chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthyroidism, Myalgia, Myocardial necrosis marker normal, Peripheral swelling, Pyrexia
Clinical narrative: First symptom was swelling of legs/feet on 10/30/2021. This was followed low grade fever, some muscle aches, some shortness of breath, increased heart rate. Saw internist on 11/09/2021 and she ordered ultrasound of legs and blood work. Blood work from 11/11/2021 came back 11/12/2021 indicating hyperthyroidism. Heart rate increased and patient concerned that atrial fibrillation may develop. Went to ER on 11/14/21. No atrial fibrillation but cardiac enzyme troponin was borderline elevated. Rx given of propanolol to decrease heart rate and thyroid activity. Admitted. Follow up troponin in hospital normal. Thyroid and heart ultrasounds, and radioiodine uptake and scan performed while in hospital and after discharge (on 11/15/2021). Grave's disease diagnosed and Methimazole prescribed on 11/22/21.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Scan, Troponin normal, Ultrasound thyroid
Clinical narrative: First symptom was swelling of legs/feet on 10/30/2021. This was followed low grade fever, some muscle aches, some shortness of breath, increased heart rate. Saw internist on 11/09/2021 and she ordered ultrasound of legs and blood work. Blood work from 11/11/2021 came back 11/12/2021 indicating hyperthyroidism. Heart rate increased and patient concerned that atrial fibrillation may develop. Went to ER on 11/14/21. No atrial fibrillation but cardiac enzyme troponin was borderline elevated. Rx given of propanolol to decrease heart rate and thyroid activity. Admitted. Follow up troponin in hospital normal. Thyroid and heart ultrasounds, and radioiodine uptake and scan performed while in hospital and after discharge (on 11/15/2021). Grave's disease diagnosed and Methimazole prescribed on 11/22/21.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Patient was discharged after (4) day inpatient admission. Fully vaccinated patient with COPD who developed covid pneumonia.He received remdesivir and steroids and had a milder course, although his oxygen requirements increased from his baseline of 3 l. His admission was complicated by exacerbation of COPD, and his baseline CHF, CAD, CKD, PUD. He as close to baseline on discharge.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child was brought to school w/ concent form signed  by parent and and proxy by vice-principal to be vaccinated with covid 19 vaccine Pfizer 12 year old and older .  Pt was vaccinated.  Pt is 11 years  and 11 months old.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test abnormal, Arthritis, Aspiration pleural cavity, Atrial fibrillation, Biopsy pericardium abnormal
Clinical narrative: Headache, severe night sweats, fever. Diagnosed Multisystem inflammatory syndrome based on pericardial effusion, pleural effusions, myocarditis (a. fib). and arthritis. Pericardial window with biosy and bilateral thoracentesis done. Multiple medications started, including high dose prednisone, leading to steroid myositis, fascial shingles, and opportunistic infection with presumed nocardia (lung and brain). Total 6 hospitalizations (39 nights). Recent partial, sensory seizure from residual frontal lobe abscess. Multiple COVID rapid, PCR and antibody tests from 9/10/2020 to 8/30/2021 have all been negative. Vaccine generated antibodies high at 225 on 8/30/2021.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Brain abscess, Headache, Herpes zoster, Laboratory test, Multisystem inflammatory syndrome
Clinical narrative: Headache, severe night sweats, fever. Diagnosed Multisystem inflammatory syndrome based on pericardial effusion, pleural effusions, myocarditis (a. fib). and arthritis. Pericardial window with biosy and bilateral thoracentesis done. Multiple medications started, including high dose prednisone, leading to steroid myositis, fascial shingles, and opportunistic infection with presumed nocardia (lung and brain). Total 6 hospitalizations (39 nights). Recent partial, sensory seizure from residual frontal lobe abscess. Multiple COVID rapid, PCR and antibody tests from 9/10/2020 to 8/30/2021 have all been negative. Vaccine generated antibodies high at 225 on 8/30/2021.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Myositis, Night sweats, Nocardiosis, Opportunistic infection
Clinical narrative: Headache, severe night sweats, fever. Diagnosed Multisystem inflammatory syndrome based on pericardial effusion, pleural effusions, myocarditis (a. fib). and arthritis. Pericardial window with biosy and bilateral thoracentesis done. Multiple medications started, including high dose prednisone, leading to steroid myositis, fascial shingles, and opportunistic infection with presumed nocardia (lung and brain). Total 6 hospitalizations (39 nights). Recent partial, sensory seizure from residual frontal lobe abscess. Multiple COVID rapid, PCR and antibody tests from 9/10/2020 to 8/30/2021 have all been negative. Vaccine generated antibodies high at 225 on 8/30/2021.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Partial seizures, Pericardial effusion, Pericardial excision, Pleural effusion, Pyrexia
Clinical narrative: Headache, severe night sweats, fever. Diagnosed Multisystem inflammatory syndrome based on pericardial effusion, pleural effusions, myocarditis (a. fib). and arthritis. Pericardial window with biosy and bilateral thoracentesis done. Multiple medications started, including high dose prednisone, leading to steroid myositis, fascial shingles, and opportunistic infection with presumed nocardia (lung and brain). Total 6 hospitalizations (39 nights). Recent partial, sensory seizure from residual frontal lobe abscess. Multiple COVID rapid, PCR and antibody tests from 9/10/2020 to 8/30/2021 have all been negative. Vaccine generated antibodies high at 225 on 8/30/2021.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative, Temporal lobe epilepsy
Clinical narrative: Headache, severe night sweats, fever. Diagnosed Multisystem inflammatory syndrome based on pericardial effusion, pleural effusions, myocarditis (a. fib). and arthritis. Pericardial window with biosy and bilateral thoracentesis done. Multiple medications started, including high dose prednisone, leading to steroid myositis, fascial shingles, and opportunistic infection with presumed nocardia (lung and brain). Total 6 hospitalizations (39 nights). Recent partial, sensory seizure from residual frontal lobe abscess. Multiple COVID rapid, PCR and antibody tests from 9/10/2020 to 8/30/2021 have all been negative. Vaccine generated antibodies high at 225 on 8/30/2021.
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Arthralgia, Injection site pain, Nausea, Neck pain, Pain
Clinical narrative: # 8-10 for pain to injection site -> R deltoid radiating to R neck / R wrist / Fingers. Also with nausea/vomiting x's
Age: 59.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pain in extremity, Vomiting
Clinical narrative: # 8-10 for pain to injection site -> R deltoid radiating to R neck / R wrist / Fingers. Also with nausea/vomiting x's
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: May be due to incorrect temperature that the vaccine was stored @ the time of  administration of vaccine
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Full blood count, Metabolic function test, Nausea, Vomiting
Clinical narrative: Patient was fine in clinic - Had Epipen with her. at noon she was in urgent care with chest pains, nausea vomiting - at 6:34 ED - Epi drip Patient has prior Influenza alergic reactions PPD alergic reaction Patient came with Epi pen, was observed for 20 mins after with no problems Returned to work.  Reaction happened after returning to work
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Patient was given 0.2 ml  of undiluted pfizer vaccine
Age: 1.08
Sex: M
Vaccine: FLU4, FLU4, MMR, PNC13, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine Administered 10 days to early.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: May be due to incorrect temperature that the vaccine was stored @ the time of  administration of vaccine
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: May be due to incorrect temperature that the vaccine was stored @ the time of administration of vaccine
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: May be due to incorrect temperature that the  vaccine was stored @ the time of  administrating vaccine
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: May be due to incorrect temperature that the vaccine was stored @ the time of administration of vaccine
Age: 42.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Unevaluable event
Clinical narrative: May be due to incorrect temperature that the vaccine was stored @ the time of administering vaccine
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: May be due to incorrect temperature that the vaccine was stored @ the time of  administration of vaccine
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: May be dur to incorrect temperature that the vaccine was stored @ the time of administration of vaccine
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: May be due to incorrect temperature that the vaccine was stored @ the time of administration of vaccine
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Concussion, Fall, Fatigue, Headache
Clinical narrative: Syncope Resulting in major concussion 90-year-old female with past medical history significant for hypertension, type 2 diabetes, osteoarthritis, dementia who presented to the emergency room by EMS after having a ground-level fall at nursing home. Does have mild dementia per the facility report. The patient does not remember the fall. EMS did report that the patient was ambulatory upon their arrival to the facility. The patient is alert and oriented x3. She does complain of a headache and bilateral knee pain. She denies any vision changes. She denies any fever, chills, shortness of breath, chest pain, nausea or vomiting. During my bedside evaluation I observed patient resting no distress. She appears very fatigued and complains of pain at the site of her scalp laceration in the occipital area. Daughter who is a retired nurse present at bedside supplemented the history. Patient does not recall the event. Daughter was in patient's room when she fell. Patient was walking back eating dinner to her room. She ambulates without assistance. Nothing similar to this has happened before. Daughter stated she was on the ground 10 seconds approximately before she woke up. Daughter clarified that patient is a DO NOT RESUSCITATE/allow natural death
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Skin laceration, Syncope
Clinical narrative: Syncope Resulting in major concussion 90-year-old female with past medical history significant for hypertension, type 2 diabetes, osteoarthritis, dementia who presented to the emergency room by EMS after having a ground-level fall at nursing home. Does have mild dementia per the facility report. The patient does not remember the fall. EMS did report that the patient was ambulatory upon their arrival to the facility. The patient is alert and oriented x3. She does complain of a headache and bilateral knee pain. She denies any vision changes. She denies any fever, chills, shortness of breath, chest pain, nausea or vomiting. During my bedside evaluation I observed patient resting no distress. She appears very fatigued and complains of pain at the site of her scalp laceration in the occipital area. Daughter who is a retired nurse present at bedside supplemented the history. Patient does not recall the event. Daughter was in patient's room when she fell. Patient was walking back eating dinner to her room. She ambulates without assistance. Nothing similar to this has happened before. Daughter stated she was on the ground 10 seconds approximately before she woke up. Daughter clarified that patient is a DO NOT RESUSCITATE/allow natural death
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Complex regional pain syndrome, Condition aggravated, Fibula fracture
Clinical narrative: I have had Complex Regional Pain Syndrome (CRPS) for 20 years (in remission for 18 years) until a  broken tibia and fibula  in my left ankle/leg in the late 1990's. I have a Medtroinic Pain Pump 24/7 to  deal with the pain.  Following my second COVID-19 vaccine, my body interpreted the shot as an injury which it reacted to by triggering my CRPS to kick back in. In the right arm where the vaccine was given, I had tremndous pain that traveled to my right shoulder and this pain has not gone away since that vaccine on 02/11/2021. I sought medical advise about whether or Not to take the BOOSTER given my reaction to the second vaccine. It was determined that the risks of getting COVID were greater than taking the BOOSTER,
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tibia fracture
Clinical narrative: I have had Complex Regional Pain Syndrome (CRPS) for 20 years (in remission for 18 years) until a  broken tibia and fibula  in my left ankle/leg in the late 1990's. I have a Medtroinic Pain Pump 24/7 to  deal with the pain.  Following my second COVID-19 vaccine, my body interpreted the shot as an injury which it reacted to by triggering my CRPS to kick back in. In the right arm where the vaccine was given, I had tremndous pain that traveled to my right shoulder and this pain has not gone away since that vaccine on 02/11/2021. I sought medical advise about whether or Not to take the BOOSTER given my reaction to the second vaccine. It was determined that the risks of getting COVID were greater than taking the BOOSTER,
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Dizziness
Clinical narrative: Started to experience a stabbing pain from back between shoulder blades through to heart area several  times, short of breath, fatigue, dizziness, heart palpitations . Patient did have a Bypass  Surgery in August 20, 2021 however his Drs felt this was to far out to experience Pericarditis like he was diagnosed with recently.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Fatigue, Musculoskeletal pain
Clinical narrative: Started to experience a stabbing pain from back between shoulder blades through to heart area several  times, short of breath, fatigue, dizziness, heart palpitations . Patient did have a Bypass  Surgery in August 20, 2021 however his Drs felt this was to far out to experience Pericarditis like he was diagnosed with recently.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, SARS-CoV-2 test
Clinical narrative: Started to experience a stabbing pain from back between shoulder blades through to heart area several  times, short of breath, fatigue, dizziness, heart palpitations . Patient did have a Bypass  Surgery in August 20, 2021 however his Drs felt this was to far out to experience Pericarditis like he was diagnosed with recently.
Age: 7.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Device connection issue, Exposure via skin contact, Needle issue, Underdose
Clinical narrative: While administering the COVID vax 5-11 yr the parents were attempting to hold the patient but he was able to jerk loose. He jerked so forcefully that the syringe came loose from the needle. There were a few small drops of vaccine that leaked down arm. Syringe was noted to be empty so I believe at least 75% or more of volume was delivered. I discussed the situation with the parents and they did not think that redosing was necessary at this time. I agreed. I put a note in the patients chart that extra staff will be needed for suture shots to help provide comfort and safe holds.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acrochordon, Amnesia, Asthenia, Chills, Confusional state
Clinical narrative: 1) 3rd dose (booster) Moderna administered (See VAERS ID: 1463411) a) within 6-8 hours of the 2nd vaccine: i) Dizziness. ii) Slight nausea. iii) Moderate soreness at injection site iv) Muscle aches v) Weakness, difficult to lift injected arm vi) mental confusion, difficult to concentrate. b0 After 8 hours post 3rd vaccine / overnight: i) Chills / moderate but uncontrollable shaking / teeth chattering. iii) Extreme Thirst. iii) Moderate headache. iv) Tinnitus c) 11/21/21: Three weeks post booster: i) Skin tags are emerging in "sweat" areas and along Lymph lines on neck, chest & upper arms. 11) Continue to experience mild memory loss and confusion
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: 1) 3rd dose (booster) Moderna administered (See VAERS ID: 1463411) a) within 6-8 hours of the 2nd vaccine: i) Dizziness. ii) Slight nausea. iii) Moderate soreness at injection site iv) Muscle aches v) Weakness, difficult to lift injected arm vi) mental confusion, difficult to concentrate. b0 After 8 hours post 3rd vaccine / overnight: i) Chills / moderate but uncontrollable shaking / teeth chattering. iii) Extreme Thirst. iii) Moderate headache. iv) Tinnitus c) 11/21/21: Three weeks post booster: i) Skin tags are emerging in "sweat" areas and along Lymph lines on neck, chest & upper arms. 11) Continue to experience mild memory loss and confusion
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Thirst, Tinnitus, Tremor
Clinical narrative: 1) 3rd dose (booster) Moderna administered (See VAERS ID: 1463411) a) within 6-8 hours of the 2nd vaccine: i) Dizziness. ii) Slight nausea. iii) Moderate soreness at injection site iv) Muscle aches v) Weakness, difficult to lift injected arm vi) mental confusion, difficult to concentrate. b0 After 8 hours post 3rd vaccine / overnight: i) Chills / moderate but uncontrollable shaking / teeth chattering. iii) Extreme Thirst. iii) Moderate headache. iv) Tinnitus c) 11/21/21: Three weeks post booster: i) Skin tags are emerging in "sweat" areas and along Lymph lines on neck, chest & upper arms. 11) Continue to experience mild memory loss and confusion
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: No abnormal side effects - sore arm (given tylenol by mother) *given adult dose
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Headache
Clinical narrative: Left breat pain-continuous Headache-4-6 days post covid vaccine injection Chest pain-Infrequently but present
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Dyspnoea
Clinical narrative: Patient states he got the vaccine and one hour later he felt like someone had hit him in the chest. States he had shortness of breath and heart flutters. He has had them for the last 2 weeks.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Loss of consciousness, Pain, Pyrexia
Clinical narrative: Dizzyness Passing out fever 103° headache body aches
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Phlebitis, Thrombophlebitis
Clinical narrative: covid booster given 11/12 then to ER 11/16 for right leg pain, redness and diagnosed with phelebitis  and thrombophlebitis right lower extremity
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Within 36 hours of receiving the vaccine, a few pink/red spots (1/4-3/8 inch) appeared on my lower legs/feet. They were not itchy. Within a week, I had many flat spots covering my legs and one on top of my right foot had formed a 2-inch diameter, 1/4 inch thick, hard and sore lump under the skin (unlike any of the other spots). A scab formed there too. I also noticed my right foot was puffy and sore on top. It took a very long time for the lump and scab on my foot heal. Months later I still have dark scars on my feet. Most of the sports start pink, go purple, then to fade with yellow like a bruise. Initially I thought I had flea bites, and I hoped the condition would go away on its own, but it did not. (Continued.)
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Scab, Skin discolouration, Skin mass
Clinical narrative: Within 36 hours of receiving the vaccine, a few pink/red spots (1/4-3/8 inch) appeared on my lower legs/feet. They were not itchy. Within a week, I had many flat spots covering my legs and one on top of my right foot had formed a 2-inch diameter, 1/4 inch thick, hard and sore lump under the skin (unlike any of the other spots). A scab formed there too. I also noticed my right foot was puffy and sore on top. It took a very long time for the lump and scab on my foot heal. Months later I still have dark scars on my feet. Most of the sports start pink, go purple, then to fade with yellow like a bruise. Initially I thought I had flea bites, and I hoped the condition would go away on its own, but it did not. (Continued.)
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: The pharmacist that gave the shot I questioned her if she was giving the correct dose for my 7 year old and she said yeah, but the needle used before was a total of about 5 inches this one was about a 4 inch needle & 4 inch vial it was huge with quite a bit of med in val. So she gives my daughter the shot and when she pulled the needle out it made a loud popping noise and a good amount of blood which has never happened before.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: two hours after injection I started elevated heart ratej-irregular and strong.  After one hour it was  97 BPM, still sirone and a bit strong and a bit irregular. after another half hour it return to a regular beat and soft  like normal and has been fine ever since.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Limb discomfort, Lymphadenopathy, Oedema peripheral
Clinical narrative: Large, lemon-size lump in left armpit area.  Painful and uncomfortable.  Large lymph nodes in left  neck.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I gave Covid vaccine shot to under age minors 4 yrs old discovered it when I wanted to input in the tablet and did not except patient due to under age and wrong birthday on this consent sign by the parent. He did not eligible to receive it.
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Client was given 3rd dose of Pfizer Covid 19 vaccine
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling of body temperature change, Gait disturbance, Headache
Clinical narrative: I felt tired and had a slight headache the day after the injection, hot and cold, mabe fever? About 48 hrs after the injection I felt very dizzy and went to bed. At hour 60 upon wakening I had extreme vertigo. I  felt as if I would pas out unless laying down. Each time I got up I could not walk straight and had to hold on to the walls. I felt slightly nauseated. This vertigo was very different from the "normal" BPPV I have  experienced over a dozen times. The vertigo episodes I normally get resolve a bit when I am sitting or standing and get worse when I lay down. This vertigo was the opposite. I couldn't stand up or walk with any feeling of control/safety. By the 5th day I felt tired, but had no vertigo or nausea.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vertigo
Clinical narrative: I felt tired and had a slight headache the day after the injection, hot and cold, mabe fever? About 48 hrs after the injection I felt very dizzy and went to bed. At hour 60 upon wakening I had extreme vertigo. I  felt as if I would pas out unless laying down. Each time I got up I could not walk straight and had to hold on to the walls. I felt slightly nauseated. This vertigo was very different from the "normal" BPPV I have  experienced over a dozen times. The vertigo episodes I normally get resolve a bit when I am sitting or standing and get worse when I lay down. This vertigo was the opposite. I couldn't stand up or walk with any feeling of control/safety. By the 5th day I felt tired, but had no vertigo or nausea.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives 24hrs after vacination
Sex: F
Vaccine: DTAP, MMRV, PNC, DTAP, MMRV, PNC
Symptoms: Guillain-Barre syndrome
Clinical narrative: hospitalized and diagnosed with Guillian Barre Syndrome; This spontaneous report was received from a consumer and refers to a 15-month-old female patient.  The patient's medical history was not reported. Concomitant therapies were not reported.  On 20-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 7v (crm197) (PREVNAR), administered for immunisation (dose, strength, formulation, lot #, expiry date, and route of administration were not provided); and  diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DAPTACEL), administered for immunisation (dose, strength, formulation, lot #, expiry date, and route of administration were not provided).  The patient was hospitalized and diagnosed with Guillian Barre Syndrome on 20-JAN-2023 after receiving vaccines.   This event was assessed as medically significant, and patient was hospitalized due to this event. The patient sought medical attention. At the time of reporting, the outcome of the event was unknown.  The causal relationship between the event and suspect vaccines was not provided.  Upon internal review, the event Guillian Barre Syndrome was determined to be medically significant. This event was assessed as medically significant, and patient was hospitalized due to this event.
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: C-reactive protein increased, Chest discomfort, Computerised tomogram thorax normal, Dyspnoea, Echocardiogram
Clinical narrative: On  3/10 began having soreness on Right Arm. Noted to have a clementine sized area of erythema and swelling with shortness of breath rest.  Heart Rate was 124 at that time. Also experienced chills with no fever. PCP was contacted and was told to monitor overnight. On 3/11 in the morning was having trouble standing up and experiencing shortness of breath and nausea. Chest felt uncomfortable. Her right shoulder was hurting. At this time, PCP was contacted again and was instructed to go to the ER. ER did ekg, CT, echocardiogram  and bloodwork. Toponin level was elevated - 0.11, 0.14, and 0.08. CRP was elelvated at 84, ESR elevated at 31, and D-dimer elevated at 832. CBC, CMP, urine drug screen, CT, and EKG all normal .
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Electrocardiogram, Fatigue, Fibrin D dimer increased, Palpitations, Red blood cell sedimentation rate increased
Clinical narrative: On  3/10 began having soreness on Right Arm. Noted to have a clementine sized area of erythema and swelling with shortness of breath rest.  Heart Rate was 124 at that time. Also experienced chills with no fever. PCP was contacted and was told to monitor overnight. On 3/11 in the morning was having trouble standing up and experiencing shortness of breath and nausea. Chest felt uncomfortable. Her right shoulder was hurting. At this time, PCP was contacted again and was instructed to go to the ER. ER did ekg, CT, echocardiogram  and bloodwork. Toponin level was elevated - 0.11, 0.14, and 0.08. CRP was elelvated at 84, ESR elevated at 31, and D-dimer elevated at 832. CBC, CMP, urine drug screen, CT, and EKG all normal .
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Troponin increased
Clinical narrative: On  3/10 began having soreness on Right Arm. Noted to have a clementine sized area of erythema and swelling with shortness of breath rest.  Heart Rate was 124 at that time. Also experienced chills with no fever. PCP was contacted and was told to monitor overnight. On 3/11 in the morning was having trouble standing up and experiencing shortness of breath and nausea. Chest felt uncomfortable. Her right shoulder was hurting. At this time, PCP was contacted again and was instructed to go to the ER. ER did ekg, CT, echocardiogram  and bloodwork. Toponin level was elevated - 0.11, 0.14, and 0.08. CRP was elelvated at 84, ESR elevated at 31, and D-dimer elevated at 832. CBC, CMP, urine drug screen, CT, and EKG all normal .
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Arthralgia, Blood test, C-reactive protein increased, Chest discomfort, Chills
Clinical narrative: On  3/10 began having soreness on Right Arm. Noted to have a clementine sized area of erythema and swelling with shortness of breath rest.  Heart Rate was 124 at that time. Also experienced chills with no fever. PCP was contacted and was told to monitor overnight. On 3/11 in the morning was having trouble standing up and experiencing shortness of breath and nausea. Chest felt uncomfortable. Her right shoulder was hurting. At this time, PCP was contacted again and was instructed to go to the ER. ER did ekg, CT, echocardiogram  and bloodwork. Toponin level was elevated - 0.11, 0.14, and 0.08. CRP was elelvated at 84, ESR elevated at 31, and D-dimer elevated at 832. CBC, CMP, urine drug screen, CT, and EKG all normal .
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Computerised tomogram normal, Drug screen negative, Dyspnoea, Dyspnoea at rest, Dysstasia
Clinical narrative: On  3/10 began having soreness on Right Arm. Noted to have a clementine sized area of erythema and swelling with shortness of breath rest.  Heart Rate was 124 at that time. Also experienced chills with no fever. PCP was contacted and was told to monitor overnight. On 3/11 in the morning was having trouble standing up and experiencing shortness of breath and nausea. Chest felt uncomfortable. Her right shoulder was hurting. At this time, PCP was contacted again and was instructed to go to the ER. ER did ekg, CT, echocardiogram  and bloodwork. Toponin level was elevated - 0.11, 0.14, and 0.08. CRP was elelvated at 84, ESR elevated at 31, and D-dimer elevated at 832. CBC, CMP, urine drug screen, CT, and EKG all normal .
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Echocardiogram, Electrocardiogram normal, Erythema, Fibrin D dimer, Full blood count normal
Clinical narrative: On  3/10 began having soreness on Right Arm. Noted to have a clementine sized area of erythema and swelling with shortness of breath rest.  Heart Rate was 124 at that time. Also experienced chills with no fever. PCP was contacted and was told to monitor overnight. On 3/11 in the morning was having trouble standing up and experiencing shortness of breath and nausea. Chest felt uncomfortable. Her right shoulder was hurting. At this time, PCP was contacted again and was instructed to go to the ER. ER did ekg, CT, echocardiogram  and bloodwork. Toponin level was elevated - 0.11, 0.14, and 0.08. CRP was elelvated at 84, ESR elevated at 31, and D-dimer elevated at 832. CBC, CMP, urine drug screen, CT, and EKG all normal .
Age: 17.0
Sex: F
Vaccine: UNK, UNK, MENB, MNQ
Symptoms: Metabolic function test normal, Nausea, Pain in extremity, Red blood cell sedimentation rate increased, Swelling
Clinical narrative: On  3/10 began having soreness on Right Arm. Noted to have a clementine sized area of erythema and swelling with shortness of breath rest.  Heart Rate was 124 at that time. Also experienced chills with no fever. PCP was contacted and was told to monitor overnight. On 3/11 in the morning was having trouble standing up and experiencing shortness of breath and nausea. Chest felt uncomfortable. Her right shoulder was hurting. At this time, PCP was contacted again and was instructed to go to the ER. ER did ekg, CT, echocardiogram  and bloodwork. Toponin level was elevated - 0.11, 0.14, and 0.08. CRP was elelvated at 84, ESR elevated at 31, and D-dimer elevated at 832. CBC, CMP, urine drug screen, CT, and EKG all normal .
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; A pharmacist reported that a dose of MMR II vaccine was administered to a patient via the intramuscular route instead of the subcutaneous route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 17-FEB-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) use as directed to prevent measles, mumps and rubella infection as prophylaxis, lot #U017524, expiration date: 03-JUN-2023 (strength was not provided), via the intramuscular route instead of the subcutaneous route (incorrect route of product administration). There was no additional adverse event (no adverse event).
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; A spontaneous report was received from a nurse on 18JAN2023. On 12JAN2023, a 62-year-old female patient took the first dose of Vivotif capsule (Typhoid vaccine live oral Ty21A) (lot number: unknown) followed by the second dose on 14JAN2023 and third on 16JAN2023 for immunisation. The patient subsequently had "diarrhea" (PT: Diarrhoea).  The patient had no medical history /conditions. The patient was allergic to penicillin and sulfa drugs and also had seasonal allergies.  Concomitant medications included Flonase (fluticasone propionate; nasal spray daily) and Zaditor (ketotifen fumarate; eye drop daily).  On 17JAN2023, in the evening, the patient had diarrhea which continued until 18JAN2023 around 7:30 AM. Reportedly, the patient took Imodium tablets (duration, dosage or number of tablets were not specified) which helped with her diarrhea and as of 18JAN2023; 9 AM, she no longer had diarrhea. Additionally, the patient did not take any lab work or diagnostic tests. It was reported that the patient had not taken the last dose of Vivotif yet.  The patient had recovered from the reported event on 18JAN2023. Action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a consumer developed diarrhoea following the administration of third dose of Vivotif. She had recovered from the event at the time of reporting. Considering the case information, the causality of diarrhoea is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer developed diarrhoea following the administration of third dose of Vivotif. She had recovered from the event at the time of reporting. Considering the case information, the causality of diarrhoea is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Diarrhea; A spontaneous report was received from a nurse on 18JAN2023. On an unknown date, a patient (age and gender unknown) started taking Vivotif capsule (Typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. The patient subsequently had "nausea" (Nausea), "vomiting" (Vomiting) and "diarrhea" (Diarrhoea).  The patient's medical history, concomitant medications, or known allergies were not reported.   It was reported that on an unknown date, the patient experienced adverse reactions from Vivotif such as nausea, vomiting and diarrhea.  The outcome of the reported events was unknown. The action was taken with Vivotif with respect to the reported events was unknown.  The reporter did not provide a consent to follow up for additional information.  Company comment: It was reported that a consumer developed nausea, vomiting, and diarrhoea following the administration of Vivotif. Further information regarding the events, medical history or concomitant medication is limited. Considering the case information, the causality of the events nausea, vomiting, and diarrhoea is assessed as possible with Vivotif (its role cannot be ruled out). The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer developed nausea, vomiting, and diarrhoea following the administration of Vivotif. Further information regarding the events, medical history or concomitant medication is limited. Considering the case information, the causality of the events nausea, vomiting, and diarrhoea is assessed as possible with Vivotif (its role cannot be ruled out). The case is considered non-serious as per medical assessment.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Oct2022 at 15:00 as dose 3 (booster), single (Lot number: Gh9693) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medication was taken in 2weeks.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300102512 same patient, different drug/event;
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Dec2021 as dose 2 (booster), single (Lot number: FF8841) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 09Apr2021 as dose 1, single (Lot number: 201A21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (COVID 19 Treatment) from 22Feb2023 to 27Feb2023.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ischaemic stroke, Neoplasm malignant
Clinical narrative: Ischemic stroke; Cancer; 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 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL9267), as dose 2, single (Lot number: EN6203), as dose 3 (booster), single (Lot number: EW0164) and as dose 4 (booster), single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ISCHAEMIC STROKE (medically significant), outcome "unknown", described as "Ischemic stroke"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer". The patient was asking whether it was okay to receive the Pfizer COVID vaccine if you have had a ischemic stroke. She heard there was a second booster dose out and wanted to know if it was okay to get it. She stated she asked her primary care doctor and she could not give her an answer and went to the health department where she got the "last 3 shots." The "3 prior" shots she got at where she had her cancer taken care of. None of them could give her any advice. She had all the Pfizer COVID vaccines and had no reaction from them (as reported). Read on the net about a warning on taking Pfizer COVID 19 shot if had a certain stroke, the stroke the patient had called ischemic stroke.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. The patient was treated with Paxlovid from 01Mar2023 to 05Mar2023.; Sender's Comments: The contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the reported drug ineffective event cannot be excluded since a lack of effect can generally be expected for any medicinal product as a 100% success rate cannot be reasonably assumed in every patient treated.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing), notes: Other medical history: Diabetes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Mar2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Mar2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID from 08Feb2023 to 24Feb2023 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2 NOS), on 21Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID (GF8434) from 06Mar2023 to 10Mar2023 for the treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.