chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Chills, Cough decreased, Dizziness
Clinical narrative: LOSS OF SHORT TERM MEMORY; IRON DEFICIENCY; STUFFY NOSE; KIDNEY PAIN; CONFUSION; ARM PAIN/FOOT PAIN; BAD COLD; COUGH; FEVER; MUSCLE WEAKNESS; SICK; SLEEPY; LACK OF VISION; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 (right after received the vaccine), the patient was sick, and shared the symptoms with the physician and experienced symptoms lack of vision, dizzy, sleepy, and headache. On 10-APR-2021 (after couple days), the patient got really bad cold, runny nose, cough, fever, muscle weakness and got tested for COVID (COVID-19 virus test) and result was found to be negative. It was reported that, the patient was struggling from that time until now. On 14-JUL-2021 the patient experienced stuffy nose, arm pain, foot pain, kidney pain and got iron deficiency, the patient was feeling weak, tired and had new symptoms of confusion and reports loss of short term memory at these days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad cold, cough, fever, muscle weakness, arm pain/foot pain, stuffy nose, kidney pain, iron deficiency, confusion, and loss of short term memory, and the outcome of sick, lack of vision, sleepy and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210729748 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- lack of vision- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, SARS-CoV-2 test negative, Vision blurred
Clinical narrative: LOSS OF SHORT TERM MEMORY; IRON DEFICIENCY; STUFFY NOSE; KIDNEY PAIN; CONFUSION; ARM PAIN/FOOT PAIN; BAD COLD; COUGH; FEVER; MUSCLE WEAKNESS; SICK; SLEEPY; LACK OF VISION; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 (right after received the vaccine), the patient was sick, and shared the symptoms with the physician and experienced symptoms lack of vision, dizzy, sleepy, and headache. On 10-APR-2021 (after couple days), the patient got really bad cold, runny nose, cough, fever, muscle weakness and got tested for COVID (COVID-19 virus test) and result was found to be negative. It was reported that, the patient was struggling from that time until now. On 14-JUL-2021 the patient experienced stuffy nose, arm pain, foot pain, kidney pain and got iron deficiency, the patient was feeling weak, tired and had new symptoms of confusion and reports loss of short term memory at these days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad cold, cough, fever, muscle weakness, arm pain/foot pain, stuffy nose, kidney pain, iron deficiency, confusion, and loss of short term memory, and the outcome of sick, lack of vision, sleepy and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210729748 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- lack of vision- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Blindness, Confusional state, Cough, Headache
Clinical narrative: LOSS OF SHORT TERM MEMORY; IRON DEFICIENCY; STUFFY NOSE; KIDNEY PAIN; CONFUSION; ARM PAIN/FOOT PAIN; BAD COLD; COUGH; FEVER; MUSCLE WEAKNESS; SICK; SLEEPY; LACK OF VISION; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 (right after received the vaccine), the patient was sick, and shared the symptoms with the physician and experienced symptoms lack of vision, dizzy, sleepy, and headache. On 10-APR-2021 (after couple days), the patient got really bad cold, runny nose, cough, fever, muscle weakness and got tested for COVID (COVID-19 virus test) and result was found to be negative. It was reported that, the patient was struggling from that time until now. On 14-JUL-2021 the patient experienced stuffy nose, arm pain, foot pain, kidney pain and got iron deficiency, the patient was feeling weak, tired and had new symptoms of confusion and reports loss of short term memory at these days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad cold, cough, fever, muscle weakness, arm pain/foot pain, stuffy nose, kidney pain, iron deficiency, confusion, and loss of short term memory, and the outcome of sick, lack of vision, sleepy and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210729748 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- lack of vision- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Iron deficiency, Muscular weakness, Nasal congestion, Nasopharyngitis
Clinical narrative: LOSS OF SHORT TERM MEMORY; IRON DEFICIENCY; STUFFY NOSE; KIDNEY PAIN; CONFUSION; ARM PAIN/FOOT PAIN; BAD COLD; COUGH; FEVER; MUSCLE WEAKNESS; SICK; SLEEPY; LACK OF VISION; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 (right after received the vaccine), the patient was sick, and shared the symptoms with the physician and experienced symptoms lack of vision, dizzy, sleepy, and headache. On 10-APR-2021 (after couple days), the patient got really bad cold, runny nose, cough, fever, muscle weakness and got tested for COVID (COVID-19 virus test) and result was found to be negative. It was reported that, the patient was struggling from that time until now. On 14-JUL-2021 the patient experienced stuffy nose, arm pain, foot pain, kidney pain and got iron deficiency, the patient was feeling weak, tired and had new symptoms of confusion and reports loss of short term memory at these days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad cold, cough, fever, muscle weakness, arm pain/foot pain, stuffy nose, kidney pain, iron deficiency, confusion, and loss of short term memory, and the outcome of sick, lack of vision, sleepy and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210729748 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- lack of vision- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Renal pain, SARS-CoV-2 test, Somnolence
Clinical narrative: LOSS OF SHORT TERM MEMORY; IRON DEFICIENCY; STUFFY NOSE; KIDNEY PAIN; CONFUSION; ARM PAIN/FOOT PAIN; BAD COLD; COUGH; FEVER; MUSCLE WEAKNESS; SICK; SLEEPY; LACK OF VISION; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021 (right after received the vaccine), the patient was sick, and shared the symptoms with the physician and experienced symptoms lack of vision, dizzy, sleepy, and headache. On 10-APR-2021 (after couple days), the patient got really bad cold, runny nose, cough, fever, muscle weakness and got tested for COVID (COVID-19 virus test) and result was found to be negative. It was reported that, the patient was struggling from that time until now. On 14-JUL-2021 the patient experienced stuffy nose, arm pain, foot pain, kidney pain and got iron deficiency, the patient was feeling weak, tired and had new symptoms of confusion and reports loss of short term memory at these days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad cold, cough, fever, muscle weakness, arm pain/foot pain, stuffy nose, kidney pain, iron deficiency, confusion, and loss of short term memory, and the outcome of sick, lack of vision, sleepy and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210729748 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- lack of vision- 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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia, Ultrasound joint, X-ray limb
Clinical narrative: SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of my joints and muscles. On day two I woke up with a fever of 102.1, a massive migraine and nausea, vomiting and that lasted for about three days. Around day four everything went away except the joint pain. My pain level is always between a 4-6 now, prior to that it was a 6-8 and that is when I sought treatment from a DR. I contacted my DR about a week after my vaccine. I saw a Rheumatologist and got blood work too.  I also am having short term memory problems as well which has begun after the vaccine as well so I do not know the time frame too well of everything that has happened. I do have two DRs coming up for both wrists and my knee, those are to be scheduled. I have been issues with working as well. I am very fatigued, have issues with short term memory loss and work retrieval, issues getting dressed in the morning due to joints being cramped.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray limb abnormal
Clinical narrative: SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of my joints and muscles. On day two I woke up with a fever of 102.1, a massive migraine and nausea, vomiting and that lasted for about three days. Around day four everything went away except the joint pain. My pain level is always between a 4-6 now, prior to that it was a 6-8 and that is when I sought treatment from a DR. I contacted my DR about a week after my vaccine. I saw a Rheumatologist and got blood work too.  I also am having short term memory problems as well which has begun after the vaccine as well so I do not know the time frame too well of everything that has happened. I do have two DRs coming up for both wrists and my knee, those are to be scheduled. I have been issues with working as well. I am very fatigued, have issues with short term memory loss and work retrieval, issues getting dressed in the morning due to joints being cramped.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Arthralgia, Blood test normal, Brain natriuretic peptide normal, C-reactive protein increased
Clinical narrative: SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of my joints and muscles. On day two I woke up with a fever of 102.1, a massive migraine and nausea, vomiting and that lasted for about three days. Around day four everything went away except the joint pain. My pain level is always between a 4-6 now, prior to that it was a 6-8 and that is when I sought treatment from a DR. I contacted my DR about a week after my vaccine. I saw a Rheumatologist and got blood work too.  I also am having short term memory problems as well which has begun after the vaccine as well so I do not know the time frame too well of everything that has happened. I do have two DRs coming up for both wrists and my knee, those are to be scheduled. I have been issues with working as well. I am very fatigued, have issues with short term memory loss and work retrieval, issues getting dressed in the morning due to joints being cramped.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exostosis, Fatigue, Impaired work ability, Intervertebral disc protrusion, Loss of personal independence in daily activities
Clinical narrative: SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of my joints and muscles. On day two I woke up with a fever of 102.1, a massive migraine and nausea, vomiting and that lasted for about three days. Around day four everything went away except the joint pain. My pain level is always between a 4-6 now, prior to that it was a 6-8 and that is when I sought treatment from a DR. I contacted my DR about a week after my vaccine. I saw a Rheumatologist and got blood work too.  I also am having short term memory problems as well which has begun after the vaccine as well so I do not know the time frame too well of everything that has happened. I do have two DRs coming up for both wrists and my knee, those are to be scheduled. I have been issues with working as well. I am very fatigued, have issues with short term memory loss and work retrieval, issues getting dressed in the morning due to joints being cramped.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Memory impairment, Migraine, Myalgia, Nausea
Clinical narrative: SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of my joints and muscles. On day two I woke up with a fever of 102.1, a massive migraine and nausea, vomiting and that lasted for about three days. Around day four everything went away except the joint pain. My pain level is always between a 4-6 now, prior to that it was a 6-8 and that is when I sought treatment from a DR. I contacted my DR about a week after my vaccine. I saw a Rheumatologist and got blood work too.  I also am having short term memory problems as well which has begun after the vaccine as well so I do not know the time frame too well of everything that has happened. I do have two DRs coming up for both wrists and my knee, those are to be scheduled. I have been issues with working as well. I am very fatigued, have issues with short term memory loss and work retrieval, issues getting dressed in the morning due to joints being cramped.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Spinal osteoarthritis, Spinal stenosis, Ultrasound scan normal
Clinical narrative: SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of my joints and muscles. On day two I woke up with a fever of 102.1, a massive migraine and nausea, vomiting and that lasted for about three days. Around day four everything went away except the joint pain. My pain level is always between a 4-6 now, prior to that it was a 6-8 and that is when I sought treatment from a DR. I contacted my DR about a week after my vaccine. I saw a Rheumatologist and got blood work too.  I also am having short term memory problems as well which has begun after the vaccine as well so I do not know the time frame too well of everything that has happened. I do have two DRs coming up for both wrists and my knee, those are to be scheduled. I have been issues with working as well. I am very fatigued, have issues with short term memory loss and work retrieval, issues getting dressed in the morning due to joints being cramped.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting, X-ray limb abnormal, X-ray limb normal
Clinical narrative: SO after the second shot I had a very sore left arm. Within six hours I had a lot of pain in all of my joints and muscles. On day two I woke up with a fever of 102.1, a massive migraine and nausea, vomiting and that lasted for about three days. Around day four everything went away except the joint pain. My pain level is always between a 4-6 now, prior to that it was a 6-8 and that is when I sought treatment from a DR. I contacted my DR about a week after my vaccine. I saw a Rheumatologist and got blood work too.  I also am having short term memory problems as well which has begun after the vaccine as well so I do not know the time frame too well of everything that has happened. I do have two DRs coming up for both wrists and my knee, those are to be scheduled. I have been issues with working as well. I am very fatigued, have issues with short term memory loss and work retrieval, issues getting dressed in the morning due to joints being cramped.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Needle issue, Tenderness
Clinical narrative: 1. Entered store and met female technician. She came out from the back and told us to come over to a closed aisle. 2. We told her we were walk in patients. She was a bit confused at first, but then asked for our insurance and my ID. After we provided both to her ( she found our insurance on her system) she told us to wait. 3. About 15 minutes later she came back and handed me a vaccination consent form and told me to fill it out. (Blank form can be provided) 4. I filled out the form and mommy signed on the back. I returned the form to another male technician. 5. After 5 minutes later, the female technician signaled us to follow her into a small room a few feet away from the main pharmacy area. 6. The room was quite small and there was a curtain separating the room. I sat down in the chair. Mommy stepped out the room so that the technician would have room to work. 7. The technician briefly told me about the side effects of the vaccine (fatigue, headache, etc.) then attempted to administer the shot into my left arm. 8. Immediately after placing in the shot, she pulled out the needle and said there was an issue and the fluid had all leaked out. I did not see any fluid. She wiped up the arm rest and the surrounding area with a tissue. I think she discarded the used needle, but I cannot recall. She told me I would need another shot.   9.  At this point Mommy entered the room and she was quickly briefed on the situation. She informed us that the clinic was out of COVID vaccines and had to ?mix? a new batch. 10. The technician left the room through a door pass the curtain (I could not see this door from my angle).  11. She came back in a minute later to wait with us. 12. About 10 minutes passed and then mommy and I left the room. Mommy went outside while I stayed in the store. 13. The female technician signaled me and told me my shot was ready. 14. The technician was about to administer the shot into my left arm, when Mammy came in and told her no. 15. We left the room and went back to the main pharmacy area to set up another appointment. 16. Mommy changed her mind about making another appointment and asked for a report about the incident that had occurred. 17. At this point, I left the store and left Mommy in there alone. 18. I got something to drink and then returned to the car about 15 minutes later. 19. About 30 minutes after I left the store, mommy entered the car with a sticky note in hand (picture provided below)
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: 1. Entered store and met female technician. She came out from the back and told us to come over to a closed aisle. 2. We told her we were walk in patients. She was a bit confused at first, but then asked for our insurance and my ID. After we provided both to her ( she found our insurance on her system) she told us to wait. 3. About 15 minutes later she came back and handed me a vaccination consent form and told me to fill it out. (Blank form can be provided) 4. I filled out the form and mommy signed on the back. I returned the form to another male technician. 5. After 5 minutes later, the female technician signaled us to follow her into a small room a few feet away from the main pharmacy area. 6. The room was quite small and there was a curtain separating the room. I sat down in the chair. Mommy stepped out the room so that the technician would have room to work. 7. The technician briefly told me about the side effects of the vaccine (fatigue, headache, etc.) then attempted to administer the shot into my left arm. 8. Immediately after placing in the shot, she pulled out the needle and said there was an issue and the fluid had all leaked out. I did not see any fluid. She wiped up the arm rest and the surrounding area with a tissue. I think she discarded the used needle, but I cannot recall. She told me I would need another shot.   9.  At this point Mommy entered the room and she was quickly briefed on the situation. She informed us that the clinic was out of COVID vaccines and had to ?mix? a new batch. 10. The technician left the room through a door pass the curtain (I could not see this door from my angle).  11. She came back in a minute later to wait with us. 12. About 10 minutes passed and then mommy and I left the room. Mommy went outside while I stayed in the store. 13. The female technician signaled me and told me my shot was ready. 14. The technician was about to administer the shot into my left arm, when Mammy came in and told her no. 15. We left the room and went back to the main pharmacy area to set up another appointment. 16. Mommy changed her mind about making another appointment and asked for a report about the incident that had occurred. 17. At this point, I left the store and left Mommy in there alone. 18. I got something to drink and then returned to the car about 15 minutes later. 19. About 30 minutes after I left the store, mommy entered the car with a sticky note in hand (picture provided below)
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Pallor
Clinical narrative: Extreme pain at injection site.  Nauseous, dizzy, blood pressure drop
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Dizziness, Injection site pain, Nausea
Clinical narrative: Extreme pain at injection site.  Nauseous, dizzy, blood pressure drop
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: LOSS OF CONSCIOUSNESS; CONVULSIONS; This spontaneous report received from a patient concerned a patient of unspecified age and sex with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), dose was not reported, 1 total, administered on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-JUL-2021, approximately ten minutes after the vaccination, the patient experienced loss of consciousness and began going into convulsions. The patient's spouse and the pharmacist on site were able to revive the patient and monitored blood pressure for about an hour afterwards to ensure that the patient was stabilizing, once the patient regained consciousness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, and convulsions on 11-JUL-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210734205-JANSSEN COVID-19 VACCINE-Loss of consciousness,convulsions. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Loss of consciousness, Seizure
Clinical narrative: LOSS OF CONSCIOUSNESS; CONVULSIONS; This spontaneous report received from a patient concerned a patient of unspecified age and sex with unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), dose was not reported, 1 total, administered on 11-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-JUL-2021, approximately ten minutes after the vaccination, the patient experienced loss of consciousness and began going into convulsions. The patient's spouse and the pharmacist on site were able to revive the patient and monitored blood pressure for about an hour afterwards to ensure that the patient was stabilizing, once the patient regained consciousness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, and convulsions on 11-JUL-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210734205-JANSSEN COVID-19 VACCINE-Loss of consciousness,convulsions. 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: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chest discomfort, Computerised tomogram thorax abnormal, Dyspnoea, Flank pain
Clinical narrative: Multiple pulmonary embolisms / hospitalized for 2 days; Shortness of Breath; Mild lower back pain / had become severe; Rapid Heart Beat; This case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2021 15:30, the patient received the 1st dose of Shingrix (intramuscular). On 3rd July 2021, 2 days after receiving Shingrix and an unknown time after starting Heparin, the patient experienced shortness of breath (serious criteria hospitalization), back pain (serious criteria hospitalization) and heartbeats increased (serious criteria hospitalization). On 9th July 2021, the patient experienced pulmonary embolism (serious criteria hospitalization and GSK medically significant). The patient was treated with heparin (nos) (Heparin) and apixaban (Eliquis). On an unknown date, the outcome of the pulmonary embolism was not recovered/not resolved and the outcome of the shortness of breath, back pain and heartbeats increased were recovered/resolved.   It was unknown if the reporter considered the pulmonary embolism, shortness of breath, back pain and heartbeats increased to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for himself. The patient received 1st dose of Shingrix on left arm and experienced shortness of breath, rapid heartbeat and mild lower back pain. On 4th July 2021, the patient went to an urgent care and pneumonia was ruled out with a chest x-ray. On 7th July 2021, the lower back pain had become severe back pain.  On 8th July 2021, the patient went to his chiropractor, who sent him to his health care professional. On 9th July 2021, the patient reported that his wife took him to the emergency room.  At the emergency room, they did two computerized tomogram scans, one of the abdomen and the other of his chest.  The health care professional said he had multiple pulmonary embolisms in the pulmonary artery and the lower right side of his lung.  The patient was put on a heparin drip and he was hospitalized for 2 days.  After discharge the patient was given Eliquis as a blood thinner, which he was currently on (no dosage shared).  The patient was referred to a hematologist at the hospital and he had an appointment next week. The patient did not give permission to contact health care professional. The reporter did not consent to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pulmonary thrombosis
Clinical narrative: Multiple pulmonary embolisms / hospitalized for 2 days; Shortness of Breath; Mild lower back pain / had become severe; Rapid Heart Beat; This case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2021 15:30, the patient received the 1st dose of Shingrix (intramuscular). On 3rd July 2021, 2 days after receiving Shingrix and an unknown time after starting Heparin, the patient experienced shortness of breath (serious criteria hospitalization), back pain (serious criteria hospitalization) and heartbeats increased (serious criteria hospitalization). On 9th July 2021, the patient experienced pulmonary embolism (serious criteria hospitalization and GSK medically significant). The patient was treated with heparin (nos) (Heparin) and apixaban (Eliquis). On an unknown date, the outcome of the pulmonary embolism was not recovered/not resolved and the outcome of the shortness of breath, back pain and heartbeats increased were recovered/resolved.   It was unknown if the reporter considered the pulmonary embolism, shortness of breath, back pain and heartbeats increased to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for himself. The patient received 1st dose of Shingrix on left arm and experienced shortness of breath, rapid heartbeat and mild lower back pain. On 4th July 2021, the patient went to an urgent care and pneumonia was ruled out with a chest x-ray. On 7th July 2021, the lower back pain had become severe back pain.  On 8th July 2021, the patient went to his chiropractor, who sent him to his health care professional. On 9th July 2021, the patient reported that his wife took him to the emergency room.  At the emergency room, they did two computerized tomogram scans, one of the abdomen and the other of his chest.  The health care professional said he had multiple pulmonary embolisms in the pulmonary artery and the lower right side of his lung.  The patient was put on a heparin drip and he was hospitalized for 2 days.  After discharge the patient was given Eliquis as a blood thinner, which he was currently on (no dosage shared).  The patient was referred to a hematologist at the hospital and he had an appointment next week. The patient did not give permission to contact health care professional. The reporter did not consent to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anticoagulant therapy, Back pain, Chest X-ray normal, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal
Clinical narrative: Multiple pulmonary embolisms / hospitalized for 2 days; Shortness of Breath; Mild lower back pain / had become severe; Rapid Heart Beat; This case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2021 15:30, the patient received the 1st dose of Shingrix (intramuscular). On 3rd July 2021, 2 days after receiving Shingrix and an unknown time after starting Heparin, the patient experienced shortness of breath (serious criteria hospitalization), back pain (serious criteria hospitalization) and heartbeats increased (serious criteria hospitalization). On 9th July 2021, the patient experienced pulmonary embolism (serious criteria hospitalization and GSK medically significant). The patient was treated with heparin (nos) (Heparin) and apixaban (Eliquis). On an unknown date, the outcome of the pulmonary embolism was not recovered/not resolved and the outcome of the shortness of breath, back pain and heartbeats increased were recovered/resolved.   It was unknown if the reporter considered the pulmonary embolism, shortness of breath, back pain and heartbeats increased to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for himself. The patient received 1st dose of Shingrix on left arm and experienced shortness of breath, rapid heartbeat and mild lower back pain. On 4th July 2021, the patient went to an urgent care and pneumonia was ruled out with a chest x-ray. On 7th July 2021, the lower back pain had become severe back pain.  On 8th July 2021, the patient went to his chiropractor, who sent him to his health care professional. On 9th July 2021, the patient reported that his wife took him to the emergency room.  At the emergency room, they did two computerized tomogram scans, one of the abdomen and the other of his chest.  The health care professional said he had multiple pulmonary embolisms in the pulmonary artery and the lower right side of his lung.  The patient was put on a heparin drip and he was hospitalized for 2 days.  After discharge the patient was given Eliquis as a blood thinner, which he was currently on (no dosage shared).  The patient was referred to a hematologist at the hospital and he had an appointment next week. The patient did not give permission to contact health care professional. The reporter did not consent to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Heart rate increased, Pulmonary embolism
Clinical narrative: Multiple pulmonary embolisms / hospitalized for 2 days; Shortness of Breath; Mild lower back pain / had become severe; Rapid Heart Beat; This case was reported by a consumer via call center representative and described the occurrence of pulmonary embolism in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st July 2021 15:30, the patient received the 1st dose of Shingrix (intramuscular). On 3rd July 2021, 2 days after receiving Shingrix and an unknown time after starting Heparin, the patient experienced shortness of breath (serious criteria hospitalization), back pain (serious criteria hospitalization) and heartbeats increased (serious criteria hospitalization). On 9th July 2021, the patient experienced pulmonary embolism (serious criteria hospitalization and GSK medically significant). The patient was treated with heparin (nos) (Heparin) and apixaban (Eliquis). On an unknown date, the outcome of the pulmonary embolism was not recovered/not resolved and the outcome of the shortness of breath, back pain and heartbeats increased were recovered/resolved.   It was unknown if the reporter considered the pulmonary embolism, shortness of breath, back pain and heartbeats increased to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient for himself. The patient received 1st dose of Shingrix on left arm and experienced shortness of breath, rapid heartbeat and mild lower back pain. On 4th July 2021, the patient went to an urgent care and pneumonia was ruled out with a chest x-ray. On 7th July 2021, the lower back pain had become severe back pain.  On 8th July 2021, the patient went to his chiropractor, who sent him to his health care professional. On 9th July 2021, the patient reported that his wife took him to the emergency room.  At the emergency room, they did two computerized tomogram scans, one of the abdomen and the other of his chest.  The health care professional said he had multiple pulmonary embolisms in the pulmonary artery and the lower right side of his lung.  The patient was put on a heparin drip and he was hospitalized for 2 days.  After discharge the patient was given Eliquis as a blood thinner, which he was currently on (no dosage shared).  The patient was referred to a hematologist at the hospital and he had an appointment next week. The patient did not give permission to contact health care professional. The reporter did not consent to follow up.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF protein increased, CSF red blood cell count, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging spinal abnormal
Clinical narrative: I took my daughter to ER twice on July 7th and July 11th and she has been in the hospital ever since.  They suspect GBS.  She can?t walk, has extreme pain, and is struggling to understand what is happening to her.  She was a healthy 19 year old woman jumping on a trampoline and enjoying her life as we hiked through the park just 2 weeks ago.   Now she can not walk, has 80% paralysis and has pain that makes her cry constantly. As a reference she is a tough woman - she had her wisdom teeth removed and never used the pain medication they sent home with her.  She is in the hospital with no clear path back to a normal life and all of the doctors implied that the most logical cause is the vaccine.  She has insurance for the moment (through me)  but she can?t work and my insurance may not renew.  This will destroy her (and possibly me) financially if there is no help.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging thoracic abnormal
Clinical narrative: I took my daughter to ER twice on July 7th and July 11th and she has been in the hospital ever since.  They suspect GBS.  She can?t walk, has extreme pain, and is struggling to understand what is happening to her.  She was a healthy 19 year old woman jumping on a trampoline and enjoying her life as we hiked through the park just 2 weeks ago.   Now she can not walk, has 80% paralysis and has pain that makes her cry constantly. As a reference she is a tough woman - she had her wisdom teeth removed and never used the pain medication they sent home with her.  She is in the hospital with no clear path back to a normal life and all of the doctors implied that the most logical cause is the vaccine.  She has insurance for the moment (through me)  but she can?t work and my insurance may not renew.  This will destroy her (and possibly me) financially if there is no help.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: I took my daughter to ER twice on July 7th and July 11th and she has been in the hospital ever since.  They suspect GBS.  She can?t walk, has extreme pain, and is struggling to understand what is happening to her.  She was a healthy 19 year old woman jumping on a trampoline and enjoying her life as we hiked through the park just 2 weeks ago.   Now she can not walk, has 80% paralysis and has pain that makes her cry constantly. As a reference she is a tough woman - she had her wisdom teeth removed and never used the pain medication they sent home with her.  She is in the hospital with no clear path back to a normal life and all of the doctors implied that the most logical cause is the vaccine.  She has insurance for the moment (through me)  but she can?t work and my insurance may not renew.  This will destroy her (and possibly me) financially if there is no help.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Crying, Gait inability, Guillain-Barre syndrome, Impaired work ability, Pain
Clinical narrative: I took my daughter to ER twice on July 7th and July 11th and she has been in the hospital ever since.  They suspect GBS.  She can?t walk, has extreme pain, and is struggling to understand what is happening to her.  She was a healthy 19 year old woman jumping on a trampoline and enjoying her life as we hiked through the park just 2 weeks ago.   Now she can not walk, has 80% paralysis and has pain that makes her cry constantly. As a reference she is a tough woman - she had her wisdom teeth removed and never used the pain medication they sent home with her.  She is in the hospital with no clear path back to a normal life and all of the doctors implied that the most logical cause is the vaccine.  She has insurance for the moment (through me)  but she can?t work and my insurance may not renew.  This will destroy her (and possibly me) financially if there is no help.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: I took my daughter to ER twice on July 7th and July 11th and she has been in the hospital ever since.  They suspect GBS.  She can?t walk, has extreme pain, and is struggling to understand what is happening to her.  She was a healthy 19 year old woman jumping on a trampoline and enjoying her life as we hiked through the park just 2 weeks ago.   Now she can not walk, has 80% paralysis and has pain that makes her cry constantly. As a reference she is a tough woman - she had her wisdom teeth removed and never used the pain medication they sent home with her.  She is in the hospital with no clear path back to a normal life and all of the doctors implied that the most logical cause is the vaccine.  She has insurance for the moment (through me)  but she can?t work and my insurance may not renew.  This will destroy her (and possibly me) financially if there is no help.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriogram normal, Blood test, Chest discomfort, Chest pain, Chills
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: Dyspnoea, Echocardiogram, Electrocardiogram, Hyperhidrosis, Injection site 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).