chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose was expired/ Expiration date 21May2021.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose was expired/ Expiration date 21May2021.) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 037B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-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 EXPIRED PRODUCT ADMINISTERED (2nd dose was expired/ Expiration date 21May2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose was expired/ Expiration date 21May2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine may have been administered to a Patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine may have been administered to a Patient) 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. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine may have been administered to a Patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine may have been administered to a Patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. The treatment information was not provided
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness on nose, cheek, upper left lip and gums; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (numbness on nose, cheek, upper left lip and gums) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (Injected Lyft on left cheek.) on 30-Mar-2021. Previously administered products included for an unreported indication: INFLUENZA in September 2020. Concomitant products included HYALURONIC ACID (RESTYLANE) from 30-Mar-2021 to an unknown date for Dermal filler injection.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness on nose, cheek, upper left lip and gums). At the time of the report, HYPOAESTHESIA (numbness on nose, cheek, upper left lip and gums) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   It was reported by the reported that patient has had numerous fillers in the past to her facial area. It was reported by the reporter the patient concomitant medications includes various vitamins and hormone pellets. Treatment information was not provided by the reporter.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: never got second dose (more than 35 days after first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never got second dose (more than 35 days after first dose)) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 (never got second dose (more than 35 days after first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never got second dose (more than 35 days after first dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse event reported; 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 NO ADVERSE EVENT (No adverse event reported) 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 NO ADVERSE EVENT (No adverse event reported). At the time of the report, NO ADVERSE EVENT (No adverse event reported) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list  was not provided. No treatment information was provided. Reporter contact details were updated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Inflammation, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: coughing which is getting horrible; painful  throat cannot eat or drink water since her throat is irritated; Painful foot feels her foot frature that not healing as well; whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful  throat cannot eat or drink water since her throat is irritated), PAIN IN EXTREMITY (Painful foot feels her foot frature that not healing as well) and INFLAMMATION (whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M204 and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats. Concomitant products included GABAPENTIN and VITAMINS NOS for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-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 PAIN IN EXTREMITY (Sore arm), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful  throat cannot eat or drink water since her throat is irritated), PAIN IN EXTREMITY (Painful foot feels her foot frature that not healing as well) and INFLAMMATION (whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Allergic to cats, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful  throat cannot eat or drink water since her throat is irritated), PAIN IN EXTREMITY (Painful foot feels her foot frature that not healing as well) and INFLAMMATION (whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had experiencing all the events since 4 months and were still ongoing.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: coughing which is getting horrible; painful  throat cannot eat or drink water since her throat is irritated; Painful foot feels her foot frature that not healing as well; whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful  throat cannot eat or drink water since her throat is irritated), PAIN IN EXTREMITY (Painful foot feels her foot frature that not healing as well) and INFLAMMATION (whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M204 and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats. Concomitant products included GABAPENTIN and VITAMINS NOS for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-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 PAIN IN EXTREMITY (Sore arm), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful  throat cannot eat or drink water since her throat is irritated), PAIN IN EXTREMITY (Painful foot feels her foot frature that not healing as well) and INFLAMMATION (whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Allergic to cats, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), COUGH (coughing which is getting horrible), OROPHARYNGEAL PAIN (painful  throat cannot eat or drink water since her throat is irritated), PAIN IN EXTREMITY (Painful foot feels her foot frature that not healing as well) and INFLAMMATION (whole body inflammation from inside out but not visible, and feels that it is progressively getting worse every day) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had experiencing all the events since 4 months and were still ongoing.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid19 after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid19 after being vaccinated) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No relevant medical history was provided.  Concomitant products included DICLOFENAC, ATORVASTATIN, VALSARTAN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced COVID-19 (Tested positive for Covid19 after being vaccinated). The patient was treated with AZITHROMYCIN ongoing since an unknown date for Sinusitis, at a dose of 1 dosage form and BENZONATATE ongoing since an unknown date for Sinusitis, at a dose of 100 milligram. At the time of the report, COVID-19 (Tested positive for Covid19 after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         This case was linked to MOD-2021-114418 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Swelling to upper and lower lips; lump to cheeks; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (Swelling to upper and lower lips) and SWELLING FACE (lump to cheeks) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PREDNISONE and HYALURONIC ACID (RESTYLANE) from 27-Feb-2021 to an unknown date for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced LIP SWELLING (Swelling to upper and lower lips) and SWELLING FACE (lump to cheeks). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) from 03-Jul-2021 to 11-Jul-2021 for Swelling lips and Cheek swelling, at a dose of 1 dosage form. At the time of the report, LIP SWELLING (Swelling to upper and lower lips) and SWELLING FACE (lump to cheeks) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were antibiotics.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: swelling of her feet; she broke out in 3 different rashes 2 days after getting the 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of her feet) and RASH (she broke out in 3 different rashes 2 days after getting the 2nd vaccine) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-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 PERIPHERAL SWELLING (swelling of her feet) and RASH (she broke out in 3 different rashes 2 days after getting the 2nd vaccine). The patient was treated with TRIAMCINOLONE (topical) ongoing from 05-Mar-2021 at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (swelling of her feet) and RASH (she broke out in 3 different rashes 2 days after getting the 2nd vaccine) had not resolved.            Patient stated she was having a lot of problems since having the 2nd vaccine. Patient stated that she  broke out in 3 different places 2 days after getting the 2nd vaccine. Patient stated that  rashes were  all on her left side including her face. Patient also reported swelling of her feet. Patient stated her right side had rash as well, but it was not as bad as the left. Patient stated that she went to see a dermatologist who initially gave her some samples of ointment to use and when she returned 2 weeks later, he prescribed more creams to apply.   No concomitant medication information was provided.   This case was linked to MOD-2021-033010 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received and two dose details were added , patient demographics, treatment medication and event outcome was updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache; Chills; Fatigue; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant product use was provided by the reporter.  No treatment medication was provided for the first dose.  Drop in folic acid was extremely low after the second dose. The caller said she already spoke to her doctor and had a laboratory test done. She was given folic acid for the low folic acid test.    This case was linked to MOD-2021-255306 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood folate, Dizziness, Fatigue, Muscle spasms, Vaccination site pain
Clinical narrative: severe leg cramps; light fatigue; pain in the injection site; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), MUSCLE SPASMS (severe leg cramps), FATIGUE (light fatigue) and VACCINATION SITE PAIN (pain in the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Light headedness), FATIGUE (light fatigue) and VACCINATION SITE PAIN (pain in the injection site). On an unknown date, the patient experienced MUSCLE SPASMS (severe leg cramps). The patient was treated with FOLIC ACID for Folic acid supplementation, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headedness), MUSCLE SPASMS (severe leg cramps), FATIGUE (light fatigue) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood folate: low (Low) low folic acid test.         Concomitant medication was not reported. Other treatment information included something cold on the cramps.   This case was linked to MOD-2021-255303 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Alopecia, Anosmia, Asthenia, Chills
Clinical narrative: Hair started falling out; Got a dry cough; Felt like he would run out of oxygen; Foggy brain; Weak; Sweating at night; Temporary loss of taste; Lost smell; Chills; Tired; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Hair started falling out), COUGH (Got a dry cough), DYSPNOEA (Felt like he would run out of oxygen), FEELING ABNORMAL (Foggy brain) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid-19 in Nov2020.).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced ALOPECIA (Hair started falling out), COUGH (Got a dry cough), DYSPNOEA (Felt like he would run out of oxygen), FEELING ABNORMAL (Foggy brain), ASTHENIA (Weak) and FATIGUE (Tired). 13-Jul-2021, the patient experienced HYPERHIDROSIS (Sweating at night), AGEUSIA (Temporary loss of taste), ANOSMIA (Lost smell) and CHILLS (Chills). At the time of the report, ALOPECIA (Hair started falling out), COUGH (Got a dry cough), DYSPNOEA (Felt like he would run out of oxygen), FEELING ABNORMAL (Foggy brain), ASTHENIA (Weak), HYPERHIDROSIS (Sweating at night), AGEUSIA (Temporary loss of taste), ANOSMIA (Lost smell), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive.         This case was linked to MOD-2021-032822 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: Hair started falling out; Got a dry cough; Felt like he would run out of oxygen; Foggy brain; Weak; Sweating at night; Temporary loss of taste; Lost smell; Chills; Tired; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Hair started falling out), COUGH (Got a dry cough), DYSPNOEA (Felt like he would run out of oxygen), FEELING ABNORMAL (Foggy brain) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid-19 in Nov2020.).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced ALOPECIA (Hair started falling out), COUGH (Got a dry cough), DYSPNOEA (Felt like he would run out of oxygen), FEELING ABNORMAL (Foggy brain), ASTHENIA (Weak) and FATIGUE (Tired). 13-Jul-2021, the patient experienced HYPERHIDROSIS (Sweating at night), AGEUSIA (Temporary loss of taste), ANOSMIA (Lost smell) and CHILLS (Chills). At the time of the report, ALOPECIA (Hair started falling out), COUGH (Got a dry cough), DYSPNOEA (Felt like he would run out of oxygen), FEELING ABNORMAL (Foggy brain), ASTHENIA (Weak), HYPERHIDROSIS (Sweating at night), AGEUSIA (Temporary loss of taste), ANOSMIA (Lost smell), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive.         This case was linked to MOD-2021-032822 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Hair started falling out; Got a dry cough; Felt like he would run out of oxygen; Foggy brain; Weak; Sweating at night; Temporary loss of taste; Lost smell; Chills; Tired; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Hair started falling out), COUGH (Got a dry cough), DYSPNOEA (Felt like he would run out of oxygen), FEELING ABNORMAL (Foggy brain) and ASTHENIA (Weak) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had Covid-19 in Nov2020.).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced ALOPECIA (Hair started falling out), COUGH (Got a dry cough), DYSPNOEA (Felt like he would run out of oxygen), FEELING ABNORMAL (Foggy brain), ASTHENIA (Weak) and FATIGUE (Tired). 13-Jul-2021, the patient experienced HYPERHIDROSIS (Sweating at night), AGEUSIA (Temporary loss of taste), ANOSMIA (Lost smell) and CHILLS (Chills). At the time of the report, ALOPECIA (Hair started falling out), COUGH (Got a dry cough), DYSPNOEA (Felt like he would run out of oxygen), FEELING ABNORMAL (Foggy brain), ASTHENIA (Weak), HYPERHIDROSIS (Sweating at night), AGEUSIA (Temporary loss of taste), ANOSMIA (Lost smell), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive.         This case was linked to MOD-2021-032822 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site rash
Clinical narrative: Rash around the injection site; feverish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site) and PYREXIA (feverish) 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 VACCINATION SITE RASH (Rash around the injection site) and PYREXIA (feverish). At the time of the report, VACCINATION SITE RASH (Rash around the injection site) and PYREXIA (feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication information were provided. No treatment information were provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Neck pain
Clinical narrative: Turning their head is really hard to do; Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored; Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored), HEAD DISCOMFORT (Turning their head is really hard to do) and HEADACHE (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 24-Feb-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 NECK PAIN (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored), HEAD DISCOMFORT (Turning their head is really hard to do) and HEADACHE (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored). At the time of the report, NECK PAIN (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored), HEAD DISCOMFORT (Turning their head is really hard to do) and HEADACHE (Soreness in the back of the head and down the neck/From the middle of the head down their neck it is really sored) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication: high blood pressure medication.   This case was linked to MOD-2021-255326 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, DYSGEUSIA (Metallic taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant product use was Allergy pill.  Treatment medication include toothpaste, gum and mouthwash.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow- up document contains updated date of  birth of the patient and updated batch/lot number of the suspect drug
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Myalgia, Neck pain
Clinical narrative: soreness in the back of the head and down the neck; Turning their head is really hard to do; From the middle of the head down their neck it is really sored; soreness in the back of the head and down the neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (soreness in the back of the head and down the neck), HYPOKINESIA (Turning their head is really hard to do), MYALGIA (From the middle of the head down their neck it is really sored) and HEADACHE (soreness in the back of the head and down the neck) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 26A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (soreness in the back of the head and down the neck), HYPOKINESIA (Turning their head is really hard to do), MYALGIA (From the middle of the head down their neck it is really sored) and HEADACHE (soreness in the back of the head and down the neck). At the time of the report, NECK PAIN (soreness in the back of the head and down the neck), HYPOKINESIA (Turning their head is really hard to do), MYALGIA (From the middle of the head down their neck it is really sored) and HEADACHE (soreness in the back of the head and down the neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   No treatment information was provided.   No laboratory data was provided   This case was linked to MOD-2021-255318 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received his first dose on 15APR2021 and has not received the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received his first dose on 15APR2021 and has not received the second dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Received his first dose on 15APR2021 and has not received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received his first dose on 15APR2021 and has not received the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication was provided by the reporter.  No treatment information was reported by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Computerised tomogram, Disorientation, Nerve injury
Clinical narrative: nerve damage in head; trigeminal neuralgia; very hard to cut things; has been shaking/whole body shaking; limbs are weak are shaking; has had really bad anxiety ever since this started; rash on both shoulders; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (nerve damage in head), TRIGEMINAL NEURALGIA (trigeminal neuralgia), DISORIENTATION (very hard to cut things), TREMOR (has been shaking/whole body shaking) and ASTHENIA (limbs are weak are shaking) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, CLONIDINE, VANCOMYCIN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-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 NERVE INJURY (nerve damage in head), TRIGEMINAL NEURALGIA (trigeminal neuralgia), DISORIENTATION (very hard to cut things), TREMOR (has been shaking/whole body shaking), ASTHENIA (limbs are weak are shaking), ANXIETY (has had really bad anxiety ever since this started) and RASH (rash on both shoulders). At the time of the report, NERVE INJURY (nerve damage in head), TRIGEMINAL NEURALGIA (trigeminal neuralgia), DISORIENTATION (very hard to cut things), TREMOR (has been shaking/whole body shaking), ASTHENIA (limbs are weak are shaking), ANXIETY (has had really bad anxiety ever since this started) and RASH (rash on both shoulders) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, Computerised tomogram: other (Inconclusive) nerve damage in her head.          Treatment information was not provided.    This case was linked to MOD-2021-187508 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tremor, Trigeminal neuralgia
Clinical narrative: nerve damage in head; trigeminal neuralgia; very hard to cut things; has been shaking/whole body shaking; limbs are weak are shaking; has had really bad anxiety ever since this started; rash on both shoulders; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (nerve damage in head), TRIGEMINAL NEURALGIA (trigeminal neuralgia), DISORIENTATION (very hard to cut things), TREMOR (has been shaking/whole body shaking) and ASTHENIA (limbs are weak are shaking) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, CLONIDINE, VANCOMYCIN and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-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 NERVE INJURY (nerve damage in head), TRIGEMINAL NEURALGIA (trigeminal neuralgia), DISORIENTATION (very hard to cut things), TREMOR (has been shaking/whole body shaking), ASTHENIA (limbs are weak are shaking), ANXIETY (has had really bad anxiety ever since this started) and RASH (rash on both shoulders). At the time of the report, NERVE INJURY (nerve damage in head), TRIGEMINAL NEURALGIA (trigeminal neuralgia), DISORIENTATION (very hard to cut things), TREMOR (has been shaking/whole body shaking), ASTHENIA (limbs are weak are shaking), ANXIETY (has had really bad anxiety ever since this started) and RASH (rash on both shoulders) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, Computerised tomogram: other (Inconclusive) nerve damage in her head.          Treatment information was not provided.    This case was linked to MOD-2021-187508 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Mass excision, Nodule, Pain
Clinical narrative: Had nodules around left ankle; They hurt; They need to get removed; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Had nodules around left ankle), PAIN (They hurt) and MASS EXCISION (They need to get removed) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20a) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced NODULE (Had nodules around left ankle), PAIN (They hurt) and MASS EXCISION (They need to get removed). At the time of the report, NODULE (Had nodules around left ankle), PAIN (They hurt) and MASS EXCISION (They need to get removed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant: Blood pressure meds.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: report contained no new information
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Weight decreased
Clinical narrative: Not received 2nd dose as patient forgot; weight loss; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose as patient forgot) and WEIGHT DECREASED (weight loss) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Reflux esophagitis.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose as patient forgot) and WEIGHT DECREASED (weight loss). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose as patient forgot) had resolved and WEIGHT DECREASED (weight loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.  It was reported that patient experienced weight loss before dose 1.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue
Clinical narrative: Cough that doesn´t go away; Feeling tired; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough that doesn´t go away) and FATIGUE (Feeling tired) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jul-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 02-Jul-2021, the patient experienced COUGH (Cough that doesn´t go away) and FATIGUE (Feeling tired). The patient was treated with BENZONATATE at an unspecified dose and frequency. At the time of the report, COUGH (Cough that doesn´t go away) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received vaccine from vial that was punctured for almost 48hs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received vaccine from vial that was punctured for almost 48hs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received vaccine from vial that was punctured for almost 48hs). On 12-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patients received vaccine from vial that was punctured for almost 48hs) 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 relevant concomitant medications were reported. Treatment information was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: Developed tinnitus; My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Developed tinnitus) and VACCINATION SITE PAIN (My arm was sore) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore). On 20-Apr-2021, the patient experienced TINNITUS (Developed tinnitus). At the time of the report, TINNITUS (Developed tinnitus) had not resolved and VACCINATION SITE PAIN (My arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication details was provided.  No treatment medication details was provided.  The patient experienced tinnitus which was a nuisance and not debilitating, two or three  weeks after the first dose of the vaccine.  On 04 Jun 2021 patient visited an audiologist and an ENT doctor.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event Pain in extremity, a causal relationship cannot be excluded. Concerning the event Tinnitus, very limited information regarding the event has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-255375 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Patient details, event start date and i narrative supplement updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event Pain in extremity, a causal relationship cannot be excluded. Concerning the event Tinnitus, very limited information regarding the event has been provided at this time.  Further information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered to patients which has been greater than 30 days in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patients which has been greater than 30 days in the refrigerator) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patients which has been greater than 30 days in the refrigerator). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patients which has been greater than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not receive 2nd dose between day 25 and 35; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between day 25 and 35) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between day 25 and 35). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between day 25 and 35) 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 medications were reported. No treatment medications were provided.