chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Myocarditis, Pain, Vaccination complication
Clinical narrative: MYOCARDITIS; SWEATS; CHILLS; ACHY AND SORE ALL OVER; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included left knee surgery six year ago, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 24-AUG-2021) dose was not reported, 1 total, administered on 21-JUN-2021 to left arm for prophylactic vaccination. The patient was now on three different medications for cardiac precautions. Next day of vaccination (on 22-JUN-2021), the patient felt achy and sore all over. On 23-JUN-2021, the patient began alternating between chills and sweats then he went to bed and woke up 03:00 and felt like a gorilla was sitting on his chest, chest heaviness and shortness of breath, the patient went to the ER (emergency room) and admitted for cardiac tests, was told he had a heart attack then the patient was transferred by ambulance and admitted to hospital on 25-JUN-2021. There he had an arteriogram, hospital cardiologist told him it was not a heart attack. After additional lab tests he was told that he developed myocarditis as a result of the vaccine. The patient was discharged on 26-JUN-2021. He was hospitalised for a day. The patient had a follow up with cardiologist for first time on 30-JUN-2021, magnetic resonance imaging (MRI) was done on 06-Jul-2021 (results were not provided) and second follow up visit with cardiologist on 19-Jul-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myocarditis, and the outcome of chills, sweats and achy and sore all over was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730558-covid-19 vaccine ad26.cov2.s -Myocarditis. 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: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriogram, Cardiovascular evaluation, Chills, Hyperhidrosis, Laboratory test
Clinical narrative: MYOCARDITIS; SWEATS; CHILLS; ACHY AND SORE ALL OVER; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included left knee surgery six year ago, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 24-AUG-2021) dose was not reported, 1 total, administered on 21-JUN-2021 to left arm for prophylactic vaccination. The patient was now on three different medications for cardiac precautions. Next day of vaccination (on 22-JUN-2021), the patient felt achy and sore all over. On 23-JUN-2021, the patient began alternating between chills and sweats then he went to bed and woke up 03:00 and felt like a gorilla was sitting on his chest, chest heaviness and shortness of breath, the patient went to the ER (emergency room) and admitted for cardiac tests, was told he had a heart attack then the patient was transferred by ambulance and admitted to hospital on 25-JUN-2021. There he had an arteriogram, hospital cardiologist told him it was not a heart attack. After additional lab tests he was told that he developed myocarditis as a result of the vaccine. The patient was discharged on 26-JUN-2021. He was hospitalised for a day. The patient had a follow up with cardiologist for first time on 30-JUN-2021, magnetic resonance imaging (MRI) was done on 06-Jul-2021 (results were not provided) and second follow up visit with cardiologist on 19-Jul-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myocarditis, and the outcome of chills, sweats and achy and sore all over was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730558-covid-19 vaccine ad26.cov2.s -Myocarditis. 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: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Myocarditis, Pain
Clinical narrative: MYOCARDITIS; SWEATS; CHILLS; ACHY AND SORE ALL OVER; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included left knee surgery six year ago, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: 24-AUG-2021) dose was not reported, 1 total, administered on 21-JUN-2021 to left arm for prophylactic vaccination. The patient was now on three different medications for cardiac precautions. Next day of vaccination (on 22-JUN-2021), the patient felt achy and sore all over. On 23-JUN-2021, the patient began alternating between chills and sweats then he went to bed and woke up 03:00 and felt like a gorilla was sitting on his chest, chest heaviness and shortness of breath, the patient went to the ER (emergency room) and admitted for cardiac tests, was told he had a heart attack then the patient was transferred by ambulance and admitted to hospital on 25-JUN-2021. There he had an arteriogram, hospital cardiologist told him it was not a heart attack. After additional lab tests he was told that he developed myocarditis as a result of the vaccine. The patient was discharged on 26-JUN-2021. He was hospitalised for a day. The patient had a follow up with cardiologist for first time on 30-JUN-2021, magnetic resonance imaging (MRI) was done on 06-Jul-2021 (results were not provided) and second follow up visit with cardiologist on 19-Jul-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myocarditis, and the outcome of chills, sweats and achy and sore all over was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730558-covid-19 vaccine ad26.cov2.s -Myocarditis. 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: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Cough, Malaise, Movement disorder
Clinical narrative: It started on June 21 around 11:30 PM with fever continuous high fever rashes hives extreme joint pain muscle pain muscle spasms throwing up extreme headache extreme neck pain and spine I felt like I was paralyzed and every movement was in extreme pain up to where I could not move on my own and the fevers just kept going up had to go to four different emergencies clinics because no one wanted to help me until finally at one he said I was extremely bad and could die or because of the pains in height because my body could have gone into shock or seizures I was finally admitted July 2,2021 Into a hospital room  I was seen by many doctors but they did not know what to do but did their best and help relieve the extreme pain, I was released July 11, 2021 even though I still had fevers and rashes. Today is July 19th and I still have headaches and minor bodyaches and rashes I?m still suffering from the shot.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Pyrexia, Urticaria, Vomiting
Clinical narrative: It started on June 21 around 11:30 PM with fever continuous high fever rashes hives extreme joint pain muscle pain muscle spasms throwing up extreme headache extreme neck pain and spine I felt like I was paralyzed and every movement was in extreme pain up to where I could not move on my own and the fevers just kept going up had to go to four different emergencies clinics because no one wanted to help me until finally at one he said I was extremely bad and could die or because of the pains in height because my body could have gone into shock or seizures I was finally admitted July 2,2021 Into a hospital room  I was seen by many doctors but they did not know what to do but did their best and help relieve the extreme pain, I was released July 11, 2021 even though I still had fevers and rashes. Today is July 19th and I still have headaches and minor bodyaches and rashes I?m still suffering from the shot.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Mobility decreased, Muscle spasms
Clinical narrative: It started on June 21 around 11:30 PM with fever continuous high fever rashes hives extreme joint pain muscle pain muscle spasms throwing up extreme headache extreme neck pain and spine I felt like I was paralyzed and every movement was in extreme pain up to where I could not move on my own and the fevers just kept going up had to go to four different emergencies clinics because no one wanted to help me until finally at one he said I was extremely bad and could die or because of the pains in height because my body could have gone into shock or seizures I was finally admitted July 2,2021 Into a hospital room  I was seen by many doctors but they did not know what to do but did their best and help relieve the extreme pain, I was released July 11, 2021 even though I still had fevers and rashes. Today is July 19th and I still have headaches and minor bodyaches and rashes I?m still suffering from the shot.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Neck pain, Pain, Pyrexia, Rash
Clinical narrative: It started on June 21 around 11:30 PM with fever continuous high fever rashes hives extreme joint pain muscle pain muscle spasms throwing up extreme headache extreme neck pain and spine I felt like I was paralyzed and every movement was in extreme pain up to where I could not move on my own and the fevers just kept going up had to go to four different emergencies clinics because no one wanted to help me until finally at one he said I was extremely bad and could die or because of the pains in height because my body could have gone into shock or seizures I was finally admitted July 2,2021 Into a hospital room  I was seen by many doctors but they did not know what to do but did their best and help relieve the extreme pain, I was released July 11, 2021 even though I still had fevers and rashes. Today is July 19th and I still have headaches and minor bodyaches and rashes I?m still suffering from the shot.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal pain, Urticaria, Vomiting
Clinical narrative: It started on June 21 around 11:30 PM with fever continuous high fever rashes hives extreme joint pain muscle pain muscle spasms throwing up extreme headache extreme neck pain and spine I felt like I was paralyzed and every movement was in extreme pain up to where I could not move on my own and the fevers just kept going up had to go to four different emergencies clinics because no one wanted to help me until finally at one he said I was extremely bad and could die or because of the pains in height because my body could have gone into shock or seizures I was finally admitted July 2,2021 Into a hospital room  I was seen by many doctors but they did not know what to do but did their best and help relieve the extreme pain, I was released July 11, 2021 even though I still had fevers and rashes. Today is July 19th and I still have headaches and minor bodyaches and rashes I?m still suffering from the shot.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: VACCINATED WITH EXPIRED JANSSEN COVID-19 VACCINE; ADMINISTERED 20.5 HOURS AFTER FIRST PUNCTURE; This spontaneous report received from a health care professional concerned an 18 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: 206A21, and batch number: 206A21 expiry: 07-AUG-2021) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-JUL-2021, the subject experienced vaccinated with expired janssen covid-19 vaccine. On 14-JUL-2021, the subject experienced administered 20.5 hours after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated with expired janssen covid-19 vaccine and administered 20.5 hours after first puncture was not reported. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINATED WITH EXPIRED JANSSEN COVID-19 VACCINE; ADMINISTERED 20.5 HOURS AFTER FIRST PUNCTURE; This spontaneous report received from a health care professional concerned an 18 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: 206A21, and batch number: 206A21 expiry: 07-AUG-2021) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-JUL-2021, the subject experienced vaccinated with expired janssen covid-19 vaccine. On 14-JUL-2021, the subject experienced administered 20.5 hours after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated with expired janssen covid-19 vaccine and administered 20.5 hours after first puncture was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chest discomfort, Dyspnoea, Feeling hot, Pruritus
Clinical narrative: Dizzy, lightheaded, hard to breathe, both arms turned bright red Lasted 2 min or so and symptoms started to dwindle on their own
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Dizzy, lightheaded, hard to breathe, both arms turned bright red Lasted 2 min or so and symptoms started to dwindle on their own
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Erythema
Clinical narrative: Dizzy, lightheaded, hard to breathe, both arms turned bright red Lasted 2 min or so and symptoms started to dwindle on their own
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF protein increased, Guillain-Barre syndrome, Lumbar puncture, Red blood cell count increased, White blood cell count normal
Clinical narrative: Developed severe pains in both legs, kept falling, slurred vision, pain in right side of body especially right jaw, fractured C4, hospitalized for 3 days, swollen legs , had a spinal tap done and diagnosed with Gillian Bar
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cervical vertebral fracture, Fall, Guillain-Barre syndrome, Lumbar puncture abnormal, Pain
Clinical narrative: Developed severe pains in both legs, kept falling, slurred vision, pain in right side of body especially right jaw, fractured C4, hospitalized for 3 days, swollen legs , had a spinal tap done and diagnosed with Gillian Bar
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pain in jaw, Peripheral swelling, Vision blurred
Clinical narrative: Developed severe pains in both legs, kept falling, slurred vision, pain in right side of body especially right jaw, fractured C4, hospitalized for 3 days, swollen legs , had a spinal tap done and diagnosed with Gillian Bar
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Balance disorder, Colitis ulcerative, Condition aggravated
Clinical narrative: Paresthesia spreading from left lower extremity to other extremities with significant pain on light touch.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Fatigue, Haematochezia
Clinical narrative: Paresthesia spreading from left lower extremity to other extremities with significant pain on light touch.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hyperacusis, Hyperhidrosis, Laboratory test, Movement disorder
Clinical narrative: Paresthesia spreading from left lower extremity to other extremities with significant pain on light touch.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscle spasms, Muscle twitching, Nausea, Nervous system disorder, Pain
Clinical narrative: Paresthesia spreading from left lower extremity to other extremities with significant pain on light touch.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Paraesthesia, Photophobia, Tremor
Clinical narrative: Paresthesia spreading from left lower extremity to other extremities with significant pain on light touch.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Paresthesia spreading from left lower extremity to other extremities with significant pain on light touch.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Paraesthesia, Scan with contrast, Tenderness
Clinical narrative: Paresthesia spreading from left lower extremity to other extremities with significant pain on light touch.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Balance disorder, Blood test, Colitis ulcerative, Gait inability, Headache
Clinical narrative: Paresthesia spreading from left lower extremity to other extremities with significant pain on light touch.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Muscle spasms, Muscle twitching, Pain, Palpitations
Clinical narrative: Paresthesia spreading from left lower extremity to other extremities with significant pain on light touch.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Photosensitivity reaction, Tremor, Urine analysis
Clinical narrative: Paresthesia spreading from left lower extremity to other extremities with significant pain on light touch.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram head, Headache, Scan with contrast
Clinical narrative: Intermittent HA x 1week- ER found extensive dural sinus thrombosis involving the superior sagittal sinus, torcula, and bilateral transverse sinuses, right cortical vein thrombosis overlying the frontal convexity on CT Head with Contrast seen 7/17/21 in hospital
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Headache, Scan with contrast abnormal
Clinical narrative: Intermittent HA x 1week- ER found extensive dural sinus thrombosis involving the superior sagittal sinus, torcula, and bilateral transverse sinuses, right cortical vein thrombosis overlying the frontal convexity on CT Head with Contrast seen 7/17/21 in hospital
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Pain in extremity
Clinical narrative: Severe pain in both knees, could not walk. Symptoms lessened with cold compresses and Naprosyn, but stayed in bed most of the day.  Chronic knee pain, pain in hands, more so than usual.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Influenza like illness, Pruritus, Sensitive skin
Clinical narrative: My skin has become sensitive and itchy.   Any abrasion causes redness and low hives - even holding the steering wheel.    For the first day or two my skin felt hot -- similar to the feeling when you come out of a tanning bed.      I was worried about getting the 2nd shot, but i did it.   The skin condition continues, but it did not get worse with the 2nd shot.   I did get the flu feeling that is the normal reaction (for 1 day).    i am hoping that my skin gets back to normal soon.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Skin abrasion, Urticaria
Clinical narrative: My skin has become sensitive and itchy.   Any abrasion causes redness and low hives - even holding the steering wheel.    For the first day or two my skin felt hot -- similar to the feeling when you come out of a tanning bed.      I was worried about getting the 2nd shot, but i did it.   The skin condition continues, but it did not get worse with the 2nd shot.   I did get the flu feeling that is the normal reaction (for 1 day).    i am hoping that my skin gets back to normal soon.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Whole body joints pain for 2 days, Injecting site still in pain for 2 weeks now, Tingling whole body starting at 10th day , still ongoing, Left neck(injected at left arm) pain / stifness on and off, Light headache ongoing
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Whole body joints pain for 2 days, Injecting site still in pain for 2 weeks now, Tingling whole body starting at 10th day , still ongoing, Left neck(injected at left arm) pain / stifness on and off, Light headache ongoing
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blindness transient, Gait disturbance, Headache, Migraine
Clinical narrative: Extreme migraine began within 4 hours of vaccination. Migraine lasted about three more hours, affected sight. Sight completely lost for two hours. Migraine and difficulty seeing have come and gone ever since. Head all over body pain for all day the next day and the following day. Still experiencing side effects such as fever and all over body pain. Can't walk very much without extreme pain and joints still. Fever comes and goes around the clock.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Visual impairment
Clinical narrative: Extreme migraine began within 4 hours of vaccination. Migraine lasted about three more hours, affected sight. Sight completely lost for two hours. Migraine and difficulty seeing have come and gone ever since. Head all over body pain for all day the next day and the following day. Still experiencing side effects such as fever and all over body pain. Can't walk very much without extreme pain and joints still. Fever comes and goes around the clock.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Extreme Joint pain in hands, wrists, shoulders, thumbs and elbows.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Mobility decreased, Pain
Clinical narrative: Extreme Joint pain in hands, wrists, shoulders, thumbs and elbows.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Tinnitus
Clinical narrative: Tinnitus (both ears) Major Skin Rashes (very itchy) -lower back, abdomen,   Minor Skin Rashes (very itchy) - legs, back of neck.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Biopsy skin, Rash, Rash erythematous, Rash papular
Clinical narrative: Red raised bumps, rash on abdomen that started approximately a week after second dose, spread quickly. After biopsy, diagnosed as roseola. Treated with triamcinolone acetonide steroid cream. Went away in a few weeks.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Roseola
Clinical narrative: Red raised bumps, rash on abdomen that started approximately a week after second dose, spread quickly. After biopsy, diagnosed as roseola. Treated with triamcinolone acetonide steroid cream. Went away in a few weeks.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Red, raised rash under injection site on left arm.   Very warm and sore to the touch.  Noticed 7/18 (2 days after 2nd covid vaccine).  Applied cool compress.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, Blood lactic acid, Blood pressure decreased, COVID-19
Clinical narrative: This patient developed COVID-19 about 3 weeks after being vaccinated.  The patient had the Janssen adenovirus COVID-19 vaccine at a local pharmacy.  She developed COVID-19 on 6/19/2021 and was diagnosed at the urgent care, placed on Zithromax, medrol dosepak, and albuterol MDI.  Also was placed on hydroxychloroquine.   She developed hypoxia on the 25th of June, and acute on chronic renal failure, was transferred for higher level of care to medical Center.  Discharged eventually and re-presented on 7/1/2021.  Was sent home with continued oxygen.  Patient was confused and kept taking oxygen off at home and was direct admitted by myself on7/1/2021.  I was treating her daughter for the same infection (COVID-19).  The patient rebounded, had normal mental status, but continued to have signs and symptoms of a severe COVID-19 pneumonia.  On 7/4/2021, the patient had a sudden escalation in oxygen requirement, sudden drop in blood pressure,  and she became febrile and hypotension and septic.  She did not recover.  Eventually family elected to withdraw care and the patient expired.  Was on remdesivir,dexamethasone, had a dose of actemra, had vitamin C, Vitamin D,  zinc
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Confusional state, Death, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: This patient developed COVID-19 about 3 weeks after being vaccinated.  The patient had the Janssen adenovirus COVID-19 vaccine at a local pharmacy.  She developed COVID-19 on 6/19/2021 and was diagnosed at the urgent care, placed on Zithromax, medrol dosepak, and albuterol MDI.  Also was placed on hydroxychloroquine.   She developed hypoxia on the 25th of June, and acute on chronic renal failure, was transferred for higher level of care to medical Center.  Discharged eventually and re-presented on 7/1/2021.  Was sent home with continued oxygen.  Patient was confused and kept taking oxygen off at home and was direct admitted by myself on7/1/2021.  I was treating her daughter for the same infection (COVID-19).  The patient rebounded, had normal mental status, but continued to have signs and symptoms of a severe COVID-19 pneumonia.  On 7/4/2021, the patient had a sudden escalation in oxygen requirement, sudden drop in blood pressure,  and she became febrile and hypotension and septic.  She did not recover.  Eventually family elected to withdraw care and the patient expired.  Was on remdesivir,dexamethasone, had a dose of actemra, had vitamin C, Vitamin D,  zinc
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Hypoxia, Oxygen saturation decreased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This patient developed COVID-19 about 3 weeks after being vaccinated.  The patient had the Janssen adenovirus COVID-19 vaccine at a local pharmacy.  She developed COVID-19 on 6/19/2021 and was diagnosed at the urgent care, placed on Zithromax, medrol dosepak, and albuterol MDI.  Also was placed on hydroxychloroquine.   She developed hypoxia on the 25th of June, and acute on chronic renal failure, was transferred for higher level of care to medical Center.  Discharged eventually and re-presented on 7/1/2021.  Was sent home with continued oxygen.  Patient was confused and kept taking oxygen off at home and was direct admitted by myself on7/1/2021.  I was treating her daughter for the same infection (COVID-19).  The patient rebounded, had normal mental status, but continued to have signs and symptoms of a severe COVID-19 pneumonia.  On 7/4/2021, the patient had a sudden escalation in oxygen requirement, sudden drop in blood pressure,  and she became febrile and hypotension and septic.  She did not recover.  Eventually family elected to withdraw care and the patient expired.  Was on remdesivir,dexamethasone, had a dose of actemra, had vitamin C, Vitamin D,  zinc
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, White blood cell count decreased
Clinical narrative: This patient developed COVID-19 about 3 weeks after being vaccinated.  The patient had the Janssen adenovirus COVID-19 vaccine at a local pharmacy.  She developed COVID-19 on 6/19/2021 and was diagnosed at the urgent care, placed on Zithromax, medrol dosepak, and albuterol MDI.  Also was placed on hydroxychloroquine.   She developed hypoxia on the 25th of June, and acute on chronic renal failure, was transferred for higher level of care to medical Center.  Discharged eventually and re-presented on 7/1/2021.  Was sent home with continued oxygen.  Patient was confused and kept taking oxygen off at home and was direct admitted by myself on7/1/2021.  I was treating her daughter for the same infection (COVID-19).  The patient rebounded, had normal mental status, but continued to have signs and symptoms of a severe COVID-19 pneumonia.  On 7/4/2021, the patient had a sudden escalation in oxygen requirement, sudden drop in blood pressure,  and she became febrile and hypotension and septic.  She did not recover.  Eventually family elected to withdraw care and the patient expired.  Was on remdesivir,dexamethasone, had a dose of actemra, had vitamin C, Vitamin D,  zinc
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: My period has come 10 days early in June and 11 days early in July, and has been significantly heavier than normal.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: I had fever and  headache the day after reviving the 2nd shot. The fever last about 2 days. Started to experience sore throat since the 3rd day after the 2nd shot. And I am still experiencing the sore throat after 45 days. I even took the Covid test and it came back negative.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: Chills and sweats, upset stomach/diarrhea, muscle and joint pain, fatigue. I was not able to take Tylenol or aspirin because I am taking a steroid. Symptoms went away after about 36 hours.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia
Clinical narrative: Chills and sweats, upset stomach/diarrhea, muscle and joint pain, fatigue. I was not able to take Tylenol or aspirin because I am taking a steroid. Symptoms went away after about 36 hours.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature abnormal, Chills, Feeling abnormal, Hyperaesthesia, Pyrexia
Clinical narrative: Within about 5 hours of the vaccine, started to feel skin sensitivity all over my body.  It felt like every pore on my body was open and hyper sensitive to touch.  My scalp was very sensitive to touch and there was a strange sensation when my clothes touched my body- I've never been hyper sensitive like this before. Within about 12 hours, developed a fever, chills and inability to get warm.   Symptoms persisted for about 36 hours.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: Within about 5 hours of the vaccine, started to feel skin sensitivity all over my body.  It felt like every pore on my body was open and hyper sensitive to touch.  My scalp was very sensitive to touch and there was a strange sensation when my clothes touched my body- I've never been hyper sensitive like this before. Within about 12 hours, developed a fever, chills and inability to get warm.   Symptoms persisted for about 36 hours.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pyrexia, Rash
Clinical narrative: Fever- resolved Rash- shingles- treated
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations, Tremor
Clinical narrative: Around 4pm, the same day I got my vaccine, I got horrible heart palpitations, and my heart rate went up very high. I also started to get very shaky (not related to the chills). This lasted for hours at first, but now it is on & off.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Ultrasound scan abnormal
Clinical narrative: The day after the second shot April 6, 2021, I had a swollen lymph node and a very swollen and painful right armpit.  On approximately April 30 2021, I had a large swollen lymph node above my right collar bone, and a series of smaller swollen lymph nodes along my neck to the an area near the mastoid sinus behind my right ear.  On approximately July 10, 2021 I had a swollen lymph node and  moderate pain in right armpit.  On July 19, 2021 the swollen lymph node and enlarged  right armpit returned.  PLEASE NOTE that the incidents of lymph node and armpit swelling that occurred in July were smaller and less painful than the initial event that occurred the day after my second injection.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Death, Myocardial infarction
Clinical narrative: arrhythmia, presumed MI, death
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: Soreness, heat and 3x5 in swelling at injection site from about 8 hrs after through next two weeks, gradually reducing. Fever up and down of 101 to 103 for day 1.5 thru day 4.  Soreness and 2x2 in swelling of lymph gland in left arm pit from day 2 thru day 8.  Soreness of rest of arm pit and left breast.  Lack of apetite from 24 hrs to about day 7.  Tiredness and excessive sleeping for about 1 week after.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Lymphadenopathy, Pyrexia
Clinical narrative: Soreness, heat and 3x5 in swelling at injection site from about 8 hrs after through next two weeks, gradually reducing. Fever up and down of 101 to 103 for day 1.5 thru day 4.  Soreness and 2x2 in swelling of lymph gland in left arm pit from day 2 thru day 8.  Soreness of rest of arm pit and left breast.  Lack of apetite from 24 hrs to about day 7.  Tiredness and excessive sleeping for about 1 week after.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Initially given pfizer and requested second shot of moderna as patient is  in deployed setting and pfizer is not available
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Magnetic resonance imaging, Pain, Pain in extremity, X-ray
Clinical narrative: Severe pain in L arm radiating to fingers, limiting range of motion, worse at night.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 antibody test, SARS-CoV-2 test, Skin lesion
Clinical narrative: After the 2nd Phizer COVID 19 shot, my skin has broken out all over, my body. Very scratchy and the open  sores have not gone away.  I had no  problem before the Phiser COVID 19 shots. Is this normal?
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: After the 2nd Phizer COVID 19 shot, my skin has broken out all over, my body. Very scratchy and the open  sores have not gone away.  I had no  problem before the Phiser COVID 19 shots. Is this normal?
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: Swollen lymph node under right arm. My entire arm was sore to my finger tip it felt as if my circulation was being cut off in my arm and it lasted about 48hrs. My under arm is still swollen and sore. I did have all the other side affects, fever, chills, dizzy, muscle aches and fatigue.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Swollen lymph node under right arm. My entire arm was sore to my finger tip it felt as if my circulation was being cut off in my arm and it lasted about 48hrs. My under arm is still swollen and sore. I did have all the other side affects, fever, chills, dizzy, muscle aches and fatigue.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: after the second dose of the vaccine, urticaria started to appear in a very strong way. I was too close to get in shock, I had to visit an emergency clinck. everything started after the second dose and since then it didn't go well. each day I had more symptoms
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest X-ray normal, Chest discomfort, Dizziness, Electrocardiogram normal
Clinical narrative: impending doom, dizzy, nausea, chest pressure, itchy throat
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Metabolic function test, Nausea, Throat irritation, Troponin normal
Clinical narrative: impending doom, dizzy, nausea, chest pressure, itchy throat
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, X-ray
Clinical narrative: trouble breathing possible myocarditis cannot afford CT scan to confirm at this time
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Ear infection, Respiratory tract congestion, SARS-CoV-2 test negative, Sinusitis
Clinical narrative: Unsure related , but extreme congestion almost immediate sinus infection and both ears infected and bronchial tubes (I never have sinus or ear aches ever my whole life).  Started on 6/16 went to fast pace and after over two weeks went to doctors office and still having problems  as of today 7/19/21.  Will not go away! I have never had anything like this that will not clear.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray abnormal
Clinical narrative: Unsure related , but extreme congestion almost immediate sinus infection and both ears infected and bronchial tubes (I never have sinus or ear aches ever my whole life).  Started on 6/16 went to fast pace and after over two weeks went to doctors office and still having problems  as of today 7/19/21.  Will not go away! I have never had anything like this that will not clear.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Vaccine positive rechallenge
Clinical narrative: I experienced and right ear infection 2 or 3 weeks after each vaccine
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Blood test, Burning sensation
Clinical narrative: Joint stiffness and pain Flu like symptoms Back pain Stiffness impairing ambulation Fatigue General malaise Generalize weakness Burning sensation in muscles
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Influenza like illness, Joint stiffness, Malaise
Clinical narrative: Joint stiffness and pain Flu like symptoms Back pain Stiffness impairing ambulation Fatigue General malaise Generalize weakness Burning sensation in muscles
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Spinal X-ray
Clinical narrative: Joint stiffness and pain Flu like symptoms Back pain Stiffness impairing ambulation Fatigue General malaise Generalize weakness Burning sensation in muscles
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Dizziness, Dysphonia, Pyrexia
Clinical narrative: Fever 7/3/21 Cough and Mucous - green mucous 7/3/21  to 7/13/21 Sore Throat 7/3/21 - 7:00am Lost voice 7/3/21 - 8:00pm. 24 hours Hoarse voice - 7/5/21 to 7/13/21. 9 days Dizziness 7/5/21 to Present. Treatment over the counter dizziness medication.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: Fever 7/3/21 Cough and Mucous - green mucous 7/3/21  to 7/13/21 Sore Throat 7/3/21 - 7:00am Lost voice 7/3/21 - 8:00pm. 24 hours Hoarse voice - 7/5/21 to 7/13/21. 9 days Dizziness 7/5/21 to Present. Treatment over the counter dizziness medication.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; an expired ZOSTAVAX was administered to a patient.; This spontaneous report was received from a pharmacist (conflicting information also reported as physician) referring to a patient of unknown age and gender. The patient concurrent conditions, pertinent medical history, concomitant therapies, drug allergies or reactions were not reported.  On 23-JUN-2021, the patient was vaccinated with an expired dose of zoster vaccine live (ZOSTAVAX) (strength, dose, frequency, route of administration and lot # were not reported), expiration date 22-APR-2022) for prophylaxis. It was reported that, prior to the administration the product had no prior temperature excursions, and the patient did not experience an additional adverse event (reported as no supported disclaimer was provided). At the time of the report, the outcome of the events was not reported. The action taken with zoster vaccine live (ZOSTAVAX) regarding the events were not reported. No product quality complaint involved.  The causal relationship between the events and the suspect vaccine was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: no adverse event; a dose of V ARlV AX was administered via IM route versus subcutaneous as recommended in the Prescribing Information; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not provided.   On 09-JUL-2021 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose:0.5ml, lot # T032315, expiration date 22-SEP-2022; strenght was unknown) via intramuscular (IM) route versus subcutaneous as recommended in the Prescribing Information for prophylaxis (incorrect route of product administration). No additional adverse events was reported. No product quality complaint.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs; The nurse states V ARlV AX was inadvertently administered to a patient by the intramuscular route instead of the subcutaneous route; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.     On 09-JUL-2021, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml, lot # T035398, expiration date 16-OCT-2022; strength was unknown) by the intramuscular route instead of the subcutaneous route for prophylaxis (incorrect route of product administration). No additional adverse event was provided. The nurse preferred any follow up with herself rather than prescribing physician assistant.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pregnancy
Clinical narrative: patient received MMRlI and VARIVAX approximately 40 days before becoming pregnant; No additional AEs reported; This spontaneous prospective pregnancy report as received from a physician referring to a female patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dosage regimen, routes of administration, lot numbers and expiration dates were not provided) both for prophylaxis.    40 days later, the patient became pregnant (maternal exposure before pregnancy). The last menstrual period (LMP), estimated due date (EDD) and the pregnancy outcome were not known. No adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; a 12 month old  patient received a dose of M-M-R II on 07/12/2021 that had a labeled expiry of 6/17/2021; This spontaneous report was received from a medical assistant, referring to a 12 months old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 12-JUL-2021, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant Human albumin (rHA) (M-M-R II) 0.5 ml, lot# S018595, expiration date 17-JUN-2021, for prophylaxis (strength, route, frequency were not reported). No additional adverse events reported. There were not known temperature excursions.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: HA (headche); muscle ache; tiredness; fever; This case was reported by a physician via sales rep and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2021).   In June 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced headache, muscle pain, tiredness and fever. On an unknown date, the outcome of the headache, muscle pain, tiredness and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscle pain, tiredness and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix in early June 2021 and experienced headache, muscle pain, tiredness and fever. One month post 2nd dose, the patient still not feeling ok and still complaining of all the same side effects but not as severe as initial post dose 2. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: I did get the 2 shots and I'm still on meds for nerve pain.; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was recovered/resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient received Shingrix and had nerve pain. No contact details were reported. For tolerance of 2nd dose, refer case US2021AMR151897, reported by same reporter. Note : Since the reporter did not specify temporality between the event and the doses of vaccine( if the nerve pain was experienced after the first or second dose), Hence case was processed conservatively.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151897:Same reporter