chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pain in extremity, Sinusitis
Clinical narrative: felt like she had a cold or a sinus infection; slight fatigue; sore arm; shortness of breath/ occasionally still presents shortness of breath/occasionally still presents shortness of breath/She can just be sitting and present shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (felt like she had a cold or a sinus infection), DYSPNOEA (shortness of breath/ occasionally still presents shortness of breath/occasionally still presents shortness of breath/She can just be sitting and present shortness of breath), FATIGUE (slight fatigue) and PAIN IN EXTREMITY (sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (shortness of breath/ occasionally still presents shortness of breath/occasionally still presents shortness of breath/She can just be sitting and present shortness of breath). On an unknown date, the patient experienced SINUSITIS (felt like she had a cold or a sinus infection), FATIGUE (slight fatigue) and PAIN IN EXTREMITY (sore arm). At the time of the report, SINUSITIS (felt like she had a cold or a sinus infection), FATIGUE (slight fatigue) and PAIN IN EXTREMITY (sore arm) outcome was unknown and DYSPNOEA (shortness of breath/ occasionally still presents shortness of breath/occasionally still presents shortness of breath/She can just be sitting and present shortness of breath) had not resolved.            No concomitant medications were reported. The patient was prescribed with Antibiotics. Patient had a cardiac MRI with the rest of the tests.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: red patch on her arm,  but the redness is slightly gone but the circle is still visible; swollen; somewhat itchy but the redness is slightly gone but the circle is still visible; somewhat itchy; little clammy; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (little clammy), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red patch on her arm,  but the redness is slightly gone but the circle is still visible) and VACCINATION SITE SWELLING (swollen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced COLD SWEAT (little clammy), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red patch on her arm,  but the redness is slightly gone but the circle is still visible), VACCINATION SITE SWELLING (swollen), VACCINATION SITE RASH (somewhat itchy but the redness is slightly gone but the circle is still visible) and VACCINATION SITE PRURITUS (somewhat itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 22-Nov-2021, COLD SWEAT (little clammy), HEADACHE (headache) and FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red patch on her arm,  but the redness is slightly gone but the circle is still visible), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE RASH (somewhat itchy but the redness is slightly gone but the circle is still visible) was resolving and VACCINATION SITE PRURITUS (somewhat itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: red patch on her arm,  but the redness is slightly gone but the circle is still visible; swollen; somewhat itchy but the redness is slightly gone but the circle is still visible; somewhat itchy; little clammy; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (little clammy), HEADACHE (headache), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (red patch on her arm,  but the redness is slightly gone but the circle is still visible) and VACCINATION SITE SWELLING (swollen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced COLD SWEAT (little clammy), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red patch on her arm,  but the redness is slightly gone but the circle is still visible), VACCINATION SITE SWELLING (swollen), VACCINATION SITE RASH (somewhat itchy but the redness is slightly gone but the circle is still visible) and VACCINATION SITE PRURITUS (somewhat itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 22-Nov-2021, COLD SWEAT (little clammy), HEADACHE (headache) and FATIGUE (fatigue) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red patch on her arm,  but the redness is slightly gone but the circle is still visible), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE RASH (somewhat itchy but the redness is slightly gone but the circle is still visible) was resolving and VACCINATION SITE PRURITUS (somewhat itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Swelling
Clinical narrative: had her neck swell up like a balloon; My digestive system has shut down since 11/17; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (had her neck swell up like a balloon) and DYSPEPSIA (My digestive system has shut down since 11/17) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (had her neck swell up like a balloon) and DYSPEPSIA (My digestive system has shut down since 11/17). At the time of the report, SWELLING (had her neck swell up like a balloon) and DYSPEPSIA (My digestive system has shut down since 11/17) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Dec-2021: Follow-up received and it contains no significant information. On 27-Dec-2021: Follow-up received and it contains significant information a new event added
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Dizziness, Dysphonia
Clinical narrative: body feels weak; throat is acting up more meaning it's becoming raspy & he's starting to cough; he's starting to cough; has shortness of breath; feels so bad; head feels dizzy; fever; has a headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (body feels weak), DYSPHONIA (throat is acting up more meaning it's becoming raspy & he's starting to cough), COUGH (he's starting to cough), DYSPNOEA (has shortness of breath) and FEELING ABNORMAL (feels so bad) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 037A21B and 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-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 ASTHENIA (body feels weak), DYSPHONIA (throat is acting up more meaning it's becoming raspy & he's starting to cough), COUGH (he's starting to cough), DYSPNOEA (has shortness of breath), FEELING ABNORMAL (feels so bad), DIZZINESS (head feels dizzy), PYREXIA (fever), HEADACHE (has a headache) and CHILLS (chills). At the time of the report, ASTHENIA (body feels weak), DYSPNOEA (has shortness of breath), DIZZINESS (head feels dizzy), PYREXIA (fever), HEADACHE (has a headache) and CHILLS (chills) outcome was unknown and DYSPHONIA (throat is acting up more meaning it's becoming raspy & he's starting to cough), COUGH (he's starting to cough) and FEELING ABNORMAL (feels so bad) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.  The patient stated that he had chills, fever, his head feels dizzy, he had a headache, his body feels weak, his throat is acting up more meaning it's becoming raspy and he's starting to cough, and he has shortness of breath.  He stated that he was going to go ahead and go to the hospital because he feels so bad and wanted to end the call.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Headache, Pyrexia
Clinical narrative: body feels weak; throat is acting up more meaning it's becoming raspy & he's starting to cough; he's starting to cough; has shortness of breath; feels so bad; head feels dizzy; fever; has a headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (body feels weak), DYSPHONIA (throat is acting up more meaning it's becoming raspy & he's starting to cough), COUGH (he's starting to cough), DYSPNOEA (has shortness of breath) and FEELING ABNORMAL (feels so bad) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 037A21B and 034F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-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 ASTHENIA (body feels weak), DYSPHONIA (throat is acting up more meaning it's becoming raspy & he's starting to cough), COUGH (he's starting to cough), DYSPNOEA (has shortness of breath), FEELING ABNORMAL (feels so bad), DIZZINESS (head feels dizzy), PYREXIA (fever), HEADACHE (has a headache) and CHILLS (chills). At the time of the report, ASTHENIA (body feels weak), DYSPNOEA (has shortness of breath), DIZZINESS (head feels dizzy), PYREXIA (fever), HEADACHE (has a headache) and CHILLS (chills) outcome was unknown and DYSPHONIA (throat is acting up more meaning it's becoming raspy & he's starting to cough), COUGH (he's starting to cough) and FEELING ABNORMAL (feels so bad) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.  The patient stated that he had chills, fever, his head feels dizzy, he had a headache, his body feels weak, his throat is acting up more meaning it's becoming raspy and he's starting to cough, and he has shortness of breath.  He stated that he was going to go ahead and go to the hospital because he feels so bad and wanted to end the call.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021. This lot number expiration date was not extended.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021. This lot number expiration date was not extended.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension, Ex-smoker, Hyperlipidemia and Obesity. Concomitant products included METFORMIN, LISINOPRIL, AMLODIPINE, HCTZ and LOVASTATIN for an unknown indication.    On 03-Sep-2021 at 11:09 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021 at 11:09 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021. This lot number expiration date was not extended.). On 03-Sep-2021 at 11:09 AM, EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021. This lot number expiration date was not extended.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021. This lot number expiration date was not extended.) to be not related.    The patient had no known drug allergy. There were no any other potential causes of this event.   This case was linked to MOD-2021-328706 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Joint swelling, Rash, Skin discolouration, Urticaria
Clinical narrative: Hives all over his body / a hives reaction of some sort / huge hives on his hands / huge hives on his palms / welts on his hands / welts on his palms; Skin is inflamed; Ankles are black and blue; Ankles are super swollen; Rashes all over his body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over his body / a hives reaction of some sort / huge hives on his hands / huge hives on his palms / welts on his hands / welts on his palms), DERMATITIS (Skin is inflamed), SKIN DISCOLORATION (Ankles are black and blue), JOINT SWELLING (Ankles are super swollen) and RASH (Rashes all over his body) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 037A21B and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Infection in March 2020.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Nov-2021, the patient experienced URTICARIA (Hives all over his body / a hives reaction of some sort / huge hives on his hands / huge hives on his palms / welts on his hands / welts on his palms), DERMATITIS (Skin is inflamed), SKIN DISCOLORATION (Ankles are black and blue), JOINT SWELLING (Ankles are super swollen) and RASH (Rashes all over his body). The patient was treated with AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ORIGINAL) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over his body / a hives reaction of some sort / huge hives on his hands / huge hives on his palms / welts on his hands / welts on his palms), DERMATITIS (Skin is inflamed), SKIN DISCOLORATION (Ankles are black and blue), JOINT SWELLING (Ankles are super swollen) and RASH (Rashes all over his body) outcome was unknown.      The patient experienced "a hives reaction of some sort".  He stated his skin is inflamed and if he scratches the rash it causes "flares".  It was reported that he has huge hives and welts on his hands and palms, and it hurts to walk on feet due to the bad rash.   He stated his ankles are black and blue and "super swollen". He also reported taking Benadryl. He reported the doctor did not think the rash was diet related. Went to doctor (02Dec2021) as was prescribed Steroids   No known food or drug allergies reported.  not had hives in the past.  No concomitant medication details was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested for positive for COVID after a shot in May; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested for positive for COVID after a shot in May) 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.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced COVID-19 (Tested for positive for COVID after a shot in May). At the time of the report, COVID-19 (Tested for positive for COVID after a shot in May) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive test results on the 11th..     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.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient had the IV Inoculant on the 13th.  Company comment: This spontaneous case report concerns a patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19.  The event was reported to occur after the administration of an unknown dose of the mRNA-1273 vaccine in an unknown schedule of vaccination.  It is to be noticed that no information on the patient´s vaccination schedule as well as the clinical course, diagnosis and treatment received (if required) was disclosed.  At the time of the report, the outcome was Unknown. The rechallenge is unknown as the event happened after one dose of mRNA-1273 vaccine and since no information on schedule of administration is provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The case has been assessed with available information.; Sender's Comments: This spontaneous case report concerns a patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19.  The event was reported to occur after the administration of an unknown dose of the mRNA-1273 vaccine in an unknown schedule of vaccination.  It is to be noticed that no information on the patient´s vaccination schedule as well as the clinical course, diagnosis and treatment received (if required) was disclosed.  At the time of the report, the outcome was Unknown. The rechallenge is unknown as the event happened after one dose of mRNA-1273 vaccine and since no information on schedule of administration is provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The case has been assessed with available information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got COVID in late September; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Got COVID in late September) 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. In September 2021, the patient experienced COVID-19 (Got COVID in late September). At the time of the report, COVID-19 (Got COVID in late September) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. 1st and 2nd doses of Moderna Vaccine, then got Covid in late September. On 19-Oct-2021, the patient  was able to get the additional dose of Moderna. Treatment information was not provided.  Company comment: This spontaneous case report concerns a patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19.  The event was reported to occur after the administration of two doses of the mRNA-1273 vaccine in an unknown schedule of vaccination.  It is to be noticed that no information on the patient´s vaccination schedule (dates not reported) as well as the clinical course, diagnosis and treatment received (if required) was disclosed.  At the time of the report, the outcome was Unknown. The rechallenge is unknown as the event happened after the administration of an unknown schedule of vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The case has been assessed with available information.; Sender's Comments: This spontaneous case report concerns a patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19.  The event was reported to occur after the administration of two doses of the mRNA-1273 vaccine in an unknown schedule of vaccination.  It is to be noticed that no information on the patient´s vaccination schedule (dates not reported) as well as the clinical course, diagnosis and treatment received (if required) was disclosed.  At the time of the report, the outcome was Unknown. The rechallenge is unknown as the event happened after the administration of an unknown schedule of vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The case has been assessed with available information.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Erythema, Myalgia, Nausea
Clinical narrative: Involuntary jerks, convulsion; Full color of face change, really red; temp 99F for a few moments; Looks really painful; A lot of muscular pain; Shivering; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Involuntary jerks, convulsion), ERYTHEMA (Full color of face change, really red), BODY TEMPERATURE INCREASED (temp 99F for a few moments), PAIN (Looks really painful) and MYALGIA (A lot of muscular pain) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Dec-2021 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced SEIZURE (Involuntary jerks, convulsion), ERYTHEMA (Full color of face change, really red), BODY TEMPERATURE INCREASED (temp 99F for a few moments), PAIN (Looks really painful), MYALGIA (A lot of muscular pain), CHILLS (Shivering) and NAUSEA (nauseas). At the time of the report, SEIZURE (Involuntary jerks, convulsion), ERYTHEMA (Full color of face change, really red), BODY TEMPERATURE INCREASED (temp 99F for a few moments), PAIN (Looks really painful), MYALGIA (A lot of muscular pain), CHILLS (Shivering) and NAUSEA (nauseas) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2021, Body temperature increased: 99 (High) 99F for a few moments.         Concomitant products were not provided. Treatment medication were not reported. Patient does not have fever, he had 99F for a few moments breathing is fine, but he looks really painful. He's having a lot of muscular pain, like electrical, it comes in waves, it's kind of involuntary. This spontaneous case is concerning of 47 years old male patient with no medical history, who  experienced the unexpected, AESI of Seizures and unexpected  nonserious events of erythema and increased body temperature. The event occurred few hours  after the booster dose of mRNA-1273 vaccine. The outcome of the events were reported unknown. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case is concerning of 47 years old male patient with no medical history, who  experienced the unexpected, AESI of Seizures and unexpected  nonserious events of erythema and increased body temperature. The event occurred few hours  after the booster dose of mRNA-1273 vaccine. The outcome of the events were reported unknown. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Seizure
Clinical narrative: Involuntary jerks, convulsion; Full color of face change, really red; temp 99F for a few moments; Looks really painful; A lot of muscular pain; Shivering; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Involuntary jerks, convulsion), ERYTHEMA (Full color of face change, really red), BODY TEMPERATURE INCREASED (temp 99F for a few moments), PAIN (Looks really painful) and MYALGIA (A lot of muscular pain) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Dec-2021 at 10:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Dec-2021, the patient experienced SEIZURE (Involuntary jerks, convulsion), ERYTHEMA (Full color of face change, really red), BODY TEMPERATURE INCREASED (temp 99F for a few moments), PAIN (Looks really painful), MYALGIA (A lot of muscular pain), CHILLS (Shivering) and NAUSEA (nauseas). At the time of the report, SEIZURE (Involuntary jerks, convulsion), ERYTHEMA (Full color of face change, really red), BODY TEMPERATURE INCREASED (temp 99F for a few moments), PAIN (Looks really painful), MYALGIA (A lot of muscular pain), CHILLS (Shivering) and NAUSEA (nauseas) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2021, Body temperature increased: 99 (High) 99F for a few moments.         Concomitant products were not provided. Treatment medication were not reported. Patient does not have fever, he had 99F for a few moments breathing is fine, but he looks really painful. He's having a lot of muscular pain, like electrical, it comes in waves, it's kind of involuntary. This spontaneous case is concerning of 47 years old male patient with no medical history, who  experienced the unexpected, AESI of Seizures and unexpected  nonserious events of erythema and increased body temperature. The event occurred few hours  after the booster dose of mRNA-1273 vaccine. The outcome of the events were reported unknown. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case is concerning of 47 years old male patient with no medical history, who  experienced the unexpected, AESI of Seizures and unexpected  nonserious events of erythema and increased body temperature. The event occurred few hours  after the booster dose of mRNA-1273 vaccine. The outcome of the events were reported unknown. The rechallenge not applicable as the events occurred after the third dose and no other dose is expected at this moment.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Haemorrhage, Headache, Lymphadenopathy, Muscle spasms
Clinical narrative: bleeding from the underarm; muscle cramps; dizziness; headache; muscle pain; swelling in their armpit; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding from the underarm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (bleeding from the underarm) (seriousness criterion medically significant), MUSCLE SPASMS (muscle cramps), DIZZINESS (dizziness), HEADACHE (headache), MYALGIA (muscle pain) and LYMPHADENOPATHY (swelling in their armpit). The patient was treated with NAPROXEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, HAEMORRHAGE (bleeding from the underarm), MUSCLE SPASMS (muscle cramps), DIZZINESS (dizziness), HEADACHE (headache), MYALGIA (muscle pain) and LYMPHADENOPATHY (swelling in their armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Patient experienced headache, dizziness, muscle pain/cramps, swelling in their armpit, and bleeding from the underarm. Therefore, patient decided to switch it up for their second dose.  Company Comment: This is a spontaneous case concerning a 61-year-old, female patient with no reported medical history, who experienced the unexpected serious event of Haemorrhage. The event occurred on an unknown date after the first dose of mRNA-1273 vaccine. Naproxen and Tylenol are used as treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-413636 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 61-year-old, female patient with no reported medical history, who experienced the unexpected serious event of Haemorrhage. The event occurred on an unknown date after the first dose of mRNA-1273 vaccine. Naproxen and Tylenol are used as treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: bleeding from the underarm; muscle cramps; dizziness; headache; muscle pain; swelling in their armpit; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding from the underarm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (bleeding from the underarm) (seriousness criterion medically significant), MUSCLE SPASMS (muscle cramps), DIZZINESS (dizziness), HEADACHE (headache), MYALGIA (muscle pain) and LYMPHADENOPATHY (swelling in their armpit). The patient was treated with NAPROXEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, HAEMORRHAGE (bleeding from the underarm), MUSCLE SPASMS (muscle cramps), DIZZINESS (dizziness), HEADACHE (headache), MYALGIA (muscle pain) and LYMPHADENOPATHY (swelling in their armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Patient experienced headache, dizziness, muscle pain/cramps, swelling in their armpit, and bleeding from the underarm. Therefore, patient decided to switch it up for their second dose.  Company Comment: This is a spontaneous case concerning a 61-year-old, female patient with no reported medical history, who experienced the unexpected serious event of Haemorrhage. The event occurred on an unknown date after the first dose of mRNA-1273 vaccine. Naproxen and Tylenol are used as treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-413636 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 61-year-old, female patient with no reported medical history, who experienced the unexpected serious event of Haemorrhage. The event occurred on an unknown date after the first dose of mRNA-1273 vaccine. Naproxen and Tylenol are used as treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Tachycardia
Clinical narrative: chest really tight; shortness of breath; heart is beating faster; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest really tight), DYSPNOEA (shortness of breath) and TACHYCARDIA (heart is beating faster) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J2LA) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced CHEST DISCOMFORT (chest really tight), DYSPNOEA (shortness of breath) and TACHYCARDIA (heart is beating faster). At the time of the report, CHEST DISCOMFORT (chest really tight) and DYSPNOEA (shortness of breath) had not resolved and TACHYCARDIA (heart is beating faster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2021, Heart rate: high (High) heart is beating faster.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures, seizure every week for 5 weeks; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizures, seizure every week for 5 weeks) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizures (minor seizures twice a month).    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced SEIZURE (seizures, seizure every week for 5 weeks) (seriousness criterion medically significant). The patient was treated with CANNABIS for Seizures, at an unspecified dose and frequency. In October 2021, SEIZURE (seizures, seizure every week for 5 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient had minor seizures twice a month. When she got the first Moderna shot, she got a seizure every week for 5 weeks.  Company Comment:This is a spontaneous case concerning a 55-year-old, female patient with current condition of seizures, who experienced the unexpected serious event of Seizures on an unknown date after the first dose of mRNA-1273 vaccine. Patients current condition is confounder for the case. The outcome of the event was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-415060 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 55-year-old, female patient with current condition of seizures, who experienced the unexpected serious  event of Seizures on an unknown date after the first dose of mRNA-1273 vaccine. Patients current condition is confounder for the case. The outcome of the event was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: Patient had lymphoma after primary vaccination with Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Patient had lymphoma after primary vaccination with Moderna COVID-19 Vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHOMA (Patient had lymphoma after primary vaccination with Moderna COVID-19 Vaccine) (seriousness criterion life threatening). At the time of the report, LYMPHOMA (Patient had lymphoma after primary vaccination with Moderna COVID-19 Vaccine) outcome was unknown.            Concomitant medications were not provided. Treatment information included chemo.  Company Comment - This case concerns a 77 year old female patient with no relevant medical history, who experienced the serious (life threatening) unexpected event of lymphoma. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 77 year old female patient with no relevant medical history, who experienced the serious (life threatening) unexpected event of lymphoma. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: had appendicitis & an appendectomy on 23Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (had appendicitis & an appendectomy on 23Oct2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced APPENDICITIS (had appendicitis & an appendectomy on 23Oct2021) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (Appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (had appendicitis & an appendectomy on 23Oct2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication has been provided.  No treatment medication has been provided.  Company Comment: This spontaneous case concerns a 29-year-old, male patient with no medical history reported, who experienced the unexpected, serious AESI of appendicitis. The event occurred approximately 8 months after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient underwent an Appendectomy on 23Oct2021. No further details were provided. The outcome of the event was unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 29-year-old, male patient with no medical history reported, who experienced the unexpected, serious AESI of appendicitis. The event occurred approximately 8 months after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient underwent an Appendectomy on 23Oct2021. No further details were provided. The outcome of the event was unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: a raising heart rate; Headaches; Fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (a raising heart rate), HEADACHE (Headaches), PYREXIA (Fever) and MYALGIA (Body aches) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069f21a, 011j20a and 030l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced HEART RATE INCREASED (a raising heart rate), HEADACHE (Headaches), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (a raising heart rate), HEADACHE (Headaches), PYREXIA (Fever) and MYALGIA (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2021, Heart rate: increased (High) raising heart rate..         Concomitant medication was not provided.  Company Comment: This spontaneous case concerns a 32-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious event of heart rate increased and other associated expected, non-serious events. The events occurred on the same day after administration of the booster dose of the Moderna mRNA-1273 vaccine. The patient took Tylenol (paracetmol), unspecified dose and frequency, affording no relief of symptoms. The events had not resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 32-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious event of heart rate increased and other associated expected, non-serious events. The events occurred on the same day after administration of the booster dose of the Moderna mRNA-1273 vaccine. The patient took Tylenol (paracetmol), unspecified dose and frequency, affording no relief of symptoms. The events had not resolved at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: breakthrough case; got COVID; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (breakthrough case) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History 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 VACCINE BREAKTHROUGH INFECTION (breakthrough case) (seriousness criterion medically significant) and COVID-19 (got COVID). At the time of the report, VACCINE BREAKTHROUGH INFECTION (breakthrough case) and COVID-19 (got COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that he and his wife were exposed to their 27-year-old daughter, who also received the Moderna COVID-19 vaccine. The patient stated that she also had a breakthrough case. The patient's daughter's vaccination information was unknown. He stated that she was vaccinated around the same time he was.  No concomitant medication was reported. No treatment information was provided.  Company Comment: This spontaneous case concerns a 27-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious  of COVID-19 and vaccine breakthrough infection after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. No further information was provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 27-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and vaccine breakthrough infection after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. No further information was provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.