chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects were minor; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects were minor) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Crohn's disease (auto immune ptoblems) and Inflammation (inflamation in her eyes and head). Concurrent medical conditions included Immune disorder (NOS) (krones and inflamation in her eyes and head).   On 01-Mar-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 VACCINATION COMPLICATION (side effects were minor). At the time of the report, VACCINATION COMPLICATION (side effects were minor) outcome was unknown.            No concomitant medications reported. Treatment information not reported.   This case was linked to MOD-2021-315273 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) 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.   Concomitant medication information not provided by the reporter.  Date refrigerated: 20-Apr-2021. Temperature changes (in F): 40.  Treatment information not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a dose from a vial first punctured more than 12 hours ago; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial first punctured more than 12 hours ago) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial first punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial first punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received on 10-Sep-2021 updated suspect lot number and expiration date.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered past the 30 day refrigeration time; administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Per reporter, some doses of the Moderna COVID Vaccine had been administered past the 30-day refrigeration time, with temperature fluctuations between 42-43 degrees Fahrenheit.  No treatment medications were reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Illness
Clinical narrative: constantly getting sick/ after second dose felt sick after a couple hours; Sore throat; It is like he is sweating every pinch of liquid out of his body; Headache; Fever; Cold chills; Fatigue; body pain; felt sick came back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), ILLNESS (felt sick came back) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (felt sick came back). On an unknown date, the patient experienced ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Cold chills), FATIGUE (Fatigue) and MYALGIA (body pain). At the time of the report, ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours) had resolved and OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), ILLNESS (felt sick came back), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Cold chills), FATIGUE (Fatigue) and MYALGIA (body pain) outcome was unknown.            No concomitant drug information  was provided. No Treatment drug information  was provided.  On 26-Aug-2021, the patient went to the emergency room, and they told him he does not have COVID. He was good for a week, then the symptoms came back.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: constantly getting sick/ after second dose felt sick after a couple hours; Sore throat; It is like he is sweating every pinch of liquid out of his body; Headache; Fever; Cold chills; Fatigue; body pain; felt sick came back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), ILLNESS (felt sick came back) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (felt sick came back). On an unknown date, the patient experienced ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Cold chills), FATIGUE (Fatigue) and MYALGIA (body pain). At the time of the report, ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours) had resolved and OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), ILLNESS (felt sick came back), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Cold chills), FATIGUE (Fatigue) and MYALGIA (body pain) outcome was unknown.            No concomitant drug information  was provided. No Treatment drug information  was provided.  On 26-Aug-2021, the patient went to the emergency room, and they told him he does not have COVID. He was good for a week, then the symptoms came back.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  Treatment information not reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Aggression
Clinical narrative: Tremendous increase in aggression; This spontaneous case was reported by a consumer and describes the occurrence of AGGRESSION (Tremendous increase in aggression) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products RISPERIDONE tablet for Irritability, Aggression and Autism and RISPERIDONE tablet for Irritability, Aggression and Autism.    Concurrent medical conditions included Autism, Intellectual disability, Irritability and Aggression. Concomitant products included CLONAZEPAM for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, RISPERIDONE (Oral) 2 milligram once a day and RISPERIDONE (Oral) .5 milligram once a day. In 2021, the patient experienced AGGRESSION (Tremendous increase in aggression). At the time of the report, AGGRESSION (Tremendous increase in aggression) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that on an unknown date ("for ages"), the patient started treatment with risperidone 2mg and 0.5mg for irritability and aggression related to autism.  On an unknown date, the patient received the COVID-19 vaccine (Moderna).  On an unknown date in 2021, during his last 90-day supply of risperidone, the patient experienced a tremendous increase in aggression, which had increased gradually over time, while taking that specific 90-day supply of risperidone. He reportedly broke furniture and attacked his mother in the car. The patient's mother originally thought the aggression was related to receiving the Moderna COVID-19 vaccine, but eventually she realized it was not likely related. On an unspecified date in 2021, the patient got a new bottle of risperidone 2mg, and within a couple days of taking the new bottle, the patient was back to normal. His mother attributed the increase in aggression specifically to the risperidone 2mg tablets and thought maybe they did not have enough of the active ingredient in them. She spoke with the patient's psychiatrist, but no changes in therapy were made. As of 27-Aug-2021, treatment with risperidone 2mg and 0.5mg was ongoing.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got COVID-19 and Miserable with symptoms exactly like we have virus again; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Got COVID-19 and Miserable with symptoms exactly like we have virus again) 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 COVID-19 (Got COVID-19 and Miserable with symptoms exactly like we have virus again). At the time of the report, COVID-19 (Got COVID-19 and Miserable with symptoms exactly like we have virus again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-315958.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered past the 30 day refrigeration time; Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Body aches; Fever of 102.2 (degrees Fahrenheit); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and PYREXIA (Fever of 102.2 (degrees Fahrenheit)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (Fever of 102.2 (degrees Fahrenheit)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 UNK. At the time of the report, MYALGIA (Body aches) was resolving and PYREXIA (Fever of 102.2 (degrees Fahrenheit)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: 102.2 (High) Fever of 102.2 degrees Fahrenheit.         No concomitant medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: received my 3rd Moderna vaccine yesterday and my armpit is tender; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (received my 3rd Moderna vaccine yesterday and my armpit is tender) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced AXILLARY PAIN (received my 3rd Moderna vaccine yesterday and my armpit is tender). At the time of the report, AXILLARY PAIN (received my 3rd Moderna vaccine yesterday and my armpit is tender) outcome was unknown.            No treatment medications were provided.  No concomitant medications were provided.  Patient  received 3rd Moderna vaccine yesterday, which resulted in tender armpit and enquiring whether that was normal? or not and denied to be followed by safety   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A, 042620A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (On chemo).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered past the 30 day refrigeration time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was reported.     On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) 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.   Concomitant information was not reported. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: events are ongoing; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (events are ongoing) 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 COMPLICATION (events are ongoing). At the time of the report, VACCINATION COMPLICATION (events are ongoing) had not resolved. Not Provided      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.   Patient was injected with Restylane Kysse in the lips. Three months later the patient had a touch up with Restylane Defyne. Five weeks post injection with Defyne, the patient experienced delayed onset nodules to the injection area. Treated with steroids and products dissolved. Concomitant medications was not reported.  Treatment medications was not reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of a vaccine from a vial that was punctured more than 12hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of a vaccine from a vial that was punctured more than 12hours ago) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of a vaccine from a vial that was punctured more than 12hours ago). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administration of a vaccine from a vial that was punctured more than 12hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vial was first punctured on 03-Sep-2021, and put back in the fridge after the initial puncture. The vaccine was administered on 10-Sep-2021. The patient was observed for 25 minutes and did not experience any adverse events.  Treatment medications was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dysphonia, Dyspnoea, Feeling abnormal
Clinical narrative: not been able to breath for days/difficulty breathing; voice has change; difficulty to  talk; felling scare; throat swollen; Chills; body aches; sly fever; cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), SPEECH DISORDER (difficulty to  talk), FEELING ABNORMAL (felling scare) and COUGH (cough) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced COUGH (cough). On 03-Sep-2021, the patient experienced DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), SPEECH DISORDER (difficulty to  talk), FEELING ABNORMAL (felling scare), PHARYNGEAL SWELLING (throat swollen), CHILLS (Chills), MYALGIA (body aches) and PYREXIA (sly fever). The patient was treated with GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency. On 06-Sep-2021, CHILLS (Chills), MYALGIA (body aches) and PYREXIA (sly fever) had resolved. At the time of the report, DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), COUGH (cough) and PHARYNGEAL SWELLING (throat swollen) had not resolved and SPEECH DISORDER (difficulty to  talk) and FEELING ABNORMAL (felling scare) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pharyngeal swelling, Pyrexia, Speech disorder
Clinical narrative: not been able to breath for days/difficulty breathing; voice has change; difficulty to  talk; felling scare; throat swollen; Chills; body aches; sly fever; cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), SPEECH DISORDER (difficulty to  talk), FEELING ABNORMAL (felling scare) and COUGH (cough) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced COUGH (cough). On 03-Sep-2021, the patient experienced DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), SPEECH DISORDER (difficulty to  talk), FEELING ABNORMAL (felling scare), PHARYNGEAL SWELLING (throat swollen), CHILLS (Chills), MYALGIA (body aches) and PYREXIA (sly fever). The patient was treated with GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency. On 06-Sep-2021, CHILLS (Chills), MYALGIA (body aches) and PYREXIA (sly fever) had resolved. At the time of the report, DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), COUGH (cough) and PHARYNGEAL SWELLING (throat swollen) had not resolved and SPEECH DISORDER (difficulty to  talk) and FEELING ABNORMAL (felling scare) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Taste disorder
Clinical narrative: Funny taste in my mouth; Right back of neck sore; 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 TASTE DISORDER (Funny taste in my mouth) and NECK PAIN (Right back of neck sore) 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 TASTE DISORDER (Funny taste in my mouth) and NECK PAIN (Right back of neck sore). At the time of the report, TASTE DISORDER (Funny taste in my mouth) and NECK PAIN (Right back of neck sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (past the 30-day refrigeration time) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Aug 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 13, 2021, patient administered expired product (past the 30-day refrigeration time). On Aug 13, 2021, administered expired product (past the 30-day refrigeration time) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. Date of refrigeration of the vial reported as Apr 13, 2021 and temperature changes reported to be 40-42 F. Sender's comments: This case of expired product administered in a patient (unknown age and gender) with no associated events. The patient administered Moderna COVID-19 vaccine (past the 30-day refrigeration time). The re-challenge not applicable. The causality for the event expired product administered will be considered not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 vaccine not affected by this report.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: it itches like crazy; the area is a little bit swollen; red around the injection site. Today it is still real red around the injection site, is worse than it was to begin with, and the redness is drifting away from injection site to the under side of her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (it itches like crazy), VACCINATION SITE ERYTHEMA (red around the injection site. Today it is still real red around the injection site, is worse than it was to begin with, and the redness is drifting away from injection site to the under side of her arm) and VACCINATION SITE SWELLING (the area is a little bit swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced VACCINATION SITE ERYTHEMA (red around the injection site. Today it is still real red around the injection site, is worse than it was to begin with, and the redness is drifting away from injection site to the under side of her arm). On 10-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (it itches like crazy) and VACCINATION SITE SWELLING (the area is a little bit swollen). At the time of the report, VACCINATION SITE PRURITUS (it itches like crazy) and VACCINATION SITE SWELLING (the area is a little bit swollen) outcome was unknown and VACCINATION SITE ERYTHEMA (red around the injection site. Today it is still real red around the injection site, is worse than it was to begin with, and the redness is drifting away from injection site to the under side of her arm) had not resolved.            No Concomitant and Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Eye contusion
Clinical narrative: Eye lid was black; 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 EYE CONTUSION (Eye lid was black) 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 EYE CONTUSION (Eye lid was black). At the time of the report, EYE CONTUSION (Eye lid was black) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. Treatment medications was not provided.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness in arm) and product dose omission issue (didn't get her 2nd shot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot 027A21A) for COVID-19 vaccination. Concomitant products included furosemide for an unknown indication. On Mar 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Mar 19, 2021, patient experienced pain in extremity (soreness in arm) and product dose omission issue (didn't get her 2nd shot). On Mar 19, 2021, product dose omission issue (didn't get her 2nd shot) resolved. On Mar 23, 2021, pain in extremity (soreness in arm) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Other concomitant medications included blood thinner and inactive thyroid medicines. No treatment medication reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose from punctured vial after 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from punctured vial after 12 hours) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from punctured vial after 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose from punctured vial after 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication reported  No Treatment medication reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: pain in arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) and CHILLS (chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PAIN IN EXTREMITY (pain in arm) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (pain in arm) and CHILLS (chills) had not resolved.            Concomitant medications were not provided.  Treatment medications were not provided.   This case was linked to MOD-2021-315977 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Tenderness, Vaccination site pain
Clinical narrative: Tenderness in the armpit on the shoulder; Did not notice the pain until he touched the arm.; General soreness; It really hurt for a while, right in the muscle below the armpit.; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in the armpit on the shoulder), VACCINATION SITE PAIN (Did not notice the pain until he touched the arm.), ARTHRALGIA (General soreness) and MYALGIA (It really hurt for a while, right in the muscle below the armpit.) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-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 TENDERNESS (Tenderness in the armpit on the shoulder), VACCINATION SITE PAIN (Did not notice the pain until he touched the arm.), ARTHRALGIA (General soreness) and MYALGIA (It really hurt for a while, right in the muscle below the armpit.). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of 1 dosage form. At the time of the report, TENDERNESS (Tenderness in the armpit on the shoulder), VACCINATION SITE PAIN (Did not notice the pain until he touched the arm.), ARTHRALGIA (General soreness) and MYALGIA (It really hurt for a while, right in the muscle below the armpit.) outcome was unknown.            No concomitant medication was provided.  Ice bag was used to treat symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: been having sleeping problems ever since my first dose of Moderna/ Every night over the last 3 weeks I am waking up between 1230-4am far a little bit; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (been having sleeping problems ever since my first dose of Moderna/ Every night over the last 3 weeks I am waking up between 1230-4am far a little bit) 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 INSOMNIA (been having sleeping problems ever since my first dose of Moderna/ Every night over the last 3 weeks I am waking up between 1230-4am far a little bit). At the time of the report, INSOMNIA (been having sleeping problems ever since my first dose of Moderna/ Every night over the last 3 weeks I am waking up between 1230-4am far a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dry mouth, Dry throat
Clinical narrative: throat feels really dry; Dry mouth; 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 DRY THROAT (throat feels really dry) and DRY MOUTH (Dry mouth) 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 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced DRY THROAT (throat feels really dry) and DRY MOUTH (Dry mouth). At the time of the report, DRY THROAT (throat feels really dry) and DRY MOUTH (Dry mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications, Lab data details and Treatment informations were not provided.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hyperhidrosis, Pallor
Clinical narrative: Patient was cold to the touch; Sweating profusely; Became pale; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING COLD (Patient was cold to the touch), HYPERHIDROSIS (Sweating profusely) and PALLOR (Became pale) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced FEELING COLD (Patient was cold to the touch), HYPERHIDROSIS (Sweating profusely) and PALLOR (Became pale). At the time of the report, FEELING COLD (Patient was cold to the touch) and HYPERHIDROSIS (Sweating profusely) outcome was unknown and PALLOR (Became pale) was resolving.        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 were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Leg cramps in both legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Leg cramps in both legs) 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 MUSCLE SPASMS (Leg cramps in both legs). At the time of the report, MUSCLE SPASMS (Leg cramps in both legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-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 EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine temperature reported as temperature changes 40-41 F.  No concomitant medication was reported. No treatment medication was reported.