chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: sick to her stomach; Feeling rotten; pain in leg; pain in knee/pain in joint/very painful from hip down to knee; tired all the time/still feels the same way; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to her stomach), FEELING ABNORMAL (Feeling rotten), PAIN IN EXTREMITY (pain in leg), ARTHRALGIA (pain in knee/pain in joint/very painful from hip down to knee) and FATIGUE (tired all the time/still feels the same way) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043BZ1A and 028A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included AMLODIPINE, ATORVASTATIN, DICYCLOMINE [DICYCLOVERINE], METOPROLOL TARTRATE, OMEPRAZOLE and TRAMADOL for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to her stomach), FEELING ABNORMAL (Feeling rotten), PAIN IN EXTREMITY (pain in leg), ARTHRALGIA (pain in knee/pain in joint/very painful from hip down to knee) and FATIGUE (tired all the time/still feels the same way). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency and VITAMINS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (sick to her stomach) and FATIGUE (tired all the time/still feels the same way) had not resolved and FEELING ABNORMAL (Feeling rotten), PAIN IN EXTREMITY (pain in leg) and ARTHRALGIA (pain in knee/pain in joint/very painful from hip down to knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had contacted her doctor about it and received 2 shots of steroids in her hip 4 weeks. Patient had also taken Tramadol as treatment drug.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received a 4 day expired vaccine.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.) 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.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were provided.
Sex: U
Vaccine: COVID19
Symptoms: Thrombocytopenia
Clinical narrative: thrombocytopenia; 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 THROMBOCYTOPENIA (thrombocytopenia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOCYTOPENIA (thrombocytopenia). At the time of the report, THROMBOCYTOPENIA (thrombocytopenia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Patient stated it has shortened the patient life in 20 years now.  Company comment- This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious AESI of Thrombocytopenia. The event occurred an unknown amount of time after an unspecified dose of mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from the event based on review of source document that did not include information supporting seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious  of Thrombocytopenia. The event occurred an unknown amount of time after an unspecified dose of mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from the event based on review of source document that did not include information supporting seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Pruritus, Vaccination complication
Clinical narrative: After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast; Feels like it's burning; Blisters; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast), BURNING SENSATION (Feels like it's burning), BLISTER (Blisters) and PRURITUS (Itching) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, CHLORPROMAZINE, LOSARTAN and ALLOPURINOL for an unknown indication.   On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BLISTER (Blisters) and PRURITUS (Itching). On 18-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast) and BURNING SENSATION (Feels like it's burning). At the time of the report, VACCINATION COMPLICATION (After the second dose the reaction occurs in different part of the body, in the arms, on the face and on the breast) and BURNING SENSATION (Feels like it's burning) outcome was unknown and BLISTER (Blisters) and PRURITUS (Itching) had resolved.            Treatment information was not provided. After the second dose patient experienced the reaction  in different part of the body, in the arms, on the face and on the breast. It's where it gets the reactions  most. After the itches went away it burns where the blisters was and lasts 1 or two minutes. Doesn't know if it's  because of the itch. Patient Felts l it was like burning.   This case was linked to MOD-2021-358723 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) 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. Moderna COVID-19 vaccine that was refrigerated for more than 30 days was administered to the patient. The vaccine was defrosted in 30-Aug-2021 and it was administered on 01-Oct-2021.   This case was linked to MOD-2021-358921, MOD-2021-358735, MOD-2021-358779, MOD-2021-358800, MOD-2021-358865, MOD-2021-359032, MOD-2021-359764, MOD-2021-359183, MOD-2021-358799, MOD-2021-358841, MOD-2021-358753 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain, Vertigo
Clinical narrative: midnight he had vertigo once; Soreness at the injection site; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (midnight he had vertigo once), VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 014F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache). On 18-Oct-2021, the patient experienced VERTIGO (midnight he had vertigo once). In October 2021, VERTIGO (midnight he had vertigo once) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) and MYALGIA (Body ache) outcome was unknown.            Treatment medications included Antibiotic and steroids.   This case was linked to MOD-2021-358840 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) 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.  It was reported that the vial did not undergo any temperature excursions.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID after the first dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID after the first dose of the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced COVID-19 (Tested positive for COVID after the first dose of the vaccine). At the time of the report, COVID-19 (Tested positive for COVID after the first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided.  Concomitant medications were not provided. This case concerns a male patient of an unknown age with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event COVID-19 occurred approximately one to two weeks after the first dose of Spikevax. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event COVID-19 occurred approximately one to two weeks after the first dose of Spikevax. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Malaise, Rash, Vaccination site pain
Clinical narrative: soreness of the Left Arm (vaccination site); wheezing; rash in the groin area; said he is not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (said he is not feeling well), WHEEZING (wheezing), RASH (rash in the groin area) and VACCINATION SITE PAIN (soreness of the Left Arm (vaccination site)) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     The patient's past medical history included Asthma (He had no attacks for 10 years now. But he has one Asthma Inhaler for emergency purposes.).    On 19-Oct-2021 at 6:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced MALAISE (said he is not feeling well). On 19-Oct-2021, the patient experienced WHEEZING (wheezing) and RASH (rash in the groin area). On 19-Oct-2021 at 9:00 PM, the patient experienced VACCINATION SITE PAIN (soreness of the Left Arm (vaccination site)). At the time of the report, MALAISE (said he is not feeling well) and WHEEZING (wheezing) had not resolved and RASH (rash in the groin area) and VACCINATION SITE PAIN (soreness of the Left Arm (vaccination site)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Blood pressure measurement: 148/94 (abnormal) 148/94. In October 2021, Heart rate: 86 (normal) pulse rate of 86.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient used his unspecified Asthma inhaler for the event wheezing.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: soreness of the Left Arm (vaccination site); wheezing; rash in the groin area; said he is not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (said he is not feeling well), WHEEZING (wheezing), RASH (rash in the groin area) and VACCINATION SITE PAIN (soreness of the Left Arm (vaccination site)) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     The patient's past medical history included Asthma (He had no attacks for 10 years now. But he has one Asthma Inhaler for emergency purposes.).    On 19-Oct-2021 at 6:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced MALAISE (said he is not feeling well). On 19-Oct-2021, the patient experienced WHEEZING (wheezing) and RASH (rash in the groin area). On 19-Oct-2021 at 9:00 PM, the patient experienced VACCINATION SITE PAIN (soreness of the Left Arm (vaccination site)). At the time of the report, MALAISE (said he is not feeling well) and WHEEZING (wheezing) had not resolved and RASH (rash in the groin area) and VACCINATION SITE PAIN (soreness of the Left Arm (vaccination site)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Blood pressure measurement: 148/94 (abnormal) 148/94. In October 2021, Heart rate: 86 (normal) pulse rate of 86.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient used his unspecified Asthma inhaler for the event wheezing.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling cold, Headache, Illness
Clinical narrative: Sickness; Had no energy; I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes; I had the worst headache of my life/ feeling headache; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Sickness), ASTHENIA (Had no energy), FEELING COLD (I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes) and HEADACHE (I had the worst headache of my life/ feeling headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VITAMIN B12 [VITAMIN B12 NOS], SUCRALFATE (CARAFATE), VERAPAMIL HYDROCHLORIDE (CALAN [VERAPAMIL HYDROCHLORIDE]) and MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 ILLNESS (Sickness), ASTHENIA (Had no energy), FEELING COLD (I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes) and HEADACHE (I had the worst headache of my life/ feeling headache). At the time of the report, ILLNESS (Sickness), ASTHENIA (Had no energy) and HEADACHE (I had the worst headache of my life/ feeling headache) had resolved and FEELING COLD (I was shivering, feeling so cold felt like ice in my veins/I felt frozen, had no energy/The chills come and go still in episodes) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-358790 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 patients administered expired vaccine; 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 (6 patients administered expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Less than 26 days for administration of second dose; This spontaneous case was reported by a physician assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 26 days for administration of second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A and 939906) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 26 days for administration of second dose). On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 26 days for administration of second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: got the 2nd dose beyond the approved time frame in refrigerator; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got the 2nd dose beyond the approved time frame in refrigerator) in an adult 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 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 EXPIRED PRODUCT ADMINISTERED (got the 2nd dose beyond the approved time frame in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got the 2nd dose beyond the approved time frame in refrigerator) had resolved.            No concomitant medications was reported. No treatment drug details was reported.  Age of the patient was mentioned as mid 20s but not provided exactly.   This case was linked to MOD-2021-358910 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart flip-flopped; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart flip-flopped) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart flip-flopped). At the time of the report, PALPITATIONS (heart flip-flopped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: sick for a week; flu like symptoms for a week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for a week) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for a week) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week). At the time of the report, ILLNESS (sick for a week) and INFLUENZA LIKE ILLNESS (flu like symptoms for a week) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       no concomitant medications are provided, treatment to the events given as laid in bad.   This case was linked to MOD-2021-358900 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: heat/hot; rash on my upper arm where the injection site was/spread across the upper arm; red; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat/hot), VACCINATION SITE RASH (rash on my upper arm where the injection site was/spread across the upper arm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included METFORMIN and ENALAPRIL for an unknown indication.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE WARMTH (heat/hot), VACCINATION SITE RASH (rash on my upper arm where the injection site was/spread across the upper arm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy). The patient was treated with HYDROCORTISONE from September 2021 to September 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (heat/hot), VACCINATION SITE RASH (rash on my upper arm where the injection site was/spread across the upper arm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PRURITUS (itchy) 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.   Patient had also taken the supplement of Vitamin B and D3 once a day as a concomitant medication.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Not immunocompromised and received full third dose of 0.5ml; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not immunocompromised and received full third dose of 0.5ml) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00F421A, 038K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinsonism.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Not immunocompromised and received full third dose of 0.5ml). On 19-Oct-2021, OFF LABEL USE (Not immunocompromised and received full third dose of 0.5ml) had resolved.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-358835 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Myalgia, Pain in extremity
Clinical narrative: Arm pain; I was sicker than a dog; If I rub on left arm, site of injection hurts when touched; After the third dose my arm was incredibly sore, I couldn't lift my arm; I had a fever of 102 degrees Fahrenheit; I had chills which lasted 24 to 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), MALAISE (I was sicker than a dog), VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm) and PYREXIA (I had a fever of 102 degrees Fahrenheit) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 030L20A and 022M20A) 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 ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), MALAISE (I was sicker than a dog), VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm), PYREXIA (I had a fever of 102 degrees Fahrenheit) and CHILLS (I had chills which lasted 24 to 30 hours). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched) had not resolved and MALAISE (I was sicker than a dog), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm), PYREXIA (I had a fever of 102 degrees Fahrenheit) and CHILLS (I had chills which lasted 24 to 30 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) I had a fever of 102 degrees Fahrenheit.         The patient reported that they didn't had any side effects with the first two doses, but they did feel incredibly sore and was not able to lift their arm after the third dose. Reportedly, the patient had a fever, chills, and arm pain and most symptoms had resolved except the arm pain.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Arm pain; I was sicker than a dog; If I rub on left arm, site of injection hurts when touched; After the third dose my arm was incredibly sore, I couldn't lift my arm; I had a fever of 102 degrees Fahrenheit; I had chills which lasted 24 to 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), MALAISE (I was sicker than a dog), VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm) and PYREXIA (I had a fever of 102 degrees Fahrenheit) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 030L20A and 022M20A) 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 ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), MALAISE (I was sicker than a dog), VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm), PYREXIA (I had a fever of 102 degrees Fahrenheit) and CHILLS (I had chills which lasted 24 to 30 hours). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm pain) and VACCINATION SITE PAIN (If I rub on left arm, site of injection hurts when touched) had not resolved and MALAISE (I was sicker than a dog), MYALGIA (After the third dose my arm was incredibly sore, I couldn't lift my arm), PYREXIA (I had a fever of 102 degrees Fahrenheit) and CHILLS (I had chills which lasted 24 to 30 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) I had a fever of 102 degrees Fahrenheit.         The patient reported that they didn't had any side effects with the first two doses, but they did feel incredibly sore and was not able to lift their arm after the third dose. Reportedly, the patient had a fever, chills, and arm pain and most symptoms had resolved except the arm pain.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema
Clinical narrative: band-aid mark on the injection site (right arm); pea-size lymph node on her neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (band-aid mark on the injection site (right arm)) and LYMPHADENOPATHY (pea-size lymph node on her neck) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (pea-size lymph node on her neck). On an unknown date, the patient experienced VACCINATION SITE PAIN (band-aid mark on the injection site (right arm)). At the time of the report, VACCINATION SITE PAIN (band-aid mark on the injection site (right arm)) had resolved and LYMPHADENOPATHY (pea-size lymph node on her neck) outcome was unknown.        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.   This case was linked to MOD-2021-358991 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Myocarditis, Oropharyngeal discomfort
Clinical narrative: My son experienced mild myocarditis, with tightness in his throat and chest; with tightness in his throat and chest; with tightness in his throat and chest; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (My son experienced mild myocarditis, with tightness in his throat and chest) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 MYOCARDITIS (My son experienced mild myocarditis, with tightness in his throat and chest) (seriousness criterion medically significant), CHEST DISCOMFORT (with tightness in his throat and chest) and OROPHARYNGEAL DISCOMFORT (with tightness in his throat and chest). At the time of the report, MYOCARDITIS (My son experienced mild myocarditis, with tightness in his throat and chest), CHEST DISCOMFORT (with tightness in his throat and chest) and OROPHARYNGEAL DISCOMFORT (with tightness in his throat and chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.  Company Comment: This case concerns a male patient with unknown age and no relevant medical history, who experienced the serious expected event of myocarditis and non-serious unexpected events of chest discomfort and oropharyngeal discomfort. The events occurred on an unknown date after a dose of Spikevax. The rechallenge was assessed as not applicable as the dose number was unknown. The benefit-risk relationship of Spikevax is not affected by this report. Sender's Comments: This case concerns a male patient with unknown age and no relevant medical history, who experienced the serious expected event of myocarditis and non-serious unexpected events of chest discomfort and oropharyngeal discomfort. The events occurred on an unknown date after a dose of Spikevax. The rechallenge was assessed as not applicable as the dose number was unknown. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Burning sensation, Depressed mood, Depression, Dizziness
Clinical narrative: pain in her right leg; sadness; feels like her body is burning; dizziness; not feeling good; shingles on the left side of her mouth; couldn't open her mouth; depression; burning gums; stomach issues; can't sleep; can't go to the bathroom; only wanting to sleep; vomiting; nausea/nauseas so strong she couldn't eat; fever that wouldn't leave; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, and FEELING ABNORMAL in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012f21a and 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL, VITAMIN D, VITAMIN C, and VITAMIN E for an unknown indication.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-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 (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA outcome was unknown.            Patient reported treatment medication as antibiotics, ice pack, and tea  Patient reported use of concomitant medication high blood pressure medicine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Feeling abnormal, Gingival discomfort, Herpes zoster, Insomnia
Clinical narrative: pain in her right leg; sadness; feels like her body is burning; dizziness; not feeling good; shingles on the left side of her mouth; couldn't open her mouth; depression; burning gums; stomach issues; can't sleep; can't go to the bathroom; only wanting to sleep; vomiting; nausea/nauseas so strong she couldn't eat; fever that wouldn't leave; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, and FEELING ABNORMAL in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012f21a and 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL, VITAMIN D, VITAMIN C, and VITAMIN E for an unknown indication.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-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 (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA outcome was unknown.            Patient reported treatment medication as antibiotics, ice pack, and tea  Patient reported use of concomitant medication high blood pressure medicine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: pain in her right leg; sadness; feels like her body is burning; dizziness; not feeling good; shingles on the left side of her mouth; couldn't open her mouth; depression; burning gums; stomach issues; can't sleep; can't go to the bathroom; only wanting to sleep; vomiting; nausea/nauseas so strong she couldn't eat; fever that wouldn't leave; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, and FEELING ABNORMAL in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012f21a and 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL, VITAMIN D, VITAMIN C, and VITAMIN E for an unknown indication.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-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 (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA outcome was unknown.            Patient reported treatment medication as antibiotics, ice pack, and tea  Patient reported use of concomitant medication high blood pressure medicine.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: pain in her right leg; sadness; feels like her body is burning; dizziness; not feeling good; shingles on the left side of her mouth; couldn't open her mouth; depression; burning gums; stomach issues; can't sleep; can't go to the bathroom; only wanting to sleep; vomiting; nausea/nauseas so strong she couldn't eat; fever that wouldn't leave; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, and FEELING ABNORMAL in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012f21a and 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL, VITAMIN D, VITAMIN C, and VITAMIN E for an unknown indication.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-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 (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (right leg), DEPRESSED MOOD, BURNING SENSATION, DIZZINESS, FEELING ABNORMAL, HERPES ZOSTER, DYSKINESIA, DEPRESSION, GINGIVAL DISCOMFORT, ABDOMINAL DISCOMFORT, INSOMNIA, MOBILITY DECREASED, SOMNOLENCE, VOMITING, NAUSEA, and PYREXIA outcome was unknown.            Patient reported treatment medication as antibiotics, ice pack, and tea  Patient reported use of concomitant medication high blood pressure medicine.