported those symptoms seemed to gone away and did not take any medication to try alleviate the symptom.  The patient had  second dose scheduled on 18 jun2021.   Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up information received on 15/Jun/2021: processed with initial report, reporter's email address added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Diarrhoea, Myalgia, Nausea
Clinical narrative: Diarrhea; Crushing chest pain that comes and go; Nauseous; vomiting; Fever at 102.4 degrees Fahrenheit; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHEST PAIN (Crushing chest pain that comes and go), MYALGIA (Sore arm), NAUSEA (Nauseous) and VOMITING (vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced MYALGIA (Sore arm). On 13-Jun-2021, the patient experienced DIARRHOEA (Diarrhea), CHEST PAIN (Crushing chest pain that comes and go), NAUSEA (Nauseous), VOMITING (vomiting) and PYREXIA (Fever at 102.4 degrees Fahrenheit). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Myalgia, Diarrhoea, Nausea, Vomiting, Chest pain and Pyrexia, at an unspecified dose and frequency and ALPRAZOLAM (XANAX) for Chest pain, Nausea, Diarrhoea, Vomiting, Myalgia and Pyrexia, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), CHEST PAIN (Crushing chest pain that comes and go), MYALGIA (Sore arm), NAUSEA (Nauseous), VOMITING (vomiting) and PYREXIA (Fever at 102.4 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jun-2021, Body temperature: 102.4 (High) 102.4 degree Fahrenheit.     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 medication was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Diarrhea; Crushing chest pain that comes and go; Nauseous; vomiting; Fever at 102.4 degrees Fahrenheit; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), CHEST PAIN (Crushing chest pain that comes and go), MYALGIA (Sore arm), NAUSEA (Nauseous) and VOMITING (vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced MYALGIA (Sore arm). On 13-Jun-2021, the patient experienced DIARRHOEA (Diarrhea), CHEST PAIN (Crushing chest pain that comes and go), NAUSEA (Nauseous), VOMITING (vomiting) and PYREXIA (Fever at 102.4 degrees Fahrenheit). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Myalgia, Diarrhoea, Nausea, Vomiting, Chest pain and Pyrexia, at an unspecified dose and frequency and ALPRAZOLAM (XANAX) for Chest pain, Nausea, Diarrhoea, Vomiting, Myalgia and Pyrexia, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), CHEST PAIN (Crushing chest pain that comes and go), MYALGIA (Sore arm), NAUSEA (Nauseous), VOMITING (vomiting) and PYREXIA (Fever at 102.4 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jun-2021, Body temperature: 102.4 (High) 102.4 degree Fahrenheit.     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 medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) 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 14-Jun-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021 at 8:30 AM, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Hypotension, Oedema peripheral, Tachycardia
Clinical narrative: shortness of breath; low blood pressure; tachycardia; edema of feet and ankles; This spontaneous case was reported by a nurse and describes the occurrence of DYSPNOEA (shortness of breath), HYPOTENSION (low blood pressure), TACHYCARDIA (tachycardia) and OEDEMA PERIPHERAL (edema of feet and ankles) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and FUROSEMIDE for an unknown indication.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), HYPOTENSION (low blood pressure), TACHYCARDIA (tachycardia) and OEDEMA PERIPHERAL (edema of feet and ankles). At the time of the report, DYSPNOEA (shortness of breath), HYPOTENSION (low blood pressure), TACHYCARDIA (tachycardia) and OEDEMA PERIPHERAL (edema of feet and ankles) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Echocardiogram: inconclusive (Inconclusive) Test showed Low ejection fraction.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-222316 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Arm has pretty large bump; Arm is warm; Arm is pink; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm has pretty large bump), FEELING HOT (Arm is warm) and ERYTHEMA (Arm is pink) 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 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 PERIPHERAL SWELLING (Arm has pretty large bump), FEELING HOT (Arm is warm) and ERYTHEMA (Arm is pink). At the time of the report, PERIPHERAL SWELLING (Arm has pretty large bump), FEELING HOT (Arm is warm) and ERYTHEMA (Arm is pink) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm hurt so bad) 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 (my arm hurt so bad). At the time of the report, PAIN IN EXTREMITY (my arm hurt so bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Achiness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Achiness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Achiness at the injection site). At the time of the report, VACCINATION SITE PAIN (Achiness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Feeling hot, Skin exfoliation
Clinical narrative: Arm was baked in the sun; Dry; Flaky; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm was baked in the sun), DRY SKIN (Dry) and SKIN EXFOLIATION (Flaky) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concomitant products included VERAPAMIL for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Arm was baked in the sun), DRY SKIN (Dry) and SKIN EXFOLIATION (Flaky). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 800 milligram. At the time of the report, FEELING HOT (Arm was baked in the sun), DRY SKIN (Dry) and SKIN EXFOLIATION (Flaky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in the sub clavicular area; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node in the sub clavicular area) in a 28-year-old patient of an unknown 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 LYMPHADENOPATHY (Swollen lymph node in the sub clavicular area). At the time of the report, LYMPHADENOPATHY (Swollen lymph node in the sub clavicular area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose administered beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered beyond use date). On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The nurse had administered the second dose of vaccine to the patients and the dose had a threw date of 29-Apr-2021 and do not use date of 29-May-2021. The patient did not have any reaction to the dose that was administered and were therefore discharged. The nurse was unable to answer all the medical questions as the nurse no longer had access to the patient's records and the patient was gone from the facility.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Significant followup : route and site of administration, lot number and expiration date updated for dose 2 of suspect vaccine, updated patient demographics (ethnicity and ethnic group), updated facility information and an updated narrative
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered about 24 hours after 1st puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered about 24 hours after 1st puncture) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03acz1a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered about 24 hours after 1st puncture). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered about 24 hours after 1st puncture) 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 and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Feeling hot, Nasopharyngitis
Clinical narrative: body temperature always feels warm/very warm; very warm; normally run cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (body temperature always feels warm/very warm), NASOPHARYNGITIS (normally run cold) and FEELING HOT (very warm) 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 BODY TEMPERATURE INCREASED (body temperature always feels warm/very warm), NASOPHARYNGITIS (normally run cold) and FEELING HOT (very warm). At the time of the report, BODY TEMPERATURE INCREASED (body temperature always feels warm/very warm), NASOPHARYNGITIS (normally run cold) and FEELING HOT (very warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Malaise, Pain, Sluggishness, Tongue ulceration
Clinical narrative: Ulcers on both side of tongue; A red rashy patch on the injection arm; A red rashy patch on the injection arm; That is sore to the touch; Hurt him to get up; Feeling Ill; Back pain; Sluggish; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling Ill), BACK PAIN (Back pain), SLUGGISHNESS (Sluggish), TONGUE ULCERATION (Ulcers on both side of tongue) and PAIN (Hurt him to get up) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VERAPAMIL for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced MALAISE (Feeling Ill), BACK PAIN (Back pain) and SLUGGISHNESS (Sluggish). On 12-Jun-2021, the patient experienced PAIN (Hurt him to get up). On 15-Jun-2021, the patient experienced TONGUE ULCERATION (Ulcers on both side of tongue), VACCINATION SITE ERYTHEMA (A red rashy patch on the injection arm), VACCINATION SITE RASH (A red rashy patch on the injection arm) and VACCINATION SITE PAIN (That is sore to the touch). The patient was treated with IBUPROFEN at a dose of 800 milligram. At the time of the report, MALAISE (Feeling Ill), BACK PAIN (Back pain), SLUGGISHNESS (Sluggish), TONGUE ULCERATION (Ulcers on both side of tongue), PAIN (Hurt him to get up), VACCINATION SITE ERYTHEMA (A red rashy patch on the injection arm), VACCINATION SITE RASH (A red rashy patch on the injection arm) and VACCINATION SITE PAIN (That is sore to the touch) outcome was unknown.            This case was linked to MOD-2021-222399 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Ulcers on both side of tongue; A red rashy patch on the injection arm; A red rashy patch on the injection arm; That is sore to the touch; Hurt him to get up; Feeling Ill; Back pain; Sluggish; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling Ill), BACK PAIN (Back pain), SLUGGISHNESS (Sluggish), TONGUE ULCERATION (Ulcers on both side of tongue) and PAIN (Hurt him to get up) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VERAPAMIL for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced MALAISE (Feeling Ill), BACK PAIN (Back pain) and SLUGGISHNESS (Sluggish). On 12-Jun-2021, the patient experienced PAIN (Hurt him to get up). On 15-Jun-2021, the patient experienced TONGUE ULCERATION (Ulcers on both side of tongue), VACCINATION SITE ERYTHEMA (A red rashy patch on the injection arm), VACCINATION SITE RASH (A red rashy patch on the injection arm) and VACCINATION SITE PAIN (That is sore to the touch). The patient was treated with IBUPROFEN at a dose of 800 milligram. At the time of the report, MALAISE (Feeling Ill), BACK PAIN (Back pain), SLUGGISHNESS (Sluggish), TONGUE ULCERATION (Ulcers on both side of tongue), PAIN (Hurt him to get up), VACCINATION SITE ERYTHEMA (A red rashy patch on the injection arm), VACCINATION SITE RASH (A red rashy patch on the injection arm) and VACCINATION SITE PAIN (That is sore to the touch) outcome was unknown.            This case was linked to MOD-2021-222399 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Left arm was very sore for two days; Very tired for one week; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Very tired for one week) and MYALGIA (Left arm was very sore for two days) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced FATIGUE (Very tired for one week). On 09-Jun-2021, the patient experienced MYALGIA (Left arm was very sore for two days). On 09-Jun-2021, FATIGUE (Very tired for one week) had resolved. On 11-Jun-2021, MYALGIA (Left arm was very sore for two days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Vaccination site pain
Clinical narrative: Muscle tensed up from injection site into side of neck after 1st dose; Injection site sore after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Muscle tensed up from injection site into side of neck after 1st dose) and VACCINATION SITE PAIN (Injection site sore after 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0u7bz1a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (Muscle tensed up from injection site into side of neck after 1st dose) and VACCINATION SITE PAIN (Injection site sore after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, MUSCLE TIGHTNESS (Muscle tensed up from injection site into side of neck after 1st dose) and VACCINATION SITE PAIN (Injection site sore after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Followup received on 16 Jul 2021: Event outcome updated
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Myalgia, Tooth fracture
Clinical narrative: soreness in each arm after each vaccine dose; Found a crack in a tooth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (Found a crack in a tooth) and MYALGIA (soreness in each arm after each vaccine dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008L20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Migraine headache. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MULTIVITAMIN [VITAMINS NOS], VITAMIN D3, ACETYLSALICYLIC ACID (ASPIRIN 81), PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]), IBUPROFEN (ADVIL [IBUPROFEN]) and ZINC for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced TOOTH FRACTURE (Found a crack in a tooth). On an unknown date, the patient experienced MYALGIA (soreness in each arm after each vaccine dose). At the time of the report, TOOTH FRACTURE (Found a crack in a tooth) and MYALGIA (soreness in each arm after each vaccine dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) blood testing showed had antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 16 Mar 2021 , the patient reported gave a blood transfusion donation and was told blood testing showed had antibodies.  No treatment information was provided.   This case was linked to MOD-2021-222516 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired first dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN, ALLOPURINOL, LOSARTAN and SILDENAFIL for an unknown indication.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired first dose). On 14-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Having an allergic reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Having an allergic reaction) 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 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced ALLERGY TO VACCINE (Having an allergic reaction). At the time of the report, ALLERGY TO VACCINE (Having an allergic reaction) outcome was unknown.            No concomitant medication was provided. No treatment medication was provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Neck and Spine Problem; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Neck and Spine Problem) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Spinal canal stenosis (Narrowing of Spinal Canal about 3 years ago).    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Neck and Spine Problem). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Neck and Spine Problem) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.  The reporter stated that Patient had to receive epidural injection on 16JUN2021 in the Neck and Spine.    Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up was received and event outcome was updated from unknown to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product administered to patient of inappropriate age
Clinical narrative: She is real sick; My child that got the vaccine( got the vaccine under 18 years of age); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She is real sick) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My child that got the vaccine( got the vaccine under 18 years of age)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She is real sick) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My child that got the vaccine( got the vaccine under 18 years of age)). At the time of the report, ILLNESS (She is real sick) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My child that got the vaccine( got the vaccine under 18 years of age)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
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 provided by reporter. No treatment information was provided.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Product administered to patient of inappropriate age; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 years old received the moderna vaccine) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Acne on 09-Nov-2020, Asthma on 25-Sep-2018 and ADHD on 10-May-2018. Concurrent medical conditions included Allergic reaction to antibiotics (Amoxicillin), Allergic reaction to antibiotics (Rocephin), Allergic rhinitis due to pollen on 17-May-2021 and Environmental allergy since 10-May-2018. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 17-May-2021 to an unknown date for Allergy, FLUTICASONE from 11-Oct-2017 to an unknown date for Allergy and Asthma.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 years old received the moderna vaccine). On 15-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient less than 18 years old received the moderna vaccine) 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.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Medical history, Patient race information, Concomitant drugs and route of administration was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Erythema, Fatigue, Illness
Clinical narrative: I felt like I had the flu; Arm swelled; Felt sick; Red mark like a sunburn; Had 100.2 fever; Aches in joints; I felt tired that night; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I felt like I had the flu), PERIPHERAL SWELLING (Arm swelled), ILLNESS (Felt sick), ERYTHEMA (Red mark like a sunburn) and PYREXIA (Had 100.2 fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (I felt tired that night). On 05-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (I felt like I had the flu), PERIPHERAL SWELLING (Arm swelled), ILLNESS (Felt sick), ERYTHEMA (Red mark like a sunburn), PYREXIA (Had 100.2 fever) and ARTHRALGIA (Aches in joints). The patient was treated with CALAMINE for Symptomatic treatment, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of arthritis strength Tylenol. On 06-Jun-2021, INFLUENZA LIKE ILLNESS (I felt like I had the flu), PERIPHERAL SWELLING (Arm swelled), ILLNESS (Felt sick), ERYTHEMA (Red mark like a sunburn), PYREXIA (Had 100.2 fever), ARTHRALGIA (Aches in joints) and FATIGUE (I felt tired that night) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, Body temperature: 100.2 (High) fever.         Concomitant information not provided   This case was linked to MOD-2021-187158 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Peripheral swelling, Pyrexia
Clinical narrative: I felt like I had the flu; Arm swelled; Felt sick; Red mark like a sunburn; Had 100.2 fever; Aches in joints; I felt tired that night; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I felt like I had the flu), PERIPHERAL SWELLING (Arm swelled), ILLNESS (Felt sick), ERYTHEMA (Red mark like a sunburn) and PYREXIA (Had 100.2 fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (I felt tired that night). On 05-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (I felt like I had the flu), PERIPHERAL SWELLING (Arm swelled), ILLNESS (Felt sick), ERYTHEMA (Red mark like a sunburn), PYREXIA (Had 100.2 fever) and ARTHRALGIA (Aches in joints). The patient was treated with CALAMINE for Symptomatic treatment, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of arthritis strength Tylenol. On 06-Jun-2021, INFLUENZA LIKE ILLNESS (I felt like I had the flu), PERIPHERAL SWELLING (Arm swelled), ILLNESS (Felt sick), ERYTHEMA (Red mark like a sunburn), PYREXIA (Had 100.2 fever), ARTHRALGIA (Aches in joints) and FATIGUE (I felt tired that night) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, Body temperature: 100.2 (High) fever.         Concomitant information not provided   This case was linked to MOD-2021-187158 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Nasopharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: Missed to receive the 2nd dose of Moderna vaccine; cold; fever; Tested positive for Covid infection by mid April after receiving the 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed to receive the 2nd dose of Moderna vaccine), NASOPHARYNGITIS (cold), PYREXIA (fever) and COVID-19 (Tested positive for Covid infection by mid April after receiving the 1st dose of vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed to receive the 2nd dose of Moderna vaccine), NASOPHARYNGITIS (cold), PYREXIA (fever) and COVID-19 (Tested positive for Covid infection by mid April after receiving the 1st dose of vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed to receive the 2nd dose of Moderna vaccine) had resolved and NASOPHARYNGITIS (cold), PYREXIA (fever) and COVID-19 (Tested positive for Covid infection by mid April after receiving the 1st dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder hurt; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder hurt) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ARTHRALGIA (Shoulder hurt). At the time of the report, ARTHRALGIA (Shoulder hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. The patient had her second dose in February. Her shoulder was still hurting at the time of the reporting.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine) 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 MIGRAINE (migraine). At the time of the report, MIGRAINE (migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.