chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Fatigue
Clinical narrative: almost every symptom except for loss of taste and smell; nasal congestion; back aches; runny nose; sore throat; extreme fatigue; chills; Fever; joint pain/the pain was even in my knuckles; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell), NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), FATIGUE (extreme fatigue), CHILLS (chills), PYREXIA (Fever), ARTHRALGIA (joint pain/the pain was even in my knuckles) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event NOS, at a dose of 800 mg; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; VITAMIN D NOS for Adverse event, at a dose of 5000 unit; HYDROXYCHLOROQUINE for Adverse event, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) for Sinusitis, at an unspecified dose and frequency. On 25-Aug-2021, NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), FATIGUE (extreme fatigue), CHILLS (chills), PYREXIA (Fever), ARTHRALGIA (joint pain/the pain was even in my knuckles) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4f (High) Increased. On an unknown date, SARS-CoV-2 test: neagtive (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient reported that her doctor prescribed antibiotics. And also patient stated that she had using mucinex and something for her sinuses.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: almost every symptom except for loss of taste and smell; nasal congestion; back aches; runny nose; sore throat; extreme fatigue; chills; Fever; joint pain/the pain was even in my knuckles; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell), NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), FATIGUE (extreme fatigue), CHILLS (chills), PYREXIA (Fever), ARTHRALGIA (joint pain/the pain was even in my knuckles) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event NOS, at a dose of 800 mg; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; VITAMIN D NOS for Adverse event, at a dose of 5000 unit; HYDROXYCHLOROQUINE for Adverse event, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) for Sinusitis, at an unspecified dose and frequency. On 25-Aug-2021, NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), FATIGUE (extreme fatigue), CHILLS (chills), PYREXIA (Fever), ARTHRALGIA (joint pain/the pain was even in my knuckles) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4f (High) Increased. On an unknown date, SARS-CoV-2 test: neagtive (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient reported that her doctor prescribed antibiotics. And also patient stated that she had using mucinex and something for her sinuses.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination complication
Clinical narrative: almost every symptom except for loss of taste and smell; nasal congestion; back aches; runny nose; sore throat; extreme fatigue; chills; Fever; joint pain/the pain was even in my knuckles; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell), NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), FATIGUE (extreme fatigue), CHILLS (chills), PYREXIA (Fever), ARTHRALGIA (joint pain/the pain was even in my knuckles) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event NOS, at a dose of 800 mg; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; VITAMIN D NOS for Adverse event, at a dose of 5000 unit; HYDROXYCHLOROQUINE for Adverse event, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) for Sinusitis, at an unspecified dose and frequency. On 25-Aug-2021, NASAL CONGESTION (nasal congestion), BACK PAIN (back aches), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), FATIGUE (extreme fatigue), CHILLS (chills), PYREXIA (Fever), ARTHRALGIA (joint pain/the pain was even in my knuckles) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION COMPLICATION (almost every symptom except for loss of taste and smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4f (High) Increased. On an unknown date, SARS-CoV-2 test: neagtive (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient reported that her doctor prescribed antibiotics. And also patient stated that she had using mucinex and something for her sinuses.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Feeling abnormal, Myalgia, Neck pain
Clinical narrative: woke up extremely achy in shoulder and neck; all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck; everything ached; feeling kind of beat up after; Consumer states he was knocked out; This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (woke up extremely achy in shoulder and neck), ARTHRALGIA (all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck), MYALGIA (everything ached), FEELING ABNORMAL (feeling kind of beat up after) and FALL (Consumer states he was knocked out) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (he previously has pneumonia and was intubated). Concomitant products included APIXABAN (ELIQUIS), ROSUVASTATIN CALCIUM (CRESTOR), DOFETILIDE, COLCHICINE, PREDNISONE and LOSARTAN for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-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 NECK PAIN (woke up extremely achy in shoulder and neck), ARTHRALGIA (all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck), MYALGIA (everything ached), FEELING ABNORMAL (feeling kind of beat up after) and FALL (Consumer states he was knocked out). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (woke up extremely achy in shoulder and neck), ARTHRALGIA (all joints were achy, including wrist, knees, shoulder, and hips,woke up extremely achy in shoulder and neck), MYALGIA (everything ached), FEELING ABNORMAL (feeling kind of beat up after) and FALL (Consumer states he was knocked out) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-300373 (Patient Link).
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Product administered to patient of inappropriate age, SARS-CoV-2 test, Vaccination site swelling
Clinical narrative: patient had arm swelling at site of injection; fatigue; Twelve Year Old patient received the Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (patient had arm swelling at site of injection), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Twelve Year Old patient received the Moderna Covid-19 vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 17-Jul-2021.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Twelve Year Old patient received the Moderna Covid-19 vaccine). On 28-Aug-2021, the patient experienced VACCINATION SITE SWELLING (patient had arm swelling at site of injection) and FATIGUE (fatigue). On 27-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Twelve Year Old patient received the Moderna Covid-19 vaccine) had resolved. On 29-Aug-2021, FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE SWELLING (patient had arm swelling at site of injection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications are provided. No treatment  medications to the events were reported. Allergies to medications, food, and other products - NKDA   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Vaccine  information - Updated the start date and patient route of administration updated from the initial case.Significant follow up received on 01-SEP-2021 contains- Updated Patient demographics, Medical history,Added the dose number, Vaccine History and Updated  Events- Patient had arm swelling at site of injection, Fatigue and the non-drug treatment also updated.
Sex: F
Vaccine: COVID19
Symptoms: Fracture
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FRACTURE (Fractured cheek bone) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. Concurrent medical conditions included Steroid therapy (She is currently taking steroid). In April 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 an unknown date, the patient experienced FRACTURE (Fractured cheek bone). At the time of the report, FRACTURE (Fractured cheek bone) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment information was not reported. Patient received her 2nd dose APR2021 and the surgery was in JUL2021.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Head injury, Headache
Clinical narrative: feeling weak; hurt his head; headache / hurt his head; exhausted; nausea; muscle aches; joint aches; 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 ASTHENIA (feeling weak), HEAD INJURY (hurt his head), HEADACHE (headache / hurt his head), FATIGUE (exhausted) and NAUSEA (nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Aug-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 an unknown date, the patient experienced ASTHENIA (feeling weak), HEAD INJURY (hurt his head), HEADACHE (headache / hurt his head), FATIGUE (exhausted), NAUSEA (nausea), MYALGIA (muscle aches) and ARTHRALGIA (joint aches). At the time of the report, ASTHENIA (feeling weak), HEAD INJURY (hurt his head), HEADACHE (headache / hurt his head), FATIGUE (exhausted), NAUSEA (nausea), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: feeling weak; hurt his head; headache / hurt his head; exhausted; nausea; muscle aches; joint aches; 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 ASTHENIA (feeling weak), HEAD INJURY (hurt his head), HEADACHE (headache / hurt his head), FATIGUE (exhausted) and NAUSEA (nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Aug-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 an unknown date, the patient experienced ASTHENIA (feeling weak), HEAD INJURY (hurt his head), HEADACHE (headache / hurt his head), FATIGUE (exhausted), NAUSEA (nausea), MYALGIA (muscle aches) and ARTHRALGIA (joint aches). At the time of the report, ASTHENIA (feeling weak), HEAD INJURY (hurt his head), HEADACHE (headache / hurt his head), FATIGUE (exhausted), NAUSEA (nausea), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got the first dose of the Moderna vaccine on 14Jun2021 and has not gotten the second dose yet.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 14Jun2021 and has not gotten the second dose yet.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) 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 PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 14Jun2021 and has not gotten the second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 14Jun2021 and has not gotten the second dose yet.) 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.   As per source document HCP was calling to know about the second dose after getting the first dose on 14 june 2021. Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered to patient after improper storage and handling; Vaccine thawed then freezed then thawed then gven to the patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Vaccine thawed then freezed then thawed then gven to the patient) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS since 02-Aug-2021 and Post-traumatic stress disorder since 21-Jul-2021. Concomitant products included VENLAFAXINE from 14-Jul-2021 to an unknown date and OLANZAPINE (ZYPREXA) from 21-Jul-2021 to an unknown date for Mental disorder.    On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Vaccine thawed then freezed then thawed then gven to the patient). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) and EXPIRED PRODUCT ADMINISTERED (Vaccine thawed then freezed then thawed then gven to the patient) had resolved.        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 MOD21-136361 (E2B Linked Report). This case was linked to MOD-2021-299985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Patient details updated. Patient's relevant history updated. Vaccine information and vaccination facility information included. Concomitant medications included. New event- Expired vaccine used added.; Sender's Comments:  MOD21-136361:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Urine odour abnormal
Clinical narrative: Flu like symptoms normal side effects to be expected after vaccine; My urine has a strange smell after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms normal side effects to be expected after vaccine) and URINE ODOUR ABNORMAL (My urine has a strange smell after receiving the vaccine) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023D21A and E53E21A) for COVID-19 vaccination.     No medical history information  was reported.  Concomitant products included INSULIN ASPART (NOVOLOG) and LEVOTHYROXINE SODIUM (TIROSINT) for an unknown indication.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms normal side effects to be expected after vaccine) and URINE ODOUR ABNORMAL (My urine has a strange smell after receiving the vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms normal side effects to be expected after vaccine) and URINE ODOUR ABNORMAL (My urine has a strange smell after receiving the vaccine) had not resolved.            The treatment information was  not provided.  It was reported that patient experienced the events after first dose of vaccine and its still continues
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old) in a 15-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    The concomitant medications were not reported. The treatment information was not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: have used a vial ( Lot # 004F21A ) that was first punctured yesterday ( 26Aug2021 ) at 8:28 am; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (have used a vial ( Lot # 004F21A ) that was first punctured yesterday ( 26Aug2021 ) at 8:28 am) in a 47-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (have used a vial ( Lot # 004F21A ) that was first punctured yesterday ( 26Aug2021 ) at 8:28 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (have used a vial ( Lot # 004F21A ) that was first punctured yesterday ( 26Aug2021 ) at 8:28 am) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vials that were more than 30 days in refrigerator administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials that were more than 30 days in refrigerator administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) 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 (Vials that were more than 30 days in refrigerator administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials that were more than 30 days in refrigerator administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vials that were more than 30 days in refrigerator administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) 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 (vials that were more than 30 days in refrigerator administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients) 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.   No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vials that were more than 30 days in refrigerator administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) 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 EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients) 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 medication were provided by the reporter. No treatment medication were provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Lacrimation increased, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19; A cold; Cough; Watery eyes; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for COVID-19), NASOPHARYNGITIS (A cold), COUGH (Cough) and LACRIMATION INCREASED (Watery eyes) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included OXYGEN for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced COVID-19 (Patient tested positive for COVID-19), NASOPHARYNGITIS (A cold), COUGH (Cough) and LACRIMATION INCREASED (Watery eyes). At the time of the report, COVID-19 (Patient tested positive for COVID-19), NASOPHARYNGITIS (A cold), COUGH (Cough) and LACRIMATION INCREASED (Watery eyes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, SARS-CoV-2 test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant drug included sugar pill, blood pressure medications and COPD medications. Treatment medication was not reported.  it was reported that cold lasted for 3-4 days.   This case was linked to MOD-2021-299886 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vials that were more than 30 days in refrigerator administered to patients; Out of specification product use; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vials that were more than 30 days in refrigerator administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Out of specification product use) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) 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 PRODUCT STORAGE ERROR (vials that were more than 30 days in refrigerator administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Out of specification product use). At the time of the report, PRODUCT STORAGE ERROR (vials that were more than 30 days in refrigerator administered to patients) and POOR QUALITY PRODUCT ADMINISTERED (Out of specification product use) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment history was reported. HCP would like to know what to do with patients who received doses from vials that were more than 30 days in the refrigerator. They were stored from 2 to 8 °C.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (general fever after the first dose) and headache (little headache after the first dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jul 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (general fever after the first dose) and headache (little headache after the first dose). Patient treated with Tylenol (paracetamol) for fever, at an unspecified dose and frequency. At the time of the report, pyrexia (general fever after the first dose) and headache (little headache after the first dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported. This case linked to MOD-2021-300046 (patient link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Depression, Fatigue
Clinical narrative: Woke up with stiff neck; Hip hurts; Depression; It is bad; Has no energy; Gotten sick from the shot/Is so sick; Very tired; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Woke up with stiff neck), ARTHRALGIA (Hip hurts), DEPRESSION (Depression), FEELING ABNORMAL (It is bad) and ASTHENIA (Has no energy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arteriovenous malformations (flowing vein" or swollen vein in the skull by the eye) in 2009. Concomitant products included WARFARIN and WARFARIN for Deep vein thrombosis, TOPIRAMATE for Headache, VENLAFAXINE and CITALOPRAM for an unknown indication.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-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 MUSCULOSKELETAL STIFFNESS (Woke up with stiff neck), ARTHRALGIA (Hip hurts), DEPRESSION (Depression), FEELING ABNORMAL (It is bad), ASTHENIA (Has no energy), MALAISE (Gotten sick from the shot/Is so sick), FATIGUE (Very tired), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, MUSCULOSKELETAL STIFFNESS (Woke up with stiff neck), ARTHRALGIA (Hip hurts), DEPRESSION (Depression), FEELING ABNORMAL (It is bad), ASTHENIA (Has no energy), MALAISE (Gotten sick from the shot/Is so sick), FATIGUE (Very tired), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 virus test was positive.         The treatment information was not provided.  Patient had swollen vein  behind the neck in 2009 and she still wears a neck brace that "pumps up and stretches the skull.   This case was linked to MOD-2021-299861 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Musculoskeletal stiffness, SARS-CoV-2 test
Clinical narrative: Woke up with stiff neck; Hip hurts; Depression; It is bad; Has no energy; Gotten sick from the shot/Is so sick; Very tired; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Woke up with stiff neck), ARTHRALGIA (Hip hurts), DEPRESSION (Depression), FEELING ABNORMAL (It is bad) and ASTHENIA (Has no energy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arteriovenous malformations (flowing vein" or swollen vein in the skull by the eye) in 2009. Concomitant products included WARFARIN and WARFARIN for Deep vein thrombosis, TOPIRAMATE for Headache, VENLAFAXINE and CITALOPRAM for an unknown indication.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-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 MUSCULOSKELETAL STIFFNESS (Woke up with stiff neck), ARTHRALGIA (Hip hurts), DEPRESSION (Depression), FEELING ABNORMAL (It is bad), ASTHENIA (Has no energy), MALAISE (Gotten sick from the shot/Is so sick), FATIGUE (Very tired), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, MUSCULOSKELETAL STIFFNESS (Woke up with stiff neck), ARTHRALGIA (Hip hurts), DEPRESSION (Depression), FEELING ABNORMAL (It is bad), ASTHENIA (Has no energy), MALAISE (Gotten sick from the shot/Is so sick), FATIGUE (Very tired), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Aug-2021, SARS-CoV-2 test: positive (Positive) COVID-19 virus test was positive.         The treatment information was not provided.  Patient had swollen vein  behind the neck in 2009 and she still wears a neck brace that "pumps up and stretches the skull.   This case was linked to MOD-2021-299861 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: COVID-19; Got very sick; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) and ILLNESS (Got very sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome and Immunocompromised.   In May 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 an unknown date, the patient experienced COVID-19 (COVID-19) and ILLNESS (Got very sick). At the time of the report, COVID-19 (COVID-19) and ILLNESS (Got very sick) 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 were reported.  The patient was treated with high dose steroids.   Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Less than 25 days for administration of second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days for administration of second dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included Colectomy and Cholecystectomy (Patient ended up with some scar tissue, which does bother him from time to time.) in February 2020. Concomitant products included ALOPURINOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), OMEPRAZOLE, AMLODIPINE and VALSARTAN for an unknown indication.    On 07-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days for administration of second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 25 days for administration of second dose) had resolved.            Treatment information was not  provided.   This case was linked to MOD-2021-299901 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Mobility decreased, Neck pain, Pain
Clinical narrative: Neck pain in the back of her neck; Terrible feeling.; She can't even drive in the car because her neck is so tight/, she can't turn to left, right; Is so severe it won't go away/pain gets more and more severe, she is still experiencing it/it was going up into the back of her head/pain is continuous/so severe it won't go away; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain in the back of her neck), FEELING ABNORMAL (Terrible feeling.), MOBILITY DECREASED (She can't even drive in the car because her neck is so tight/, she can't turn to left, right) and PAIN (Is so severe it won't go away/pain gets more and more severe, she is still experiencing it/it was going up into the back of her head/pain is continuous/so severe it won't go away) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 063E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-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 NECK PAIN (Neck pain in the back of her neck), FEELING ABNORMAL (Terrible feeling.), MOBILITY DECREASED (She can't even drive in the car because her neck is so tight/, she can't turn to left, right) and PAIN (Is so severe it won't go away/pain gets more and more severe, she is still experiencing it/it was going up into the back of her head/pain is continuous/so severe it won't go away). At the time of the report, NECK PAIN (Neck pain in the back of her neck) and PAIN (Is so severe it won't go away/pain gets more and more severe, she is still experiencing it/it was going up into the back of her head/pain is continuous/so severe it won't go away) had not resolved and FEELING ABNORMAL (Terrible feeling.) and MOBILITY DECREASED (She can't even drive in the car because her neck is so tight/, she can't turn to left, right) outcome was unknown.            No concomitant medications reported.  No treatment information was reported by reporter.  Crossed linked-MOD21-136252, MOD21-136310, MOD21-136311
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBIN DECREASED (A steady decline in my hemoglobin levels) 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 February 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 HAEMOGLOBIN DECREASED (A steady decline in my hemoglobin levels). At the time of the report, HAEMOGLOBIN DECREASED (A steady decline in my hemoglobin levels) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: 10 (Low) Decreased. Patient used to run hemoglobin 14 but now it decreased to 10. Patient does not have any life style changes and don`t have uterus. Concomitant medications were not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Illness, Pyrexia
Clinical narrative: Feeling weak; Ill; Temp of 100.2; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak), ILLNESS (Ill) and PYREXIA (Temp of 100.2) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Organizing pneumonia. Concurrent medical conditions included COPD.    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 ASTHENIA (Feeling weak), ILLNESS (Ill) and PYREXIA (Temp of 100.2). At the time of the report, ASTHENIA (Feeling weak), ILLNESS (Ill) and PYREXIA (Temp of 100.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) high.         No concomitant medication was provided.  No treatment medication was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Dose administered to patient after improper storage and handling; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cough syrup), Penicillin allergy (PCN), Hypertension (HTN) since 27-Feb-2020 and Hepatitis C (Hep c) since 27-Feb-2020. Concomitant products included AMLODIPINE BESILATE (AMLOPINE) from 05-Aug-2021 to an unknown date for Blood pressure high, ATORVASTATIN from 28-Jul-2021 to an unknown date, MIRTAZAPINE from 05-Aug-2021 to an unknown date and PANTOPRAZOLE from 05-Aug-2021 to an unknown date for an unknown indication.   On 26-Aug-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 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Reporter states that they received 100 vials out of this one of the vials was taken out of the freezer on 26 Aug 2021 and thawed. Seven vaccination shots were given to patients on 26 Aug 2021. Some patients were given their first shots and some were given their 2nd shot and the remaining 90 vials were disposed  on 27 Aug 2021 along with the one used vial.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-Sep-2021 contains significant information includes Reporter's address, Patient demographics (Height, Weight, Race and age at vaccination), Medical history, Suspect product anatomical location, Concomitant products(Strength, route, start date and indication) and event outcome.