chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pelvic venous thrombosis, Vomiting
Clinical narrative: BLOOD CLOT IN PELVIC VEIN; ABDOMINAL PAIN; NAUSEA; VOMITING; CHILLS; BODYACHE; DRUG EXPOSURE DURING PREGNANCY; MISCARRIAGE; This spontaneous pregnancy self-report concerned a 25 year old female patient. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978) dose was not reported, administered on 01-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient received the vaccine and experienced drug exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On 02-APR-2021, within 24 hours of receiving the vaccine, the patient experienced abdominal pain, nausea, vomiting, chills, body ache. On 10-APR-2021, the patient experienced blood clot in pelvic vein. On an unspecified date in APR-2021, 2 weeks after receiving the vaccine, the patient experienced miscarriage as confirmed by her OBGYN.   Treatment included iron infusion, Pradaxa (dabigatran etexilate mesilate) and also getting blood work twice a week.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 08-APR-2021, and had not recovered from blood clot in pelvic vein, miscarriage, drug exposure during pregnancy, abdominal pain, nausea, chills, and body ache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This report on a 25 year old , female patient who suffered a miscarriage around 2 weeks (specific date not specified) after receiving the covid-19 vaccine ad26.cov.2 at the right deltoid. The patient's height and weight were not reported. No other medical history and concomitant medications reported. No allergies reported.  One (1) day after receiving the vaccine, the patient experienced abdominal pain, nausea, vomiting, chills and body ache. Ten (10) days after receiving the vaccine, patient was noted to have blood clot in the pelvic vein, actual result not reported. The information provided precludes a meaningful medical assessment. Additional information requested.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Intensive care, Seizure
Clinical narrative: 10 minutes after receiving the vaccine, Patient stated she didn?t feel right. She then progressed to ongoing continuous convulsions the clinic administered epinephrine with no relief of symptoms. Patient was transported by ambulance to Medical center and then transferred to Hospital by her mother where she had a 5 day stay in ICU. From 10 minutes after the vaccine until we found someone willing to try non invasive stem cell therapy on her (name or location of treatment will not be disclosed), she was having intermittent convulsions, vision problems, ataxia, and dysarthria. Some of these episodes would last up to 20 minutes at a time. Patient was completely normal that morning and then 10 minutes after the vaccine had an adverse reaction. We have found several others that experienced the same thing.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ataxia, Dysarthria, Feeling abnormal, Intensive care, Seizure
Clinical narrative: 10 minutes after receiving the vaccine, Patient stated she didn?t feel right. She then progressed to ongoing continuous convulsions the clinic administered epinephrine with no relief of symptoms. Patient was transported by ambulance to Medical center and then transferred to Hospital by her mother where she had a 5 day stay in ICU. From 10 minutes after the vaccine until we found someone willing to try non invasive stem cell therapy on her (name or location of treatment will not be disclosed), she was having intermittent convulsions, vision problems, ataxia, and dysarthria. Some of these episodes would last up to 20 minutes at a time. Patient was completely normal that morning and then 10 minutes after the vaccine had an adverse reaction. We have found several others that experienced the same thing.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: 10 minutes after receiving the vaccine, Patient stated she didn?t feel right. She then progressed to ongoing continuous convulsions the clinic administered epinephrine with no relief of symptoms. Patient was transported by ambulance to Medical center and then transferred to Hospital by her mother where she had a 5 day stay in ICU. From 10 minutes after the vaccine until we found someone willing to try non invasive stem cell therapy on her (name or location of treatment will not be disclosed), she was having intermittent convulsions, vision problems, ataxia, and dysarthria. Some of these episodes would last up to 20 minutes at a time. Patient was completely normal that morning and then 10 minutes after the vaccine had an adverse reaction. We have found several others that experienced the same thing.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature abnormal, Chills, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: FEVER; HEADACHE; NAUSEA; LIVER PAIN; TIPSY; LIGHT HEADEDNESS; COLD CHILLS; LEFT LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis c, and concurrent conditions included controlled epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included silybum marianum for hepatitis c, bifidobacterium bifidum/bifidobacterium lactis/fructooligosaccharides/lactobacillus acidophilus/lactobacillus casei for immune system, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for nutritional supplement. On APR-2021, the subject experienced cold chills. On APR-2021, the subject experienced left leg pain. Laboratory data included: Pain scale (NR: not provided) pain score 2 or 3. On 09-APR-2021, the subject experienced liver pain. On 09-APR-2021, the subject experienced tipsy. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver pain, left leg pain, light headedness, tipsy, headache, nausea, fever and cold chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Impaired work ability, Nausea, Pain in extremity
Clinical narrative: FEVER; HEADACHE; NAUSEA; LIVER PAIN; TIPSY; LIGHT HEADEDNESS; COLD CHILLS; LEFT LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis c, and concurrent conditions included controlled epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included silybum marianum for hepatitis c, bifidobacterium bifidum/bifidobacterium lactis/fructooligosaccharides/lactobacillus acidophilus/lactobacillus casei for immune system, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for nutritional supplement. On APR-2021, the subject experienced cold chills. On APR-2021, the subject experienced left leg pain. Laboratory data included: Pain scale (NR: not provided) pain score 2 or 3. On 09-APR-2021, the subject experienced liver pain. On 09-APR-2021, the subject experienced tipsy. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver pain, left leg pain, light headedness, tipsy, headache, nausea, fever and cold chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Gait disturbance, Headache, Hepatic pain
Clinical narrative: FEVER; HEADACHE; NAUSEA; LIVER PAIN; TIPSY; LIGHT HEADEDNESS; COLD CHILLS; LEFT LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis c, and concurrent conditions included controlled epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included silybum marianum for hepatitis c, bifidobacterium bifidum/bifidobacterium lactis/fructooligosaccharides/lactobacillus acidophilus/lactobacillus casei for immune system, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for nutritional supplement. On APR-2021, the subject experienced cold chills. On APR-2021, the subject experienced left leg pain. Laboratory data included: Pain scale (NR: not provided) pain score 2 or 3. On 09-APR-2021, the subject experienced liver pain. On 09-APR-2021, the subject experienced tipsy. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver pain, left leg pain, light headedness, tipsy, headache, nausea, fever and cold chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain assessment, Pain in extremity, Pyrexia
Clinical narrative: FEVER; HEADACHE; NAUSEA; LIVER PAIN; TIPSY; LIGHT HEADEDNESS; COLD CHILLS; LEFT LEG PAIN; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis c, and concurrent conditions included controlled epileptic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included silybum marianum for hepatitis c, bifidobacterium bifidum/bifidobacterium lactis/fructooligosaccharides/lactobacillus acidophilus/lactobacillus casei for immune system, and ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride for nutritional supplement. On APR-2021, the subject experienced cold chills. On APR-2021, the subject experienced left leg pain. Laboratory data included: Pain scale (NR: not provided) pain score 2 or 3. On 09-APR-2021, the subject experienced liver pain. On 09-APR-2021, the subject experienced tipsy. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver pain, left leg pain, light headedness, tipsy, headache, nausea, fever and cold chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Cyst removal, Dizziness, Dyspnoea, Knee operation
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; DIFFICULTY BREATHING; KNEE SURGERY; This spontaneous report received from a consumer and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On unspecified date, a few days earlier, prior to surgery, the patient was having trouble breathing while working in the yard. On unspecified date, 14 days post vaccination, the patient patient had a surgery in the knee. The patient went home after surgery and thought she was fine. On Saturday, unspecified date, the patient could not breathe. The patient went to emergency room, then she had a drip for 36 hours. In the hospital, they found major big blood clot in both her lung. The patient will be treated with Eliquis (apixaban) for 12 months. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the difficulty breathing, blood clot in both lungs and knee surgery was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a report of a female patient, unspecified age, White (not Hispanic or Latino), who was noted to have blood clot in both lungs  a little after 14 days upon receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Medical and smoking history and concomitant medications were not reported. History of allergy, alcohol intake and illicit drug use were not reported.  Few days prior to surgery (unspecified number of days after the vaccine), the patient was already having trouble breathing while working in the yard. Fourteen (14) days after receiving the vaccine, the patient underwent knee surgery. On an unspecified date after the surgery, patient experienced difficulty in breathing and was brought to the hospital, where a big clot on both lungs were noted.  Temporal relationship may be observed but there is insufficient definitive evidence for the vaccine to cause the events; this is assessed as indeterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Pulmonary embolism, Troponin normal
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; DIFFICULTY BREATHING; KNEE SURGERY; This spontaneous report received from a consumer and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On unspecified date, a few days earlier, prior to surgery, the patient was having trouble breathing while working in the yard. On unspecified date, 14 days post vaccination, the patient patient had a surgery in the knee. The patient went home after surgery and thought she was fine. On Saturday, unspecified date, the patient could not breathe. The patient went to emergency room, then she had a drip for 36 hours. In the hospital, they found major big blood clot in both her lung. The patient will be treated with Eliquis (apixaban) for 12 months. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the difficulty breathing, blood clot in both lungs and knee surgery was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a report of a female patient, unspecified age, White (not Hispanic or Latino), who was noted to have blood clot in both lungs  a little after 14 days upon receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Medical and smoking history and concomitant medications were not reported. History of allergy, alcohol intake and illicit drug use were not reported.  Few days prior to surgery (unspecified number of days after the vaccine), the patient was already having trouble breathing while working in the yard. Fourteen (14) days after receiving the vaccine, the patient underwent knee surgery. On an unspecified date after the surgery, patient experienced difficulty in breathing and was brought to the hospital, where a big clot on both lungs were noted.  Temporal relationship may be observed but there is insufficient definitive evidence for the vaccine to cause the events; this is assessed as indeterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Knee operation, Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; DIFFICULTY BREATHING; KNEE SURGERY; This spontaneous report received from a consumer and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On unspecified date, a few days earlier, prior to surgery, the patient was having trouble breathing while working in the yard. On unspecified date, 14 days post vaccination, the patient patient had a surgery in the knee. The patient went home after surgery and thought she was fine. On Saturday, unspecified date, the patient could not breathe. The patient went to emergency room, then she had a drip for 36 hours. In the hospital, they found major big blood clot in both her lung. The patient will be treated with Eliquis (apixaban) for 12 months. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the difficulty breathing, blood clot in both lungs and knee surgery was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a report of a female patient, unspecified age, White (not Hispanic or Latino), who was noted to have blood clot in both lungs  a little after 14 days upon receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Medical and smoking history and concomitant medications were not reported. History of allergy, alcohol intake and illicit drug use were not reported.  Few days prior to surgery (unspecified number of days after the vaccine), the patient was already having trouble breathing while working in the yard. Fourteen (14) days after receiving the vaccine, the patient underwent knee surgery. On an unspecified date after the surgery, patient experienced difficulty in breathing and was brought to the hospital, where a big clot on both lungs were noted.  Temporal relationship may be observed but there is insufficient definitive evidence for the vaccine to cause the events; this is assessed as indeterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Computerised tomogram, Dizziness, Dyspnoea
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; DIFFICULTY BREATHING; KNEE SURGERY; This spontaneous report received from a consumer and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On unspecified date, a few days earlier, prior to surgery, the patient was having trouble breathing while working in the yard. On unspecified date, 14 days post vaccination, the patient patient had a surgery in the knee. The patient went home after surgery and thought she was fine. On Saturday, unspecified date, the patient could not breathe. The patient went to emergency room, then she had a drip for 36 hours. In the hospital, they found major big blood clot in both her lung. The patient will be treated with Eliquis (apixaban) for 12 months. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the difficulty breathing, blood clot in both lungs and knee surgery was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a report of a female patient, unspecified age, White (not Hispanic or Latino), who was noted to have blood clot in both lungs  a little after 14 days upon receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Medical and smoking history and concomitant medications were not reported. History of allergy, alcohol intake and illicit drug use were not reported.  Few days prior to surgery (unspecified number of days after the vaccine), the patient was already having trouble breathing while working in the yard. Fourteen (14) days after receiving the vaccine, the patient underwent knee surgery. On an unspecified date after the surgery, patient experienced difficulty in breathing and was brought to the hospital, where a big clot on both lungs were noted.  Temporal relationship may be observed but there is insufficient definitive evidence for the vaccine to cause the events; this is assessed as indeterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Hypertension, Magnetic resonance imaging, Migraine, Nausea
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; DIFFICULTY BREATHING; KNEE SURGERY; This spontaneous report received from a consumer and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On unspecified date, a few days earlier, prior to surgery, the patient was having trouble breathing while working in the yard. On unspecified date, 14 days post vaccination, the patient patient had a surgery in the knee. The patient went home after surgery and thought she was fine. On Saturday, unspecified date, the patient could not breathe. The patient went to emergency room, then she had a drip for 36 hours. In the hospital, they found major big blood clot in both her lung. The patient will be treated with Eliquis (apixaban) for 12 months. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the difficulty breathing, blood clot in both lungs and knee surgery was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a report of a female patient, unspecified age, White (not Hispanic or Latino), who was noted to have blood clot in both lungs  a little after 14 days upon receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Medical and smoking history and concomitant medications were not reported. History of allergy, alcohol intake and illicit drug use were not reported.  Few days prior to surgery (unspecified number of days after the vaccine), the patient was already having trouble breathing while working in the yard. Fourteen (14) days after receiving the vaccine, the patient underwent knee surgery. On an unspecified date after the surgery, patient experienced difficulty in breathing and was brought to the hospital, where a big clot on both lungs were noted.  Temporal relationship may be observed but there is insufficient definitive evidence for the vaccine to cause the events; this is assessed as indeterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Ultrasound scan
Clinical narrative: BLOOD CLOT IN BOTH LUNGS; DIFFICULTY BREATHING; KNEE SURGERY; This spontaneous report received from a consumer and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On unspecified date, a few days earlier, prior to surgery, the patient was having trouble breathing while working in the yard. On unspecified date, 14 days post vaccination, the patient patient had a surgery in the knee. The patient went home after surgery and thought she was fine. On Saturday, unspecified date, the patient could not breathe. The patient went to emergency room, then she had a drip for 36 hours. In the hospital, they found major big blood clot in both her lung. The patient will be treated with Eliquis (apixaban) for 12 months. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the difficulty breathing, blood clot in both lungs and knee surgery was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a report of a female patient, unspecified age, White (not Hispanic or Latino), who was noted to have blood clot in both lungs  a little after 14 days upon receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Medical and smoking history and concomitant medications were not reported. History of allergy, alcohol intake and illicit drug use were not reported.  Few days prior to surgery (unspecified number of days after the vaccine), the patient was already having trouble breathing while working in the yard. Fourteen (14) days after receiving the vaccine, the patient underwent knee surgery. On an unspecified date after the surgery, patient experienced difficulty in breathing and was brought to the hospital, where a big clot on both lungs were noted.  Temporal relationship may be observed but there is insufficient definitive evidence for the vaccine to cause the events; this is assessed as indeterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemorrhoid operation, Haemorrhoids thrombosed
Clinical narrative: RECTAL BLOOD CLOT; THROMBOSED EXTERNAL HEMORRHOID; FEVER; This spontaneous report received from a patient concerned a 29 years old male. The patient's height, and weight were not reported. Patient was non-smoker. Patient had no hemorrhoid history and no known drug allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, patient had fever and experienced rectal blood clot in Hemorrhoid thrombosed external with lot of blood. On 15-APR-2021, patient hospitalized and had a surgery (hemorrhoidectomy) on the same day. On 15-APR-2021, Laboratory data included: Colonoscopy (NR: not provided) which showed Thrombosed External Hemorrhoid, and Esophagogastroduodenoscopy (NR: not provided) showed Thrombosed external Hemorrhoid. Treatment medications (dates unspecified) included: lidocaine, stool softer and was advised to resume diet and to take sitz bath. The patient was discharged on 15-APR-2021 at 16:44. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, rectal blood clot and thrombosed external hemorrhoid was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 29 year old male patient, unknown ethnicity,  who was noted to have rectal blood clot 2 days after receiving the Janssen COVID-19 vaccine. Patient's height and weight were not reported. Patient has no history of allergies. Patient has no history of hemorrhoids. Patient is a non smoker. Two (2) days after receiving the vaccine, patient experienced rectal blood clot and was diagnosed with Thrombosed External Hemorrhoid, via Colonoscopy, and Thrombosed External Hemorrhoid, via Esophagogastroduodenoscopy. Patient was scheduled for hemorrhoidectomy. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminate. Additional information requested.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Haemorrhoids thrombosed, Oesophagogastroduodenoscopy, Pyrexia
Clinical narrative: RECTAL BLOOD CLOT; THROMBOSED EXTERNAL HEMORRHOID; FEVER; This spontaneous report received from a patient concerned a 29 years old male. The patient's height, and weight were not reported. Patient was non-smoker. Patient had no hemorrhoid history and no known drug allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, patient had fever and experienced rectal blood clot in Hemorrhoid thrombosed external with lot of blood. On 15-APR-2021, patient hospitalized and had a surgery (hemorrhoidectomy) on the same day. On 15-APR-2021, Laboratory data included: Colonoscopy (NR: not provided) which showed Thrombosed External Hemorrhoid, and Esophagogastroduodenoscopy (NR: not provided) showed Thrombosed external Hemorrhoid. Treatment medications (dates unspecified) included: lidocaine, stool softer and was advised to resume diet and to take sitz bath. The patient was discharged on 15-APR-2021 at 16:44. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, rectal blood clot and thrombosed external hemorrhoid was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 29 year old male patient, unknown ethnicity,  who was noted to have rectal blood clot 2 days after receiving the Janssen COVID-19 vaccine. Patient's height and weight were not reported. Patient has no history of allergies. Patient has no history of hemorrhoids. Patient is a non smoker. Two (2) days after receiving the vaccine, patient experienced rectal blood clot and was diagnosed with Thrombosed External Hemorrhoid, via Colonoscopy, and Thrombosed External Hemorrhoid, via Esophagogastroduodenoscopy. Patient was scheduled for hemorrhoidectomy. Based on the available information, the relationship with Janssen Covid-19 vaccine is considered indeterminate. Additional information requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase normal, Anion gap, Aspartate aminotransferase normal, Blood albumin normal
Clinical narrative: BLOOD CLOT IN RIGHT LUNG; This spontaneous report received from a patient via a company representative via email concerned a patient of unspecified age and sex.  Patient's race and ethnicity were not reported.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin unknown) dose, anatomical vaccination site, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in right lung. The patient emailed in regards to a possible adverse event reaction to the Janssen Covid vaccine that he received on an unspecified date. The patient was in a hospital at the time of report with a blood clot in right lung. One of the doctor insinuated that it may have been caused by the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event blood clot in right lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a patient of unspecified age and gender who experienced  a blood clot in the right lung an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, diagnostic tests, corrective treatments, and outcome were not provided. Based on the limited available information, the relationship to vaccination is considered unclassifiable. Additional information is being requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal
Clinical narrative: BLOOD CLOT IN RIGHT LUNG; This spontaneous report received from a patient via a company representative via email concerned a patient of unspecified age and sex.  Patient's race and ethnicity were not reported.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin unknown) dose, anatomical vaccination site, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in right lung. The patient emailed in regards to a possible adverse event reaction to the Janssen Covid vaccine that he received on an unspecified date. The patient was in a hospital at the time of report with a blood clot in right lung. One of the doctor insinuated that it may have been caused by the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event blood clot in right lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a patient of unspecified age and gender who experienced  a blood clot in the right lung an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, diagnostic tests, corrective treatments, and outcome were not provided. Based on the limited available information, the relationship to vaccination is considered unclassifiable. Additional information is being requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood fibrinogen increased, Blood glucose increased, Blood potassium normal, Blood sodium normal, Blood urea decreased
Clinical narrative: BLOOD CLOT IN RIGHT LUNG; This spontaneous report received from a patient via a company representative via email concerned a patient of unspecified age and sex.  Patient's race and ethnicity were not reported.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin unknown) dose, anatomical vaccination site, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in right lung. The patient emailed in regards to a possible adverse event reaction to the Janssen Covid vaccine that he received on an unspecified date. The patient was in a hospital at the time of report with a blood clot in right lung. One of the doctor insinuated that it may have been caused by the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event blood clot in right lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a patient of unspecified age and gender who experienced  a blood clot in the right lung an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, diagnostic tests, corrective treatments, and outcome were not provided. Based on the limited available information, the relationship to vaccination is considered unclassifiable. Additional information is being requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Creatinine renal clearance increased, Fibrin D dimer, Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: BLOOD CLOT IN RIGHT LUNG; This spontaneous report received from a patient via a company representative via email concerned a patient of unspecified age and sex.  Patient's race and ethnicity were not reported.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin unknown) dose, anatomical vaccination site, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in right lung. The patient emailed in regards to a possible adverse event reaction to the Janssen Covid vaccine that he received on an unspecified date. The patient was in a hospital at the time of report with a blood clot in right lung. One of the doctor insinuated that it may have been caused by the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event blood clot in right lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a patient of unspecified age and gender who experienced  a blood clot in the right lung an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, diagnostic tests, corrective treatments, and outcome were not provided. Based on the limited available information, the relationship to vaccination is considered unclassifiable. Additional information is being requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: International normalised ratio normal, Lipase normal, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased
Clinical narrative: BLOOD CLOT IN RIGHT LUNG; This spontaneous report received from a patient via a company representative via email concerned a patient of unspecified age and sex.  Patient's race and ethnicity were not reported.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin unknown) dose, anatomical vaccination site, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in right lung. The patient emailed in regards to a possible adverse event reaction to the Janssen Covid vaccine that he received on an unspecified date. The patient was in a hospital at the time of report with a blood clot in right lung. One of the doctor insinuated that it may have been caused by the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event blood clot in right lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a patient of unspecified age and gender who experienced  a blood clot in the right lung an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, diagnostic tests, corrective treatments, and outcome were not provided. Based on the limited available information, the relationship to vaccination is considered unclassifiable. Additional information is being requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Protein total normal, Pulmonary embolism, Red blood cell count decreased, Red cell distribution width normal
Clinical narrative: BLOOD CLOT IN RIGHT LUNG; This spontaneous report received from a patient via a company representative via email concerned a patient of unspecified age and sex.  Patient's race and ethnicity were not reported.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin unknown) dose, anatomical vaccination site, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in right lung. The patient emailed in regards to a possible adverse event reaction to the Janssen Covid vaccine that he received on an unspecified date. The patient was in a hospital at the time of report with a blood clot in right lung. One of the doctor insinuated that it may have been caused by the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event blood clot in right lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a patient of unspecified age and gender who experienced  a blood clot in the right lung an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, diagnostic tests, corrective treatments, and outcome were not provided. Based on the limited available information, the relationship to vaccination is considered unclassifiable. Additional information is being requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenia, Troponin I normal, White blood cell count normal
Clinical narrative: BLOOD CLOT IN RIGHT LUNG; This spontaneous report received from a patient via a company representative via email concerned a patient of unspecified age and sex.  Patient's race and ethnicity were not reported.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin unknown) dose, anatomical vaccination site, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in right lung. The patient emailed in regards to a possible adverse event reaction to the Janssen Covid vaccine that he received on an unspecified date. The patient was in a hospital at the time of report with a blood clot in right lung. One of the doctor insinuated that it may have been caused by the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event blood clot in right lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a patient of unspecified age and gender who experienced  a blood clot in the right lung an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, diagnostic tests, corrective treatments, and outcome were not provided. Based on the limited available information, the relationship to vaccination is considered unclassifiable. Additional information is being requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN RIGHT LUNG; This spontaneous report received from a patient via a company representative via email concerned a patient of unspecified age and sex.  Patient's race and ethnicity were not reported.  The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin unknown) dose, anatomical vaccination site, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in right lung. The patient emailed in regards to a possible adverse event reaction to the Janssen Covid vaccine that he received on an unspecified date. The patient was in a hospital at the time of report with a blood clot in right lung. One of the doctor insinuated that it may have been caused by the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event blood clot in right lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This case concerns a patient of unspecified age and gender who experienced  a blood clot in the right lung an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, diagnostic tests, corrective treatments, and outcome were not provided. Based on the limited available information, the relationship to vaccination is considered unclassifiable. Additional information is being requested.