chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, CSF cell count normal, CSF culture negative, CSF protein increased
Clinical narrative: In April 2021  I had 3 outpt visits and 4 ER visits for intractable headache, complicated by intense pain around torso. Numb hands, feet, signicant symptoms including numb chest and perieal area. All Imaging and blood work was negative. Sent home without a diagnosis.  Admitted to Medical Center 4 days for pain control and worsening numbness.   Spinal tap there showed high red cells and the diagnosis of GBS was made. Transferred from Medical Center to Hospital for 4 IVIG infusions. Transferred to Rehab Hospital for 21 days. Outpatient Physical and Therapy for 8 weeks. Waiting for intensive Neurological PT and OT.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Gram stain, Headache, Immunoglobulin therapy, Muscle spasms
Clinical narrative: In April 2021  I had 3 outpt visits and 4 ER visits for intractable headache, complicated by intense pain around torso. Numb hands, feet, signicant symptoms including numb chest and perieal area. All Imaging and blood work was negative. Sent home without a diagnosis.  Admitted to Medical Center 4 days for pain control and worsening numbness.   Spinal tap there showed high red cells and the diagnosis of GBS was made. Transferred from Medical Center to Hospital for 4 IVIG infusions. Transferred to Rehab Hospital for 21 days. Outpatient Physical and Therapy for 8 weeks. Waiting for intensive Neurological PT and OT.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, CSF red blood cell count positive, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: In April 2021  I had 3 outpt visits and 4 ER visits for intractable headache, complicated by intense pain around torso. Numb hands, feet, signicant symptoms including numb chest and perieal area. All Imaging and blood work was negative. Sent home without a diagnosis.  Admitted to Medical Center 4 days for pain control and worsening numbness.   Spinal tap there showed high red cells and the diagnosis of GBS was made. Transferred from Medical Center to Hospital for 4 IVIG infusions. Transferred to Rehab Hospital for 21 days. Outpatient Physical and Therapy for 8 weeks. Waiting for intensive Neurological PT and OT.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Imaging procedure, Immunoglobulin therapy, Laboratory test, Lumbar puncture abnormal, Pain
Clinical narrative: In April 2021  I had 3 outpt visits and 4 ER visits for intractable headache, complicated by intense pain around torso. Numb hands, feet, signicant symptoms including numb chest and perieal area. All Imaging and blood work was negative. Sent home without a diagnosis.  Admitted to Medical Center 4 days for pain control and worsening numbness.   Spinal tap there showed high red cells and the diagnosis of GBS was made. Transferred from Medical Center to Hospital for 4 IVIG infusions. Transferred to Rehab Hospital for 21 days. Outpatient Physical and Therapy for 8 weeks. Waiting for intensive Neurological PT and OT.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Blood thyroid stimulating hormone, Fibrin D dimer normal, Full blood count, Haemoglobin normal
Clinical narrative: SLIGHT LOSS OF SENSATION; SOME PAIN; NUMB FINGERS; TOTAL BODY WEAKNESS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced slight loss of sensation, some pain, numb fingers, total body weakness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight loss of sensation, numb fingers, some pain, total body weakness and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lipids normal, Metabolic function test, Sensory loss, Vitamin B12 normal
Clinical narrative: SLIGHT LOSS OF SENSATION; SOME PAIN; NUMB FINGERS; TOTAL BODY WEAKNESS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced slight loss of sensation, some pain, numb fingers, total body weakness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight loss of sensation, numb fingers, some pain, total body weakness and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Back pain, Fatigue, Mobility decreased, Nephropathy
Clinical narrative: SLIGHT LOSS OF SENSATION; SOME PAIN; NUMB FINGERS; TOTAL BODY WEAKNESS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced slight loss of sensation, some pain, numb fingers, total body weakness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight loss of sensation, numb fingers, some pain, total body weakness and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Sensory loss, Sleep disorder, Visual impairment
Clinical narrative: SLIGHT LOSS OF SENSATION; SOME PAIN; NUMB FINGERS; TOTAL BODY WEAKNESS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced slight loss of sensation, some pain, numb fingers, total body weakness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight loss of sensation, numb fingers, some pain, total body weakness and fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Pain, Sensory loss
Clinical narrative: SLIGHT LOSS OF SENSATION; SOME PAIN; NUMB FINGERS; TOTAL BODY WEAKNESS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced slight loss of sensation, some pain, numb fingers, total body weakness, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight loss of sensation, numb fingers, some pain, total body weakness and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anti-thyroid antibody, Autoimmune thyroiditis, Condition aggravated
Clinical narrative: CANNOT LIVE WITH THESE  SYMPTOMS IN ANY FUNCTIONAL  CAPACITY; RELAPSE OF HASHIMOTO'S AUTOIMMUNE DISEASE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAY-2021, since the day patient received vaccine, the patient was extremely symptomatic, experienced relapse of hashimoto's autoimmune disease. The patient had been in remission for over 10 years until she received the vaccination. On an unspecified date, the patient cannot live with these symptoms in any functional capacity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from relapse of hashimoto's autoimmune disease, and cannot live with these symptoms in any functional capacity. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210833873-COVID-19 VACCINE AD26.COV2.S-Relapse of Hashimoto's Auto-immune Disease- This event(s) is considered un-assessable. 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: Autoimmune thyroiditis, Loss of personal independence in daily activities
Clinical narrative: CANNOT LIVE WITH THESE  SYMPTOMS IN ANY FUNCTIONAL  CAPACITY; RELAPSE OF HASHIMOTO'S AUTOIMMUNE DISEASE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: hashimoto's autoimmune disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAY-2021, since the day patient received vaccine, the patient was extremely symptomatic, experienced relapse of hashimoto's autoimmune disease. The patient had been in remission for over 10 years until she received the vaccination. On an unspecified date, the patient cannot live with these symptoms in any functional capacity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from relapse of hashimoto's autoimmune disease, and cannot live with these symptoms in any functional capacity. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210833873-COVID-19 VACCINE AD26.COV2.S-Relapse of Hashimoto's Auto-immune Disease- This event(s) is considered un-assessable. 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: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash, Scab, Skin fissures
Clinical narrative: Patient received Varivax vaccine and developed severe outbreak of blisters and scabs/her entire body is covered with quarter-sized blisters and scabs/child has chicken pox/maculopapular rash generalized, crusting, various stages.; This solicited report was received from a consumer referring to her daughter, a 1-year-old female patient and from a physician. Information regarding the patient's pertinent medical history, previous drug reactions, or allergies was not reported.  Concomitant therapies included ibuprofen (MOTRIN).  On 16-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) on her thigh (dose, route of administration, and vaccination scheme frequency were not reported; reported lot number T033166 has been verified to be a valid lot number,  expiration date not provided, but upon internal validation, established as 29-SEP-2022 ), as her one year shot (prophylaxis)  On 18-JUL-2021 (reported as day number 3), the patient developed a severe outbreak of quarter sized  blisters and scabs that covered the entire body (also reported as: maculopapular rash generalized, crusting, various stages), which were generalized and too numerous. The patient sought medical attention and the physician prescribed Mupirocin antibiotic ointment to treat the blisters and scabs. On 22-JUL-2021, the patient developed new skin lesions and blisters. On 19-JUL-2021 the patient was clinically examined by her physician and diagnosed the patient with chicken pox and no testing was performed. When the child was seen the rash was "at the end of everything" and was "non-existent, nothing active". The reporter was asked to contact the Center for Disease Control and Prevention (CDC) and isolate the patient due to chickenpox.Subsequently the patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. The specimen collection date was on 02-AUG-2021 from a scab, papule and a swab of the patient's right arm. The patient was not on oral antivirals prior to the specimen collection. The VZV DNA was not amplified and beta-globin DNA was amplified. The final PCR specimen results were negative (no VZV identified, adequate specimen). At the time of the report, the outcome of rash maculo-papular was reported as recovering resolving ( the physician also reported that there was no complication). Additionally, there was no reported exposure to varicella through daycare or household contacts.   The causal relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the events patient isolation and rash maculo-papular was not reported.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Rash maculo-papular, Scab, Skin lesion, Varicella
Clinical narrative: Patient received Varivax vaccine and developed severe outbreak of blisters and scabs/her entire body is covered with quarter-sized blisters and scabs/child has chicken pox/maculopapular rash generalized, crusting, various stages.; This solicited report was received from a consumer referring to her daughter, a 1-year-old female patient and from a physician. Information regarding the patient's pertinent medical history, previous drug reactions, or allergies was not reported.  Concomitant therapies included ibuprofen (MOTRIN).  On 16-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) on her thigh (dose, route of administration, and vaccination scheme frequency were not reported; reported lot number T033166 has been verified to be a valid lot number,  expiration date not provided, but upon internal validation, established as 29-SEP-2022 ), as her one year shot (prophylaxis)  On 18-JUL-2021 (reported as day number 3), the patient developed a severe outbreak of quarter sized  blisters and scabs that covered the entire body (also reported as: maculopapular rash generalized, crusting, various stages), which were generalized and too numerous. The patient sought medical attention and the physician prescribed Mupirocin antibiotic ointment to treat the blisters and scabs. On 22-JUL-2021, the patient developed new skin lesions and blisters. On 19-JUL-2021 the patient was clinically examined by her physician and diagnosed the patient with chicken pox and no testing was performed. When the child was seen the rash was "at the end of everything" and was "non-existent, nothing active". The reporter was asked to contact the Center for Disease Control and Prevention (CDC) and isolate the patient due to chickenpox.Subsequently the patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. The specimen collection date was on 02-AUG-2021 from a scab, papule and a swab of the patient's right arm. The patient was not on oral antivirals prior to the specimen collection. The VZV DNA was not amplified and beta-globin DNA was amplified. The final PCR specimen results were negative (no VZV identified, adequate specimen). At the time of the report, the outcome of rash maculo-papular was reported as recovering resolving ( the physician also reported that there was no complication). Additionally, there was no reported exposure to varicella through daycare or household contacts.   The causal relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the events patient isolation and rash maculo-papular was not reported.
Age: 1.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Patient received Varivax vaccine and developed severe outbreak of blisters and scabs/her entire body is covered with quarter-sized blisters and scabs/child has chicken pox/maculopapular rash generalized, crusting, various stages.; This solicited report was received from a consumer referring to her daughter, a 1-year-old female patient and from a physician. Information regarding the patient's pertinent medical history, previous drug reactions, or allergies was not reported.  Concomitant therapies included ibuprofen (MOTRIN).  On 16-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) on her thigh (dose, route of administration, and vaccination scheme frequency were not reported; reported lot number T033166 has been verified to be a valid lot number,  expiration date not provided, but upon internal validation, established as 29-SEP-2022 ), as her one year shot (prophylaxis)  On 18-JUL-2021 (reported as day number 3), the patient developed a severe outbreak of quarter sized  blisters and scabs that covered the entire body (also reported as: maculopapular rash generalized, crusting, various stages), which were generalized and too numerous. The patient sought medical attention and the physician prescribed Mupirocin antibiotic ointment to treat the blisters and scabs. On 22-JUL-2021, the patient developed new skin lesions and blisters. On 19-JUL-2021 the patient was clinically examined by her physician and diagnosed the patient with chicken pox and no testing was performed. When the child was seen the rash was "at the end of everything" and was "non-existent, nothing active". The reporter was asked to contact the Center for Disease Control and Prevention (CDC) and isolate the patient due to chickenpox.Subsequently the patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV was present and if it was present, to identify if it was associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine strain. The specimen collection date was on 02-AUG-2021 from a scab, papule and a swab of the patient's right arm. The patient was not on oral antivirals prior to the specimen collection. The VZV DNA was not amplified and beta-globin DNA was amplified. The final PCR specimen results were negative (no VZV identified, adequate specimen). At the time of the report, the outcome of rash maculo-papular was reported as recovering resolving ( the physician also reported that there was no complication). Additionally, there was no reported exposure to varicella through daycare or household contacts.   The causal relationship between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the events patient isolation and rash maculo-papular was not reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Back pain, Chest pain, Chills, Deep vein thrombosis
Clinical narrative: SHORTNESS OF BREATH; FEELING UNWELL; CLOTS ON LEFT ARM; CLOTS TO RIGHT LEG (THROMBOSIS); NUMBNESS IN RIGHT LEG; CHEST PAIN; FEEL HEART ACCELERATED AT TIMES; This spontaneous report received from a patient concerned a 41 year old Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: gastritis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: the patient had no known allergies, no history of drug abuse or illicit drug use. 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, frequency one total, administered at left arm  on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for gastritis.  On 08-APR-2021, the patient experienced clots to right leg (thrombosis) (pain to right leg, heat, discomfort) numbness in right leg, was hospitalized and was treated with rivaroxaban (Xarelto). On an unspecified date, the patient experienced shortness of breath, feel heart accelerated at times, chest pain, and feeling unwell. On 02-AUG-2021, the patient experienced clots on left arm (thrombosis), then treatment was changed to Apixaban (Eliquis) 5 mg twice a day, then after one week, then continue with it for once a day. The patient was discharged on 04-Aug-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness in right leg, and had not recovered from shortness of breath, feeling unwell, clots to right leg (thrombosis), clots on left arm (thrombosis), chest pain, and feel heart accelerated at times. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Clots to right leg, Clots on left arm, 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). V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Feeling unwell, Numbness in right leg. This event(s) is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Discouragement, Erythema, Fatigue, Headache
Clinical narrative: SHORTNESS OF BREATH; FEELING UNWELL; CLOTS ON LEFT ARM; CLOTS TO RIGHT LEG (THROMBOSIS); NUMBNESS IN RIGHT LEG; CHEST PAIN; FEEL HEART ACCELERATED AT TIMES; This spontaneous report received from a patient concerned a 41 year old Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: gastritis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: the patient had no known allergies, no history of drug abuse or illicit drug use. 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, frequency one total, administered at left arm  on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for gastritis.  On 08-APR-2021, the patient experienced clots to right leg (thrombosis) (pain to right leg, heat, discomfort) numbness in right leg, was hospitalized and was treated with rivaroxaban (Xarelto). On an unspecified date, the patient experienced shortness of breath, feel heart accelerated at times, chest pain, and feeling unwell. On 02-AUG-2021, the patient experienced clots on left arm (thrombosis), then treatment was changed to Apixaban (Eliquis) 5 mg twice a day, then after one week, then continue with it for once a day. The patient was discharged on 04-Aug-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness in right leg, and had not recovered from shortness of breath, feeling unwell, clots to right leg (thrombosis), clots on left arm (thrombosis), chest pain, and feel heart accelerated at times. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Clots to right leg, Clots on left arm, 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). V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Feeling unwell, Numbness in right leg. This event(s) is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Malaise, Mammogram, Pain, Pain in extremity
Clinical narrative: SHORTNESS OF BREATH; FEELING UNWELL; CLOTS ON LEFT ARM; CLOTS TO RIGHT LEG (THROMBOSIS); NUMBNESS IN RIGHT LEG; CHEST PAIN; FEEL HEART ACCELERATED AT TIMES; This spontaneous report received from a patient concerned a 41 year old Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: gastritis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: the patient had no known allergies, no history of drug abuse or illicit drug use. 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, frequency one total, administered at left arm  on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for gastritis.  On 08-APR-2021, the patient experienced clots to right leg (thrombosis) (pain to right leg, heat, discomfort) numbness in right leg, was hospitalized and was treated with rivaroxaban (Xarelto). On an unspecified date, the patient experienced shortness of breath, feel heart accelerated at times, chest pain, and feeling unwell. On 02-AUG-2021, the patient experienced clots on left arm (thrombosis), then treatment was changed to Apixaban (Eliquis) 5 mg twice a day, then after one week, then continue with it for once a day. The patient was discharged on 04-Aug-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness in right leg, and had not recovered from shortness of breath, feeling unwell, clots to right leg (thrombosis), clots on left arm (thrombosis), chest pain, and feel heart accelerated at times. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Clots to right leg, Clots on left arm, 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). V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Feeling unwell, Numbness in right leg. This event(s) is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Ultrasound scan abnormal
Clinical narrative: SHORTNESS OF BREATH; FEELING UNWELL; CLOTS ON LEFT ARM; CLOTS TO RIGHT LEG (THROMBOSIS); NUMBNESS IN RIGHT LEG; CHEST PAIN; FEEL HEART ACCELERATED AT TIMES; This spontaneous report received from a patient concerned a 41 year old Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: gastritis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: the patient had no known allergies, no history of drug abuse or illicit drug use. 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, frequency one total, administered at left arm  on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for gastritis.  On 08-APR-2021, the patient experienced clots to right leg (thrombosis) (pain to right leg, heat, discomfort) numbness in right leg, was hospitalized and was treated with rivaroxaban (Xarelto). On an unspecified date, the patient experienced shortness of breath, feel heart accelerated at times, chest pain, and feeling unwell. On 02-AUG-2021, the patient experienced clots on left arm (thrombosis), then treatment was changed to Apixaban (Eliquis) 5 mg twice a day, then after one week, then continue with it for once a day. The patient was discharged on 04-Aug-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness in right leg, and had not recovered from shortness of breath, feeling unwell, clots to right leg (thrombosis), clots on left arm (thrombosis), chest pain, and feel heart accelerated at times. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Clots to right leg, Clots on left arm, 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). V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Feeling unwell, Numbness in right leg. This event(s) is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Hypoaesthesia, Malaise
Clinical narrative: SHORTNESS OF BREATH; FEELING UNWELL; CLOTS ON LEFT ARM; CLOTS TO RIGHT LEG (THROMBOSIS); NUMBNESS IN RIGHT LEG; CHEST PAIN; FEEL HEART ACCELERATED AT TIMES; This spontaneous report received from a patient concerned a 41 year old Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: gastritis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: the patient had no known allergies, no history of drug abuse or illicit drug use. 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, frequency one total, administered at left arm  on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for gastritis.  On 08-APR-2021, the patient experienced clots to right leg (thrombosis) (pain to right leg, heat, discomfort) numbness in right leg, was hospitalized and was treated with rivaroxaban (Xarelto). On an unspecified date, the patient experienced shortness of breath, feel heart accelerated at times, chest pain, and feeling unwell. On 02-AUG-2021, the patient experienced clots on left arm (thrombosis), then treatment was changed to Apixaban (Eliquis) 5 mg twice a day, then after one week, then continue with it for once a day. The patient was discharged on 04-Aug-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness in right leg, and had not recovered from shortness of breath, feeling unwell, clots to right leg (thrombosis), clots on left arm (thrombosis), chest pain, and feel heart accelerated at times. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Clots to right leg, Clots on left arm, 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). V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Feeling unwell, Numbness in right leg. This event(s) is labeled and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: SHORTNESS OF BREATH; FEELING UNWELL; CLOTS ON LEFT ARM; CLOTS TO RIGHT LEG (THROMBOSIS); NUMBNESS IN RIGHT LEG; CHEST PAIN; FEEL HEART ACCELERATED AT TIMES; This spontaneous report received from a patient concerned a 41 year old Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: gastritis, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: the patient had no known allergies, no history of drug abuse or illicit drug use. 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, frequency one total, administered at left arm  on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for gastritis.  On 08-APR-2021, the patient experienced clots to right leg (thrombosis) (pain to right leg, heat, discomfort) numbness in right leg, was hospitalized and was treated with rivaroxaban (Xarelto). On an unspecified date, the patient experienced shortness of breath, feel heart accelerated at times, chest pain, and feeling unwell. On 02-AUG-2021, the patient experienced clots on left arm (thrombosis), then treatment was changed to Apixaban (Eliquis) 5 mg twice a day, then after one week, then continue with it for once a day. The patient was discharged on 04-Aug-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness in right leg, and had not recovered from shortness of breath, feeling unwell, clots to right leg (thrombosis), clots on left arm (thrombosis), chest pain, and feel heart accelerated at times. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Clots to right leg, Clots on left arm, 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). V0: 20210819893-Covid-19 vaccine ad26.cov2.s-Feeling unwell, Numbness in right leg. This event(s) is labeled and is therefore considered potentially related.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head normal, Culture urine positive, Diplopia, Full blood count, Headache
Clinical narrative: About two weeks after the vaccine I started having spontaneous reccuring tremors in my left arm and hand. This progressed over two months. In July I started having chest pain and trouble breathing but cardiologist cleared me. Come August 5, 2021 I was hospitalized with a cerebellar ishaemic stroke. I had to be life flighted to Seattle to have a thrombectomy and was subsequently hospitalized for two weeks. I am still on long term rehabilitation going forward. All blood tests for genetic conditions or blood disease came back negative. The doctors can only speculate that it could be vaccine related since I am otherwise relatively healthy.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Muscular weakness, Neurological symptom, Thromboembolectomy, Tremor
Clinical narrative: About two weeks after the vaccine I started having spontaneous reccuring tremors in my left arm and hand. This progressed over two months. In July I started having chest pain and trouble breathing but cardiologist cleared me. Come August 5, 2021 I was hospitalized with a cerebellar ishaemic stroke. I had to be life flighted to Seattle to have a thrombectomy and was subsequently hospitalized for two weeks. I am still on long term rehabilitation going forward. All blood tests for genetic conditions or blood disease came back negative. The doctors can only speculate that it could be vaccine related since I am otherwise relatively healthy.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid abnormal, Blood test normal, Brain oedema, Cerebellar stroke
Clinical narrative: About two weeks after the vaccine I started having spontaneous reccuring tremors in my left arm and hand. This progressed over two months. In July I started having chest pain and trouble breathing but cardiologist cleared me. Come August 5, 2021 I was hospitalized with a cerebellar ishaemic stroke. I had to be life flighted to Seattle to have a thrombectomy and was subsequently hospitalized for two weeks. I am still on long term rehabilitation going forward. All blood tests for genetic conditions or blood disease came back negative. The doctors can only speculate that it could be vaccine related since I am otherwise relatively healthy.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral infarction, Chest pain, Cytogenetic analysis normal, Dyspnoea, Hyperintensity in brain deep nuclei
Clinical narrative: About two weeks after the vaccine I started having spontaneous reccuring tremors in my left arm and hand. This progressed over two months. In July I started having chest pain and trouble breathing but cardiologist cleared me. Come August 5, 2021 I was hospitalized with a cerebellar ishaemic stroke. I had to be life flighted to Seattle to have a thrombectomy and was subsequently hospitalized for two weeks. I am still on long term rehabilitation going forward. All blood tests for genetic conditions or blood disease came back negative. The doctors can only speculate that it could be vaccine related since I am otherwise relatively healthy.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ischaemic stroke, Magnetic resonance imaging head abnormal, Scan with contrast abnormal, Thrombectomy, Tremor
Clinical narrative: About two weeks after the vaccine I started having spontaneous reccuring tremors in my left arm and hand. This progressed over two months. In July I started having chest pain and trouble breathing but cardiologist cleared me. Come August 5, 2021 I was hospitalized with a cerebellar ishaemic stroke. I had to be life flighted to Seattle to have a thrombectomy and was subsequently hospitalized for two weeks. I am still on long term rehabilitation going forward. All blood tests for genetic conditions or blood disease came back negative. The doctors can only speculate that it could be vaccine related since I am otherwise relatively healthy.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: About two weeks after the vaccine I started having spontaneous reccuring tremors in my left arm and hand. This progressed over two months. In July I started having chest pain and trouble breathing but cardiologist cleared me. Come August 5, 2021 I was hospitalized with a cerebellar ishaemic stroke. I had to be life flighted to Seattle to have a thrombectomy and was subsequently hospitalized for two weeks. I am still on long term rehabilitation going forward. All blood tests for genetic conditions or blood disease came back negative. The doctors can only speculate that it could be vaccine related since I am otherwise relatively healthy.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Skin discolouration, Throat tightness
Clinical narrative: LEFT SCAPULA GETS A INTENSE PAIN; SHIN SPLINTS; WEIRD SORENESS UNDER TONGUE; TINGLING IN LIPS/WEIRD TINGLING UNDER TONGUE; BELLS PALSY; SWOLLEN FEET; CALVE TIGHTNESS STARTED IN LEFT CALF BUT MOVED TO AFFECT THE RIGHT CALF TOO; FACE TIGHTENING; EXTREME FATIGUE/TIRED; EXTREME WEAKNESS IN QUADS/LEGS; BURNING RASH ON FACE MOSTLY ON RIGHT BUT ON LEFT SOME ON BOTH CHEEKS AND WORSE ON THE RIGHT; COLD CHILLS THAT COME AND GO; IMMEDIATE ALLERGIC REACTION; TINGLING UP AND DOWN LEFT ARMS AND LEGS; This spontaneous report received from a patient concerned a 53 year old female, unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 09-AUG-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-AUG-2021, the patient experienced an immediate allergic reaction within 5 minutes. She got a shot benadryl and steroids. Tingling went left hand up left arm and down left leg and Cold chills that come go suddenly. On 10-AUG-2021, the patient experienced face tightening, calves feel really tight, extreme weakness in quads/legs, burning rash on face mostly on right but on left some on both cheeks and worse on the right and extreme fatigue/tired. On 11-AUG-2021, the patient experienced swollen feet. On 12-AUG-2021, the patient experienced bells palsy. On 13-AUG-2021, the patient experienced shin splints, weird soreness under tongue, tingling in lips/weird tingling under tongue. On 14-AUG-2021, the patient experienced left scapula gets a intense pain. Treatment medications (dates unspecified) included: valaciclovir hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen feet on 12-AUG-2021, and had not recovered from bells palsy, tingling up and down left arms and legs, extreme weakness in quads/legs, shin splints, burning rash on face mostly on right but on left some on both cheeks and worse on the right, extreme fatigue/tired, face tightening, weird soreness under tongue, cold chills that come and go, tingling in lips, left scapula gets a intense pain, immediate allergic reaction, and calves feel really tight. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210832652-covid-19 vaccine ad26.cov2.s -Bells palsy. 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: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Magnetic resonance imaging spinal abnormal
Clinical narrative: LEFT SCAPULA GETS A INTENSE PAIN; SHIN SPLINTS; WEIRD SORENESS UNDER TONGUE; TINGLING IN LIPS/WEIRD TINGLING UNDER TONGUE; BELLS PALSY; SWOLLEN FEET; CALVE TIGHTNESS STARTED IN LEFT CALF BUT MOVED TO AFFECT THE RIGHT CALF TOO; FACE TIGHTENING; EXTREME FATIGUE/TIRED; EXTREME WEAKNESS IN QUADS/LEGS; BURNING RASH ON FACE MOSTLY ON RIGHT BUT ON LEFT SOME ON BOTH CHEEKS AND WORSE ON THE RIGHT; COLD CHILLS THAT COME AND GO; IMMEDIATE ALLERGIC REACTION; TINGLING UP AND DOWN LEFT ARMS AND LEGS; This spontaneous report received from a patient concerned a 53 year old female, unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered on 09-AUG-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-AUG-2021, the patient experienced an immediate allergic reaction within 5 minutes. She got a shot benadryl and steroids. Tingling went left hand up left arm and down left leg and Cold chills that come go suddenly. On 10-AUG-2021, the patient experienced face tightening, calves feel really tight, extreme weakness in quads/legs, burning rash on face mostly on right but on left some on both cheeks and worse on the right and extreme fatigue/tired. On 11-AUG-2021, the patient experienced swollen feet. On 12-AUG-2021, the patient experienced bells palsy. On 13-AUG-2021, the patient experienced shin splints, weird soreness under tongue, tingling in lips/weird tingling under tongue. On 14-AUG-2021, the patient experienced left scapula gets a intense pain. Treatment medications (dates unspecified) included: valaciclovir hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen feet on 12-AUG-2021, and had not recovered from bells palsy, tingling up and down left arms and legs, extreme weakness in quads/legs, shin splints, burning rash on face mostly on right but on left some on both cheeks and worse on the right, extreme fatigue/tired, face tightening, weird soreness under tongue, cold chills that come and go, tingling in lips, left scapula gets a intense pain, immediate allergic reaction, and calves feel really tight. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210832652-covid-19 vaccine ad26.cov2.s -Bells palsy. 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).