chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: weak with no energy; pain in the arm; little fever; very tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak with no energy), PAIN IN EXTREMITY (pain in the arm), PYREXIA (little fever) and FATIGUE (very tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-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 an unknown date, the patient experienced ASTHENIA (weak with no energy), PAIN IN EXTREMITY (pain in the arm), PYREXIA (little fever) and FATIGUE (very tired). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain in arm, at a dose of 1 dosage form and IBUPROFEN for Pain in arm, at a dose of 1 dosage form. At the time of the report, ASTHENIA (weak with no energy), PAIN IN EXTREMITY (pain in the arm), PYREXIA (little fever) and FATIGUE (very tired) was resolving.            No concomitant medications was reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain; Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain) and ARTHRALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain) and ARTHRALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain). At the time of the report, MYALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain) and ARTHRALGIA (Caller mentioned that she knows people, both male and female that have gotten the side effects of muscle pain and joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-269783 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) 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 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) 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.   treatment medications were not reported no concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non significant follow up. Contact information was updated.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave three doses from one expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave three doses from one expired vial) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and UNK) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), ALBUTEROL [SALBUTAMOL], ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, SUCRALFATE (CARAFATE), BUPROPION HYDROCHLORIDE (WELLBUTRIN), CLOPIDOGREL BISULFATE (PLAVIX), DICLOFENAC (VOLTAREN [DICLOFENAC]), FAMOTIDINE (PEPCID [FAMOTIDINE]), HYDROXYZINE, ISOSORBIDE MONONITRATE (IMDUR), METOPROLOL, GLYCERYL TRINITRATE (NITROGLYCERIN), SCOPOLAMINE [HYOSCINE] and SIMETICONE (SIMETHICONE) for an unknown indication.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 (gave three doses from one expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave three doses from one expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was provided  The nurse stated the patient did not mention having any adverse events from either dose.   This case was linked to US-MODERNATX, INC.-MOD-2021-124470, US-MODERNATX, INC.-MOD-2021-124502 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-124470:Crosslinked with other patients US-MODERNATX, INC.-MOD-2021-124502:Crosslinked with other patients
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) 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 relevant concomitant medications was reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: has not received second dose and more than 42 days have passed; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received second dose and more than 42 days have passed) 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 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received second dose and more than 42 days have passed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received second dose and more than 42 days have passed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: getting a dose of the Moderna vaccine/Injected vaccine from vial left for 17hours under room temperature/Injected vaccine from vial left for 17hours under room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (getting a dose of the Moderna vaccine/Injected vaccine from vial left for 17hours under room temperature/Injected vaccine from vial left for 17hours under room temperature) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (getting a dose of the Moderna vaccine/Injected vaccine from vial left for 17hours under room temperature/Injected vaccine from vial left for 17hours under room temperature). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (getting a dose of the Moderna vaccine/Injected vaccine from vial left for 17hours under room temperature/Injected vaccine from vial left for 17hours under room temperature) 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 provided by reporter.   The treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received and updated Patient Demographics. added lot number of vaccine.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) 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 product use was not provided by the reporter.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: Cough; Runny nose; 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 COUGH (Cough) and RHINORRHOEA (Runny nose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough) and RHINORRHOEA (Runny nose). At the time of the report, COUGH (Cough) and RHINORRHOEA (Runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination complication, Vaccination site movement impairment
Clinical narrative: Right shoulder hurts after Second Vaccine on and off; Can not lift anything with the Left Arm after Second Vaccine or pain comes back,/Intense Pain in the left arm with Movement  after Second Vaccine; Feeling sick after Second Vaccine; Pain in the upper and lower Left  arm  after Second Vaccine, Pain on and off in both arms after Second Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Right shoulder hurts after Second Vaccine on and off), PAIN IN EXTREMITY (Pain in the upper and lower Left  arm  after Second Vaccine, Pain on and off in both arms after Second Vaccine), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not lift anything with the Left Arm after Second Vaccine or pain comes back,/Intense Pain in the left arm with Movement  after Second Vaccine) and VACCINATION COMPLICATION (Feeling sick after Second Vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the upper and lower Left  arm  after Second Vaccine, Pain on and off in both arms after Second Vaccine) and VACCINATION COMPLICATION (Feeling sick after Second Vaccine). On 15-Apr-2021, the patient experienced ARTHRALGIA (Right shoulder hurts after Second Vaccine on and off) and VACCINATION SITE MOVEMENT IMPAIRMENT (Can not lift anything with the Left Arm after Second Vaccine or pain comes back,/Intense Pain in the left arm with Movement  after Second Vaccine). The patient was treated with MENTHOL (ICE [MENTHOL]) at an unspecified dose and frequency. On 14-Apr-2021, PAIN IN EXTREMITY (Pain in the upper and lower Left  arm  after Second Vaccine, Pain on and off in both arms after Second Vaccine) and VACCINATION COMPLICATION (Feeling sick after Second Vaccine) had resolved. At the time of the report, ARTHRALGIA (Right shoulder hurts after Second Vaccine on and off) and VACCINATION SITE MOVEMENT IMPAIRMENT (Can not lift anything with the Left Arm after Second Vaccine or pain comes back,/Intense Pain in the left arm with Movement  after Second Vaccine) outcome was unknown.            No Concomitant medication was received by the patient.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: depression is gone /does not "feel like crap" anymore /anger is goWoke up and depression and anxiety and anger have gone and have not come back again/ does not "feel like sne / anxiety is gone / did not feel messed up / brain is operating differently; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (depression is gone /does not "feel like crap" anymore /anger is goWoke up and depression and anxiety and anger have gone and have not come back again/ does not "feel like sne / anxiety is gone / did not feel messed up / brain is operating differently) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 033B21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety (Started suffering from anxiety when she was 21 years old), Depression (Started suffering from  depression when she was 21 years old) and Agitation (Started suffering from  agitation when she was 21 years old).   On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-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 THERAPEUTIC RESPONSE UNEXPECTED (depression is gone /does not "feel like crap" anymore /anger is goWoke up and depression and anxiety and anger have gone and have not come back again/ does not "feel like sne / anxiety is gone / did not feel messed up / brain is operating differently). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (depression is gone /does not "feel like crap" anymore /anger is goWoke up and depression and anxiety and anger have gone and have not come back again/ does not "feel like sne / anxiety is gone / did not feel messed up / brain is operating differently) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment information were reported.  Three weeks after the 1st dose of vaccine, the patient woke up and her depression and anxiety and anger were gone and have not come back again. She did not "feel like crap" anymore, she did not feel messed up like that anymore. She was really calm. Her brain was operating differently. It feels like it's gone, it's been like a month since these went away. The patient was hoping they won't come back. And she would keep seeing her psychiatrist. No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Immune system disorder
Clinical narrative: Decreases immunity; This spontaneous case was reported by a physician and describes the occurrence of IMMUNE SYSTEM DISORDER (Decreases immunity) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema. Concomitant products included DUPILUMAB (DUPIXENT) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-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 IMMUNE SYSTEM DISORDER (Decreases immunity). At the time of the report, IMMUNE SYSTEM DISORDER (Decreases immunity) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that he has Immunologic skin disease ("lichen planos" a rare disease).  No concomitant medications was provided by the reporter.  No treatment was provided by the reporter. Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site mass, Vaccination site pain
Clinical narrative: Not get to sleep last night; Knot on the area of the injection; Pain on left arm where the vaccine was administered; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not get to sleep last night), VACCINATION SITE MASS (Knot on the area of the injection) and VACCINATION SITE PAIN (Pain on left arm where the vaccine was administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-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 INSOMNIA (Not get to sleep last night), VACCINATION SITE MASS (Knot on the area of the injection) and VACCINATION SITE PAIN (Pain on left arm where the vaccine was administered). At the time of the report, INSOMNIA (Not get to sleep last night), VACCINATION SITE MASS (Knot on the area of the injection) and VACCINATION SITE PAIN (Pain on left arm where the vaccine was administered) outcome was unknown.            No concomitant medication were reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Receiving 2nd dose 14 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving 2nd dose 14 days after the 1st dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026d21a and 006d21a) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving 2nd dose 14 days after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Receiving 2nd dose 14 days after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication information was not provided. Concomitant medication information was not provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) 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 medications were mentioned. No treatment details were reported.
Age: 13.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a moderna vaccine was given to a 13 yr old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a moderna vaccine was given to a 13 yr old) in a 13-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a moderna vaccine was given to a 13 yr old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a moderna vaccine was given to a 13 yr old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were provided.  No treatment medication were provided.  No lab data has been provided by the reporter.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Past 36 days for 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past 36 days for 2nd dose) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past 36 days for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past 36 days for 2nd dose) 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 medications were reported. No treatment details were reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Really bad muscle spasm which went in her right calf, right foot, left upper thigh and right hand by thumb; She is either rocking her leg or walking around/To the point where she can't sit still,; Fever; Chills; Body ache; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (Really bad muscle spasm which went in her right calf, right foot, left upper thigh and right hand by thumb), MOBILITY DECREASED (She is either rocking her leg or walking around/To the point where she can't sit still,), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body ache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008D21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (In May).    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body ache). On 26-Jul-2021, the patient experienced MUSCLE SPASMS (Really bad muscle spasm which went in her right calf, right foot, left upper thigh and right hand by thumb) and MOBILITY DECREASED (She is either rocking her leg or walking around/To the point where she can't sit still,). At the time of the report, MUSCLE SPASMS (Really bad muscle spasm which went in her right calf, right foot, left upper thigh and right hand by thumb) and MOBILITY DECREASED (She is either rocking her leg or walking around/To the point where she can't sit still,) had not resolved and PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body ache) 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 medications were not reported. The Patient had been drinking lot of water and Gatorade.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Round swollen mass in her arm where she received the injection it was about the size of a quarter but it got bigger, now it's like a plum; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Round swollen mass in her arm where she received the injection it was about the size of a quarter but it got bigger, now it's like a plum) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Round swollen mass in her arm where she received the injection it was about the size of a quarter but it got bigger, now it's like a plum). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE SWELLING (Round swollen mass in her arm where she received the injection it was about the size of a quarter but it got bigger, now it's like a plum) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026LZ0A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left arm injection site). At the time of the report, VACCINATION SITE PAIN (Sore left arm injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication included steroids.  Treatment medication was not provided by the reporter.  The patient date of birth is reported 11-May-2021 as per source document.   This case was linked to MOD-2021-269994 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Tremor
Clinical narrative: Shakkyness; Dizziness; Felt some kind of weakness in hand; This spontaneous case was reported by a health care professional and describes the occurrence of TREMOR (Shakkyness), DIZZINESS (Dizziness) and ASTHENIA (Felt some kind of weakness in hand) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced TREMOR (Shakkyness), DIZZINESS (Dizziness) and ASTHENIA (Felt some kind of weakness in hand). On 27-Jul-2021, TREMOR (Shakkyness), DIZZINESS (Dizziness) and ASTHENIA (Felt some kind of weakness in hand) 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 product use was provided by the reporter. No treatment medication was provided.  Within few minutes of receiving the vaccine patient experienced dizziness, shakiness, and some kind of weakness in the hand. Paramedics were called at the pharmacy and they evaluated the patient. The vitals were normal, and patient refused to be transported to the hospital.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oropharyngeal pain
Clinical narrative: Felt like was getting a sore throat; Felt tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OROPHARYNGEAL PAIN (Felt like was getting a sore throat) and FATIGUE (Felt tired) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Felt like was getting a sore throat) and FATIGUE (Felt tired). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Felt like was getting a sore throat) and FATIGUE (Felt tired) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue
Clinical narrative: Got Covid after getting his first shot of what she thinks was the Moderna Covid-19 Vaccine; Still tired all time; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Covid after getting his first shot of what she thinks was the Moderna Covid-19 Vaccine) and FATIGUE (Still tired all time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got Covid after getting his first shot of what she thinks was the Moderna Covid-19 Vaccine) and FATIGUE (Still tired all time). At the time of the report, COVID-19 (Got Covid after getting his first shot of what she thinks was the Moderna Covid-19 Vaccine) outcome was unknown and FATIGUE (Still tired all time) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Drug ineffective, SARS-CoV-2 antibody test, Vaccination complication
Clinical narrative: reaction after the dose; he had no antibodies for the virus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction after the dose) and DRUG INEFFECTIVE (he had no antibodies for the virus) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukaemia.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction after the dose) and DRUG INEFFECTIVE (he had no antibodies for the virus). At the time of the report, VACCINATION COMPLICATION (reaction after the dose) and DRUG INEFFECTIVE (he had no antibodies for the virus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) small temperature. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) no antibodies for the virus.    Concomitant drug was not reported.  Treatment medication was not reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 004C21) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported by the reporter.  Treatment medication for these events were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Product dose omission issue
Clinical narrative: Aches; Chills; Fatigue; Has missed the window to get her  second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (Has missed the window to get her  second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (Has missed the window to get her  second dose). At the time of the report, PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (Has missed the window to get her  second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth, Pigmentation disorder
Clinical narrative: teeth sensitivity; pigmentation on skin brown spots; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (teeth sensitivity) and PIGMENTATION DISORDER (pigmentation on skin brown spots) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERAESTHESIA TEETH (teeth sensitivity) and PIGMENTATION DISORDER (pigmentation on skin brown spots). At the time of the report, HYPERAESTHESIA TEETH (teeth sensitivity) and PIGMENTATION DISORDER (pigmentation on skin brown spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant history was not reported. The treatment history was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received the1st dose of the Moderna Covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the1st dose of the Moderna Covid-19 vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Dec-2020 and the estimated date of delivery was 10-Sep-2021. On 28-Jul-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the1st dose of the Moderna Covid-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  On 28-Jul-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the1st dose of the Moderna Covid-19 vaccine) had resolved.            Concomitant medications were not provided. Treatment information was not reported.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a dose from a vial 24 hs after it was punctured; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jul-2021 and was forwarded to the company on 27-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from a vial 24 hs after it was punctured) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from a vial 24 hs after it was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose from a vial 24 hs after it was punctured) 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 drug details were reported. No treatment details were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non significant follow up
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was administered >12 hours after vial puncture (expired). / HCP accidentally gave an expired dose to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered >12 hours after vial puncture (expired). / HCP accidentally gave an expired dose to a patient) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021 at 10:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered >12 hours after vial puncture (expired). / HCP accidentally gave an expired dose to a patient). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Dose was administered >12 hours after vial puncture (expired). / HCP accidentally gave an expired dose to a patient) 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 medications were provided.  On 27-Jul-2021 the vial was removed from the refrigerator and needle punctured around 19:00 and then stored at room temperature.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Myalgia, Nausea, Pain in extremity
Clinical narrative: Sore arm; Body aches; Nausea; Patient receieved 1 mL instead of the recommended 0.5 mL; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches), NAUSEA (Nausea) and ACCIDENTAL OVERDOSE (Patient receieved 1 mL instead of the recommended 0.5 mL) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (morphine), Hypertension, Pain, Anxiety, ADD and Vitamin D deficiency. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for ADD, DIAZEPAM (VALIUM) for Anxiety, LOSARTAN for Hypertension, HYDROCODONE and MORPHINE for Pain, ERGOCALCIFEROL for Vitamin D deficiency.    On 28-Jul-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 28-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Patient receieved 1 mL instead of the recommended 0.5 mL). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches) and NAUSEA (Nausea). On 28-Jul-2021, ACCIDENTAL OVERDOSE (Patient receieved 1 mL instead of the recommended 0.5 mL) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches) and NAUSEA (Nausea) 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 Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Relevant medical history updated, vaccine facility details updated, doctor/HCP details updated, concomitant medications updated, new events added.