chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Allergy test, Attention deficit hyperactivity disorder, Blood test, Gastrointestinal disorder, Gene mutation identification test
Clinical narrative: my daughter had 11 vaccines injected into her blood stream that day and she has not been the same ever since. she has been suffering with severe gut issues, allergies, fevers, and sickness like she never had before.  She also shows signs of ADHD which she never had before either. We are still treating her almost 2 yrs later, it will be ongoing until my child is back to normal
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Hypersensitivity, Illness, Pyrexia
Clinical narrative: my daughter had 11 vaccines injected into her blood stream that day and she has not been the same ever since. she has been suffering with severe gut issues, allergies, fevers, and sickness like she never had before.  She also shows signs of ADHD which she never had before either. We are still treating her almost 2 yrs later, it will be ongoing until my child is back to normal
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Laboratory test abnormal
Clinical narrative: Guillain-Barre syndrome
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Urticaria
Clinical narrative: Hives, headache, passing out
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Allergy test, Blood test, Bone development abnormal, Chronic fatigue syndrome, Dyspnoea
Clinical narrative: After 6 Vaccines he felt like he was going to die. He laid on the ground for a week in severe head pain sweating and not able to move. Then from there it was 8 months of hell. He was sick constantly with a fever, vomiting, ear infection, it was non stop. He had leg pain and was having trouble breathing when he moved around too much. Its been two yrs almost and we have been in and out of the ER a handful of times with breathing problems. His body still hurts. He blacks out every day. He is in pain, He had chronic fatigue syndrome, his chest is now growing strange. His gut is destroyed and he has allergies. We have been seeing drs for about the last 6 months and they have no idea what is going on?
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea exertional, Ear infection, Feeling abnormal, Gastrointestinal disorder, Headache
Clinical narrative: After 6 Vaccines he felt like he was going to die. He laid on the ground for a week in severe head pain sweating and not able to move. Then from there it was 8 months of hell. He was sick constantly with a fever, vomiting, ear infection, it was non stop. He had leg pain and was having trouble breathing when he moved around too much. Its been two yrs almost and we have been in and out of the ER a handful of times with breathing problems. His body still hurts. He blacks out every day. He is in pain, He had chronic fatigue syndrome, his chest is now growing strange. His gut is destroyed and he has allergies. We have been seeing drs for about the last 6 months and they have no idea what is going on?
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Hyperhidrosis, Hypersensitivity, Loss of consciousness, Magnetic resonance imaging thoracic, Malaise
Clinical narrative: After 6 Vaccines he felt like he was going to die. He laid on the ground for a week in severe head pain sweating and not able to move. Then from there it was 8 months of hell. He was sick constantly with a fever, vomiting, ear infection, it was non stop. He had leg pain and was having trouble breathing when he moved around too much. Its been two yrs almost and we have been in and out of the ER a handful of times with breathing problems. His body still hurts. He blacks out every day. He is in pain, He had chronic fatigue syndrome, his chest is now growing strange. His gut is destroyed and he has allergies. We have been seeing drs for about the last 6 months and they have no idea what is going on?
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Methylenetetrahydrofolate reductase gene mutation, Movement disorder, Pain, Pain in extremity, Pyrexia
Clinical narrative: After 6 Vaccines he felt like he was going to die. He laid on the ground for a week in severe head pain sweating and not able to move. Then from there it was 8 months of hell. He was sick constantly with a fever, vomiting, ear infection, it was non stop. He had leg pain and was having trouble breathing when he moved around too much. Its been two yrs almost and we have been in and out of the ER a handful of times with breathing problems. His body still hurts. He blacks out every day. He is in pain, He had chronic fatigue syndrome, his chest is now growing strange. His gut is destroyed and he has allergies. We have been seeing drs for about the last 6 months and they have no idea what is going on?
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Ultrasound liver, Vomiting, X-ray therapy to joint
Clinical narrative: After 6 Vaccines he felt like he was going to die. He laid on the ground for a week in severe head pain sweating and not able to move. Then from there it was 8 months of hell. He was sick constantly with a fever, vomiting, ear infection, it was non stop. He had leg pain and was having trouble breathing when he moved around too much. Its been two yrs almost and we have been in and out of the ER a handful of times with breathing problems. His body still hurts. He blacks out every day. He is in pain, He had chronic fatigue syndrome, his chest is now growing strange. His gut is destroyed and he has allergies. We have been seeing drs for about the last 6 months and they have no idea what is going on?
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgraphia, Dysphemia, Fine motor skill dysfunction, Muscle spasms, Sleep disorder
Clinical narrative: I have started having an involuntary, uncontrollable tremor/spasm in my right hand.  It shakes and stops me from being able to control my hand or use my hand as I was (for instance, if I am writing, I usually have to wait out the tremor before continuing writing).  It seems to be getting worse with time - with originally happening, maybe, once a day.  Now it happens several times a day and throughout the night - even waking me, at times.    I do not know if it is related, but I have developed a mild stutter, as well.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I have started having an involuntary, uncontrollable tremor/spasm in my right hand.  It shakes and stops me from being able to control my hand or use my hand as I was (for instance, if I am writing, I usually have to wait out the tremor before continuing writing).  It seems to be getting worse with time - with originally happening, maybe, once a day.  Now it happens several times a day and throughout the night - even waking me, at times.    I do not know if it is related, but I have developed a mild stutter, as well.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in hips and knees. Seeing chiropractor for event. With no relief, I am seeing my primary on July 19.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Headache, chest pains, difficulty breathing. Went to ER, had EKG, echocardiogram and blood work. Tested troponin levels bc of recent covid vaccine. Then diagnosed with mild myocarditis Bc troponin levels were elevated to 27. Admitted to hospital and testing enzyme levels until they start heading down. Given Motrin to help with inflammation and chest  pain
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Enzyme level increased, Headache, Inflammation, Myocarditis, Troponin increased
Clinical narrative: Headache, chest pains, difficulty breathing. Went to ER, had EKG, echocardiogram and blood work. Tested troponin levels bc of recent covid vaccine. Then diagnosed with mild myocarditis Bc troponin levels were elevated to 27. Admitted to hospital and testing enzyme levels until they start heading down. Given Motrin to help with inflammation and chest  pain
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rash pruritic, Urticaria
Clinical narrative: Hours after receiving the vaccine I felt as though I had a headcold with the severity of my symptoms decreasing day-by-day for about eight days. The ninth day, after my "headcold" symptoms had abated; I started finding itchy hives first on my left arm, the left side of my back, and the left side of my upper stomach.  The next day the hives has spread to my scalp, face, ears, left hand, groin, left leg, the upper parts of both my right arm and right leg, the right side of my back, and most of my torso.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Dizziness, Electrocardiogram normal
Clinical narrative: I started experiencing some sharp chest pain on the left side that started around a week or less after the shot. I?ve been stubborn and pushing it off (not currently insured so I didn?t want to get checked up). I?ve been experiencing the sharp pain on the left side of my chest off and on a few times a week at least. I?ve never experienced this but figured it would go away eventually.   Last Sunday (July 11,2021) The chest pain was more severe than usual and I was very lightheaded and nausea and it didn?t get any better so I visited the ER. The EKG, chest x-rays, troponin levels, and other tests came back normal according to the physician assistant.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Troponin normal
Clinical narrative: I started experiencing some sharp chest pain on the left side that started around a week or less after the shot. I?ve been stubborn and pushing it off (not currently insured so I didn?t want to get checked up). I?ve been experiencing the sharp pain on the left side of my chest off and on a few times a week at least. I?ve never experienced this but figured it would go away eventually.   Last Sunday (July 11,2021) The chest pain was more severe than usual and I was very lightheaded and nausea and it didn?t get any better so I visited the ER. The EKG, chest x-rays, troponin levels, and other tests came back normal according to the physician assistant.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cold sweat, Dizziness, Loss of consciousness, Nausea
Clinical narrative: Passed out 2+ times for at least 30 sec and more over the course of about an hour. Signs were feeling light headed, dizzy, nauseous, chest pains, and clammy.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hysteroscopy, Polypectomy, Postmenopausal haemorrhage, Ultrasound scan vagina abnormal, Uterine polyp
Clinical narrative: Benign Uterine Polyp: I have no idea if this is related to the COVID vaccine, but I was seeing articles about vaccinated women experiencing menstrual irregularities when I experienced some unexpected vaginal bleeding after being menopausal with no bleeding for over a decade.  May 3, 2021 vaginal bleeding after menopause May 10, 2021 OB/GYN Dr. appointment May 20, 2021 Vaginal ultrasound - hemoragic appearing mass in uterus found June 21. 2021 Pre-Op Dr. appointment June 30, 2021 Hysteroscopy - Uterine Polyp found and removed July 6, 2021 Notified of Lab results: Polyp was benign
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Benign Uterine Polyp: I have no idea if this is related to the COVID vaccine, but I was seeing articles about vaccinated women experiencing menstrual irregularities when I experienced some unexpected vaginal bleeding after being menopausal with no bleeding for over a decade.  May 3, 2021 vaginal bleeding after menopause May 10, 2021 OB/GYN Dr. appointment May 20, 2021 Vaginal ultrasound - hemoragic appearing mass in uterus found June 21. 2021 Pre-Op Dr. appointment June 30, 2021 Hysteroscopy - Uterine Polyp found and removed July 6, 2021 Notified of Lab results: Polyp was benign
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: SERIES COMPLETED OUTSIDE OF RECOMMENDED TIME FRAME.  FIRST DOSE WAS GIVEN ON 4-30-21.  NO ADVERSE EVENTS REPORTED AT TIME OF VACCINATION.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Dysphagia, Goitre, Hypothyroidism, Insomnia
Clinical narrative: I started without getting my minstrel cycle. From there I started having other symptoms...not using the bathroom.... forgetting things...trouble swallowing...trouble sleeping. I went to doctor finally advising that it slowly started after my first shot and worsened after my 2nd. They tested me. I came back with hypo thyroid and enlarged thyroid and enlarged left ovary.  I went to the dr the october before and was perfectly healthy with nothing. Now I have thyroid issues ...still have problems sleeping...still have one had one cycle since the shots.....put on 20pds!! and have occasional pain in the arm still.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Memory impairment, Menstruation delayed, Ovarian enlargement, Pain in extremity
Clinical narrative: I started without getting my minstrel cycle. From there I started having other symptoms...not using the bathroom.... forgetting things...trouble swallowing...trouble sleeping. I went to doctor finally advising that it slowly started after my first shot and worsened after my 2nd. They tested me. I came back with hypo thyroid and enlarged thyroid and enlarged left ovary.  I went to the dr the october before and was perfectly healthy with nothing. Now I have thyroid issues ...still have problems sleeping...still have one had one cycle since the shots.....put on 20pds!! and have occasional pain in the arm still.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Weight increased
Clinical narrative: I started without getting my minstrel cycle. From there I started having other symptoms...not using the bathroom.... forgetting things...trouble swallowing...trouble sleeping. I went to doctor finally advising that it slowly started after my first shot and worsened after my 2nd. They tested me. I came back with hypo thyroid and enlarged thyroid and enlarged left ovary.  I went to the dr the october before and was perfectly healthy with nothing. Now I have thyroid issues ...still have problems sleeping...still have one had one cycle since the shots.....put on 20pds!! and have occasional pain in the arm still.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Mass, Pain
Clinical narrative: The following day I had a round, itchy, painful, red lump. It is hot to the touch. Very painful if arm rubs against something. But today, 3 days later, it seems to be spreading. At least 5 inches uneven n 5 inches across but going to back of arm. It feels like a big lump that's very hot to touch. There are also white marks in red area like hives?
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Skin warm
Clinical narrative: The following day I had a round, itchy, painful, red lump. It is hot to the touch. Very painful if arm rubs against something. But today, 3 days later, it seems to be spreading. At least 5 inches uneven n 5 inches across but going to back of arm. It feels like a big lump that's very hot to touch. There are also white marks in red area like hives?
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: COMPLETED SERIES OUTSIDE OF RECOMMENDED TIME FRAME.  HE GOT HIS FIRST DOSE ON 1-23-2021.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Computerised tomogram, Eating disorder, Impaired self-care, Impaired work ability
Clinical narrative: Shortly after receiving the second Pfizer shot I developed extremely severe spasms and cramping throughout my chest and back.  The pain level is profound and unrelenting and has not changed in two months.  Pain free time is rare, 50% of every day is spent trying to survive the pain, but I am frequently at the hospital.  I cannot eat or sleep or work and dropping weight dangerously fast.    I am completely incapacitated and now have a caretaker
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mobility decreased, Muscle spasms, Pain, Sleep disorder
Clinical narrative: Shortly after receiving the second Pfizer shot I developed extremely severe spasms and cramping throughout my chest and back.  The pain level is profound and unrelenting and has not changed in two months.  Pain free time is rare, 50% of every day is spent trying to survive the pain, but I am frequently at the hospital.  I cannot eat or sleep or work and dropping weight dangerously fast.    I am completely incapacitated and now have a caretaker
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased, X-ray
Clinical narrative: Shortly after receiving the second Pfizer shot I developed extremely severe spasms and cramping throughout my chest and back.  The pain level is profound and unrelenting and has not changed in two months.  Pain free time is rare, 50% of every day is spent trying to survive the pain, but I am frequently at the hospital.  I cannot eat or sleep or work and dropping weight dangerously fast.    I am completely incapacitated and now have a caretaker
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram abdomen abnormal, Haemoglobin decreased, Intensive care, Platelet count decreased
Clinical narrative: Patient presented after syncopal episode and abdominal pain, was found to have profound thrombocytopenia. CT abdomen was done which was concerning for ruptured ovarian cyst. Hgb dropped to 5.8, plts at time of report were 13. Patient transferred to the ICU for further management
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Thrombocytopenia
Clinical narrative: Patient presented after syncopal episode and abdominal pain, was found to have profound thrombocytopenia. CT abdomen was done which was concerning for ruptured ovarian cyst. Hgb dropped to 5.8, plts at time of report were 13. Patient transferred to the ICU for further management
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Tinnitus
Clinical narrative: Ringing in ears along with mild pain. Occasional heavy pressure and pain in ears when opening mouth.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The next day left upper arm became very warm, red, swollen  and painful and continued to spread to axilla.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Myalgia, Pain, Pain in extremity
Clinical narrative: Burning pain in the middle of my chest along with shortness of breath.  Pain spreads from my chest to my right arm and makes the muscles in my right arm sore.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus rhythm
Clinical narrative: Burning pain in the middle of my chest along with shortness of breath.  Pain spreads from my chest to my right arm and makes the muscles in my right arm sore.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Pt initially received Pfizer EW0173 6/2/21 and today 7/16/21 was given Moderna 034C21A due to vaccine availability at the event and pt status. Pt insisted and verbally gave consent in getting Moderna vaccine today despite given the option to receive same vaccine as first dose in a different clinic and different date/times.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Mobility decreased, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: -1st Covid vaccine received 04/16/2021 Lt arm. <48 hrs. later Lt arm/axilla and portion of Lt upper back very swollen and a large lump under axillary Lt painful. Lt arm difficult to raise above heart level due to very painful.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Full blood count, Herpes zoster, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: Patient developed first Shingles outbreak had been 5 days after the second covid vaccine dose. She has had 4 bouts of Shingles outbreak since covid vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal X-ray
Clinical narrative: Patient developed first Shingles outbreak had been 5 days after the second covid vaccine dose. She has had 4 bouts of Shingles outbreak since covid vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blister, Rash
Clinical narrative: Pt said she got the vaccine on 5/25/21 and a week later 5/31/21 she broke out with a rash on Both arms and it started to blister It started to go away on its own pt had Bx done 6/16/21
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Reported via phone: Numbness tingling hads + feet 1 wk p Covid Vac.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Noted patient came in today for COVID-19 vaccine to Health Center as well as a Health Clinic.
Sex: F
Vaccine: PPV, PPV
Symptoms: Anogenital warts, Inappropriate schedule of product administration
Clinical narrative: received every year; This spontaneous report was received from a lawyer referring to an approximately 34-year-old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       Every year since 1986, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).         This case was split from a legal case regarding the same patient.; Sender's Comments:  US-009507513-2103USA004197: US-009507513-2102USA003524:
Sex: F
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received every year; This spontaneous report was received from a lawyer referring to an approximately 34-year-old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.       Every year since 1986, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).         This case was split from a legal case regarding the same patient.; Sender's Comments:  US-009507513-2103USA004197: US-009507513-2102USA003524:
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Axillary vein thrombosis, Pain in extremity, Peripheral swelling, Ultrasound scan abnormal
Clinical narrative: 3 weeks later left arm felt tight , they took ultrasound and found a clot in arm
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coagulopathy, Deep vein thrombosis, Limb discomfort, Ultrasound scan abnormal
Clinical narrative: 3 weeks later left arm felt tight , they took ultrasound and found a clot in arm
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Lip swelling, Swelling face
Clinical narrative: Face Swelling to 3 times it?s size with painful rash  Left Eye swelled shut and couldn?t open Slight rash on upper left arm
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face, Swelling of eyelid
Clinical narrative: Face Swelling to 3 times it?s size with painful rash  Left Eye swelled shut and couldn?t open Slight rash on upper left arm
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Lymphadenopathy, Pain
Clinical narrative: FELT SICK; SWOLLEN LYMPH NODES; INTERMITTENT FEVER; MIGRAINE; SHORTNESS OF BREATH; CHEST PAIN; CHEST PRESSURE / LUNG PRESSURE; COUGH; LETHARGY; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic, non-alcohol user, and non-smoker, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUN-2021, the subject experienced migraine. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced chest pressure / lung pressure. On 16-JUN-2021, the subject experienced cough. On 16-JUN-2021, the subject experienced lethargy. On 16-JUN-2021, the subject experienced intermittent fever. On 19-JUN-2021, the subject experienced swollen lymph nodes. On 21-JUN-2021, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen lymph nodes, and had not recovered from migraine, shortness of breath, chest pain, cough, lethargy, intermittent fever, chest pressure / lung pressure, and felt sick. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: FELT SICK; SWOLLEN LYMPH NODES; INTERMITTENT FEVER; MIGRAINE; SHORTNESS OF BREATH; CHEST PAIN; CHEST PRESSURE / LUNG PRESSURE; COUGH; LETHARGY; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic, non-alcohol user, and non-smoker, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUN-2021, the subject experienced migraine. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced chest pressure / lung pressure. On 16-JUN-2021, the subject experienced cough. On 16-JUN-2021, the subject experienced lethargy. On 16-JUN-2021, the subject experienced intermittent fever. On 19-JUN-2021, the subject experienced swollen lymph nodes. On 21-JUN-2021, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen lymph nodes, and had not recovered from migraine, shortness of breath, chest pain, cough, lethargy, intermittent fever, chest pressure / lung pressure, and felt sick. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Cough, Dyspnoea, Lethargy
Clinical narrative: FELT SICK; SWOLLEN LYMPH NODES; INTERMITTENT FEVER; MIGRAINE; SHORTNESS OF BREATH; CHEST PAIN; CHEST PRESSURE / LUNG PRESSURE; COUGH; LETHARGY; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic, non-alcohol user, and non-smoker, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUN-2021, the subject experienced migraine. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced chest pressure / lung pressure. On 16-JUN-2021, the subject experienced cough. On 16-JUN-2021, the subject experienced lethargy. On 16-JUN-2021, the subject experienced intermittent fever. On 19-JUN-2021, the subject experienced swollen lymph nodes. On 21-JUN-2021, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen lymph nodes, and had not recovered from migraine, shortness of breath, chest pain, cough, lethargy, intermittent fever, chest pressure / lung pressure, and felt sick. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Malaise, Migraine, Pyrexia
Clinical narrative: FELT SICK; SWOLLEN LYMPH NODES; INTERMITTENT FEVER; MIGRAINE; SHORTNESS OF BREATH; CHEST PAIN; CHEST PRESSURE / LUNG PRESSURE; COUGH; LETHARGY; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic, non-alcohol user, and non-smoker, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUN-2021, the subject experienced migraine. On 16-JUN-2021, the subject experienced shortness of breath. On 16-JUN-2021, the subject experienced chest pain. On 16-JUN-2021, the subject experienced chest pressure / lung pressure. On 16-JUN-2021, the subject experienced cough. On 16-JUN-2021, the subject experienced lethargy. On 16-JUN-2021, the subject experienced intermittent fever. On 19-JUN-2021, the subject experienced swollen lymph nodes. On 21-JUN-2021, the subject experienced felt sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen lymph nodes, and had not recovered from migraine, shortness of breath, chest pain, cough, lethargy, intermittent fever, chest pressure / lung pressure, and felt sick. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: High temperature up to 102º accompanied by joint pain, fatigue, headache at base of skull from 06/08 til 06/13. Temperatures subsided by 6/14. Large rashes with bruising appeared 6/12, eventually covering over a 1/3 of the body's surface. A blood test revealed low RBC count. Rashes subsided by 07/02. Fatigue subsided 7/14. Joint and muscle pain/weakness continue to the present, although they subsided markedly on 07/14 and continue to gradually improve.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Contusion, Fatigue, Haematocrit decreased
Clinical narrative: High temperature up to 102º accompanied by joint pain, fatigue, headache at base of skull from 06/08 til 06/13. Temperatures subsided by 6/14. Large rashes with bruising appeared 6/12, eventually covering over a 1/3 of the body's surface. A blood test revealed low RBC count. Rashes subsided by 07/02. Fatigue subsided 7/14. Joint and muscle pain/weakness continue to the present, although they subsided markedly on 07/14 and continue to gradually improve.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin normal, Headache, Myalgia, Rash, Red blood cell count decreased
Clinical narrative: High temperature up to 102º accompanied by joint pain, fatigue, headache at base of skull from 06/08 til 06/13. Temperatures subsided by 6/14. Large rashes with bruising appeared 6/12, eventually covering over a 1/3 of the body's surface. A blood test revealed low RBC count. Rashes subsided by 07/02. Fatigue subsided 7/14. Joint and muscle pain/weakness continue to the present, although they subsided markedly on 07/14 and continue to gradually improve.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count normal
Clinical narrative: High temperature up to 102º accompanied by joint pain, fatigue, headache at base of skull from 06/08 til 06/13. Temperatures subsided by 6/14. Large rashes with bruising appeared 6/12, eventually covering over a 1/3 of the body's surface. A blood test revealed low RBC count. Rashes subsided by 07/02. Fatigue subsided 7/14. Joint and muscle pain/weakness continue to the present, although they subsided markedly on 07/14 and continue to gradually improve.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Eye pruritus, Laboratory test normal, Ocular hyperaemia, Pain in extremity
Clinical narrative: Started experiencing itchiness/rash same day of first shot. Now have horribly painful hives/bruises all over body. Urgent care, doctor and emergency room haven?t been able to help just say I?m ?allergic? to something.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Started experiencing itchiness/rash same day of first shot. Now have horribly painful hives/bruises all over body. Urgent care, doctor and emergency room haven?t been able to help just say I?m ?allergic? to something.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Started experiencing itchiness/rash same day of first shot. Now have horribly painful hives/bruises all over body. Urgent care, doctor and emergency room haven?t been able to help just say I?m ?allergic? to something.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: VACCINE ADMINISTERED OUTSIDE OF RECOMMENDED STORAGE AREA; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 18-AUG-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-JUL-2021, the subject experienced vaccine administered outside of recommended storage area. On 06-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of recommended storage area and incorrect product storage was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED OUTSIDE OF RECOMMENDED STORAGE AREA; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: 18-AUG-2021) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-JUL-2021, the subject experienced vaccine administered outside of recommended storage area. On 06-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of recommended storage area and incorrect product storage was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Blood test, Computerised tomogram
Clinical narrative: HANDS, ARMS AND FACE BECAME FUZZY; HANDS, ARMS AND FACE BECAME NUMB; LOST 2 POUNDS IN 4 HOURS; SEVERE SORENESS IN HIS LEFT ARM; SORENESS IN SHOULDERS AND DOWN BACK; NAUSEA; SEVERE STOMACH PAIN; SEVERE VOMITING; SORENESS ALL DAY; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no reaction to vaccines previously. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 07-JUL-2021 10:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021 around 23.00 after vaccination, the patient developed severe soreness on left arm, shoulders and down back; it was reported that the patient had soreness all the day. The patient had severe vomiting to which patient lost two pounds in four hours. On 08-JUL-2021, patient was taken to ER (emergency room) at 5:45 and he continued to have severe stomach pain (stomach was moving), nausea and vomiting. The patient's hands, arms and face became fuzzy and then numb. The patient was given multiple unspecified medications to ease symptoms, along with an unspecified IV (intravenous). The patient also had tests of blood, urine and a CAT (computerized tomography) scan and the results were not reported. The patient was treated with morphine and was discharged from ER (emergency room) around noon on 08-JUL-2021. The patient's stomach was still not all the way well at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach pain, and the outcome of severe vomiting, soreness all day, nausea, hands, arms and face became fuzzy, hands, arms and face became numb, severe soreness in his left arm, soreness in shoulders and down back and lost 2 pounds in 4 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210723452- covid-19 vaccine ad26.cov2.s- severe stomach pain,  severe vomiting, soreness all day,  hands, arms and face became fuzzy, hands, arms and face became numb, lost 2 pounds in 4 hours . 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). 20210723452- covid-19 vaccine ad26.cov2.s- nausea,  severe soreness in his left arm, soreness in shoulders and down back. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Nausea, Pain in extremity, Urine analysis
Clinical narrative: HANDS, ARMS AND FACE BECAME FUZZY; HANDS, ARMS AND FACE BECAME NUMB; LOST 2 POUNDS IN 4 HOURS; SEVERE SORENESS IN HIS LEFT ARM; SORENESS IN SHOULDERS AND DOWN BACK; NAUSEA; SEVERE STOMACH PAIN; SEVERE VOMITING; SORENESS ALL DAY; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no reaction to vaccines previously. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 07-JUL-2021 10:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021 around 23.00 after vaccination, the patient developed severe soreness on left arm, shoulders and down back; it was reported that the patient had soreness all the day. The patient had severe vomiting to which patient lost two pounds in four hours. On 08-JUL-2021, patient was taken to ER (emergency room) at 5:45 and he continued to have severe stomach pain (stomach was moving), nausea and vomiting. The patient's hands, arms and face became fuzzy and then numb. The patient was given multiple unspecified medications to ease symptoms, along with an unspecified IV (intravenous). The patient also had tests of blood, urine and a CAT (computerized tomography) scan and the results were not reported. The patient was treated with morphine and was discharged from ER (emergency room) around noon on 08-JUL-2021. The patient's stomach was still not all the way well at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach pain, and the outcome of severe vomiting, soreness all day, nausea, hands, arms and face became fuzzy, hands, arms and face became numb, severe soreness in his left arm, soreness in shoulders and down back and lost 2 pounds in 4 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210723452- covid-19 vaccine ad26.cov2.s- severe stomach pain,  severe vomiting, soreness all day,  hands, arms and face became fuzzy, hands, arms and face became numb, lost 2 pounds in 4 hours . 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). 20210723452- covid-19 vaccine ad26.cov2.s- nausea,  severe soreness in his left arm, soreness in shoulders and down back. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: HANDS, ARMS AND FACE BECAME FUZZY; HANDS, ARMS AND FACE BECAME NUMB; LOST 2 POUNDS IN 4 HOURS; SEVERE SORENESS IN HIS LEFT ARM; SORENESS IN SHOULDERS AND DOWN BACK; NAUSEA; SEVERE STOMACH PAIN; SEVERE VOMITING; SORENESS ALL DAY; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no reaction to vaccines previously. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 07-JUL-2021 10:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021 around 23.00 after vaccination, the patient developed severe soreness on left arm, shoulders and down back; it was reported that the patient had soreness all the day. The patient had severe vomiting to which patient lost two pounds in four hours. On 08-JUL-2021, patient was taken to ER (emergency room) at 5:45 and he continued to have severe stomach pain (stomach was moving), nausea and vomiting. The patient's hands, arms and face became fuzzy and then numb. The patient was given multiple unspecified medications to ease symptoms, along with an unspecified IV (intravenous). The patient also had tests of blood, urine and a CAT (computerized tomography) scan and the results were not reported. The patient was treated with morphine and was discharged from ER (emergency room) around noon on 08-JUL-2021. The patient's stomach was still not all the way well at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach pain, and the outcome of severe vomiting, soreness all day, nausea, hands, arms and face became fuzzy, hands, arms and face became numb, severe soreness in his left arm, soreness in shoulders and down back and lost 2 pounds in 4 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210723452- covid-19 vaccine ad26.cov2.s- severe stomach pain,  severe vomiting, soreness all day,  hands, arms and face became fuzzy, hands, arms and face became numb, lost 2 pounds in 4 hours . 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). 20210723452- covid-19 vaccine ad26.cov2.s- nausea,  severe soreness in his left arm, soreness in shoulders and down back. This event(s) is labeled per Agency and is therefore considered potentially related.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Computerised tomogram, Feeling abnormal
Clinical narrative: HANDS, ARMS AND FACE BECAME FUZZY; HANDS, ARMS AND FACE BECAME NUMB; LOST 2 POUNDS IN 4 HOURS; SEVERE SORENESS IN HIS LEFT ARM; SORENESS IN SHOULDERS AND DOWN BACK; NAUSEA; SEVERE STOMACH PAIN; SEVERE VOMITING; SORENESS ALL DAY; This spontaneous report received from a parent concerned a 21 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no reaction to vaccines previously. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 07-JUL-2021 10:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-JUL-2021 around 23.00 after vaccination, the patient developed severe soreness on left arm, shoulders and down back; it was reported that the patient had soreness all the day. The patient had severe vomiting to which patient lost two pounds in four hours. On 08-JUL-2021, patient was taken to ER (emergency room) at 5:45 and he continued to have severe stomach pain (stomach was moving), nausea and vomiting. The patient's hands, arms and face became fuzzy and then numb. The patient was given multiple unspecified medications to ease symptoms, along with an unspecified IV (intravenous). The patient also had tests of blood, urine and a CAT (computerized tomography) scan and the results were not reported. The patient was treated with morphine and was discharged from ER (emergency room) around noon on 08-JUL-2021. The patient's stomach was still not all the way well at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach pain, and the outcome of severe vomiting, soreness all day, nausea, hands, arms and face became fuzzy, hands, arms and face became numb, severe soreness in his left arm, soreness in shoulders and down back and lost 2 pounds in 4 hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210723452- covid-19 vaccine ad26.cov2.s- severe stomach pain,  severe vomiting, soreness all day,  hands, arms and face became fuzzy, hands, arms and face became numb, lost 2 pounds in 4 hours . 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). 20210723452- covid-19 vaccine ad26.cov2.s- nausea,  severe soreness in his left arm, soreness in shoulders and down back. This event(s) is labeled per Agency and is therefore considered potentially related.