chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Bell's Palsy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 16:00 (Batch/Lot number: unknown) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Premature Birth - 28 weeks" start date: 20Nov2010 (unspecified if ongoing), notes: Premature Birth - 28 weeks. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] and multivitamins. The following information was reported: BELL'S PALSY (medically significant) with onset 03Feb2022 06:00, outcome "not recovered", described as "Bell's Palsy". The event "bell's palsy" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) negative. Therapeutic measures were taken as a result of bell's palsy; patient was given anti-viral and steroids.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bell's Palsy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 16:00 (Batch/Lot number: unknown) at the age of 11 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Premature Birth - 28 weeks" start date: 20Nov2010 (unspecified if ongoing), notes: Premature Birth - 28 weeks. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] and multivitamins. The following information was reported: BELL'S PALSY (medically significant) with onset 03Feb2022 06:00, outcome "not recovered", described as "Bell's Palsy". The event "bell's palsy" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) negative. Therapeutic measures were taken as a result of bell's palsy; patient was given anti-viral and steroids.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ischaemic stroke
Clinical narrative: Suffered a severe stroke; the stroke was right after the booster; Has no use of her left arm, left leg, left facial; Now she is shorter. She is 5 feet 2 inches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 94 year-old female patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (Lot number: FL3127) at the age of 94 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: Blood pressure high" (unspecified if ongoing); "Verbatim: Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; FUROSEMIDE [FUROSEMIDE SODIUM]; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Bnt162b2 (Dose:2), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose:1), administration date: Mar2021, for COVID-19 Immunization; Flu shot (she did have Flu shot but that was in November.), administration date: Nov2021, for Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 13Jan2022, outcome "unknown", described as "Suffered a severe stroke; the stroke was right after the booster"; HEMIPARESIS (medically significant), outcome "unknown", described as "Has no use of her left arm, left leg, left facial"; BODY HEIGHT DECREASED (non-serious), outcome "unknown", described as "Now she is shorter. She is 5 feet 2 inches". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 3 day(s)). The event "suffered a severe stroke; the stroke was right after the booster" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: unknown results, notes: they did CT and MRI when she got to hospital; magnetic resonance imaging: unknown results, notes: they did CT and MRI when she got to hospital; body height decreased: 5 feet 2 inches. Therapeutic measures were taken as a result of cerebrovascular accident. Therapeutic measures were not taken as a result of hemiparesis, body height decreased.  Clinical course: Reporter stated, patient put into a rehab facility and has no use of her left arm, left leg, it was a whole left (incomplete sentence) left facial, so she was now in a rehab facility and will be there probably forever into a nursing home because the stroke was right after the booster. They immediately took her into the emergency room and they gave her, the one which you get within 4 hours which was Activase, which is the gold standard for ischemic stroke, they gave her that within 4 hours and luckily she did not passed away from the stroke. Patient was on the medication to help her with the high blood pressure. Furosemide is a water pill.  Follow-up attempts are completed. No further information is expected.
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body height decreased, Cerebrovascular accident, Computerised tomogram, Hemiparesis, Magnetic resonance imaging
Clinical narrative: Suffered a severe stroke; the stroke was right after the booster; Has no use of her left arm, left leg, left facial; Now she is shorter. She is 5 feet 2 inches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 94 year-old female patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (Lot number: FL3127) at the age of 94 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: Blood pressure high" (unspecified if ongoing); "Verbatim: Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; FUROSEMIDE [FUROSEMIDE SODIUM]; ATORVASTATIN taken for blood cholesterol. Vaccination history included: Bnt162b2 (Dose:2), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose:1), administration date: Mar2021, for COVID-19 Immunization; Flu shot (she did have Flu shot but that was in November.), administration date: Nov2021, for Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 13Jan2022, outcome "unknown", described as "Suffered a severe stroke; the stroke was right after the booster"; HEMIPARESIS (medically significant), outcome "unknown", described as "Has no use of her left arm, left leg, left facial"; BODY HEIGHT DECREASED (non-serious), outcome "unknown", described as "Now she is shorter. She is 5 feet 2 inches". The patient was hospitalized for cerebrovascular accident (hospitalization duration: 3 day(s)). The event "suffered a severe stroke; the stroke was right after the booster" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: unknown results, notes: they did CT and MRI when she got to hospital; magnetic resonance imaging: unknown results, notes: they did CT and MRI when she got to hospital; body height decreased: 5 feet 2 inches. Therapeutic measures were taken as a result of cerebrovascular accident. Therapeutic measures were not taken as a result of hemiparesis, body height decreased.  Clinical course: Reporter stated, patient put into a rehab facility and has no use of her left arm, left leg, it was a whole left (incomplete sentence) left facial, so she was now in a rehab facility and will be there probably forever into a nursing home because the stroke was right after the booster. They immediately took her into the emergency room and they gave her, the one which you get within 4 hours which was Activase, which is the gold standard for ischemic stroke, they gave her that within 4 hours and luckily she did not passed away from the stroke. Patient was on the medication to help her with the high blood pressure. Furosemide is a water pill.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: My lungs do feel "sick; I got my first COVID-19 Booster, which was the Pfizer one, and my brain cleared up, better than it's been for years; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: 2019 (unspecified if ongoing), notes: I would have contracted COVID before any tests were around and tested negative when the tests were produced, given I think I got COVID in 2019.; "smoke marijuana" (unspecified if ongoing), notes: I was smoking marijuana through what felt like COVID symptoms. The patient's concomitant medications were not reported. The following information was reported: LUNG DISORDER (non-serious) with onset 02Apr2021, outcome "recovered" (08Apr2021), described as "My lungs do feel "sick"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 02Apr2021, outcome "unknown", described as "I got my first COVID-19 Booster, which was the Pfizer one, and my brain cleared up, better than it's been for years". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient got his first COVID-19 Booster, which was the Pfizer one, and his brain cleared up, better than it's been for years. However, he got his shot on Friday 02Apr2021, around noon and his lungs do feel "sick" which was fine in the sense he did not enjoy or wanted to smoke marijuana.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lung disorder, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: My lungs do feel "sick; I got my first COVID-19 Booster, which was the Pfizer one, and my brain cleared up, better than it's been for years; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: 2019 (unspecified if ongoing), notes: I would have contracted COVID before any tests were around and tested negative when the tests were produced, given I think I got COVID in 2019.; "smoke marijuana" (unspecified if ongoing), notes: I was smoking marijuana through what felt like COVID symptoms. The patient's concomitant medications were not reported. The following information was reported: LUNG DISORDER (non-serious) with onset 02Apr2021, outcome "recovered" (08Apr2021), described as "My lungs do feel "sick"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 02Apr2021, outcome "unknown", described as "I got my first COVID-19 Booster, which was the Pfizer one, and my brain cleared up, better than it's been for years". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient got his first COVID-19 Booster, which was the Pfizer one, and his brain cleared up, better than it's been for years. However, he got his shot on Friday 02Apr2021, around noon and his lungs do feel "sick" which was fine in the sense he did not enjoy or wanted to smoke marijuana.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antiacetylcholine receptor antibody positive, Dysarthria, Dysphagia, Electromyogram, Eyelid disorder
Clinical narrative: Myasthenia Gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 25Aug2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 immunization. The following information was reported: MYASTHENIA GRAVIS (medically significant) with onset 2021, outcome "unknown", described as "Myasthenia Gravis". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200266818 similar report from same reporter
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Magnetic resonance imaging, Pain, Photophobia
Clinical narrative: Myasthenia Gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 25Aug2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 immunization. The following information was reported: MYASTHENIA GRAVIS (medically significant) with onset 2021, outcome "unknown", described as "Myasthenia Gravis". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200266818 similar report from same reporter
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myasthenia gravis
Clinical narrative: Myasthenia Gravis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 25Aug2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 immunization. The following information was reported: MYASTHENIA GRAVIS (medically significant) with onset 2021, outcome "unknown", described as "Myasthenia Gravis". The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200266818 similar report from same reporter
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accident, Dizziness, Hypoaesthesia, Loss of consciousness
Clinical narrative: Waited 15 minutes at store after vaccine, it was recommended by pharmacist to walk the store so he did. Left facility with our vehicle and about a mile down the road he felt numb from head to toe and fainted within 3 seconds, approximately 18 minutes after received vaccine. Ended up wrecking the vehicle and came to about 4-5 minutes later getting pulled from vehicle, not remembering anything.  About 2-3 times daily Since then he gets waves of tiredness, fussiness, dizziness and nausea. Vomited 2 days after incident without reason (wasn?t feeling sick, just vomited at work desk, didn?t feel it coming).
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Hypoaesthesia, Laboratory test normal, Nausea
Clinical narrative: Waited 15 minutes at store after vaccine, it was recommended by pharmacist to walk the store so he did. Left facility with our vehicle and about a mile down the road he felt numb from head to toe and fainted within 3 seconds, approximately 18 minutes after received vaccine. Ended up wrecking the vehicle and came to about 4-5 minutes later getting pulled from vehicle, not remembering anything.  About 2-3 times daily Since then he gets waves of tiredness, fussiness, dizziness and nausea. Vomited 2 days after incident without reason (wasn?t feeling sick, just vomited at work desk, didn?t feel it coming).
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Road traffic accident, Syncope, Vomiting
Clinical narrative: Waited 15 minutes at store after vaccine, it was recommended by pharmacist to walk the store so he did. Left facility with our vehicle and about a mile down the road he felt numb from head to toe and fainted within 3 seconds, approximately 18 minutes after received vaccine. Ended up wrecking the vehicle and came to about 4-5 minutes later getting pulled from vehicle, not remembering anything.  About 2-3 times daily Since then he gets waves of tiredness, fussiness, dizziness and nausea. Vomited 2 days after incident without reason (wasn?t feeling sick, just vomited at work desk, didn?t feel it coming).
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Computerised tomogram normal, Electrocardiogram, Magnetic resonance imaging head abnormal, Neurological symptom
Clinical narrative: bilateral thalamic strokes in association with a large patent foramen ovale. May Thurner variant, but no DVTs observed.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Bradycardia, Cerebrovascular accident, Computerised tomogram head abnormal, Confusional state
Clinical narrative: bilateral thalamic strokes in association with a large patent foramen ovale. May Thurner variant, but no DVTs observed.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Thalamic infarction
Clinical narrative: bilateral thalamic strokes in association with a large patent foramen ovale. May Thurner variant, but no DVTs observed.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial septal defect, Cerebrovascular accident, May-Thurner syndrome
Clinical narrative: bilateral thalamic strokes in association with a large patent foramen ovale. May Thurner variant, but no DVTs observed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood test normal, Cardiac stress test, Chest pain, Echocardiogram normal
Clinical narrative: When I got home after receiving my booster I went to sleep. I was woken up with chest pain a few hours later but went back to bed. Two days after my booster while sitting at home I started feeling strong, frequent palpitations. The next day I went to urgent care and they recommended going to the ER but I was able to see a cardiologist immediately. After running tests he found I had developed an arrhythmia. I was having 11,000 PACs and 1,000 PVCs in 24 hours. I have been taking metoprolol since December and am still feeling palpitations. There were no other known causes for the palpitations.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Palpitations, Sleep disorder, Specialist consultation
Clinical narrative: When I got home after receiving my booster I went to sleep. I was woken up with chest pain a few hours later but went back to bed. Two days after my booster while sitting at home I started feeling strong, frequent palpitations. The next day I went to urgent care and they recommended going to the ER but I was able to see a cardiologist immediately. After running tests he found I had developed an arrhythmia. I was having 11,000 PACs and 1,000 PVCs in 24 hours. I have been taking metoprolol since December and am still feeling palpitations. There were no other known causes for the palpitations.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: When I got home after receiving my booster I went to sleep. I was woken up with chest pain a few hours later but went back to bed. Two days after my booster while sitting at home I started feeling strong, frequent palpitations. The next day I went to urgent care and they recommended going to the ER but I was able to see a cardiologist immediately. After running tests he found I had developed an arrhythmia. I was having 11,000 PACs and 1,000 PVCs in 24 hours. I have been taking metoprolol since December and am still feeling palpitations. There were no other known causes for the palpitations.
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Autoimmune disorder, Blood test, Disease susceptibility, Immune system disorder
Clinical narrative: Pt., age 15, received her second Pfizer dose 6/10/2021. On 6/11/2021 acute pain onset in her hip region that caused considerable pain when walking or climbing stairs. We made arrangements for her to come home early if needed from plans on Friday 6/11/2021. By Monday 6/14/2021 I sent a message on record to her pediatrician's office reporting the vaccine side effect and asking if we should be seen by them or a specialist. The pain never went away.  We visited the pediatrician for this issue; we were referred to physical therapy; we were escalated to sports medicine. Sports medicine took an MRI and blood test in November 2021 when the pain persisted.  We were referred to Hospital where pt. received a diagnosis of juvenile autoimmune spondyloarthropathy. Her immune system is attacking her joints and the vaccine was the environmental trigger for this genetic predisposition, as shown with the acute onset within <24 hours of the second vaccine dose. The pain just never went away after that date and is now a chronic condition.
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Magnetic resonance imaging, Pain, Sacroiliitis, Spondyloarthropathy
Clinical narrative: Pt., age 15, received her second Pfizer dose 6/10/2021. On 6/11/2021 acute pain onset in her hip region that caused considerable pain when walking or climbing stairs. We made arrangements for her to come home early if needed from plans on Friday 6/11/2021. By Monday 6/14/2021 I sent a message on record to her pediatrician's office reporting the vaccine side effect and asking if we should be seen by them or a specialist. The pain never went away.  We visited the pediatrician for this issue; we were referred to physical therapy; we were escalated to sports medicine. Sports medicine took an MRI and blood test in November 2021 when the pain persisted.  We were referred to Hospital where pt. received a diagnosis of juvenile autoimmune spondyloarthropathy. Her immune system is attacking her joints and the vaccine was the environmental trigger for this genetic predisposition, as shown with the acute onset within <24 hours of the second vaccine dose. The pain just never went away after that date and is now a chronic condition.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod bite, Erythema, Pruritus, Rash macular, Skin discolouration
Clinical narrative: 2 weeks later; I have developed hives all over my body.  Lesser on my arms but a few individual hives on wrists, arms, hands.  Some on the back on my scalp.  A few have ranged under my chin and neck area but the primary location tends to be the base of my spine, my hips, the back of my legs, groin/pelvic region, and thighs.  A few noted on calves, especially in the joint areas, behind the knees, elbows etc.  The largest masses of hives tend to be along the belt area and extend down the legs from there.  All are itchy and white/red depending on irritation.  Hives appear splotchy and grouped in satellites; few are individual hives.  Unbearably itchy.  Note: I don't see anywhere requesting blood type.  I am A+.  This feels much like my severe reactions to mosquito bites.  Same hives, same itch, just at a much larger scale.  I am postulating there is a correlation of people experiencing these same reactions with those of a certain blood type; and I'm guessing it's type A.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Skin irritation, Urticaria
Clinical narrative: 2 weeks later; I have developed hives all over my body.  Lesser on my arms but a few individual hives on wrists, arms, hands.  Some on the back on my scalp.  A few have ranged under my chin and neck area but the primary location tends to be the base of my spine, my hips, the back of my legs, groin/pelvic region, and thighs.  A few noted on calves, especially in the joint areas, behind the knees, elbows etc.  The largest masses of hives tend to be along the belt area and extend down the legs from there.  All are itchy and white/red depending on irritation.  Hives appear splotchy and grouped in satellites; few are individual hives.  Unbearably itchy.  Note: I don't see anywhere requesting blood type.  I am A+.  This feels much like my severe reactions to mosquito bites.  Same hives, same itch, just at a much larger scale.  I am postulating there is a correlation of people experiencing these same reactions with those of a certain blood type; and I'm guessing it's type A.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Mobility decreased, Pain
Clinical narrative: It has been almost 2 months and my left arm feels weird whenever I use my left arm. It feels like there is something stuck where I had the johnson shot. Its feels painful whenever I raise my arm. Its difficult to put on my shirt/top.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Anxiety, Fatigue, Glomerulonephritis, Hypoaesthesia, Loss of consciousness
Clinical narrative: In less than 24 hours the following happened 104 fever, seizures, body and mind numbness, unconsciousness,
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Mental impairment, Pyrexia, Seizure, Sepsis
Clinical narrative: In less than 24 hours the following happened 104 fever, seizures, body and mind numbness, unconsciousness,
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Lymphadenopathy, Menstruation irregular, Nausea
Clinical narrative: MY PERIOD GOT COMPLETELY MESSED UP.  BRAIN FOG. SWOLLEN LYMPH NODES . NAUSEA, HEADACHES
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Migraine, Vomiting
Clinical narrative: Throwing up x 1-week, Migraine x 1 week, Diarrhea v 2 weeks,  Cough,
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: 1) Onset of dermatographia, itching and full body hives (trunk, thighs, arms, primarily) 10 days after receiving Moderna booster shots.  2) Patient is healthy 24 male with no prior history of skin issues.  No allergies and history of chronic hives.  No existing chronic conditions or medications taken at time of booster as well. 3) Reactions to first and second doses were unremarkable and within expected guidelines - eg. Fatigue, low fever, muscle pain that resolved within 24hours.  4) Patient is still suffering chronic hives 6 weeks after onset with little sign of symptoms resolving naturally.   Symptoms are kept in check with antihistamines and vitamin D supplements, but patient is very dependent on above medications for relief.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Four inch diameter circular redness, swelling at injection site
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Sleep disorder, Urticaria
Clinical narrative: Got my first 2 Moderna shots and had no adverse reaction. Then over 6 months late I got my Moderna booster. At first I did not have an adverse reactions. Then about 12 days later my scalp started itching uncontrollably. Then my back was itching? then my neck? then everywhere. I was itching and scratching so much I could not sleep. I took an allergy pill and it subsided. Then it came back the next day. I took another allergy pill. I thought it would go away but now it?s two weeks and I?m uncontrollably scratching everywhere and I have chronic urticaria and dermatographia with no end in sight.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Angiogram cerebral, Arteriogram carotid, Cardiolipin antibody, Computerised tomogram head
Clinical narrative: On 2/5, day after I had the 1st dose of the Pfizer Covid-19 Vaccine, I noticed that the bottom right portion on my left eye has a black shadow.   I cannot see anything around that area.     I immediately went to see an ophthalmologist  at the Institute.  He initially ruled out any detachment issue and he assumed that it might be due to inflammation or stress caused by the vaccine.    On the following Monday, 2/7, since my condition was not improved, I went to see the doctor again.   He realized that my condition was getting worse and mentioned to me that there is a branch retinal artery occlusion found on my left eye.   He asked me to seek medical care immediately since he cannot determine if it is related to stroke.   He wrote me a note and I then went to Urgent Care.  At the urgent care, they started conduct various tests to see whether I might have a stroke.   I spent a night at the hospital since they need to conduct more tests overnight.    I was release from the hospital on 2/8.   After conducting all the tests, they ruled out the possibility of stroke.   At the time of this report, my left eye is still blocked and all the medical experts I met say that I am a very healthy individual and the cause of the vision impaired is unknown to them.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine, Differential white blood cell count, Electrocardiogram, Full blood count, Glycosylated haemoglobin
Clinical narrative: On 2/5, day after I had the 1st dose of the Pfizer Covid-19 Vaccine, I noticed that the bottom right portion on my left eye has a black shadow.   I cannot see anything around that area.     I immediately went to see an ophthalmologist  at the Institute.  He initially ruled out any detachment issue and he assumed that it might be due to inflammation or stress caused by the vaccine.    On the following Monday, 2/7, since my condition was not improved, I went to see the doctor again.   He realized that my condition was getting worse and mentioned to me that there is a branch retinal artery occlusion found on my left eye.   He asked me to seek medical care immediately since he cannot determine if it is related to stroke.   He wrote me a note and I then went to Urgent Care.  At the urgent care, they started conduct various tests to see whether I might have a stroke.   I spent a night at the hospital since they need to conduct more tests overnight.    I was release from the hospital on 2/8.   After conducting all the tests, they ruled out the possibility of stroke.   At the time of this report, my left eye is still blocked and all the medical experts I met say that I am a very healthy individual and the cause of the vision impaired is unknown to them.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza A virus test, Influenza B virus test, Lipids, Magnetic resonance imaging head, Metabolic function test
Clinical narrative: On 2/5, day after I had the 1st dose of the Pfizer Covid-19 Vaccine, I noticed that the bottom right portion on my left eye has a black shadow.   I cannot see anything around that area.     I immediately went to see an ophthalmologist  at the Institute.  He initially ruled out any detachment issue and he assumed that it might be due to inflammation or stress caused by the vaccine.    On the following Monday, 2/7, since my condition was not improved, I went to see the doctor again.   He realized that my condition was getting worse and mentioned to me that there is a branch retinal artery occlusion found on my left eye.   He asked me to seek medical care immediately since he cannot determine if it is related to stroke.   He wrote me a note and I then went to Urgent Care.  At the urgent care, they started conduct various tests to see whether I might have a stroke.   I spent a night at the hospital since they need to conduct more tests overnight.    I was release from the hospital on 2/8.   After conducting all the tests, they ruled out the possibility of stroke.   At the time of this report, my left eye is still blocked and all the medical experts I met say that I am a very healthy individual and the cause of the vision impaired is unknown to them.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Pregnancy test urine, Prothrombin time, Renal function test, Retinal artery occlusion
Clinical narrative: On 2/5, day after I had the 1st dose of the Pfizer Covid-19 Vaccine, I noticed that the bottom right portion on my left eye has a black shadow.   I cannot see anything around that area.     I immediately went to see an ophthalmologist  at the Institute.  He initially ruled out any detachment issue and he assumed that it might be due to inflammation or stress caused by the vaccine.    On the following Monday, 2/7, since my condition was not improved, I went to see the doctor again.   He realized that my condition was getting worse and mentioned to me that there is a branch retinal artery occlusion found on my left eye.   He asked me to seek medical care immediately since he cannot determine if it is related to stroke.   He wrote me a note and I then went to Urgent Care.  At the urgent care, they started conduct various tests to see whether I might have a stroke.   I spent a night at the hospital since they need to conduct more tests overnight.    I was release from the hospital on 2/8.   After conducting all the tests, they ruled out the possibility of stroke.   At the time of this report, my left eye is still blocked and all the medical experts I met say that I am a very healthy individual and the cause of the vision impaired is unknown to them.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Troponin I, Urine analysis, Visual impairment
Clinical narrative: On 2/5, day after I had the 1st dose of the Pfizer Covid-19 Vaccine, I noticed that the bottom right portion on my left eye has a black shadow.   I cannot see anything around that area.     I immediately went to see an ophthalmologist  at the Institute.  He initially ruled out any detachment issue and he assumed that it might be due to inflammation or stress caused by the vaccine.    On the following Monday, 2/7, since my condition was not improved, I went to see the doctor again.   He realized that my condition was getting worse and mentioned to me that there is a branch retinal artery occlusion found on my left eye.   He asked me to seek medical care immediately since he cannot determine if it is related to stroke.   He wrote me a note and I then went to Urgent Care.  At the urgent care, they started conduct various tests to see whether I might have a stroke.   I spent a night at the hospital since they need to conduct more tests overnight.    I was release from the hospital on 2/8.   After conducting all the tests, they ruled out the possibility of stroke.   At the time of this report, my left eye is still blocked and all the medical experts I met say that I am a very healthy individual and the cause of the vision impaired is unknown to them.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Vomiting projectile
Clinical narrative: Severe projectile vomiting lasting so far 5 hoyrs, dehydration
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Gait disturbance, General physical health deterioration
Clinical narrative: Gradual decline of health, particularly around unbalanced gait/dizzyness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Lymphadenopathy
Clinical narrative: Severe headache, body aches, nausea, dizziness, stiff neck, chills alternating with sweats all lasted 36+ hours. Swollen lymph nodes began after about 18 hours and continued 48 hours+ post-vaccination. Sore arm began after about 3 hours and persisted 48+ hours post-vaccination. Treated with Tylenol and Ibuprofen and a full day of bed rest.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pain in extremity
Clinical narrative: Severe headache, body aches, nausea, dizziness, stiff neck, chills alternating with sweats all lasted 36+ hours. Swollen lymph nodes began after about 18 hours and continued 48 hours+ post-vaccination. Sore arm began after about 3 hours and persisted 48+ hours post-vaccination. Treated with Tylenol and Ibuprofen and a full day of bed rest.
Sex: U
Vaccine: MMR
Symptoms: Arm amputation, Biopsy skin abnormal, Granuloma skin, Rubella, Skin infection
Clinical narrative: non-necrotizing (M-type) skin granuloma; Literature Report:   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 17 year old patient of unknown gender. On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, the patient experienced non-necrotizing (M-type) skin granuloma. Three skin biopsies of right index finger were positive for iVDRV. The patient was treated with nitazoxanide, however it failed to clear RuV cutaneous infection.  The patient was also treated with TNF alpha antagonist (etanercept, adalimumab, infliximab) with no improvement. The patient underwent upper limb amputation. Rubella serology showed persistent RuV IgM antibody.At the time of the report, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (2202USA004885, 2202USA004886, 2202USA004887, 2202USA004888 and 2202USA004889).; Sender's Comments:  US-009507513-2202USA004885: US-009507513-2202USA004886: US-009507513-2202USA004887: US-009507513-2202USA004888: US-009507513-2202USA004889:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Fluid intake reduced, SARS-CoV-2 test negative
Clinical narrative: patient drank less fluid, patient refused to drink; This spontaneous report was received from the physician and refers to a 12-month-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Vitamin D.   On 22-DEC-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #U019286, expiration date: 15-DEC-2022, administered subcutaneously for prophylaxis (strength and site of administration was not provided). Albumin status for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) has been verified as recombinant human albumin (rHA)  On the night of 22-DEC-2021, the patient's mother noted that the patient drank less fluid, and on 23-DEC-2021 the patient refused to drink (considered as fluid intake reduced). The patient was still eating during this time. The patient's mother called the physician's office on 28-DEC-2021 because the patient still refused to drink. The physician saw the patient in the office on 28-DEC-2021, gave her "PEDIALYTE" for oral rehydration, and sent the patient home. The physician said the patient was seen again in the office the morning of 29-DEC-2021, and she continued to refuse to drink. The physician tested the patient for Covid on 29-DEC-2021, and the result was negative. The physician explained the patient started to drink more throughout the day on 29-DEC-2021. The physician reported the patient was fine and back to regular fluid intake on 30-DEC-2021. On that day, the patient recovered from the event fluid intake reduced. No additional information was provided.  The causal relationship between the event of fluid intake reduced and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Crying, Hypersensitivity, Malaise, Tongue pruritus
Clinical narrative: allergic reaction; Itching in the tongue; White blisters; General malaise; the child was crying; This spontaneous report was received from a consumer via Pfizer, regarding to a 4-year-old female patient. The patient's medical history, concomitant medication and drug reactions or allergies were not provided.   On an unspecified date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(manufacturer unknown) for prophylaxis (strength, dose, frequency, route, anatomical location, lot # and expiration date were not provided). Also the patient received an unspecified measles vaccine.     On an unspecified date, the patient experienced a severe allergic reaction (hypersensitivity). Also, since the vaccination, when the patient ate some things, she developed itching in the tongue (itching), white blister (blister), general malaise (malaise). Additionally, since an unspecified date, the patient was crying (crying). By the time of report, the outcome of severe allergic reaction, crying, malaise, blister and tongue pruritus was unknown.  The reporter did not assess the relatedness between the severe allergic reaction, crying, malaise, blister and tongue pruritus and varicella virus vaccine live (oka/merck)(manufacturer unknown).
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac disorder, Herpes zoster, Nervous system disorder, Post herpetic neuralgia
Clinical narrative: Cardiac issues; Neurological issues; Postherpetic neuralgia; Herpes zoster; Information has been received regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX), for routine health maintenance and for its intended purpose: for the prevention of shingles (herpes zoster) (strength, dose, anatomical location, route of administration, lot number and expiration date were not provided). After receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, postherpetic neuralgia, cardiac issues and neurologic issues. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the symptoms have resulted in physical limitations not presented prior to using the company's product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result of the company's conduct, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster, postherpetic neuralgia, cardiac disorder, and nervous system disorder was not recovered and the causality assessment between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  The lawyer considered the events herpes zoster, postherpetic neuralgia, cardiac disorder, and nervous system disorder to be disabling.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No other AE; A dose was administered to a patient after a temperature excursion; This spontaneous report was received from nurse practitioner and refers to a patient on unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the vaccine was under temperature excursion with a temperature of 0.5°C for 168 hours. Previous to this, there was no temperature excursion.   On 24-JAN-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1dose administered for prophylaxis (strength, and route of administration were not provided; lot #1775808, has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) , expiration date reported as 31-AUG-2022, but upon internal validation established as20-AUG-2023). No adverse events were reported.; Sender's Comments:  US-009507513-2202USA003856: US-009507513-2202USA003818:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; A dose was administered to a patient after a temperature excursion; This spontaneous report was received from nurse practitioner and refers to a patient on unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date, the vaccine was under temperature excursion with a temperature of 0.5°C for 168 hours. Previous to this, there was no temperature excursion.   On 24-JAN-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose administered for prophylaxis (strength, and route of administration were not provided; lot #U008315 with an expiration date of 15-AUG-2023). No adverse events were reported.; Sender's Comments:  US-009507513-2202USA003842: US-009507513-2202USA003818:
Sex: U
Vaccine: MMR
Symptoms: Granuloma skin
Clinical narrative: non-necrotizing (M-type) skin granuloma; Literature Report:  This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 12 year old patient of unknown gender with hemophagocytic lymphohistiocytosis (HLH). On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route not reported).         Rubella virus (RuV) has recently been found in association with granulomatous inflammation of the skin and several internal organs in patients with inborn errors of immunity (IEI). Several cases of IEI with granuloma formation have recently been identified in association with RuV vaccine strain RA27/3. Infectious immunodeficiency-related vaccine-derived rubella viruses (iVDRV) were isolated from granuloma biopsies and sequenced. Cutaneous granulomas are the most frequent manifestation diagnosed, but other organs including the liver, spleen, and lungs can also be affected. The aim of this study was to examine Rubella virus (RuV)-associated granulomas from 28 patients with inborn and acquired errors of immunity to determine whether specific inflammatory patterns localize to certain tissue sites or are associated with clinical characteristics.  On an unknown date, soon after vaccination, the patient experienced non-necrotizing (M-type) skin granuloma. Nasopharyngeal swab was positive for iVDRV. At the time of the report, the patient's outcome was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of six reports received from the same article (MARRS 2201USA004372, 2202USA004886, 2202USA004887, 2202USA004888 and 2202USA004889).; Sender's Comments:  US-009507513-2201USA004372: