chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Ultrasound scan
Clinical narrative: BLOOD CLOT RIGHT INNER THIGH; This spontaneous report was received on 15-APR-2021 from a 53 year old male patient. Initial information was received on 15-APR-2021, with additional information obtained via telephone follow up from a patient on 20-APR-2021. The patient's weight was 258 pounds, and height was 71 inches. The patient's concurrent conditions included diabetes, COPD (Chronic obstructive pulmonary disease), and hypertension. The patient no past history of blood clots. No family history of blood clots was reported. The patient experienced drug allergy when treated with sildenafil.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: 25-MAY-2021) dose was not reported, 1 total administered in left arm on 09-MAR-2021 for prophylactic vaccination.  Concomitant medications included insulin human for diabetes, metformin for diabetes, hydrochlorothiazide for drug used for unknown indication, lisinopril for drug used for unknown indication, meloxicam for drug used for unknown indication, salbutamol for drug used for unknown indication, tiotropium bromide for drug used for unknown indication, and verapamil for drug used for unknown indication. On 22-MAR-2021, the symptoms in the right calf started. On 08-APR-2021, an ultrasound scan right inner thigh blood clot and on an unspecified date, the patient platelet count was adequate (NR: not provided). Treatment medications (dates unspecified) included: apixaban. The patient had visited physician office for blood clot on his right inner thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot right inner thigh. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A 53-year-old obese (BMI 36 kg/m2)  male experienced right inner thigh blood clot 30 days after vaccine. Medical history included diabetes, COPD (Chronic obstructive pulmonary disease), hypertension, and obesity. The patient had no past or family history blood clots. Concomitant medications included insulin, metformin, hydrochlorothiazide, lisinopril, meloxicam, salbutamol, tiotropium, and verapamil. 13 days after vaccine, the patient experienced symptoms in the right calf. 30 days after vaccine, an ultrasound scan revealed right inner thigh blood clot. The platelet count was reported as adequate (numerical value not reported). The patient was treated with apixaban. Given the pre-existing risk factor of obesity, and the diagnosis occurring greater than 28 days after vaccine, there is a plausible alternate cause for the event.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT RIGHT INNER THIGH; This spontaneous report was received on 15-APR-2021 from a 53 year old male patient. Initial information was received on 15-APR-2021, with additional information obtained via telephone follow up from a patient on 20-APR-2021. The patient's weight was 258 pounds, and height was 71 inches. The patient's concurrent conditions included diabetes, COPD (Chronic obstructive pulmonary disease), and hypertension. The patient no past history of blood clots. No family history of blood clots was reported. The patient experienced drug allergy when treated with sildenafil.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: 25-MAY-2021) dose was not reported, 1 total administered in left arm on 09-MAR-2021 for prophylactic vaccination.  Concomitant medications included insulin human for diabetes, metformin for diabetes, hydrochlorothiazide for drug used for unknown indication, lisinopril for drug used for unknown indication, meloxicam for drug used for unknown indication, salbutamol for drug used for unknown indication, tiotropium bromide for drug used for unknown indication, and verapamil for drug used for unknown indication. On 22-MAR-2021, the symptoms in the right calf started. On 08-APR-2021, an ultrasound scan right inner thigh blood clot and on an unspecified date, the patient platelet count was adequate (NR: not provided). Treatment medications (dates unspecified) included: apixaban. The patient had visited physician office for blood clot on his right inner thigh. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot right inner thigh. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A 53-year-old obese (BMI 36 kg/m2)  male experienced right inner thigh blood clot 30 days after vaccine. Medical history included diabetes, COPD (Chronic obstructive pulmonary disease), hypertension, and obesity. The patient had no past or family history blood clots. Concomitant medications included insulin, metformin, hydrochlorothiazide, lisinopril, meloxicam, salbutamol, tiotropium, and verapamil. 13 days after vaccine, the patient experienced symptoms in the right calf. 30 days after vaccine, an ultrasound scan revealed right inner thigh blood clot. The platelet count was reported as adequate (numerical value not reported). The patient was treated with apixaban. Given the pre-existing risk factor of obesity, and the diagnosis occurring greater than 28 days after vaccine, there is a plausible alternate cause for the event.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrospinal fluid leakage, Condition aggravated, Ehlers-Danlos syndrome, Enlarged uvula, Head discomfort
Clinical narrative: DISLOCATING AND SUBLUXING JOINTS; UVULA; SWOLLEN NODE; INFECTION; PAIN; TENDERNESS ON THE ARM; LOW GRADE TEMPERATURE; EHLERS-DANLOS SYNDROME; This spontaneous report received from a physician concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included ehlers-danlos syndrome (eds), and concurrent conditions included asthma, csf leak, osteoarthritis, and tendonitis. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced ehlers-danlos syndrome. On 08-APR-2021, the subject experienced tenderness on the arm. On 08-APR-2021, the subject experienced low grade temperature. On 09-APR-2021, the subject experienced pain. On 10-APR-2021, the subject experienced dislocating and subluxing joints. On 10-APR-2021, the subject experienced uvula. On 10-APR-2021, the subject experienced swollen node. On 10-APR-2021, the subject experienced infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on the arm on 12-APR-2021, was recovering from low grade temperature, uvula, swollen node, and infection, had not recovered from pain, and dislocating and subluxing joints, and the outcome of ehlers-danlos syndrome was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint dislocation, Joint instability, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: DISLOCATING AND SUBLUXING JOINTS; UVULA; SWOLLEN NODE; INFECTION; PAIN; TENDERNESS ON THE ARM; LOW GRADE TEMPERATURE; EHLERS-DANLOS SYNDROME; This spontaneous report received from a physician concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included ehlers-danlos syndrome (eds), and concurrent conditions included asthma, csf leak, osteoarthritis, and tendonitis. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced ehlers-danlos syndrome. On 08-APR-2021, the subject experienced tenderness on the arm. On 08-APR-2021, the subject experienced low grade temperature. On 09-APR-2021, the subject experienced pain. On 10-APR-2021, the subject experienced dislocating and subluxing joints. On 10-APR-2021, the subject experienced uvula. On 10-APR-2021, the subject experienced swollen node. On 10-APR-2021, the subject experienced infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on the arm on 12-APR-2021, was recovering from low grade temperature, uvula, swollen node, and infection, had not recovered from pain, and dislocating and subluxing joints, and the outcome of ehlers-danlos syndrome was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal instability, Tremor
Clinical narrative: DISLOCATING AND SUBLUXING JOINTS; UVULA; SWOLLEN NODE; INFECTION; PAIN; TENDERNESS ON THE ARM; LOW GRADE TEMPERATURE; EHLERS-DANLOS SYNDROME; This spontaneous report received from a physician concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included ehlers-danlos syndrome (eds), and concurrent conditions included asthma, csf leak, osteoarthritis, and tendonitis. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced ehlers-danlos syndrome. On 08-APR-2021, the subject experienced tenderness on the arm. On 08-APR-2021, the subject experienced low grade temperature. On 09-APR-2021, the subject experienced pain. On 10-APR-2021, the subject experienced dislocating and subluxing joints. On 10-APR-2021, the subject experienced uvula. On 10-APR-2021, the subject experienced swollen node. On 10-APR-2021, the subject experienced infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on the arm on 12-APR-2021, was recovering from low grade temperature, uvula, swollen node, and infection, had not recovered from pain, and dislocating and subluxing joints, and the outcome of ehlers-danlos syndrome was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ehlers-Danlos syndrome, Enlarged uvula, Infection, Joint dislocation, Lymphadenopathy
Clinical narrative: DISLOCATING AND SUBLUXING JOINTS; UVULA; SWOLLEN NODE; INFECTION; PAIN; TENDERNESS ON THE ARM; LOW GRADE TEMPERATURE; EHLERS-DANLOS SYNDROME; This spontaneous report received from a physician concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included ehlers-danlos syndrome (eds), and concurrent conditions included asthma, csf leak, osteoarthritis, and tendonitis. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced ehlers-danlos syndrome. On 08-APR-2021, the subject experienced tenderness on the arm. On 08-APR-2021, the subject experienced low grade temperature. On 09-APR-2021, the subject experienced pain. On 10-APR-2021, the subject experienced dislocating and subluxing joints. On 10-APR-2021, the subject experienced uvula. On 10-APR-2021, the subject experienced swollen node. On 10-APR-2021, the subject experienced infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on the arm on 12-APR-2021, was recovering from low grade temperature, uvula, swollen node, and infection, had not recovered from pain, and dislocating and subluxing joints, and the outcome of ehlers-danlos syndrome was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: DISLOCATING AND SUBLUXING JOINTS; UVULA; SWOLLEN NODE; INFECTION; PAIN; TENDERNESS ON THE ARM; LOW GRADE TEMPERATURE; EHLERS-DANLOS SYNDROME; This spontaneous report received from a physician concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included ehlers-danlos syndrome (eds), and concurrent conditions included asthma, csf leak, osteoarthritis, and tendonitis. The patient experienced drug allergy when treated with erythromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced ehlers-danlos syndrome. On 08-APR-2021, the subject experienced tenderness on the arm. On 08-APR-2021, the subject experienced low grade temperature. On 09-APR-2021, the subject experienced pain. On 10-APR-2021, the subject experienced dislocating and subluxing joints. On 10-APR-2021, the subject experienced uvula. On 10-APR-2021, the subject experienced swollen node. On 10-APR-2021, the subject experienced infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tenderness on the arm on 12-APR-2021, was recovering from low grade temperature, uvula, swollen node, and infection, had not recovered from pain, and dislocating and subluxing joints, and the outcome of ehlers-danlos syndrome was not reported. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Headache, Nausea, Paranasal sinus discomfort, Pruritus
Clinical narrative: SEVERE HEADACHE/CONSTANT LINGERING HEADACHE; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced severe headache/constant lingering headache. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache/constant lingering headache. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular
Clinical narrative: SEVERE HEADACHE/CONSTANT LINGERING HEADACHE; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced severe headache/constant lingering headache. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache/constant lingering headache. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: SEVERE HEADACHE/CONSTANT LINGERING HEADACHE; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced severe headache/constant lingering headache. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache/constant lingering headache. This report was non-serious.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atelectasis, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Dizziness, Pleural effusion
Clinical narrative: This RN was informed that pt had been hospitalized for a blood clot on 4/12/21 after getting the vaccine on 3/15/21
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Pulmonary embolism
Clinical narrative: This RN was informed that pt had been hospitalized for a blood clot on 4/12/21 after getting the vaccine on 3/15/21
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: This RN was informed that pt had been hospitalized for a blood clot on 4/12/21 after getting the vaccine on 3/15/21
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: DEATH; POSSIBLE HEART ATTACK; This spontaneous report received from a consumer and concerned a 69 year old male. Initial information was received on 16-APR-2021 from patient's sister, with additional information received on 20-APR-2021 from primary care physician.  The patient's height and weight were not reported. The patient's concurrent conditions included hypertension, hypercholesterolemia, diabetes mellitus, and morbid obesity (Body mass index of 45.9). He had no history of heart attacks, strokes or blood clots.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 05-APR-2021 (also reported as 04-APR-2021) for prophylactic vaccination. Concomitant medications included amlodipine besilate, atorvastatin, bumetanide, glipizide/metformin, lisinopril and pioglitazone. The consumer reported that the patient did not have any problems after he got Janssen Covid-19 vaccine (shot). The most recent Glycosylated hemoglobin (Hgb A1C) was 9.6 (units not provided). On 15-APR-2021, the patient passed away in his sleep. The reporter believed the cause of death was possible heart attack. The patient died due to unspecified cause. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 15-APR-2021. This report was serious (Death and Other Medically Important Condition).; Sender's Comments: V0: This case concerns a 69 year-old male with medical history significant for hypertension, poorly controlled diabetes mellitus (HgbA1c 9.6), morbid obesity (BMI 45.9), and hypercholesterolemia who died of unknown causes 10 days after receiving the Janssen Covid-19 vaccine. He had no history of heart attacks, strokes, or blood clots. Concomitant medications included amlodipine besilate, atorvastatin, bumetanide, glipizide/metformin, lisinopril and pioglitazone. No adverse events were experienced on the days immediately following vaccination. Ten days after vaccination, he died while sleeping.  The cause is unknown but the patient's sister believes it was a possible heart attack. An autopsy is not planned. While the cause of death is unknown, the patient had multiple strong risk factors for myocardial infarction. The death and possible heart attack are considered to have an inconsistent relationship to vaccine.; Reported Cause(s) of Death: DEATH; POSSIBLE HEART ATTACK
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Glycosylated haemoglobin, Myocardial infarction
Clinical narrative: DEATH; POSSIBLE HEART ATTACK; This spontaneous report received from a consumer and concerned a 69 year old male. Initial information was received on 16-APR-2021 from patient's sister, with additional information received on 20-APR-2021 from primary care physician.  The patient's height and weight were not reported. The patient's concurrent conditions included hypertension, hypercholesterolemia, diabetes mellitus, and morbid obesity (Body mass index of 45.9). He had no history of heart attacks, strokes or blood clots.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 05-APR-2021 (also reported as 04-APR-2021) for prophylactic vaccination. Concomitant medications included amlodipine besilate, atorvastatin, bumetanide, glipizide/metformin, lisinopril and pioglitazone. The consumer reported that the patient did not have any problems after he got Janssen Covid-19 vaccine (shot). The most recent Glycosylated hemoglobin (Hgb A1C) was 9.6 (units not provided). On 15-APR-2021, the patient passed away in his sleep. The reporter believed the cause of death was possible heart attack. The patient died due to unspecified cause. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 15-APR-2021. This report was serious (Death and Other Medically Important Condition).; Sender's Comments: V0: This case concerns a 69 year-old male with medical history significant for hypertension, poorly controlled diabetes mellitus (HgbA1c 9.6), morbid obesity (BMI 45.9), and hypercholesterolemia who died of unknown causes 10 days after receiving the Janssen Covid-19 vaccine. He had no history of heart attacks, strokes, or blood clots. Concomitant medications included amlodipine besilate, atorvastatin, bumetanide, glipizide/metformin, lisinopril and pioglitazone. No adverse events were experienced on the days immediately following vaccination. Ten days after vaccination, he died while sleeping.  The cause is unknown but the patient's sister believes it was a possible heart attack. An autopsy is not planned. While the cause of death is unknown, the patient had multiple strong risk factors for myocardial infarction. The death and possible heart attack are considered to have an inconsistent relationship to vaccine.; Reported Cause(s) of Death: DEATH; POSSIBLE HEART ATTACK
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, Chills, Dysphagia
Clinical narrative: Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate abnormal, Heart rate increased, Hypertension, Muscle spasms
Clinical narrative: Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Paraesthesia oral, Pruritus, Pyrexia, Rash
Clinical narrative: Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, SARS-CoV-2 test negative, Stomatitis, Throat irritation, Tongue discomfort
Clinical narrative: Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test, Chills, Eyelids pruritus, Full blood count
Clinical narrative: Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Lip pruritus, Myalgia, Pain in extremity
Clinical narrative: Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia, Pruritus, Pyrexia
Clinical narrative: Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Sleep disorder, Stomatitis, Throat tightness, Urticaria
Clinical narrative: Five minutes after getting injection, I noticed a tightening and tingling in my throat, mouth, trachea; sharp sudden onset headache; racing pulse 100 beats per minute; blood pressure 154/100. Because of the headache, I had the pharmacist take my BP. Upper palate was scratchy and irritated. Took 25 milligram tablet of Benedryl. Throat getting tighter but no shortness of breath. At 4:00 BP was 164/104, pulse still 100. At 4:00 took another 25 mg of Benedryl. BP remained high. Stayed for an hour. Turned down epi-pen because her breathing was fine. 5:15 BP still 164/104. Left site and started feeling itchy-- eyelids, lip, scalp. 7:00 BP had come down. 148/94, pulse 88; headache persisted. Took 650 mg of aspirin. 9:00 headache had lessened and BP was 138/80, pulse was 84. By 10:00, moderate headache. Slept. Woke up at 12:00 am with muscle pain in right leg. 3:30 am woke with bad headache, chilled, slight fever (99.6), rash on right trunk and upper abdomen. Took two more aspirin for headache. 8:00 am 130/76, normal temp, hives.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Diarrhoea, Fatigue
Clinical narrative: NECK PAIN/NECK ACHE; VERY BAD BACK ACHE; DIARRHEA; PAIN IN SHOT ARM/PAIN IN FINGERS/THREE FINGERS ON RIGHT HAND ACHE; JOINT ACHE/KNEE PAIN/KNEES ACHE/WRIST PAIN/WRIST ACHE; GENERALLY WEAK; MUSCLE ACHE; SOME NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and sob.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced neck pain/neck ache. On APR-2021, the subject experienced very bad back ache. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced pain in shot arm/pain in fingers/three fingers on right hand ache. On APR-2021, the subject experienced joint ache/knee pain/knees ache/wrist pain/wrist ache. On APR-2021, the subject experienced generally weak. On APR-2021, the subject experienced muscle ache. On APR-2021, the subject experienced some nausea. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle ache, joint ache/knee pain/knees ache/wrist pain/wrist ache, neck pain/neck ache, tiredness, diarrhea, and generally weak, and had not recovered from pain in shot arm/pain in fingers/three fingers on right hand ache, very bad back ache, and some nausea. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: NECK PAIN/NECK ACHE; VERY BAD BACK ACHE; DIARRHEA; PAIN IN SHOT ARM/PAIN IN FINGERS/THREE FINGERS ON RIGHT HAND ACHE; JOINT ACHE/KNEE PAIN/KNEES ACHE/WRIST PAIN/WRIST ACHE; GENERALLY WEAK; MUSCLE ACHE; SOME NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and sob.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced neck pain/neck ache. On APR-2021, the subject experienced very bad back ache. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced pain in shot arm/pain in fingers/three fingers on right hand ache. On APR-2021, the subject experienced joint ache/knee pain/knees ache/wrist pain/wrist ache. On APR-2021, the subject experienced generally weak. On APR-2021, the subject experienced muscle ache. On APR-2021, the subject experienced some nausea. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle ache, joint ache/knee pain/knees ache/wrist pain/wrist ache, neck pain/neck ache, tiredness, diarrhea, and generally weak, and had not recovered from pain in shot arm/pain in fingers/three fingers on right hand ache, very bad back ache, and some nausea. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain in extremity
Clinical narrative: NECK PAIN/NECK ACHE; VERY BAD BACK ACHE; DIARRHEA; PAIN IN SHOT ARM/PAIN IN FINGERS/THREE FINGERS ON RIGHT HAND ACHE; JOINT ACHE/KNEE PAIN/KNEES ACHE/WRIST PAIN/WRIST ACHE; GENERALLY WEAK; MUSCLE ACHE; SOME NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and sob.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced neck pain/neck ache. On APR-2021, the subject experienced very bad back ache. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced pain in shot arm/pain in fingers/three fingers on right hand ache. On APR-2021, the subject experienced joint ache/knee pain/knees ache/wrist pain/wrist ache. On APR-2021, the subject experienced generally weak. On APR-2021, the subject experienced muscle ache. On APR-2021, the subject experienced some nausea. On APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle ache, joint ache/knee pain/knees ache/wrist pain/wrist ache, neck pain/neck ache, tiredness, diarrhea, and generally weak, and had not recovered from pain in shot arm/pain in fingers/three fingers on right hand ache, very bad back ache, and some nausea. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Urticaria
Clinical narrative: ITCHING AND REDNESS PROGRESSED TO HIVES; SORE THROAT; This spontaneous report received from a patient concerned a 55 year old female. 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 not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included cannabidiol for drug used for unknown indication. On 07-APR-2021, the subject experienced sore throat. On an unspecified date, the subject experienced itching and redness progressed to hives. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 09-APR-2021, and was recovering from itching and redness progressed to hives. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Magnetic resonance imaging heart
Clinical narrative: Patient presented with severe chest pain and after EKG, echocardiogram and MRI was diagnosed with acute myopericarditis.  Testing for any other cause for myopericarditis was completely normal. From the time course it appears that it is related to his vaccination
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericardial effusion, Troponin I increased
Clinical narrative: Patient presented with severe chest pain and after EKG, echocardiogram and MRI was diagnosed with acute myopericarditis.  Testing for any other cause for myopericarditis was completely normal. From the time course it appears that it is related to his vaccination
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal, Magnetic resonance imaging abnormal, Myocarditis
Clinical narrative: Patient presented with severe chest pain and after EKG, echocardiogram and MRI was diagnosed with acute myopericarditis.  Testing for any other cause for myopericarditis was completely normal. From the time course it appears that it is related to his vaccination
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dystonia
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Anti-thyroid antibody, Aspartate aminotransferase normal, Bacterial test negative, Blood albumin increased
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood copper, Blood creatine phosphokinase normal
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood folate normal, Blood glucose decreased, Blood immunoglobulin A, Blood immunoglobulin G normal, Blood thyroid stimulating hormone
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram neck, Cryptococcus test, Dysphagia, Electromyogram
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.