chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Eye pain, Eye swelling, Hypoaesthesia oral
Clinical narrative: About 4 hours later, I started to really tired and had a headache. Later that even, I started feeling like I have the flu.  I had aching in back and over. I continued to headache. Those same symptoms continued the whole next day. On Friday afternoon my right eye started swelling up. I continued to stay swollen until that next week. My right lymph node on my right arm pit was swollen that lasted 24 hours. I continued to have low energy. In July, I started having heart problems. This is still going on. Since March, I had more headaches more often several days a week.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip pain, Lip swelling
Clinical narrative: About 4 hours later, I started to really tired and had a headache. Later that even, I started feeling like I have the flu.  I had aching in back and over. I continued to headache. Those same symptoms continued the whole next day. On Friday afternoon my right eye started swelling up. I continued to stay swollen until that next week. My right lymph node on my right arm pit was swollen that lasted 24 hours. I continued to have low energy. In July, I started having heart problems. This is still going on. Since March, I had more headaches more often several days a week.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Blood test, Cardiac disorder, Chest X-ray
Clinical narrative: About 4 hours later, I started to really tired and had a headache. Later that even, I started feeling like I have the flu.  I had aching in back and over. I continued to headache. Those same symptoms continued the whole next day. On Friday afternoon my right eye started swelling up. I continued to stay swollen until that next week. My right lymph node on my right arm pit was swollen that lasted 24 hours. I continued to have low energy. In July, I started having heart problems. This is still going on. Since March, I had more headaches more often several days a week.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Eye swelling, Fatigue, Headache, Influenza like illness
Clinical narrative: About 4 hours later, I started to really tired and had a headache. Later that even, I started feeling like I have the flu.  I had aching in back and over. I continued to headache. Those same symptoms continued the whole next day. On Friday afternoon my right eye started swelling up. I continued to stay swollen until that next week. My right lymph node on my right arm pit was swollen that lasted 24 hours. I continued to have low energy. In July, I started having heart problems. This is still going on. Since March, I had more headaches more often several days a week.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: About 4 hours later, I started to really tired and had a headache. Later that even, I started feeling like I have the flu.  I had aching in back and over. I continued to headache. Those same symptoms continued the whole next day. On Friday afternoon my right eye started swelling up. I continued to stay swollen until that next week. My right lymph node on my right arm pit was swollen that lasted 24 hours. I continued to have low energy. In July, I started having heart problems. This is still going on. Since March, I had more headaches more often several days a week.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Computerised tomogram normal, Confusional state, Eye swelling
Clinical narrative: 02/01/2021- Repetitive Seizure and migraines, inflammation around head and neck 06/23/2021 Admitted in hospital for seizure 08/17/2021 - Taken by ambulance due to seizure 08/17/2021- Airlifted to Medical  08/27/2021- Had 5 more seizures
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis, Fatigue, Headache, Joint range of motion decreased, Lip swelling
Clinical narrative: 02/01/2021- Repetitive Seizure and migraines, inflammation around head and neck 06/23/2021 Admitted in hospital for seizure 08/17/2021 - Taken by ambulance due to seizure 08/17/2021- Airlifted to Medical  08/27/2021- Had 5 more seizures
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Memory impairment, Meningitis, Motor dysfunction, Neck pain
Clinical narrative: 02/01/2021- Repetitive Seizure and migraines, inflammation around head and neck 06/23/2021 Admitted in hospital for seizure 08/17/2021 - Taken by ambulance due to seizure 08/17/2021- Airlifted to Medical  08/27/2021- Had 5 more seizures
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oedema, Photophobia, Rash, Swelling, Swelling face
Clinical narrative: 02/01/2021- Repetitive Seizure and migraines, inflammation around head and neck 06/23/2021 Admitted in hospital for seizure 08/17/2021 - Taken by ambulance due to seizure 08/17/2021- Airlifted to Medical  08/27/2021- Had 5 more seizures
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred, White blood cell count increased
Clinical narrative: 02/01/2021- Repetitive Seizure and migraines, inflammation around head and neck 06/23/2021 Admitted in hospital for seizure 08/17/2021 - Taken by ambulance due to seizure 08/17/2021- Airlifted to Medical  08/27/2021- Had 5 more seizures
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electroencephalogram, Epilepsy, Inflammation, Laboratory test
Clinical narrative: 02/01/2021- Repetitive Seizure and migraines, inflammation around head and neck 06/23/2021 Admitted in hospital for seizure 08/17/2021 - Taken by ambulance due to seizure 08/17/2021- Airlifted to Medical  08/27/2021- Had 5 more seizures
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Seizure
Clinical narrative: 02/01/2021- Repetitive Seizure and migraines, inflammation around head and neck 06/23/2021 Admitted in hospital for seizure 08/17/2021 - Taken by ambulance due to seizure 08/17/2021- Airlifted to Medical  08/27/2021- Had 5 more seizures
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Bronchospasm, Dyspnoea, Headache, Myalgia
Clinical narrative: throat began to swell,  itching, shortness of breath, chills, fever
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: throat began to swell,  itching, shortness of breath, chills, fever
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Dyspnoea, Pharyngeal swelling, Pruritus, Pyrexia
Clinical narrative: throat began to swell,  itching, shortness of breath, chills, fever
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bronchospasm, Dyspnoea, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: throat began to swell,  itching, shortness of breath, chills, fever
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Chest pain, Dyspnoea, Troponin
Clinical narrative: Chest Tightness 4 days after 2nd dose of Pfizer vaccine. 17yoF without cardiac risk factors with episodes of exertional chest pain, SOB, and fatigue.  Initial EKG without signs of cardiac ischemia or pericarditis.  Elevated Troponins 6/16: Trop I: 6.420>7.690 (0.012-0.034) SARS Cov-2 PCR - Neg CRP: 1.1 mg/dl (1) Admitted to a HOST hospital in Japan for "mild myocarditis". Limited records available.  f/u on 8-10-21: Symptoms have resolved. She was not dc'd on any medications from the hospital.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: Chest Tightness 4 days after 2nd dose of Pfizer vaccine. 17yoF without cardiac risk factors with episodes of exertional chest pain, SOB, and fatigue.  Initial EKG without signs of cardiac ischemia or pericarditis.  Elevated Troponins 6/16: Trop I: 6.420>7.690 (0.012-0.034) SARS Cov-2 PCR - Neg CRP: 1.1 mg/dl (1) Admitted to a HOST hospital in Japan for "mild myocarditis". Limited records available.  f/u on 8-10-21: Symptoms have resolved. She was not dc'd on any medications from the hospital.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myocarditis, SARS-CoV-2 test negative, Troponin I increased
Clinical narrative: Chest Tightness 4 days after 2nd dose of Pfizer vaccine. 17yoF without cardiac risk factors with episodes of exertional chest pain, SOB, and fatigue.  Initial EKG without signs of cardiac ischemia or pericarditis.  Elevated Troponins 6/16: Trop I: 6.420>7.690 (0.012-0.034) SARS Cov-2 PCR - Neg CRP: 1.1 mg/dl (1) Admitted to a HOST hospital in Japan for "mild myocarditis". Limited records available.  f/u on 8-10-21: Symptoms have resolved. She was not dc'd on any medications from the hospital.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Confusional state, Decreased appetite, Dizziness, Fall, Fatigue
Clinical narrative: He had onset of neurological symptoms in late April and was worked up by neurologist starting 6/8/21.  The most likely diagnosis was immune-mediated encephalitis, possibly secondary to vaccination.  He died 8/28/21 and vaccine-associated immune-mediated encephalitis is listed as the initial cause of death.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Impaired self-care, Magnetic resonance imaging abnormal, Nausea
Clinical narrative: He had onset of neurological symptoms in late April and was worked up by neurologist starting 6/8/21.  The most likely diagnosis was immune-mediated encephalitis, possibly secondary to vaccination.  He died 8/28/21 and vaccine-associated immune-mediated encephalitis is listed as the initial cause of death.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Immune-mediated encephalitis, Neurological symptom, Vaccine associated enhanced disease
Clinical narrative: He had onset of neurological symptoms in late April and was worked up by neurologist starting 6/8/21.  The most likely diagnosis was immune-mediated encephalitis, possibly secondary to vaccination.  He died 8/28/21 and vaccine-associated immune-mediated encephalitis is listed as the initial cause of death.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ataxia, Encephalitis
Clinical narrative: He had onset of neurological symptoms in late April and was worked up by neurologist starting 6/8/21.  The most likely diagnosis was immune-mediated encephalitis, possibly secondary to vaccination.  He died 8/28/21 and vaccine-associated immune-mediated encephalitis is listed as the initial cause of death.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Swollen lymph nodes left side of neck Face and tongue swelling  Rash Feeling hot but no fever
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Lymphadenopathy, Swelling face, Swollen tongue
Clinical narrative: Swollen lymph nodes left side of neck Face and tongue swelling  Rash Feeling hot but no fever
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Lymphadenopathy, Rash, Swelling face, Swollen tongue
Clinical narrative: Swollen lymph nodes left side of neck Face and tongue swelling  Rash Feeling hot but no fever
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Muscle twitching, Paraesthesia
Clinical narrative: PATIENT RETURNED TO PHARMACY ON 8-23-21 COMPLAINING OF HER LEFT ARM. SHE SAID HER LEFT ARM WAS FROZEN, HEAVY, HOT, SWOLLEN AND RED, AND HURT INTO HER FINGERS. SHE SAID HER LEFT ARM STARTED HURTING HER IMMEDIATELY WHEN SHE RECEIVED THE VACCCINE AND SHE HAD FLU LIKE SYMPTOMS OVER THE WEEKEND.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT RETURNED TO PHARMACY ON 8-23-21 COMPLAINING OF HER LEFT ARM. SHE SAID HER LEFT ARM WAS FROZEN, HEAVY, HOT, SWOLLEN AND RED, AND HURT INTO HER FINGERS. SHE SAID HER LEFT ARM STARTED HURTING HER IMMEDIATELY WHEN SHE RECEIVED THE VACCCINE AND SHE HAD FLU LIKE SYMPTOMS OVER THE WEEKEND.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Joint range of motion decreased, Limb discomfort, Pain in extremity
Clinical narrative: PATIENT RETURNED TO PHARMACY ON 8-23-21 COMPLAINING OF HER LEFT ARM. SHE SAID HER LEFT ARM WAS FROZEN, HEAVY, HOT, SWOLLEN AND RED, AND HURT INTO HER FINGERS. SHE SAID HER LEFT ARM STARTED HURTING HER IMMEDIATELY WHEN SHE RECEIVED THE VACCCINE AND SHE HAD FLU LIKE SYMPTOMS OVER THE WEEKEND.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: hives; muscle  pain; joint pain; chills; exhaustion; tightness in my throat; This case was reported by a consumer via call center representative and described the occurrence of hives in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 25th August 2021, less than a day after receiving Shingrix, the patient experienced hives, muscle pain, joint pain, chills, exhaustion and throat tightness. On an unknown date, the outcome of the hives, muscle pain, joint pain, chills, exhaustion and throat tightness were not recovered/not resolved.   It was unknown if the reporter considered the hives, muscle pain, joint pain, chills, exhaustion and throat tightness to be related to Shingrix.  Additional details were provided as follow: The case was reported by the consumer for herself. The reporter stated that, she had her first dose of Shingrix, and she experienced hives, muscle and joint pain, chills, exhaustion, tightness in her throat after the vaccination. The reporter stated that, the events were unresolved till the time of reporting..  The reporter gave medical disclaimer, referred to health care professional.  The reporter spoke per pharmaceutical inspectorate and content, offered pharmaceutical inspectorate. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Throat tightness
Clinical narrative: hives; muscle  pain; joint pain; chills; exhaustion; tightness in my throat; This case was reported by a consumer via call center representative and described the occurrence of hives in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 25th August 2021, less than a day after receiving Shingrix, the patient experienced hives, muscle pain, joint pain, chills, exhaustion and throat tightness. On an unknown date, the outcome of the hives, muscle pain, joint pain, chills, exhaustion and throat tightness were not recovered/not resolved.   It was unknown if the reporter considered the hives, muscle pain, joint pain, chills, exhaustion and throat tightness to be related to Shingrix.  Additional details were provided as follow: The case was reported by the consumer for herself. The reporter stated that, she had her first dose of Shingrix, and she experienced hives, muscle and joint pain, chills, exhaustion, tightness in her throat after the vaccination. The reporter stated that, the events were unresolved till the time of reporting..  The reporter gave medical disclaimer, referred to health care professional.  The reporter spoke per pharmaceutical inspectorate and content, offered pharmaceutical inspectorate. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: hives; muscle  pain; joint pain; chills; exhaustion; tightness in my throat; This case was reported by a consumer via call center representative and described the occurrence of hives in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 25th August 2021, less than a day after receiving Shingrix, the patient experienced hives, muscle pain, joint pain, chills, exhaustion and throat tightness. On an unknown date, the outcome of the hives, muscle pain, joint pain, chills, exhaustion and throat tightness were not recovered/not resolved.   It was unknown if the reporter considered the hives, muscle pain, joint pain, chills, exhaustion and throat tightness to be related to Shingrix.  Additional details were provided as follow: The case was reported by the consumer for herself. The reporter stated that, she had her first dose of Shingrix, and she experienced hives, muscle and joint pain, chills, exhaustion, tightness in her throat after the vaccination. The reporter stated that, the events were unresolved till the time of reporting..  The reporter gave medical disclaimer, referred to health care professional.  The reporter spoke per pharmaceutical inspectorate and content, offered pharmaceutical inspectorate. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Echocardiogram abnormal, Electrocardiogram, Electrocardiogram ST segment depression
Clinical narrative: Felt fatigued with headache post vaccination (8/24). Woke up at midnight on 8/27 with chest pain and low grade fever and presented to ED. Transferred to Hospital via ambulance.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Left ventricular dysfunction, Pain in jaw, Pyrexia, Troponin increased
Clinical narrative: Felt fatigued with headache post vaccination (8/24). Woke up at midnight on 8/27 with chest pain and low grade fever and presented to ED. Transferred to Hospital via ambulance.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Felt fatigued with headache post vaccination (8/24). Woke up at midnight on 8/27 with chest pain and low grade fever and presented to ED. Transferred to Hospital via ambulance.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Electrocardiogram ST segment depression, Electrocardiogram ST segment elevation, Electrocardiogram abnormal
Clinical narrative: Felt fatigued with headache post vaccination (8/24). Woke up at midnight on 8/27 with chest pain and low grade fever and presented to ED. Transferred to Hospital via ambulance.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myocarditis, Nodal rhythm, Pyrexia
Clinical narrative: Felt fatigued with headache post vaccination (8/24). Woke up at midnight on 8/27 with chest pain and low grade fever and presented to ED. Transferred to Hospital via ambulance.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder, Troponin increased, Ventricular tachycardia
Clinical narrative: Felt fatigued with headache post vaccination (8/24). Woke up at midnight on 8/27 with chest pain and low grade fever and presented to ED. Transferred to Hospital via ambulance.
Age: 9.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: patient immediately had a red mark at the injection site; she has experienced swelling and redness at the injection site; The patient is having difficulty moving her left arm; This spontaneous report as received from a nurse refers to a 9 year old female patient with allergy to Apples. dairy, latex and "CIPRO".   Concomitant therapies included macrogol 3350(MIRALAX).      On 27-AUG-2021, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), prefilled syringe,  dose:0.5 milliliter.  lot # T025370, expiration date not reported, but upon internal validation established as 01-DEC-2022), intramuscular in the left deltoid for prophylaxis.    On the same date, the patient immediately had a red mark at the injection site (left deltoid). Since then she had experienced swelling and redness at the injection site that has progressively worsened (vaccination site erythema; vaccination site swelling). The swollen and red area currently measures 15cm by 11cm. The patient was having difficulty moving her left arm (vaccination site movement impairment). The nurse reported that the physician did not believe that the symptoms were due to infection.She sought unspecified medical attention. The patient has not yet received treatment for her symptoms however the patient's physician was considering steroids.  The outcome of vaccination site erythema, vaccination site movement impairment and vaccination site swelling was reported as not recovered. The causality assessment for the events were not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 9.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: patient immediately had a red mark at the injection site; she has experienced swelling and redness at the injection site; The patient is having difficulty moving her left arm; This spontaneous report as received from a nurse refers to a 9 year old female patient with allergy to Apples. dairy, latex and "CIPRO".   Concomitant therapies included macrogol 3350(MIRALAX).      On 27-AUG-2021, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), prefilled syringe,  dose:0.5 milliliter.  lot # T025370, expiration date not reported, but upon internal validation established as 01-DEC-2022), intramuscular in the left deltoid for prophylaxis.    On the same date, the patient immediately had a red mark at the injection site (left deltoid). Since then she had experienced swelling and redness at the injection site that has progressively worsened (vaccination site erythema; vaccination site swelling). The swollen and red area currently measures 15cm by 11cm. The patient was having difficulty moving her left arm (vaccination site movement impairment). The nurse reported that the physician did not believe that the symptoms were due to infection.She sought unspecified medical attention. The patient has not yet received treatment for her symptoms however the patient's physician was considering steroids.  The outcome of vaccination site erythema, vaccination site movement impairment and vaccination site swelling was reported as not recovered. The causality assessment for the events were not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on my legs; extreme itching.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Gait inability, Joint swelling, Muscle spasms, Peripheral swelling
Clinical narrative: thrombotic thrombocytopenia
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Rash erythematous
Clinical narrative: thrombotic thrombocytopenia
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombotic thrombocytopenic purpura
Clinical narrative: thrombotic thrombocytopenia
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Confusional state, Delirium, Gravitational oedema, Henoch-Schonlein purpura
Clinical narrative: thrombotic thrombocytopenia
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Gait inability, Hypersomnia, Joint swelling, Rash macular
Clinical narrative: thrombotic thrombocytopenia
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: thrombotic thrombocytopenia
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 59 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non smoker. The patient had no known allergies, and drug abuse or illicit drug use. Patient had no prior medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 11-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021 and 25-AUG-2021, Patient tested for SARS-COV-2 IgG spike semi quantitative blood test two times and both the results were negative (-)1.00 for antibodies (coded to confirmed immunological vaccine failure). As per the test procedure, a result of 1.00 or more (positive) meant that antibodies to SARS-CoV-2 get detected in the blood sample by the test, and result less than 1.00 (negative) meant that antibodies do not get detected in the blood sample by the test. The patient was anxious about not being immune from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20210900296-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. 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: SPECIAL SITUATIONS
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 59 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non smoker. The patient had no known allergies, and drug abuse or illicit drug use. Patient had no prior medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018, expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 11-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021 and 25-AUG-2021, Patient tested for SARS-COV-2 IgG spike semi quantitative blood test two times and both the results were negative (-)1.00 for antibodies (coded to confirmed immunological vaccine failure). As per the test procedure, a result of 1.00 or more (positive) meant that antibodies to SARS-CoV-2 get detected in the blood sample by the test, and result less than 1.00 (negative) meant that antibodies do not get detected in the blood sample by the test. The patient was anxious about not being immune from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20210900296-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. 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: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis ulcerative, Colonoscopy, Constipation, Diarrhoea, Gait inability
Clinical narrative: Dissie, chills, sick as if i had covid all over. Lasted 2 1/2 days remained on tolet diareah & not able to function. After directly taking shot. Since shot symptoms started 2 to 3 wks anything i ate i had to immediately go to bathroom then turned into i could not go to bathroom at all but strained bent over in pain to try & go. Clots of blood started coming out which sent me to hospital. Currently in pain still & on medication & under doctors care.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Illness, Throat irritation
Clinical narrative: Dissie, chills, sick as if i had covid all over. Lasted 2 1/2 days remained on tolet diareah & not able to function. After directly taking shot. Since shot symptoms started 2 to 3 wks anything i ate i had to immediately go to bathroom then turned into i could not go to bathroom at all but strained bent over in pain to try & go. Clots of blood started coming out which sent me to hospital. Currently in pain still & on medication & under doctors care.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy colon, Chills, Colitis ulcerative, Colonoscopy abnormal, Computerised tomogram abdomen abnormal
Clinical narrative: Dissie, chills, sick as if i had covid all over. Lasted 2 1/2 days remained on tolet diareah & not able to function. After directly taking shot. Since shot symptoms started 2 to 3 wks anything i ate i had to immediately go to bathroom then turned into i could not go to bathroom at all but strained bent over in pain to try & go. Clots of blood started coming out which sent me to hospital. Currently in pain still & on medication & under doctors care.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Constipation, Diarrhoea, Dizziness, Gastritis, Malaise
Clinical narrative: Dissie, chills, sick as if i had covid all over. Lasted 2 1/2 days remained on tolet diareah & not able to function. After directly taking shot. Since shot symptoms started 2 to 3 wks anything i ate i had to immediately go to bathroom then turned into i could not go to bathroom at all but strained bent over in pain to try & go. Clots of blood started coming out which sent me to hospital. Currently in pain still & on medication & under doctors care.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Oesophagogastroduodenoscopy abnormal, Pain, Thrombosis
Clinical narrative: Dissie, chills, sick as if i had covid all over. Lasted 2 1/2 days remained on tolet diareah & not able to function. After directly taking shot. Since shot symptoms started 2 to 3 wks anything i ate i had to immediately go to bathroom then turned into i could not go to bathroom at all but strained bent over in pain to try & go. Clots of blood started coming out which sent me to hospital. Currently in pain still & on medication & under doctors care.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial nerve disorder, Hypoaesthesia, Hypoaesthesia oral, Lymphadenopathy, Magnetic resonance imaging head abnormal
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Paraesthesia
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Areflexia, Facial paresis, Guillain-Barre syndrome, Immunoglobulin therapy, Magnetic resonance imaging head
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Muscular weakness, Paraesthesia
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abstains from alcohol, Ageusia, Areflexia, Blood glucose normal, Bordetella test negative
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, CSF culture negative, CSF glucose increased, CSF oligoclonal band absent, CSF protein increased
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF white blood cell count negative, Computerised tomogram abdomen, Computerised tomogram head normal, Computerised tomogram thorax abnormal, Condition aggravated
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cryptococcus test, Facial pain, Facial paralysis, Facial paresis, Fatigue
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flow cytometry, Full blood count, Guillain-Barre syndrome, Hypertension, Hypoaesthesia
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Hyporeflexia, Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging head abnormal
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle fatigue, Muscle spasms, Muscular weakness, Musculoskeletal pain, Nausea
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Non-tobacco user, Paraesthesia, Pulmonary function test normal, Pulmonary mass, Red blood cell sedimentation rate increased
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Scan with contrast abnormal, Sensory loss, Speech disorder, Taste disorder
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo, Vomiting, White blood cell count normal
Clinical narrative: 4 days after vaccine started to develop paresthesias. Had unilateral facial weakness that developed to bilateral facial weakness over the next one week. Was admitted Monday August 30th for bilateral facial weakness with progressive loss of reflexes and started on IVIG for Guillian Barre Syndrome (AIDP). He also developed slow right arm and leg weakness.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Decreased appetite, Dysphagia, Erythema, Fatigue
Clinical narrative: facial swelling and hives, treated qwith benadrly
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Headache, Nausea, Swelling face, Taste disorder
Clinical narrative: facial swelling and hives, treated qwith benadrly
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: facial swelling and hives, treated qwith benadrly
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: facial swelling and hives, treated qwith benadrly
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash morbilliform
Clinical narrative: Rash ( measle type) to entire body itches and still has it.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash morbilliform
Clinical narrative: Rash ( measle type) to entire body itches and still has it.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase normal, Blood glucose normal, Blood lactic acid normal, C-reactive protein increased, Full blood count normal
Clinical narrative: pt developed severe myalgia throughout his entire body approximately 24 hrs. following his 2nd dose of Moderna COVID vaccine that was not given through our clinic - I have contacted the patient to find out where he had his vaccine administered and what was the lot number.  He had a sore arm for 24-48 hrs. with the first dose of Moderna COVID vaccine.  The myalgia persisted and he was seen and evaluated in our office on 8/4/21.  Labs (CBC, CMP, lactic acid, CPK, and CRP) were drawn - all were normal except for CRP elevated at 13.6 and glucose of 129.  His pravastatin was held.  On 8/25 we spoke with patient and he was continuing to have severe muscle pains in trunk, arms, and legs.  Prednisone was started at per day.  Within 24 hrs. his symptoms were tremendously improved.  He finished a five day course of prednisone and within 48 hrs. his symptoms were returning.  On 9/1/21 he was given the diagnosis of polymyalgia rheumatica and was restarted on 20 mg daily of prednisone.  His CRP at that time was down to 2.33.  His HgbA1C was stable at 6.3.  He will continue to follow-up in our office.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Metabolic function test normal, Myalgia, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: pt developed severe myalgia throughout his entire body approximately 24 hrs. following his 2nd dose of Moderna COVID vaccine that was not given through our clinic - I have contacted the patient to find out where he had his vaccine administered and what was the lot number.  He had a sore arm for 24-48 hrs. with the first dose of Moderna COVID vaccine.  The myalgia persisted and he was seen and evaluated in our office on 8/4/21.  Labs (CBC, CMP, lactic acid, CPK, and CRP) were drawn - all were normal except for CRP elevated at 13.6 and glucose of 129.  His pravastatin was held.  On 8/25 we spoke with patient and he was continuing to have severe muscle pains in trunk, arms, and legs.  Prednisone was started at per day.  Within 24 hrs. his symptoms were tremendously improved.  He finished a five day course of prednisone and within 48 hrs. his symptoms were returning.  On 9/1/21 he was given the diagnosis of polymyalgia rheumatica and was restarted on 20 mg daily of prednisone.  His CRP at that time was down to 2.33.  His HgbA1C was stable at 6.3.  He will continue to follow-up in our office.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site vesicles, Pain
Clinical narrative: Exhaustion, headache, severe body aching, blister at injection site
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Infection, Nasal congestion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Client had Pfizer vaccines x 2 in June, 2021 at the appropriate intervals.  Client developed Covid symptoms on 8/27/2021  (fever x 1 day, nasal congestion) and tested PCR positive for Covid on 8/30.  Reported as case of breakthrough Covid in a fully vaccinated person.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Impaired driving ability, Pericarditis, Tachycardia
Clinical narrative: I woke up on Wednesday, and felt slight pressure, a little sharpness. Eventually, the pressure and pain was too much, I went to the ER.  I coudnt drive myself, as I was dizzy I eventually self-diagnosed pericarditius When I got there at 9pm,  tachycardia of over 160.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Magnetic resonance imaging head normal, Urinary tract infection, Vertigo, Vestibular neuronitis
Clinical narrative: 5/7/21 started having vertigo   4/28/21 started to wean off of citalopram onto wellbutrin 5/5/21 started on cephalexin for UTI 6/23/21 started working up vertigo as it worsened eventually saw ENT and audiologist and diagnosed with vestibular neuritis
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Body temperature increased, Computerised tomogram normal, Eye irritation, Facial paralysis
Clinical narrative: Slightly elevated temp,  general body  ache, very sore injection site, restlessness for first several days.  Approx 7:30 PM on Aug 30, 2021, felt sharp pain in left side of neck while filling in reports..  Numbness in lip and left side of face.  Left eye felt very irritated and began watering.  When to bathroom to wash face and noted left side droop.  Consulted with on duty medic and confirmed assessment of possible stroke.  Transported to ER, a stroke destination hospital.  Initial assessment resulted in a CT scan which showed negative results for stroke.  MD assessed partial facial paralysis due to Bells Palsy.  Prednisone, Acyclovir, and eye drops prescribed with orders for follow up with internal medicine specialist and PCP.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site pain, Lacrimation increased, Neck pain
Clinical narrative: Slightly elevated temp,  general body  ache, very sore injection site, restlessness for first several days.  Approx 7:30 PM on Aug 30, 2021, felt sharp pain in left side of neck while filling in reports..  Numbness in lip and left side of face.  Left eye felt very irritated and began watering.  When to bathroom to wash face and noted left side droop.  Consulted with on duty medic and confirmed assessment of possible stroke.  Transported to ER, a stroke destination hospital.  Initial assessment resulted in a CT scan which showed negative results for stroke.  MD assessed partial facial paralysis due to Bells Palsy.  Prednisone, Acyclovir, and eye drops prescribed with orders for follow up with internal medicine specialist and PCP.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Restlessness
Clinical narrative: Slightly elevated temp,  general body  ache, very sore injection site, restlessness for first several days.  Approx 7:30 PM on Aug 30, 2021, felt sharp pain in left side of neck while filling in reports..  Numbness in lip and left side of face.  Left eye felt very irritated and began watering.  When to bathroom to wash face and noted left side droop.  Consulted with on duty medic and confirmed assessment of possible stroke.  Transported to ER, a stroke destination hospital.  Initial assessment resulted in a CT scan which showed negative results for stroke.  MD assessed partial facial paralysis due to Bells Palsy.  Prednisone, Acyclovir, and eye drops prescribed with orders for follow up with internal medicine specialist and PCP.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Blood glucose abnormal, Blood test, Chills, Eye swelling
Clinical narrative: The day of the first injection I noticed a little swelling under my eyes where fillers were 2 years ago.  The next day after the vaccine I felt very drowsy and tired, chills, body aches.  After the second vaccine I felt flu like symptoms for two days. Body aches, fever, chills, headache.  I had fillers done on my lips the week prior to the 1st vaccine and they started to get lumpy. 6/28 my lips got very lumpy and swollen. The next day my eye was swollen and left side of face. I went to urgent care where I was given Prednisone for an allergic reaction. The swelling continued. Contacted primary care Dr who prescribed Medrol. While taking medrol  and 10mg or zyrtec or Benadryl the swelling lessened. After medrol  was done swelling continued along with inflammation. I went to the ER because my life side started feeling tingly, swelling continued  and started having inflammation throughout. Lab Work showed some things off like glucose and kidney. Prescribed more prednisone, Pepcid, hydrooxyzine. Saw the Allergist  who recommended I take 40 mg daily of zyrtec. I than put myself on an anti inflammatory diet. Developed a sensitivity to certain foods like nuts and tomatoes. Caused lots of headaches and inflammation and swelling. Took zyrtec and had my fillers dissolved. Gradually with time I started feeling better, swelling went away. August 5 is when I started feeling better.