chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory rate increased, Sinus tachycardia
Clinical narrative: SHORTNESS OF BREATH; CHEST DISCOMFORT; LEG CRAMPS; OFF-BALANCE/DIZZINESS/LIGHT HEADEDNESS; JITTERY; BRAIN FOG; CHILLS; LEG PAIN; FEVER; This spontaneous report received from a patient 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, route of admin not reported, batch number: 1802070, expiry: 21-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 11:13 for prophylactic vaccination. Vaccinated on right deltoid. No concomitant medications were reported.  On 13-MAR-2021 19:00, the subject experienced leg cramps, off-balance/dizziness/light headedness, jittery, brain fog, chills, leg pain and fever.. On 15-MAR-2021, the patient started feeling short of breath and chest discomfort, which got worse on March 16th. On 16-MAR-2021 she went to the emergency room around 13:00. In emergency room she was treated with one liter of oxygen. Shortness of breath and chest discomfort and all other symptoms were getting to get better. The patient mostly had slight shortness of breath, chest pain and a little bit of leg cramping. The patient was going to make an appointment for F/U with her PCP. The patient was treated with steroids and inhalers. On 16-MAR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 100% on room air, Pulse rate (NR: not provided) 120 bpm, and Respiratory rate (NR: not provided) 20 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, leg pain, fever, chills, off-balance/dizziness/light headedness, jittery, brain fog, shortness of breath, and chest discomfort. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210335101- Covid-19 vaccine ad26.cov2.s-Shortness of breath. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Feeling abnormal
Clinical narrative: SHORTNESS OF BREATH; CHEST DISCOMFORT; LEG CRAMPS; OFF-BALANCE/DIZZINESS/LIGHT HEADEDNESS; JITTERY; BRAIN FOG; CHILLS; LEG PAIN; FEVER; This spontaneous report received from a patient 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, route of admin not reported, batch number: 1802070, expiry: 21-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 11:13 for prophylactic vaccination. Vaccinated on right deltoid. No concomitant medications were reported.  On 13-MAR-2021 19:00, the subject experienced leg cramps, off-balance/dizziness/light headedness, jittery, brain fog, chills, leg pain and fever.. On 15-MAR-2021, the patient started feeling short of breath and chest discomfort, which got worse on March 16th. On 16-MAR-2021 she went to the emergency room around 13:00. In emergency room she was treated with one liter of oxygen. Shortness of breath and chest discomfort and all other symptoms were getting to get better. The patient mostly had slight shortness of breath, chest pain and a little bit of leg cramping. The patient was going to make an appointment for F/U with her PCP. The patient was treated with steroids and inhalers. On 16-MAR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 100% on room air, Pulse rate (NR: not provided) 120 bpm, and Respiratory rate (NR: not provided) 20 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, leg pain, fever, chills, off-balance/dizziness/light headedness, jittery, brain fog, shortness of breath, and chest discomfort. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210335101- Covid-19 vaccine ad26.cov2.s-Shortness of breath. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling jittery, Heart rate, Muscle spasms, Oxygen saturation, Pain in extremity
Clinical narrative: SHORTNESS OF BREATH; CHEST DISCOMFORT; LEG CRAMPS; OFF-BALANCE/DIZZINESS/LIGHT HEADEDNESS; JITTERY; BRAIN FOG; CHILLS; LEG PAIN; FEVER; This spontaneous report received from a patient 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, route of admin not reported, batch number: 1802070, expiry: 21-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 11:13 for prophylactic vaccination. Vaccinated on right deltoid. No concomitant medications were reported.  On 13-MAR-2021 19:00, the subject experienced leg cramps, off-balance/dizziness/light headedness, jittery, brain fog, chills, leg pain and fever.. On 15-MAR-2021, the patient started feeling short of breath and chest discomfort, which got worse on March 16th. On 16-MAR-2021 she went to the emergency room around 13:00. In emergency room she was treated with one liter of oxygen. Shortness of breath and chest discomfort and all other symptoms were getting to get better. The patient mostly had slight shortness of breath, chest pain and a little bit of leg cramping. The patient was going to make an appointment for F/U with her PCP. The patient was treated with steroids and inhalers. On 16-MAR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 100% on room air, Pulse rate (NR: not provided) 120 bpm, and Respiratory rate (NR: not provided) 20 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, leg pain, fever, chills, off-balance/dizziness/light headedness, jittery, brain fog, shortness of breath, and chest discomfort. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210335101- Covid-19 vaccine ad26.cov2.s-Shortness of breath. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory rate
Clinical narrative: SHORTNESS OF BREATH; CHEST DISCOMFORT; LEG CRAMPS; OFF-BALANCE/DIZZINESS/LIGHT HEADEDNESS; JITTERY; BRAIN FOG; CHILLS; LEG PAIN; FEVER; This spontaneous report received from a patient 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, route of admin not reported, batch number: 1802070, expiry: 21-MAY-2021) dose was not reported, 1 total, administered on 13-MAR-2021 11:13 for prophylactic vaccination. Vaccinated on right deltoid. No concomitant medications were reported.  On 13-MAR-2021 19:00, the subject experienced leg cramps, off-balance/dizziness/light headedness, jittery, brain fog, chills, leg pain and fever.. On 15-MAR-2021, the patient started feeling short of breath and chest discomfort, which got worse on March 16th. On 16-MAR-2021 she went to the emergency room around 13:00. In emergency room she was treated with one liter of oxygen. Shortness of breath and chest discomfort and all other symptoms were getting to get better. The patient mostly had slight shortness of breath, chest pain and a little bit of leg cramping. The patient was going to make an appointment for F/U with her PCP. The patient was treated with steroids and inhalers. On 16-MAR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 100% on room air, Pulse rate (NR: not provided) 120 bpm, and Respiratory rate (NR: not provided) 20 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from leg cramps, leg pain, fever, chills, off-balance/dizziness/light headedness, jittery, brain fog, shortness of breath, and chest discomfort. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210335101- Covid-19 vaccine ad26.cov2.s-Shortness of breath. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: acquired shingles about 3 days after second dose.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: acquired shingles about 3 days after second dose.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody negative, Arthritis, Complement factor C3, Complement factor C4, Double stranded DNA antibody
Clinical narrative: WHITE BLOOD CELL COUNT HIGH; ELEVATED INFLAMMATORY MARKERS; GENERALIZED JOINT PAIN; SKIN RASH; FEVER; DIFFUSED MUSCLE PAIN AND BILATERAL MUSCLE PAIN TO LEGS; LEG PAIN; MALAISE; This spontaneous report received from a physician concerned a 20 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin. The patient was not pregnant at the time of reporting. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) once total dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced malaise. On 10-MAR-2021, the patient experienced diffused muscle pain and bilateral muscle pain to legs. On 10-MAR-2021, the patient experienced leg pain.  On 11-MAR-2021, the patient experienced white blood cell count high, elevated inflammatory markers, generalized joint pain, skin rash, and fever. The patient was hospitalized on 11-Mar-2021 and was discharged on 21-Mar-2021 and is still having symptoms.  The patient was hospitalized for 11 days. Laboratory data included: Body temperature (NR: not provided) 101.5 F, Inflammatory marker test (NR: not provided) increased not reported, and White blood cell count (NR: not provided) high not reported. On 13-MAR-2021, Laboratory data included: CT scan (NR: not provided) NORMAL, Chest X-ray (NR: not provided) NORMAL, and Ultrasonography (NR: not provided) Normal. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from diffused muscle pain and bilateral muscle pain to legs, and leg pain on 20-MAR-2021, and malaise on 07-MAR-2021, and had not recovered from fever, generalized joint pain, skin rash, white blood cell count high, and elevated inflammatory markers. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: v0;20210348767-COVID-19 VACCINE AD26.COV2.S - White Blood Cell Count High, Elevated Inflammatory Markers. This events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY.  20210348767-COVID-19 VACCINE AD26.COV2.S - Generalized Joint Pain, Skin Rash, Fever, Diffused Muscle Pain And Bilateral Muscle Pain To Legs. This events are labeled and is therefore considered potentially related.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Myalgia, Pyrexia, Rash
Clinical narrative: WHITE BLOOD CELL COUNT HIGH; ELEVATED INFLAMMATORY MARKERS; GENERALIZED JOINT PAIN; SKIN RASH; FEVER; DIFFUSED MUSCLE PAIN AND BILATERAL MUSCLE PAIN TO LEGS; LEG PAIN; MALAISE; This spontaneous report received from a physician concerned a 20 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin. The patient was not pregnant at the time of reporting. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) once total dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced malaise. On 10-MAR-2021, the patient experienced diffused muscle pain and bilateral muscle pain to legs. On 10-MAR-2021, the patient experienced leg pain.  On 11-MAR-2021, the patient experienced white blood cell count high, elevated inflammatory markers, generalized joint pain, skin rash, and fever. The patient was hospitalized on 11-Mar-2021 and was discharged on 21-Mar-2021 and is still having symptoms.  The patient was hospitalized for 11 days. Laboratory data included: Body temperature (NR: not provided) 101.5 F, Inflammatory marker test (NR: not provided) increased not reported, and White blood cell count (NR: not provided) high not reported. On 13-MAR-2021, Laboratory data included: CT scan (NR: not provided) NORMAL, Chest X-ray (NR: not provided) NORMAL, and Ultrasonography (NR: not provided) Normal. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from diffused muscle pain and bilateral muscle pain to legs, and leg pain on 20-MAR-2021, and malaise on 07-MAR-2021, and had not recovered from fever, generalized joint pain, skin rash, white blood cell count high, and elevated inflammatory markers. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: v0;20210348767-COVID-19 VACCINE AD26.COV2.S - White Blood Cell Count High, Elevated Inflammatory Markers. This events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY.  20210348767-COVID-19 VACCINE AD26.COV2.S - Generalized Joint Pain, Skin Rash, Fever, Diffused Muscle Pain And Bilateral Muscle Pain To Legs. This events are labeled and is therefore considered potentially related.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Serum sickness-like reaction, Tachycardia
Clinical narrative: WHITE BLOOD CELL COUNT HIGH; ELEVATED INFLAMMATORY MARKERS; GENERALIZED JOINT PAIN; SKIN RASH; FEVER; DIFFUSED MUSCLE PAIN AND BILATERAL MUSCLE PAIN TO LEGS; LEG PAIN; MALAISE; This spontaneous report received from a physician concerned a 20 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin. The patient was not pregnant at the time of reporting. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) once total dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced malaise. On 10-MAR-2021, the patient experienced diffused muscle pain and bilateral muscle pain to legs. On 10-MAR-2021, the patient experienced leg pain.  On 11-MAR-2021, the patient experienced white blood cell count high, elevated inflammatory markers, generalized joint pain, skin rash, and fever. The patient was hospitalized on 11-Mar-2021 and was discharged on 21-Mar-2021 and is still having symptoms.  The patient was hospitalized for 11 days. Laboratory data included: Body temperature (NR: not provided) 101.5 F, Inflammatory marker test (NR: not provided) increased not reported, and White blood cell count (NR: not provided) high not reported. On 13-MAR-2021, Laboratory data included: CT scan (NR: not provided) NORMAL, Chest X-ray (NR: not provided) NORMAL, and Ultrasonography (NR: not provided) Normal. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from diffused muscle pain and bilateral muscle pain to legs, and leg pain on 20-MAR-2021, and malaise on 07-MAR-2021, and had not recovered from fever, generalized joint pain, skin rash, white blood cell count high, and elevated inflammatory markers. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: v0;20210348767-COVID-19 VACCINE AD26.COV2.S - White Blood Cell Count High, Elevated Inflammatory Markers. This events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY.  20210348767-COVID-19 VACCINE AD26.COV2.S - Generalized Joint Pain, Skin Rash, Fever, Diffused Muscle Pain And Bilateral Muscle Pain To Legs. This events are labeled and is therefore considered potentially related.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chest X-ray, Computerised tomogram, Inflammatory marker increased
Clinical narrative: WHITE BLOOD CELL COUNT HIGH; ELEVATED INFLAMMATORY MARKERS; GENERALIZED JOINT PAIN; SKIN RASH; FEVER; DIFFUSED MUSCLE PAIN AND BILATERAL MUSCLE PAIN TO LEGS; LEG PAIN; MALAISE; This spontaneous report received from a physician concerned a 20 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin. The patient was not pregnant at the time of reporting. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) once total dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced malaise. On 10-MAR-2021, the patient experienced diffused muscle pain and bilateral muscle pain to legs. On 10-MAR-2021, the patient experienced leg pain.  On 11-MAR-2021, the patient experienced white blood cell count high, elevated inflammatory markers, generalized joint pain, skin rash, and fever. The patient was hospitalized on 11-Mar-2021 and was discharged on 21-Mar-2021 and is still having symptoms.  The patient was hospitalized for 11 days. Laboratory data included: Body temperature (NR: not provided) 101.5 F, Inflammatory marker test (NR: not provided) increased not reported, and White blood cell count (NR: not provided) high not reported. On 13-MAR-2021, Laboratory data included: CT scan (NR: not provided) NORMAL, Chest X-ray (NR: not provided) NORMAL, and Ultrasonography (NR: not provided) Normal. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from diffused muscle pain and bilateral muscle pain to legs, and leg pain on 20-MAR-2021, and malaise on 07-MAR-2021, and had not recovered from fever, generalized joint pain, skin rash, white blood cell count high, and elevated inflammatory markers. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: v0;20210348767-COVID-19 VACCINE AD26.COV2.S - White Blood Cell Count High, Elevated Inflammatory Markers. This events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY.  20210348767-COVID-19 VACCINE AD26.COV2.S - Generalized Joint Pain, Skin Rash, Fever, Diffused Muscle Pain And Bilateral Muscle Pain To Legs. This events are labeled and is therefore considered potentially related.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammatory marker test, Malaise, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: WHITE BLOOD CELL COUNT HIGH; ELEVATED INFLAMMATORY MARKERS; GENERALIZED JOINT PAIN; SKIN RASH; FEVER; DIFFUSED MUSCLE PAIN AND BILATERAL MUSCLE PAIN TO LEGS; LEG PAIN; MALAISE; This spontaneous report received from a physician concerned a 20 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin. The patient was not pregnant at the time of reporting. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) once total dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced malaise. On 10-MAR-2021, the patient experienced diffused muscle pain and bilateral muscle pain to legs. On 10-MAR-2021, the patient experienced leg pain.  On 11-MAR-2021, the patient experienced white blood cell count high, elevated inflammatory markers, generalized joint pain, skin rash, and fever. The patient was hospitalized on 11-Mar-2021 and was discharged on 21-Mar-2021 and is still having symptoms.  The patient was hospitalized for 11 days. Laboratory data included: Body temperature (NR: not provided) 101.5 F, Inflammatory marker test (NR: not provided) increased not reported, and White blood cell count (NR: not provided) high not reported. On 13-MAR-2021, Laboratory data included: CT scan (NR: not provided) NORMAL, Chest X-ray (NR: not provided) NORMAL, and Ultrasonography (NR: not provided) Normal. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from diffused muscle pain and bilateral muscle pain to legs, and leg pain on 20-MAR-2021, and malaise on 07-MAR-2021, and had not recovered from fever, generalized joint pain, skin rash, white blood cell count high, and elevated inflammatory markers. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: v0;20210348767-COVID-19 VACCINE AD26.COV2.S - White Blood Cell Count High, Elevated Inflammatory Markers. This events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY.  20210348767-COVID-19 VACCINE AD26.COV2.S - Generalized Joint Pain, Skin Rash, Fever, Diffused Muscle Pain And Bilateral Muscle Pain To Legs. This events are labeled and is therefore considered potentially related.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Ultrasound scan, White blood cell count, White blood cell count increased
Clinical narrative: WHITE BLOOD CELL COUNT HIGH; ELEVATED INFLAMMATORY MARKERS; GENERALIZED JOINT PAIN; SKIN RASH; FEVER; DIFFUSED MUSCLE PAIN AND BILATERAL MUSCLE PAIN TO LEGS; LEG PAIN; MALAISE; This spontaneous report received from a physician concerned a 20 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin. The patient was not pregnant at the time of reporting. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) once total dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the patient experienced malaise. On 10-MAR-2021, the patient experienced diffused muscle pain and bilateral muscle pain to legs. On 10-MAR-2021, the patient experienced leg pain.  On 11-MAR-2021, the patient experienced white blood cell count high, elevated inflammatory markers, generalized joint pain, skin rash, and fever. The patient was hospitalized on 11-Mar-2021 and was discharged on 21-Mar-2021 and is still having symptoms.  The patient was hospitalized for 11 days. Laboratory data included: Body temperature (NR: not provided) 101.5 F, Inflammatory marker test (NR: not provided) increased not reported, and White blood cell count (NR: not provided) high not reported. On 13-MAR-2021, Laboratory data included: CT scan (NR: not provided) NORMAL, Chest X-ray (NR: not provided) NORMAL, and Ultrasonography (NR: not provided) Normal. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from diffused muscle pain and bilateral muscle pain to legs, and leg pain on 20-MAR-2021, and malaise on 07-MAR-2021, and had not recovered from fever, generalized joint pain, skin rash, white blood cell count high, and elevated inflammatory markers. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: v0;20210348767-COVID-19 VACCINE AD26.COV2.S - White Blood Cell Count High, Elevated Inflammatory Markers. This events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY.  20210348767-COVID-19 VACCINE AD26.COV2.S - Generalized Joint Pain, Skin Rash, Fever, Diffused Muscle Pain And Bilateral Muscle Pain To Legs. This events are labeled and is therefore considered potentially related.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cellulitis, Gait inability, Joint swelling, Malaise
Clinical narrative: ANKLE SWELLING, DISCOMFORT AND REDNESS/CELLULITIS; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included quadriplegia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031) dose was not reported, administered at left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the patient had swelling with in his right ankle with significant discomfort. On 18-MAR-2021, the had redness in his ankle. On 21-MAR-2021, the patient went to emergency room where the treating physician mentioned he had cellulitis. On MAR-2021, the patient received treatment medications clindamycin hydrochloride (Cleocin 300mg IV) and would be on unspecified antibiotics for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ankle swelling, discomfort and redness/cellulitis. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210342988-COVID-19 VACCINE AD26.COV2.S-Cellulitis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pyrexia, Rash, Rash erythematous, X-ray
Clinical narrative: ANKLE SWELLING, DISCOMFORT AND REDNESS/CELLULITIS; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included quadriplegia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031) dose was not reported, administered at left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the patient had swelling with in his right ankle with significant discomfort. On 18-MAR-2021, the had redness in his ankle. On 21-MAR-2021, the patient went to emergency room where the treating physician mentioned he had cellulitis. On MAR-2021, the patient received treatment medications clindamycin hydrochloride (Cleocin 300mg IV) and would be on unspecified antibiotics for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ankle swelling, discomfort and redness/cellulitis. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210342988-COVID-19 VACCINE AD26.COV2.S-Cellulitis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cellulitis
Clinical narrative: ANKLE SWELLING, DISCOMFORT AND REDNESS/CELLULITIS; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included quadriplegia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031) dose was not reported, administered at left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the patient had swelling with in his right ankle with significant discomfort. On 18-MAR-2021, the had redness in his ankle. On 21-MAR-2021, the patient went to emergency room where the treating physician mentioned he had cellulitis. On MAR-2021, the patient received treatment medications clindamycin hydrochloride (Cleocin 300mg IV) and would be on unspecified antibiotics for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ankle swelling, discomfort and redness/cellulitis. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210342988-COVID-19 VACCINE AD26.COV2.S-Cellulitis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Bradyphrenia, Computerised tomogram, Electrocardiogram, Electroencephalogram
Clinical narrative: PATIENT WANTED MODERNA BUT RECEIVED JANSSEN
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye contusion, Fall, Headache, Magnetic resonance imaging, Seizure
Clinical narrative: PATIENT WANTED MODERNA BUT RECEIVED JANSSEN
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: PATIENT WANTED MODERNA BUT RECEIVED JANSSEN
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Eye swelling, Injection site pain, Injection site pustule, Lip swelling
Clinical narrative: SJS/TEN, TBSA 30-40%, suspicious for drug eruption to ibuprofen and/or COVID-19 vaccination on 3/12/21.  Biopsy by outside provider 3/24/21 from the arm and read by facility was consistent with erythema multiforme, though the patient's confluent skin sloughing of the entire back and significant mucosal involvement is consistent with SJS/TEN and biopsy findings of these conditions often overlap. Patient also has secondary impetiginization of the perioral skin, likely associated with a reduced skin barrier in the setting of full-thickness necrosis as above.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oral disorder, Peripheral swelling, Pustule, Rash, Skin burning sensation
Clinical narrative: SJS/TEN, TBSA 30-40%, suspicious for drug eruption to ibuprofen and/or COVID-19 vaccination on 3/12/21.  Biopsy by outside provider 3/24/21 from the arm and read by facility was consistent with erythema multiforme, though the patient's confluent skin sloughing of the entire back and significant mucosal involvement is consistent with SJS/TEN and biopsy findings of these conditions often overlap. Patient also has secondary impetiginization of the perioral skin, likely associated with a reduced skin barrier in the setting of full-thickness necrosis as above.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin lesion, Swelling face
Clinical narrative: SJS/TEN, TBSA 30-40%, suspicious for drug eruption to ibuprofen and/or COVID-19 vaccination on 3/12/21.  Biopsy by outside provider 3/24/21 from the arm and read by facility was consistent with erythema multiforme, though the patient's confluent skin sloughing of the entire back and significant mucosal involvement is consistent with SJS/TEN and biopsy findings of these conditions often overlap. Patient also has secondary impetiginization of the perioral skin, likely associated with a reduced skin barrier in the setting of full-thickness necrosis as above.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug eruption, Erythema multiforme, Impetigo, Mucosal biopsy, Perioral dermatitis
Clinical narrative: SJS/TEN, TBSA 30-40%, suspicious for drug eruption to ibuprofen and/or COVID-19 vaccination on 3/12/21.  Biopsy by outside provider 3/24/21 from the arm and read by facility was consistent with erythema multiforme, though the patient's confluent skin sloughing of the entire back and significant mucosal involvement is consistent with SJS/TEN and biopsy findings of these conditions often overlap. Patient also has secondary impetiginization of the perioral skin, likely associated with a reduced skin barrier in the setting of full-thickness necrosis as above.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin exfoliation, Toxic epidermal necrolysis
Clinical narrative: SJS/TEN, TBSA 30-40%, suspicious for drug eruption to ibuprofen and/or COVID-19 vaccination on 3/12/21.  Biopsy by outside provider 3/24/21 from the arm and read by facility was consistent with erythema multiforme, though the patient's confluent skin sloughing of the entire back and significant mucosal involvement is consistent with SJS/TEN and biopsy findings of these conditions often overlap. Patient also has secondary impetiginization of the perioral skin, likely associated with a reduced skin barrier in the setting of full-thickness necrosis as above.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Thermal burn, Toxic epidermal necrolysis, Urticaria
Clinical narrative: SJS/TEN, TBSA 30-40%, suspicious for drug eruption to ibuprofen and/or COVID-19 vaccination on 3/12/21.  Biopsy by outside provider 3/24/21 from the arm and read by facility was consistent with erythema multiforme, though the patient's confluent skin sloughing of the entire back and significant mucosal involvement is consistent with SJS/TEN and biopsy findings of these conditions often overlap. Patient also has secondary impetiginization of the perioral skin, likely associated with a reduced skin barrier in the setting of full-thickness necrosis as above.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: ANAPHYLAXIS (SEVERE HEADACHE, NAUSEA, COUGHING, RAPID INCREASING SHORTNESS OF BREATH LEADING TO RESTRICTION OF BREATHING, PALE, DIAPHORETIC); This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with tetanus vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 24-MAR-2021 at 10:31, the patient experienced Anaphylaxis  (severe headache, nausea, coughing, rapid increasing shortness of breath leading to restriction of breathing, pale, diaphoretic). On 24-MAR-2021 at 10:40 epinephrine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Anaphylaxis (severe headache, nausea, coughing, rapid increasing shortness of breath leading to restriction of breathing, pale, diaphoretic). This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210350143-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypopnoea, Pallor, Rhinorrhoea, Throat tightness
Clinical narrative: ANAPHYLAXIS (SEVERE HEADACHE, NAUSEA, COUGHING, RAPID INCREASING SHORTNESS OF BREATH LEADING TO RESTRICTION OF BREATHING, PALE, DIAPHORETIC); This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with tetanus vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 24-MAR-2021 at 10:31, the patient experienced Anaphylaxis  (severe headache, nausea, coughing, rapid increasing shortness of breath leading to restriction of breathing, pale, diaphoretic). On 24-MAR-2021 at 10:40 epinephrine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Anaphylaxis (severe headache, nausea, coughing, rapid increasing shortness of breath leading to restriction of breathing, pale, diaphoretic). This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210350143-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLAXIS (SEVERE HEADACHE, NAUSEA, COUGHING, RAPID INCREASING SHORTNESS OF BREATH LEADING TO RESTRICTION OF BREATHING, PALE, DIAPHORETIC); This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with tetanus vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 24-MAR-2021 at 10:31, the patient experienced Anaphylaxis  (severe headache, nausea, coughing, rapid increasing shortness of breath leading to restriction of breathing, pale, diaphoretic). On 24-MAR-2021 at 10:40 epinephrine was administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Anaphylaxis (severe headache, nausea, coughing, rapid increasing shortness of breath leading to restriction of breathing, pale, diaphoretic). This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210350143-COVID-19 VACCINE AD26.COV2.S-Anaphylaxis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Nausea
Clinical narrative: PT. states approximately 15hrs. after 1st dose of vaccine she had "tingling" in throat and wheezing. PT. given 25mg Benadryl Prior To being given 2nd dose of vaccine. History and vitals obtained. PT. released and advised to call 911 w/ any further problems.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event
Clinical narrative: PT. states approximately 15hrs. after 1st dose of vaccine she had "tingling" in throat and wheezing. PT. given 25mg Benadryl Prior To being given 2nd dose of vaccine. History and vitals obtained. PT. released and advised to call 911 w/ any further problems.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Injection site erythema, Insomnia, Lymphadenopathy, Peripheral swelling
Clinical narrative: Chart note of 3/22/21-" Local, delayed reaction to the COVID-19 vaccine. Discussed the self-limiting nature of this. Recommend treating with ibuprofen (she has tolerated this NSAID well in the past despite her other reactions to NSAIDS), Tylenol, ice, and OTC antihistamines. Provided her with an ACE bandage today to limit mobility of the wrist due to pain. F/u if no improvement in 2 weeks." chart note of 3/29/21-"Patient is a 42 year old female who presents to the office for wrist pain and rash. Both have been going on since covid vaccine. Has been wrapping her wrists intermittently  with no improvement. Swelling has decreased in her arm- left upper arm. States had hives bilaterally in the upper arms although patient has chronic urticaria. States all weekend wrists will hurt later on in the night. Will get shooting pain at night. No swelling of her wrists. When pain happens doesn't have full ROM. Does right now. When pain gets worse cant make a full fist. No fever or chills. States will get a charlie horse pain in the right back of the leg. Has been taking the motrin 800 mg tid. Doesn't want to take that much. States has taken it a couple of times, otherwise takes tylenol.  Has done ice on the arm not on the wrists. Thinks turning into a worry wart. Johnson vaccine was on 3/16. History of chronic urticaria. Does take zyrtec three times a day. Singluair patient was unable to get her allergy shot this month due to getting the covid vaccine. " A referral has been placed to Rheumatology based on labs.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Skin discolouration, Skin warm
Clinical narrative: Chart note of 3/22/21-" Local, delayed reaction to the COVID-19 vaccine. Discussed the self-limiting nature of this. Recommend treating with ibuprofen (she has tolerated this NSAID well in the past despite her other reactions to NSAIDS), Tylenol, ice, and OTC antihistamines. Provided her with an ACE bandage today to limit mobility of the wrist due to pain. F/u if no improvement in 2 weeks." chart note of 3/29/21-"Patient is a 42 year old female who presents to the office for wrist pain and rash. Both have been going on since covid vaccine. Has been wrapping her wrists intermittently  with no improvement. Swelling has decreased in her arm- left upper arm. States had hives bilaterally in the upper arms although patient has chronic urticaria. States all weekend wrists will hurt later on in the night. Will get shooting pain at night. No swelling of her wrists. When pain happens doesn't have full ROM. Does right now. When pain gets worse cant make a full fist. No fever or chills. States will get a charlie horse pain in the right back of the leg. Has been taking the motrin 800 mg tid. Doesn't want to take that much. States has taken it a couple of times, otherwise takes tylenol.  Has done ice on the arm not on the wrists. Thinks turning into a worry wart. Johnson vaccine was on 3/16. History of chronic urticaria. Does take zyrtec three times a day. Singluair patient was unable to get her allergy shot this month due to getting the covid vaccine. " A referral has been placed to Rheumatology based on labs.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Arthralgia, C-reactive protein normal, Mobility decreased, Muscle spasms
Clinical narrative: Chart note of 3/22/21-" Local, delayed reaction to the COVID-19 vaccine. Discussed the self-limiting nature of this. Recommend treating with ibuprofen (she has tolerated this NSAID well in the past despite her other reactions to NSAIDS), Tylenol, ice, and OTC antihistamines. Provided her with an ACE bandage today to limit mobility of the wrist due to pain. F/u if no improvement in 2 weeks." chart note of 3/29/21-"Patient is a 42 year old female who presents to the office for wrist pain and rash. Both have been going on since covid vaccine. Has been wrapping her wrists intermittently  with no improvement. Swelling has decreased in her arm- left upper arm. States had hives bilaterally in the upper arms although patient has chronic urticaria. States all weekend wrists will hurt later on in the night. Will get shooting pain at night. No swelling of her wrists. When pain happens doesn't have full ROM. Does right now. When pain gets worse cant make a full fist. No fever or chills. States will get a charlie horse pain in the right back of the leg. Has been taking the motrin 800 mg tid. Doesn't want to take that much. States has taken it a couple of times, otherwise takes tylenol.  Has done ice on the arm not on the wrists. Thinks turning into a worry wart. Johnson vaccine was on 3/16. History of chronic urticaria. Does take zyrtec three times a day. Singluair patient was unable to get her allergy shot this month due to getting the covid vaccine. " A referral has been placed to Rheumatology based on labs.