chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Deafness
Clinical narrative: Can't hear with my left ear; Lost my tastebuds; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Can't hear with my left ear) in a  patient of an unknown age and gender 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 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Can't hear with my left ear) (seriousness criterion medically significant) and AGEUSIA (Lost my tastebuds). At the time of the report, DEAFNESS (Can't hear with my left ear) and AGEUSIA (Lost my tastebuds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium, Blood sodium, Coma, Dehydration, Feeling abnormal
Clinical narrative: Brain infection viral meningitis; Psychosis; Dehydration; Almost in coma; Caused his body to go haywire; This spontaneous case was reported by a consumer and describes the occurrence of MENINGITIS VIRAL (Brain infection viral meningitis), PSYCHOTIC DISORDER (Psychosis), DEHYDRATION (Dehydration), COMA (Almost in coma) and FEELING ABNORMAL (Caused his body to go haywire) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Meningitis (Spinal meningitis) and Infection (Had an infection before 1st dose and took medicine.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 MENINGITIS VIRAL (Brain infection viral meningitis) (seriousness criteria hospitalization and medically significant), PSYCHOTIC DISORDER (Psychosis) (seriousness criterion hospitalization), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), COMA (Almost in coma) (seriousness criteria hospitalization and medically significant) and FEELING ABNORMAL (Caused his body to go haywire) (seriousness criterion hospitalization). At the time of the report, MENINGITIS VIRAL (Brain infection viral meningitis), PSYCHOTIC DISORDER (Psychosis), DEHYDRATION (Dehydration), COMA (Almost in coma) and FEELING ABNORMAL (Caused his body to go haywire) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood potassium: low (Low) Decreased. In 2021, Blood sodium: low (Low) Decreased.         Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226811, MOD-2021-072608 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: Meningitis viral, Psychotic disorder
Clinical narrative: Brain infection viral meningitis; Psychosis; Dehydration; Almost in coma; Caused his body to go haywire; This spontaneous case was reported by a consumer and describes the occurrence of MENINGITIS VIRAL (Brain infection viral meningitis), PSYCHOTIC DISORDER (Psychosis), DEHYDRATION (Dehydration), COMA (Almost in coma) and FEELING ABNORMAL (Caused his body to go haywire) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Meningitis (Spinal meningitis) and Infection (Had an infection before 1st dose and took medicine.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 MENINGITIS VIRAL (Brain infection viral meningitis) (seriousness criteria hospitalization and medically significant), PSYCHOTIC DISORDER (Psychosis) (seriousness criterion hospitalization), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), COMA (Almost in coma) (seriousness criteria hospitalization and medically significant) and FEELING ABNORMAL (Caused his body to go haywire) (seriousness criterion hospitalization). At the time of the report, MENINGITIS VIRAL (Brain infection viral meningitis), PSYCHOTIC DISORDER (Psychosis), DEHYDRATION (Dehydration), COMA (Almost in coma) and FEELING ABNORMAL (Caused his body to go haywire) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood potassium: low (Low) Decreased. In 2021, Blood sodium: low (Low) Decreased.         Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-226811, MOD-2021-072608 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Condition aggravated, Gait inability, Ligament pain
Clinical narrative: Excruciating pain; all joints became extremely sore; it is getting worse and worse; he believes this was caused by the vaccine; can't move and is using crutches; thinks there is autoimmune reaction happening; feels trauma in ligaments; can't move; This spontaneous case was reported by a consumer and describes the occurrence of WALKING AID USER (can't move and is using crutches) and AUTOIMMUNE DISORDER (thinks there is autoimmune reaction happening) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced WALKING AID USER (can't move and is using crutches) (seriousness criterion disability), AUTOIMMUNE DISORDER (thinks there is autoimmune reaction happening) (seriousness criterion medically significant), LIGAMENT PAIN (feels trauma in ligaments) and GAIT INABILITY (can't move). On 18-Jun-2021, the patient experienced CONDITION AGGRAVATED (it is getting worse and worse) and VACCINATION COMPLICATION (he believes this was caused by the vaccine). On an unknown date, the patient experienced PAIN (Excruciating pain) and ARTHRALGIA (all joints became extremely sore). At the time of the report, WALKING AID USER (can't move and is using crutches), AUTOIMMUNE DISORDER (thinks there is autoimmune reaction happening), LIGAMENT PAIN (feels trauma in ligaments), GAIT INABILITY (can't move), CONDITION AGGRAVATED (it is getting worse and worse), VACCINATION COMPLICATION (he believes this was caused by the vaccine), PAIN (Excruciating pain) and ARTHRALGIA (all joints became extremely sore) outcome was unknown.            No concomitant medications are reported by the reporter. No treatment information is provided.  Patient has an appointment with a rheumatologist for blood work to know more about this reaction.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-227179 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination complication, Walking aid user
Clinical narrative: Excruciating pain; all joints became extremely sore; it is getting worse and worse; he believes this was caused by the vaccine; can't move and is using crutches; thinks there is autoimmune reaction happening; feels trauma in ligaments; can't move; This spontaneous case was reported by a consumer and describes the occurrence of WALKING AID USER (can't move and is using crutches) and AUTOIMMUNE DISORDER (thinks there is autoimmune reaction happening) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced WALKING AID USER (can't move and is using crutches) (seriousness criterion disability), AUTOIMMUNE DISORDER (thinks there is autoimmune reaction happening) (seriousness criterion medically significant), LIGAMENT PAIN (feels trauma in ligaments) and GAIT INABILITY (can't move). On 18-Jun-2021, the patient experienced CONDITION AGGRAVATED (it is getting worse and worse) and VACCINATION COMPLICATION (he believes this was caused by the vaccine). On an unknown date, the patient experienced PAIN (Excruciating pain) and ARTHRALGIA (all joints became extremely sore). At the time of the report, WALKING AID USER (can't move and is using crutches), AUTOIMMUNE DISORDER (thinks there is autoimmune reaction happening), LIGAMENT PAIN (feels trauma in ligaments), GAIT INABILITY (can't move), CONDITION AGGRAVATED (it is getting worse and worse), VACCINATION COMPLICATION (he believes this was caused by the vaccine), PAIN (Excruciating pain) and ARTHRALGIA (all joints became extremely sore) outcome was unknown.            No concomitant medications are reported by the reporter. No treatment information is provided.  Patient has an appointment with a rheumatologist for blood work to know more about this reaction.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-227179 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastric ulcer, Vomiting
Clinical narrative: Ulcerations on the lining of the stomach; Vomiting; Diharrea; This spontaneous case was reported by a patient and describes the occurrence of GASTRIC ULCER (Ulcerations on the lining of the stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced GASTRIC ULCER (Ulcerations on the lining of the stomach) (seriousness criterion medically significant), VOMITING (Vomiting) and DIARRHOEA (Diharrea). At the time of the report, GASTRIC ULCER (Ulcerations on the lining of the stomach), VOMITING (Vomiting) and DIARRHOEA (Diharrea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  The patient received treatment for unknown indication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety disorder, Hypertension
Clinical narrative: high blood pressure; Anxiety disorder attacks; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and ANXIETY DISORDER (Anxiety disorder attacks) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion medically significant) and ANXIETY DISORDER (Anxiety disorder attacks) (seriousness criterion medically significant). At the time of the report, HYPERTENSION (high blood pressure) and ANXIETY DISORDER (Anxiety disorder attacks) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Live Follow-up received on 20-JUN-2021 does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus inadequate control
Clinical narrative: My Blood Sugar us OUT OF CONTROL; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (My Blood Sugar us OUT OF CONTROL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (My Blood Sugar us OUT OF CONTROL) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (My Blood Sugar us OUT OF CONTROL) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment information was provided.  The serious unexpected event Diabetes mellitus inadequate control was more consistent with the known history of underlying Diabetes mellitus. Very limited information regarding this event has been provided at this time.  Additional information required.  The serious unexpected event Diabetes mellitus inadequate control was more consistent with the known history of underlying Diabetes mellitus. Very limited information regarding this event has been provided at this time.  Additional information required.; Sender's Comments: The serious unexpected event Diabetes mellitus inadequate control was more consistent with the known history of underlying Diabetes mellitus. Very limited information regarding this event has been provided at this time.  Additional information required.
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia
Clinical narrative: developed movements on his right leg and arm / doctors find nothing causing his right leg movements; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (developed movements on his right leg and arm / doctors find nothing causing his right leg movements) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 DYSKINESIA (developed movements on his right leg and arm / doctors find nothing causing his right leg movements) (seriousness criterion hospitalization). At the time of the report, DYSKINESIA (developed movements on his right leg and arm / doctors find nothing causing his right leg movements) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Joint swelling, Peripheral swelling
Clinical narrative: Blood clot on his left leg, tibial vein; Entire leg continued to swell; Knee started to swell; This spontaneous case was reported by a nurse and describes the occurrence of DEEP VEIN THROMBOSIS (Blood clot on his left leg, tibial vein) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high, Cholesterol and Depression (antidepressants). Concomitant products included PREDNISONE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced JOINT SWELLING (Knee started to swell). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Blood clot on his left leg, tibial vein) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Entire leg continued to swell). The patient was treated with RIVAROXABAN (XARELTO) at a dose of 15 mg. At the time of the report, DEEP VEIN THROMBOSIS (Blood clot on his left leg, tibial vein), JOINT SWELLING (Knee started to swell) and PERIPHERAL SWELLING (Entire leg continued to swell) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included for High blood pressure, cholesterol, antidepressant.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Blood pressure measurement, Costochondritis, Diverticulitis
Clinical narrative: blood pressure reading have been like a roller coaster, up and down; right arm hurt; Diverticulitis; costochondritis; massive pain in the rib cage area; pressure in the lower abdomen; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8370299) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (missed diagnosis of COVID, treated for pneumonia as there were no COVID tests available.) in February 2020. Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), VITAMIN D NOS, PROBIOTICS NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), COSTOCHONDRITIS (costochondritis), MUSCULOSKELETAL CHEST PAIN (massive pain in the rib cage area), ABDOMINAL DISCOMFORT (pressure in the lower abdomen   ) and VACCINATION SITE PAIN (right arm hurt). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure reading have been like a roller coaster, up and down). At the time of the report, DIVERTICULITIS (Diverticulitis), COSTOCHONDRITIS (costochondritis), MUSCULOSKELETAL CHEST PAIN (massive pain in the rib cage area), ABDOMINAL DISCOMFORT (pressure in the lower abdomen   ), BLOOD PRESSURE INCREASED (blood pressure reading have been like a roller coaster, up and down) and VACCINATION SITE PAIN (right arm hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155/84 (High) elevated blood pressure readings.     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.   Blood tests and CAT scan were done in the ER. Results were not provided.  Patient was treated with a 10 day course of two antibiotics.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Vaccination site pain
Clinical narrative: blood pressure reading have been like a roller coaster, up and down; right arm hurt; Diverticulitis; costochondritis; massive pain in the rib cage area; pressure in the lower abdomen; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8370299) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (missed diagnosis of COVID, treated for pneumonia as there were no COVID tests available.) in February 2020. Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), VITAMIN D NOS, PROBIOTICS NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), COSTOCHONDRITIS (costochondritis), MUSCULOSKELETAL CHEST PAIN (massive pain in the rib cage area), ABDOMINAL DISCOMFORT (pressure in the lower abdomen   ) and VACCINATION SITE PAIN (right arm hurt). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure reading have been like a roller coaster, up and down). At the time of the report, DIVERTICULITIS (Diverticulitis), COSTOCHONDRITIS (costochondritis), MUSCULOSKELETAL CHEST PAIN (massive pain in the rib cage area), ABDOMINAL DISCOMFORT (pressure in the lower abdomen   ), BLOOD PRESSURE INCREASED (blood pressure reading have been like a roller coaster, up and down) and VACCINATION SITE PAIN (right arm hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155/84 (High) elevated blood pressure readings.     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.   Blood tests and CAT scan were done in the ER. Results were not provided.  Patient was treated with a 10 day course of two antibiotics.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Gout, Herpes zoster, Rheumatoid arthritis, Toxoplasmosis
Clinical narrative: Toxoplasmosis of my left eye resurfaced for the first time sine 1996; Gout in my left big toe; Bladder Infection; Shingles; Repeat rheumatoid arthritis flare; Rheumatoid Arthritis Flare; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis Flare) and RHEUMATOID ARTHRITIS (Repeat rheumatoid arthritis flare) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Toxoplasmosis (resurfaced in left eye for the first time since 1996). Concomitant products included ABATACEPT (ORENCIA), Prenisone, AZITHROMYCIN (AZO), ESTROGENS CONJUGATED (PREMARIN), LISINOPRIL, AMITRIPTYLINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis Flare) (seriousness criterion medically significant). On 23-May-2021, the patient experienced RHEUMATOID ARTHRITIS (Repeat rheumatoid arthritis flare) (seriousness criterion medically significant). On 25-May-2021, the patient experienced HERPES ZOSTER (Shingles). On 09-Jun-2021, the patient experienced CYSTITIS (Bladder Infection). On 15-Jun-2021, the patient experienced GOUT (Gout in my left big toe). On 18-Jun-2021, the patient experienced TOXOPLASMOSIS (Toxoplasmosis of my left eye resurfaced for the first time sine 1996). On 24-May-2021, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis Flare) had resolved. On 01-Jun-2021, HERPES ZOSTER (Shingles) had resolved. On 06-Jun-2021, RHEUMATOID ARTHRITIS (Repeat rheumatoid arthritis flare) had resolved. On 14-Jun-2021, CYSTITIS (Bladder Infection) had resolved. At the time of the report, GOUT (Gout in my left big toe) and TOXOPLASMOSIS (Toxoplasmosis of my left eye resurfaced for the first time sine 1996) outcome was unknown.            No treatment information provided by the reporter.  Very limited information regarding this events has been provided at this time.   This case was linked to MOD-2021-228447 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.   Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: thrombus in my left foot; my leg swelled up; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (thrombus in my left foot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Factor V deficiency and Anticoagulant therapy.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (thrombus in my left foot) (seriousness criterion medically significant) and PERIPHERAL SWELLING (my leg swelled up). At the time of the report, THROMBOSIS (thrombus in my left foot) had resolved and PERIPHERAL SWELLING (my leg swelled up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Blood Thinners. No Treatment medication details was provided. It was reported that The thrombus disappeared after 2 days.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus inadequate control, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS INADEQUATE CONTROL (blood sugar is skyscraping since the shot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for an unknown indication. On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (blood sugar is skyscraping since the shot) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Arms is a little sore). At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (blood sugar is skyscraping since the shot) and PAIN IN EXTREMITY (Arms is a little sore) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information was reported. It was reported that patient is with insulin pump but is not helping. This case concerns a 59-year-old male with a serious unexpected event of diabetes mellitus inadequate control, and non-serious pain in extremity. Event latency 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 59-year-old male with a serious unexpected event of diabetes mellitus inadequate control, and non-serious pain in extremity. Event latency 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Haematoma, Immune thrombocytopenia, Platelet count decreased
Clinical narrative: acute immune thrombocytopenia; blood spots (hematoma); .immune thrombocytopenic purpura; This spontaneous case was reported by an other health care professional and describes the occurrence of HAEMATOMA (blood spots (hematoma)), IMMUNE THROMBOCYTOPENIA (.immune thrombocytopenic purpura) and IMMUNE THROMBOCYTOPENIA (acute immune thrombocytopenia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immune thrombocytopenia.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Mar-2021, the patient experienced HAEMATOMA (blood spots (hematoma)) (seriousness criterion hospitalization) and IMMUNE THROMBOCYTOPENIA (.immune thrombocytopenic purpura) (seriousness criteria hospitalization and medically significant). On 05-May-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (acute immune thrombocytopenia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Mar-2021 due to HAEMATOMA. At the time of the report, HAEMATOMA (blood spots (hematoma)), IMMUNE THROMBOCYTOPENIA (.immune thrombocytopenic purpura) and IMMUNE THROMBOCYTOPENIA (acute immune thrombocytopenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count decreased: decreased (Low) platelets are as low as 3*1000.     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.   On 05/Mar/2021, the patient experienced several blood spots on tongue (hematoma). The tiny red spots growing on face and body. The patient thought might have internal bleeding or blood disorder and decided to drove ER (emergency room).  On 06/Mar/2021 got admitted, the physician run more than 30 blood draws, the platelet was 3x 1000 it was 240x1000. It was a disease called acute immune thrombocytopenia. No treatment drug information provided.No concomitant drug information provided.  This case concerns a female of unknown age hospitalized with serious unexpected events of immune thrombocytopenic purpura, acute immune thrombocytopenia and haematoma. Event latency 10 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a female of unknown age hospitalized with serious unexpected events of immune thrombocytopenic purpura, acute immune thrombocytopenia and haematoma. Event latency 10 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, Product dose omission issue
Clinical narrative: She never received her second dose; Suffered from an acute ischemic stroke; This spontaneous case was reported by an other health care professional and describes the occurrence of ISCHAEMIC STROKE (Suffered from an acute ischemic stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Hyperlipidemia, Type II diabetes mellitus and Atrial fibrillation.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, the patient experienced ISCHAEMIC STROKE (Suffered from an acute ischemic stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She never received her second dose). At the time of the report, ISCHAEMIC STROKE (Suffered from an acute ischemic stroke) and PRODUCT DOSE OMISSION ISSUE (She never received her second dose) 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.   Concomitant product use was not reported. Treatment information was unknown.  This report refers to a case of Product dose omission issue  for mRNA-1273,   with  associated adverse event of Ischemic stroke. Very limited information regarding this event has been provided at this time.  However, multiple underlying co-morbidities may remain as confounding factors. Further information has been requested.; Sender's Comments: This report refers to a case of Product dose omission issue  for mRNA-1273,   with  associated adverse event of Ischaemic stroke.Very limited information regarding this event has been provided at this time.  However, multiple underlying co-morbidities may remain as confounding factors.Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Thrombosis, Urticaria, Vaccination site reaction
Clinical narrative: blood clotting; hives; COVID arm; rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by an other and describes the occurrence of THROMBOSIS (blood clotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clotting) (seriousness criterion medically significant), URTICARIA (hives), VACCINATION SITE REACTION (COVID arm) and RASH (rash). At the time of the report, THROMBOSIS (blood clotting), URTICARIA (hives), VACCINATION SITE REACTION (COVID arm) and RASH (rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.  No treatment information was provided by the reporter.  Very limited information regarding these events has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Sex: M
Vaccine: COVID19
Symptoms: Coagulopathy, Contusion, Epistaxis, Headache, Pulmonary congestion
Clinical narrative: Lungs feel worse or congested; one to 3 bloody noses a day; bruising easily; clotting from nose mouth. And sometimes just clotting; headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Lungs feel worse or congested) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY CONGESTION (Lungs feel worse or congested) (seriousness criterion medically significant), EPISTAXIS (one to 3 bloody noses a day), CONTUSION (bruising easily), COAGULOPATHY (clotting from nose mouth. And sometimes just clotting) and HEADACHE (headache). At the time of the report, PULMONARY CONGESTION (Lungs feel worse or congested), EPISTAXIS (one to 3 bloody noses a day), CONTUSION (bruising easily), COAGULOPATHY (clotting from nose mouth. And sometimes just clotting) and HEADACHE (headache) had not resolved.            Concomitant product use was not reported. Treatment information was not provided.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clots; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Eye disorder, Hallucination, visual, Headache
Clinical narrative: Shingles; Weakness; Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance; Ringing in ears; inner ear infection; sleeping most of the day; blank look in his eyes; Headache; Seeing things; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Seeing things) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Patient mole removed from his back and when after having the stitches removed, the incision opened.).   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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, VISUAL (Seeing things) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache). At the time of the report, HALLUCINATION, VISUAL (Seeing things) had resolved and HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.    Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 21-Jun-2021 contains non significant information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Labyrinthitis, Somnolence, Tinnitus
Clinical narrative: Shingles; Weakness; Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance; Ringing in ears; inner ear infection; sleeping most of the day; blank look in his eyes; Headache; Seeing things; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Seeing things) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Patient mole removed from his back and when after having the stitches removed, the incision opened.).   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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, VISUAL (Seeing things) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache). At the time of the report, HALLUCINATION, VISUAL (Seeing things) had resolved and HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.    Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 21-Jun-2021 contains non significant information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.