chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
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 an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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.        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 reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Weakness; Sore arm; Joint pain; Headache; Muscle pain; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Sinusitis NOS, Depression, Migraine, Asthma and Incontinence.    On 13-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 DIZZINESS (Dizziness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint pain), HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Feeling very tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint pain), HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Feeling very tired) 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.   Patient is on some concomitant medications for anxiety, depression, pain, sinus, migraine, asthma, eye  medication, GI medication, calcium , vitamin-d and  other supplements, incontinence  medications, muscle  relaxer.  Patient had  lab work done and  result was good.   This case was linked to MOD-2021-270777 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Dizziness; Weakness; Sore arm; Joint pain; Headache; Muscle pain; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Sinusitis NOS, Depression, Migraine, Asthma and Incontinence.    On 13-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 DIZZINESS (Dizziness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint pain), HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Feeling very tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint pain), HEADACHE (Headache), MYALGIA (Muscle pain) and FATIGUE (Feeling very tired) 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.   Patient is on some concomitant medications for anxiety, depression, pain, sinus, migraine, asthma, eye  medication, GI medication, calcium , vitamin-d and  other supplements, incontinence  medications, muscle  relaxer.  Patient had  lab work done and  result was good.   This case was linked to MOD-2021-270777 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis
Clinical narrative: I am sick; I think it's a cold; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I am sick) and NASOPHARYNGITIS (I think it's a cold) 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 04-Aug-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2020, 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 ILLNESS (I am sick) and NASOPHARYNGITIS (I think it's a cold). At the time of the report, ILLNESS (I am sick) and NASOPHARYNGITIS (I think it's a cold) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.  It was reported that the patient had a COVID-19 virus test, two days prior to this report and the result was not available.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Oropharyngeal discomfort
Clinical narrative: Felt a surge then it was like someone was grabbing my throat; 15 minutes after receiving the second shot I felt a surge; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Felt a surge then it was like someone was grabbing my throat) and FEELING ABNORMAL (15 minutes after receiving the second shot I felt a surge) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (Felt a surge then it was like someone was grabbing my throat) and FEELING ABNORMAL (15 minutes after receiving the second shot I felt a surge). At the time of the report, OROPHARYNGEAL DISCOMFORT (Felt a surge then it was like someone was grabbing my throat) and FEELING ABNORMAL (15 minutes after receiving the second shot I felt a surge) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-270804 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose administered 16 days after the first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 16 days after the first shot) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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 (Second dose administered 16 days after the first shot). On 28-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 16 days after the first shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: sore arm; feeling weak; dizziness; joint pain; headache; muscle pain; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ASTHENIA (feeling weak), DIZZINESS (dizziness), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Depression, Migraine, Anxiety, Incontinence, Pain, Sinus disorder, Gastrointestinal disorder and Eye disorder. Concomitant products included CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 PAIN IN EXTREMITY (sore arm), ASTHENIA (feeling weak), DIZZINESS (dizziness), ARTHRALGIA (joint pain), HEADACHE (headache), MYALGIA (muscle pain) and FATIGUE (Feeling very tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), ASTHENIA (feeling weak), DIZZINESS (dizziness), ARTHRALGIA (joint pain), HEADACHE (headache), MYALGIA (muscle pain) and FATIGUE (Feeling very tired) outcome was unknown.            Patient had lab work done and result was good.  Patient was on some concomitant medications for anxiety, depression, pain, sinus, migraine, asthma, eye medication, GI medication, calcium, vitamin-d and other supplements, incontinence medications, muscle relaxer.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore arm; feeling weak; dizziness; joint pain; headache; muscle pain; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ASTHENIA (feeling weak), DIZZINESS (dizziness), ARTHRALGIA (joint pain) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Depression, Migraine, Anxiety, Incontinence, Pain, Sinus disorder, Gastrointestinal disorder and Eye disorder. Concomitant products included CALCIUM and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-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 PAIN IN EXTREMITY (sore arm), ASTHENIA (feeling weak), DIZZINESS (dizziness), ARTHRALGIA (joint pain), HEADACHE (headache), MYALGIA (muscle pain) and FATIGUE (Feeling very tired). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), ASTHENIA (feeling weak), DIZZINESS (dizziness), ARTHRALGIA (joint pain), HEADACHE (headache), MYALGIA (muscle pain) and FATIGUE (Feeling very tired) outcome was unknown.            Patient had lab work done and result was good.  Patient was on some concomitant medications for anxiety, depression, pain, sinus, migraine, asthma, eye medication, GI medication, calcium, vitamin-d and other supplements, incontinence medications, muscle relaxer.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: had the usual reactions; after this shot she was feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had the usual reactions) and PYREXIA (after this shot she was feverish) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 VACCINATION COMPLICATION (had the usual reactions) and PYREXIA (after this shot she was feverish). At the time of the report, VACCINATION COMPLICATION (had the usual reactions) and PYREXIA (after this shot she was feverish) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported.   This case was linked to MOD-2021-270577 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: a sore left arm shoulder deltoid muscle; a sore left arm shoulder deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (a sore left arm shoulder deltoid muscle) and INJECTION SITE PAIN (a sore left arm shoulder deltoid muscle) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011LT0A and 010M20A) for COVID-19 vaccination.     Medical history was not provided.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (a sore left arm shoulder deltoid muscle) and INJECTION SITE PAIN (a sore left arm shoulder deltoid muscle). At the time of the report, MYALGIA (a sore left arm shoulder deltoid muscle) and INJECTION SITE PAIN (a sore left arm shoulder deltoid muscle) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: i felt slight body aches; pain in the injection area.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (i felt slight body aches) and VACCINATION SITE PAIN (pain in the injection area.) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 MYALGIA (i felt slight body aches) and VACCINATION SITE PAIN (pain in the injection area.). The patient was treated with PARACETAMOL ongoing since an unknown date at a dose of 1 dosage form. On 24-Jul-2021, MYALGIA (i felt slight body aches) and VACCINATION SITE PAIN (pain in the injection area.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Additional follow up received does not contain any new information (NNI)
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Oropharyngeal discomfort
Clinical narrative: 15 minutes after receiving the second shot I felt a surge; then it was like someone was grabbing my throat, but as fast as it happened; 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 FEELING ABNORMAL (15 minutes after receiving the second shot I felt a surge) and OROPHARYNGEAL DISCOMFORT (then it was like someone was grabbing my throat, but as fast as it happened) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (15 minutes after receiving the second shot I felt a surge) and OROPHARYNGEAL DISCOMFORT (then it was like someone was grabbing my throat, but as fast as it happened). At the time of the report, FEELING ABNORMAL (15 minutes after receiving the second shot I felt a surge) and OROPHARYNGEAL DISCOMFORT (then it was like someone was grabbing my throat, but as fast as it happened) outcome was unknown.            No concomitant medication was provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-270759 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: two doses administered > 12 hours after vial puncture; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (two doses administered > 12 hours after vial puncture) 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 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (two doses administered > 12 hours after vial puncture). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (two doses administered > 12 hours after vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were  reported.  Reporter stated that vial was opened at 8:30 am on 27-JUL-2021. However, 2 doses were given on 28-JUL-2021 at 11:30 am.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: muscle pain; joint pain; 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 MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain) and ARTHRALGIA (joint pain). At the time of the report, MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was unknown Treatment information was unknown   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses of Moderna vaccine/ 3 doses administered/; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received 3 doses of Moderna vaccine/ 3 doses administered/) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 28-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Patient received 3 doses of Moderna vaccine/ 3 doses administered/). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received 3 doses of Moderna vaccine/ 3 doses administered/) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: missed the second dose in the Moderna series/skipped her second dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose in the Moderna series/skipped her second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-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 (missed the second dose in the Moderna series/skipped her second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose in the Moderna series/skipped her second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: negative (Negative) NEGATIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included birth control pills and medications for anxiety.   Treatment information was not provided by reporter.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Feeling of body temperature change
Clinical narrative: feeling icy hot in his back/ it went down to the opposite arm (his left arm)/ then traveled to the forearm/ now it is back to his back; like heat/ can feel heat going down his arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (feeling icy hot in his back/ it went down to the opposite arm (his left arm)/ then traveled to the forearm/ now it is back to his back) and FEELING HOT (like heat/ can feel heat going down his arm) in a 45-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 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (feeling icy hot in his back/ it went down to the opposite arm (his left arm)/ then traveled to the forearm/ now it is back to his back) and FEELING HOT (like heat/ can feel heat going down his arm). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (feeling icy hot in his back/ it went down to the opposite arm (his left arm)/ then traveled to the forearm/ now it is back to his back) and FEELING HOT (like heat/ can feel heat going down his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant product information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 102F; 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 PYREXIA (Fever 102F) 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 PYREXIA (Fever 102F). At the time of the report, PYREXIA (Fever 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was received by the patient No Treatment was received by the patient.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pruritus
Clinical narrative: It is now one big mass; it "welted up"; welts are now hard to touch; red; rash; throat felt like it was clogging up; "itched like crazy"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (throat felt like it was clogging up), VACCINATION SITE MASS (It is now one big mass), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS ("itched like crazy") and VACCINATION SITE URTICARIA (it "welted up") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acid reflux (oesophageal), Hypotension, Cholesterol, Penicillin allergy, Seasonal allergy and Hay fever. Concomitant products included OMEPRAZOLE for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced VACCINATION SITE PRURITUS ("itched like crazy"). On 23-Jul-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat felt like it was clogging up). On 28-Jul-2021, the patient experienced VACCINATION SITE RASH (rash). On an unknown date, the patient experienced VACCINATION SITE MASS (It is now one big mass), VACCINATION SITE URTICARIA (it "welted up"), VACCINATION SITE INDURATION (welts are now hard to touch) and VACCINATION SITE ERYTHEMA (red). The patient was treated with CORTISONE for Rash and Itch, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (throat felt like it was clogging up), VACCINATION SITE MASS (It is now one big mass), VACCINATION SITE RASH (rash), VACCINATION SITE URTICARIA (it "welted up"), VACCINATION SITE INDURATION (welts are now hard to touch) and VACCINATION SITE ERYTHEMA (red) outcome was unknown and VACCINATION SITE PRURITUS ("itched like crazy") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site urticaria
Clinical narrative: It is now one big mass; it "welted up"; welts are now hard to touch; red; rash; throat felt like it was clogging up; "itched like crazy"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (throat felt like it was clogging up), VACCINATION SITE MASS (It is now one big mass), VACCINATION SITE RASH (rash), VACCINATION SITE PRURITUS ("itched like crazy") and VACCINATION SITE URTICARIA (it "welted up") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Acid reflux (oesophageal), Hypotension, Cholesterol, Penicillin allergy, Seasonal allergy and Hay fever. Concomitant products included OMEPRAZOLE for an unknown indication.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced VACCINATION SITE PRURITUS ("itched like crazy"). On 23-Jul-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat felt like it was clogging up). On 28-Jul-2021, the patient experienced VACCINATION SITE RASH (rash). On an unknown date, the patient experienced VACCINATION SITE MASS (It is now one big mass), VACCINATION SITE URTICARIA (it "welted up"), VACCINATION SITE INDURATION (welts are now hard to touch) and VACCINATION SITE ERYTHEMA (red). The patient was treated with CORTISONE for Rash and Itch, at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL DISCOMFORT (throat felt like it was clogging up), VACCINATION SITE MASS (It is now one big mass), VACCINATION SITE RASH (rash), VACCINATION SITE URTICARIA (it "welted up"), VACCINATION SITE INDURATION (welts are now hard to touch) and VACCINATION SITE ERYTHEMA (red) outcome was unknown and VACCINATION SITE PRURITUS ("itched like crazy") was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 49.0
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 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Tounge is getting numb; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Tounge is getting numb) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Tounge is getting numb). At the time of the report, HYPOAESTHESIA ORAL (Tounge is getting numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Additional information received included vaccine route of administration.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: Lump in armpit; 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 AXILLARY MASS (Lump in armpit) 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 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (Lump in armpit). At the time of the report, AXILLARY MASS (Lump in armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: No taste for a month; No smell for a month; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (No taste for a month) and ANOSMIA (No smell for a month) in a 61-year-old male patient 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 AGEUSIA (No taste for a month) and ANOSMIA (No smell for a month). At the time of the report, AGEUSIA (No taste for a month) and ANOSMIA (No smell for a month) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle fatigue, Myalgia, Pain
Clinical narrative: her pain has diminished.; she wakes up with her back muscles exhausted; her muscles continue to bhe bad; she wakes up with fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (her pain has diminished.), MUSCLE FATIGUE (she wakes up with her back muscles exhausted), MYALGIA (her muscles continue to bhe bad) and FATIGUE (she wakes up with fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (her pain has diminished.), MUSCLE FATIGUE (she wakes up with her back muscles exhausted), MYALGIA (her muscles continue to bhe bad) and FATIGUE (she wakes up with fatigue). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (her pain has diminished.), MUSCLE FATIGUE (she wakes up with her back muscles exhausted), MYALGIA (her muscles continue to bhe bad) and FATIGUE (she wakes up with fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the patient said she was still in treatment, she hadn't been able to work and she had been at home. she said that from a scale of 1to 10, to feel better she was at 4. No concomitant product use was reported
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick the second day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick the second day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 ILLNESS (very sick the second day). At the time of the report, ILLNESS (very sick the second day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants medication were provided. No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle aches; Deep pain within her hip bone; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches) and ARTHRALGIA (Deep pain within her hip bone) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle aches) and ARTHRALGIA (Deep pain within her hip bone). At the time of the report, MYALGIA (Muscle aches) and ARTHRALGIA (Deep pain within her hip bone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose back in February; 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 PRODUCT DOSE OMISSION ISSUE (First dose back in February) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose back in February). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose back in February) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medication provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-1 test
Clinical narrative: Has not gotten his 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not gotten his 2nd dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 (Has not gotten his 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not gotten his 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, SARS-CoV-1 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       N concomitant medications was reported. No treatment drug details was reported.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old receiving Moderna; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving Moderna) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 021C21A) 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 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving Moderna). On 02-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving Moderna) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving Moderna) to be not related.    No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-201421 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Three doses were left out at ambient room temperature past there beyond use date; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jul-2021 and was forwarded to Moderna on 28-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date). On 12-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) to be not related.    No Concomitant Medications were provided. No Treatment Medications were provided. Three doses were left out at ambient room temperature past there beyond use date. There was a possibility that this individual as well as two others may had received one of these doses. There had been no physical adverse effects reported due to the possible excursion. However, it was possible that this individual did not receive a viable dose. Patient was made aware of the possibility that he might not had received a viable dose. After following up with the patient, he did not feel that further action was required at this time.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccines have been administered after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines have been administered after excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No information on medical history 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 EXPIRED PRODUCT ADMINISTERED (vaccines have been administered after excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines have been administered after excursion) 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 information on medical history was reported. No information on concomitant medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received on 29-07-2021.Includes No new information Added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Got really sleepy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Got really sleepy) and PAIN IN EXTREMITY (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac) and CPAP (C-pap mask). Concurrent medical conditions included Seasonal allergy, Lupus syndrome since 1997, Scleroderma and Heart valve regurgitation. Concomitant products included PREDNISONE, TRAZODONE, DIAZEPAM (VALIUM), OMEPRAZOLE and LOSARTAN for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced SOMNOLENCE (Got really sleepy) and PAIN IN EXTREMITY (Sore arm). At the time of the report, SOMNOLENCE (Got really sleepy) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not reported  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.   This case was linked to MOD-2021-193529 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received contains no new information.; 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, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.