chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: first dose to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose to a 16 year old). On 20-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pollakiuria, Somnolence, Syncope
Clinical narrative: when she stood up, she fainted; Increased urination for a few days/got up in the morning, she urinated; Stayed in bed all day because was so sleepy; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (when she stood up, she fainted) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In 2021, the patient experienced SYNCOPE (when she stood up, she fainted) (seriousness criterion medically significant), POLLAKIURIA (Increased urination for a few days/got up in the morning, she urinated), SOMNOLENCE (Stayed in bed all day because was so sleepy) and FATIGUE (Very tired). At the time of the report, SYNCOPE (when she stood up, she fainted), POLLAKIURIA (Increased urination for a few days/got up in the morning, she urinated), SOMNOLENCE (Stayed in bed all day because was so sleepy) and FATIGUE (Very tired) had resolved.            No concomitant medication information was reported. No treatment information was reported.  Company comment: This case concerns a  83-year-old, female patient with no relevant medical history, who experienced the unexpected event of Syncope. The event occurred unspecified date after the second dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable as event occurred after administration of second dose. The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a  83-year-old, female patient with no relevant medical history, who experienced the unexpected event of Syncope. The event occurred unspecified date after the second dose of Moderna Covid-19 Vaccine. The rechallenge was not applicable as event occurred after administration of second dose. The benefit-risk relationship of Moderna Covid-19 Vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Peripheral swelling, Vaccination site pain, Vaccination site pruritus
Clinical narrative: swollen arm; It itched, it was like a bee sting; it hurt at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (It itched, it was like a bee sting) and VACCINATION SITE PAIN (it hurt at the injection site) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (It itched, it was like a bee sting) and VACCINATION SITE PAIN (it hurt at the injection site). At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS (It itched, it was like a bee sting) and VACCINATION SITE PAIN (it hurt at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, Antibody test: low (Low) Low.         No concomitant medication was provided. The first dose was fine. After second dose the patient had a swollen arm, it hurt at the injection site, and it itched, it was like a bee sting. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Depression, Feeling abnormal
Clinical narrative: depression; feel horrible; repulsion; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), FEELING ABNORMAL (feel horrible) and ANXIETY (repulsion) 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 DEPRESSION (depression), FEELING ABNORMAL (feel horrible) and ANXIETY (repulsion). At the time of the report, DEPRESSION (depression), FEELING ABNORMAL (feel horrible) and ANXIETY (repulsion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. No treatment medications was reported. After introduction of vaccination, the patient was in a little bit of guilt, repulsion and depression with horrible feeling (reported in a crosslinked case). The vaccine should get to everybody and that the formula should be shared.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Non significant follow up received on 22-sep-2021
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 030L20A) for COVID-19 immunization. No medical history reported. On Jan 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 25, 2021, patient experienced vaccination site pain (sore arm at the injection site). At the time of the report, vaccination site pain (sore arm at the injection site) outcome unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-328755 (patient link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle atrophy, Muscular weakness, Vaccination site coldness, Vaccination site discolouration
Clinical narrative: Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius; Injection site feels cool; Injection site white in appearance; Feels atrophied; Injection site firm; Pain is now "migrating to the elbow and it feels atrophied"; Injection site was sore afterwards/ tender; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius), VACCINATION SITE COLDNESS (Injection site feels cool), VACCINATION SITE DISCOLOURATION (Injection site white in appearance), MUSCLE ATROPHY (Feels atrophied) and VACCINATION SITE REACTION (Injection site firm) in a 33-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 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius), VACCINATION SITE COLDNESS (Injection site feels cool), VACCINATION SITE DISCOLOURATION (Injection site white in appearance), MUSCLE ATROPHY (Feels atrophied), VACCINATION SITE REACTION (Injection site firm), ARTHRALGIA (Pain is now "migrating to the elbow and it feels atrophied") and VACCINATION SITE PAIN (Injection site was sore afterwards/ tender). The patient was treated with EMERGEN C at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of Three 800 mg. At the time of the report, MUSCULAR WEAKNESS (Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius), VACCINATION SITE COLDNESS (Injection site feels cool), VACCINATION SITE DISCOLOURATION (Injection site white in appearance), MUSCLE ATROPHY (Feels atrophied), VACCINATION SITE REACTION (Injection site firm), ARTHRALGIA (Pain is now "migrating to the elbow and it feels atrophied") and VACCINATION SITE PAIN (Injection site was sore afterwards/ tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information also included drinking plenty of water and cool and warm compresses.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius; Injection site feels cool; Injection site white in appearance; Feels atrophied; Injection site firm; Pain is now "migrating to the elbow and it feels atrophied"; Injection site was sore afterwards/ tender; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius), VACCINATION SITE COLDNESS (Injection site feels cool), VACCINATION SITE DISCOLOURATION (Injection site white in appearance), MUSCLE ATROPHY (Feels atrophied) and VACCINATION SITE REACTION (Injection site firm) in a 33-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 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius), VACCINATION SITE COLDNESS (Injection site feels cool), VACCINATION SITE DISCOLOURATION (Injection site white in appearance), MUSCLE ATROPHY (Feels atrophied), VACCINATION SITE REACTION (Injection site firm), ARTHRALGIA (Pain is now "migrating to the elbow and it feels atrophied") and VACCINATION SITE PAIN (Injection site was sore afterwards/ tender). The patient was treated with EMERGEN C at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of Three 800 mg. At the time of the report, MUSCULAR WEAKNESS (Feels muscle weakness from her collar bone to her elbow/ radiating from her elbow down to her radius), VACCINATION SITE COLDNESS (Injection site feels cool), VACCINATION SITE DISCOLOURATION (Injection site white in appearance), MUSCLE ATROPHY (Feels atrophied), VACCINATION SITE REACTION (Injection site firm), ARTHRALGIA (Pain is now "migrating to the elbow and it feels atrophied") and VACCINATION SITE PAIN (Injection site was sore afterwards/ tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information also included drinking plenty of water and cool and warm compresses.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Past the 30 day beyond use date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past the 30 day beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) 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 (Past the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past the 30 day beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vials did not undergone previous temperature excursion.  The vials were removed from the freezer on 03-Sep-2021 and  17-Sep-2021. Date of administration (if applicable) 03-Sept-2021 and 17-Sept-2021.  No concomitant medications were provided. No treatment information was reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patients) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patients). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  The vial was stored in refrigerator on 14 Sep 2021 and  vial was punctured  on 22 Sep 2021 at 6 am . The vial did not undergo any temperature excursions. The person who pre - draw the doses took around 6- 10 min, then the syringes were stored in the fridge.   This case was linked to MOD-2021-328726 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: My sister looked like she's having seizures after she got the 2nd dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (My sister looked like she's having seizures after she got the 2nd dose of the Moderna Covid-19 vaccine) 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 23-Sep-2021, the patient experienced SEIZURE (My sister looked like she's having seizures after she got the 2nd dose of the Moderna Covid-19 vaccine) (seriousness criterion medically significant). At the time of the report, SEIZURE (My sister looked like she's having seizures after she got the 2nd dose of the Moderna Covid-19 vaccine) outcome was unknown.      Concomitant medications was not reported. Treatment history was not reported. Patient's vascular surgeon told her that showed that it worked.  company Comment: This case concerns a female patient of an unknown age with no previous relevant medical reported, who experienced the unexpected event of seizure. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a female patient of an unknown age with no previous relevant medical reported, who experienced the unexpected event of seizure. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients were administered "expired vaccines"/ the vial was punctured for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered "expired vaccines"/ the vial was punctured for more than 24 hours) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered "expired vaccines"/ the vial was punctured for more than 24 hours). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patients were administered "expired vaccines"/ the vial was punctured for more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. Date the vial was initially stored in the refrigerator:14Sep2021. Date(s) of administration of vaccine when applicable: 23Sep2021.    This case was linked to MOD-2021-328710 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Myalgia, Nodule, Tension
Clinical narrative: developed some nodules under his arm; afraid of these "nodules"; probably muscle pain; When he touched under his arm, it hurt; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (developed some nodules under his arm), TENSION (afraid of these "nodules"), MYALGIA (probably muscle pain) and AXILLARY PAIN (When he touched under his arm, it hurt) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NODULE (developed some nodules under his arm), TENSION (afraid of these "nodules"), MYALGIA (probably muscle pain) and AXILLARY PAIN (When he touched under his arm, it hurt). At the time of the report, NODULE (developed some nodules under his arm), TENSION (afraid of these "nodules"), MYALGIA (probably muscle pain) and AXILLARY PAIN (When he touched under his arm, it hurt) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-328758 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: More than 36 days after the first dose without receiving the second dose, finally got the injection on 06May2021; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain in the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose, finally got the injection on 06May2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A. and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose, finally got the injection on 06May2021). In May 2021, the patient experienced INJECTION SITE PAIN (pain in the injection site). At the time of the report, INJECTION SITE PAIN (pain in the injection site) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose,finally got the injection on 06May2021) had resolved.            no concomitant medications are provided. treatment to the events not reported.   This case was linked to MOD-2021-328736 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: 7 people who turned up with appendicitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of APPENDICITIS (7 people who turned up with appendicitis) 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 APPENDICITIS (7 people who turned up with appendicitis) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (7 people who turned up with appendicitis) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter also mentioned that there was 7 people who turned up with appendicitis in a research group who received the vaccine (unknown which vaccine).  Concomitant product use was not provided by reporter.  Treatment information was not provided.  Company Comment - This case concerns a patient of unknown age and gender who experienced the serious unexpected event of Appendicitis. The event occurred an unknown time after a COVID-19 vaccine of unknown manufacturer. Re-challenge is unknown as no information about the dose(s) is reported. The Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-313517 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender who experienced the serious unexpected event of Appendicitis. The event occurred an unknown time after a COVID-19 vaccine of unknown manufacturer. Re-challenge is unknown as no information about the dose(s) is reported. The Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received his 1st dose and now wants to take his 2nd dose 90 days later; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received his 1st dose and now wants to take his 2nd dose 90 days later) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received his 1st dose and now wants to take his 2nd dose 90 days later). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received his 1st dose and now wants to take his 2nd dose 90 days later) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient wanted to take his 2nd Moderna vaccine 90 days later.  No concomitant and treatment medication was reported by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: internal burning sensation all over her body; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (internal burning sensation all over her body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced BURNING SENSATION (internal burning sensation all over her body). On 19-Sep-2021, BURNING SENSATION (internal burning sensation all over her body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment  medication was provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.  Patient had called to report that he had headaches few hours after taking the Moderna vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered beyond expiration date; 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 (Doses administered beyond expiration date) 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 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date). On 17-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  All 4 were second doses and/or third ones. No first doses. The vials were expired while being stored in the freezer. It was unknown if the vial undergo any temperature excursions.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain in extremity, Paraesthesia
Clinical narrative: Had a tingling cold sensation in the left ear to the left side of her neck; Had a tingling cold sensation in the left ear to the left side of her neck; Pain from elbowto wrist and hand/Pain from elbowto wrist; Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Had a tingling cold sensation in the left ear to the left side of her neck), FEELING COLD (Had a tingling cold sensation in the left ear to the left side of her neck), PAIN IN EXTREMITY (Pain from elbowto wrist and hand/Pain from elbowto wrist) and PAIN IN EXTREMITY (Sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced PARAESTHESIA (Had a tingling cold sensation in the left ear to the left side of her neck), FEELING COLD (Had a tingling cold sensation in the left ear to the left side of her neck), PAIN IN EXTREMITY (Pain from elbowto wrist and hand/Pain from elbowto wrist) and PAIN IN EXTREMITY (Sore arm). On 16-Sep-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PARAESTHESIA (Had a tingling cold sensation in the left ear to the left side of her neck), FEELING COLD (Had a tingling cold sensation in the left ear to the left side of her neck) and PAIN IN EXTREMITY (Pain from elbowto wrist and hand/Pain from elbowto wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Cough, SARS-CoV-2 test
Clinical narrative: weakened/second shot (it) knocked her out for a month; very bad cough; every bone hurt; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakened/second shot (it) knocked her out for a month), COUGH (very bad cough) and BONE PAIN (every bone hurt) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037AZ1B and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Stage 4 Cancer) since 2019.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakened/second shot (it) knocked her out for a month), COUGH (very bad cough) and BONE PAIN (every bone hurt). At the time of the report, ASTHENIA (weakened/second shot (it) knocked her out for a month) had resolved and COUGH (very bad cough) and BONE PAIN (every bone hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include chemotherapy. Treatment medication include medication for chest relief to get the mucous out.  Patient's cancer spread to kidney ,then to stomach , then to brain around the end of 2020 and beginning of 2021. Now patient is able to walk and got some strength.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: After 1st dose, she had body aches.; She also had headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (After 1st dose, she had body aches.) and HEADACHE (She also had headaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL (COREG) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Apr-2021, the patient experienced MYALGIA (After 1st dose, she had body aches.) and HEADACHE (She also had headaches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (After 1st dose, she had body aches.) and HEADACHE (She also had headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-329004 (Patient Link).; Sender's Comments: This case concerns a 59-year-old, female patient with no relevant medical history, who experienced the expected non-serious events of headache and myalgia. The events occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the outcome of the events of myalgia and headache is unknown (no specific information if they were resolved after the second dose according to source document narrative). The events are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test
Clinical narrative: mildly sore arm; Positive for Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mildly sore arm) and COVID-19 (Positive for Covid-19) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included Ex-smoker (smoked 35 years), Open heart surgery and Triple vessel bypass graft. Concurrent medical conditions included Amputee, Diabetes and High cholesterol.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (mildly sore arm) and COVID-19 (Positive for Covid-19). At the time of the report, PAIN IN EXTREMITY (mildly sore arm) and COVID-19 (Positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         She did not experience any side effects except for a mildly sore arm.  She recently tested positive for COVID-19 but was completely asymptomatic.  She attributed her lack of problems from COVID-19 to vaccine.  No concomitant medications were reported.  No treatment information was reported.; Sender's Comments: This report concerns a 62 year old female patient with relevant medical history of open heart surgery, diabetes and a past history of smoking who experienced unexpected non-serious events of pain in extremity and COVID-19. It was reported that the patient tested positive for COVID-19, however was asymptomatic. The events occurred after an unknown duration following vaccination with mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Inflammation, Loss of personal independence in daily activities
Clinical narrative: Inflammation; now I'm not able to do it; Mainly on the back and lower muscles/Back down; Sometimes in neck and lower part of head; Head pain; my body aches so bad; lower part of head; Extreme muscle pain; Extremely exhausted and fatigued; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head) and HEADACHE (Head pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced FATIGUE (Extremely exhausted and fatigued). In July 2021, the patient experienced MYALGIA (Extreme muscle pain). On an unknown date, the patient experienced INFLAMMATION (Inflammation), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head), HEADACHE (Head pain), PAIN (my body aches so bad) and HEADACHE (lower part of head). The patient was treated with IBUPROFEN for Back pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. On 02-Apr-2021, FATIGUE (Extremely exhausted and fatigued) had resolved. At the time of the report, INFLAMMATION (Inflammation) and HEADACHE (Head pain) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head), PAIN (my body aches so bad), HEADACHE (lower part of head) and MYALGIA (Extreme muscle pain) had not resolved.            Concomitant and Treatment was not specified.  Doctor told patient to take Ibuprofen or Tylenol for the pain, but patient didn't like taking medication.   This case was linked to MOD-2021-329014 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain
Clinical narrative: Inflammation; now I'm not able to do it; Mainly on the back and lower muscles/Back down; Sometimes in neck and lower part of head; Head pain; my body aches so bad; lower part of head; Extreme muscle pain; Extremely exhausted and fatigued; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head) and HEADACHE (Head pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced FATIGUE (Extremely exhausted and fatigued). In July 2021, the patient experienced MYALGIA (Extreme muscle pain). On an unknown date, the patient experienced INFLAMMATION (Inflammation), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head), HEADACHE (Head pain), PAIN (my body aches so bad) and HEADACHE (lower part of head). The patient was treated with IBUPROFEN for Back pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Back pain, at an unspecified dose and frequency. On 02-Apr-2021, FATIGUE (Extremely exhausted and fatigued) had resolved. At the time of the report, INFLAMMATION (Inflammation) and HEADACHE (Head pain) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (now I'm not able to do it), BACK PAIN (Mainly on the back and lower muscles/Back down), NECK PAIN (Sometimes in neck and lower part of head), PAIN (my body aches so bad), HEADACHE (lower part of head) and MYALGIA (Extreme muscle pain) had not resolved.            Concomitant and Treatment was not specified.  Doctor told patient to take Ibuprofen or Tylenol for the pain, but patient didn't like taking medication.   This case was linked to MOD-2021-329014 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) 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 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 21-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported. Treatment information was not provided.  Patient was claiming that he was not given a vaccine so another pharmacist gave another dose.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Hallucination, auditory, Paranoia, Psychotic disorder
Clinical narrative: hallucinations; hearing voices; Psychosis\mental problems; paranoia; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations) and HALLUCINATION, AUDITORY (hearing voices) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-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 HALLUCINATION (hallucinations) (seriousness criterion medically significant), HALLUCINATION, AUDITORY (hearing voices) (seriousness criterion medically significant), PSYCHOTIC DISORDER (Psychosis\mental problems) and PARANOIA (paranoia). At the time of the report, HALLUCINATION (hallucinations), HALLUCINATION, AUDITORY (hearing voices), PSYCHOTIC DISORDER (Psychosis\mental problems) and PARANOIA (paranoia) outcome was unknown.            No concomitant and treatment drugs were provided.  Company comment: This case concerns a 22 -year-old male patient with no medical history, who experienced the unexpected events of Hallucination, hallucination auditory, Psychotic disorder, Acoustic stimulation tests abnormal and Paranoia. The events occurred after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-329076 (Patient Link).; Sender's Comments: This case concerns a 22 -year-old male patient with no medical history, who experienced the unexpected events of Hallucination, hallucination auditory, Psychotic disorder, Acoustic stimulation tests abnormal and Paranoia. The events occurred after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site warmth
Clinical narrative: COVID arm; injection site hot to the touch; injection site really hard; big round red rash on her injection arm; injection arm itches crazy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE INDURATION (injection site really hard), VACCINATION SITE RASH (big round red rash on her injection arm) and VACCINATION SITE PRURITUS (injection arm itches crazy) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE INDURATION (injection site really hard), VACCINATION SITE RASH (big round red rash on her injection arm) and VACCINATION SITE PRURITUS (injection arm itches crazy). At the time of the report, VACCINATION SITE REACTION (COVID arm) had not resolved and VACCINATION SITE WARMTH (injection site hot to the touch), VACCINATION SITE INDURATION (injection site really hard), VACCINATION SITE RASH (big round red rash on her injection arm) and VACCINATION SITE PRURITUS (injection arm itches crazy) outcome was unknown.            No concomitant medications were provided.  The patient received both doses of the Moderna COVID-19 vaccine. The patient developed what is called COVID arm. It happened after the second dose and still has it. It was a big round red rash on injection arm that itches crazy, was hot to the touch and really hard. The red mark appeared almost immediately after the second dose.  No treatment medications were provided.