chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Subarachnoid haemorrhage, Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. The individual received the Moderna product on 11/05/2021 and the Pfizer product on 02/06/2021 and 02/27/2021. They tested positive for COVID-19 via antigen test on 08/20/2022. They presented to emergency department on 08/21/2022  with general weakness and unwitnessed fall.  They were admitted to hospital on 08/21/2022. They were diagnosed with COVID-19 pneumonia and found to have an acute subarachnoid hemorrhage. Due to poor prognosis, they were transitioned to comfort care and remained hospitalized until their death on 08/26/2022.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Headache, Nausea, Vomiting
Clinical narrative: Severe headache, nausea, vomiting, redness on back of neck
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus that has not resolved after an entire year
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine instead of bivalent vaccine
Age: 46.0
Sex: F
Vaccine: FLUA4, PNC20
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling. Developed cellulitis by Sunday evening. Hot to touch. Cellulitis progressed to elbow and to shoulder. Saw NP on monday. Prescribed Clindamycin 300 3 times a day for 7 days.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram, C-reactive protein increased, Computerised tomogram thorax, Dyspnoea, Fibrin D dimer increased
Clinical narrative: Pulmonary embolism. Awoke Monday 11/7 with pain and difficulty breathing. Labwork done by doctor on 11/7 was abnormal. Extremely difficult to breathe the night of 11/7 with intense pain, admitted on 11/8 mid morning
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Laboratory test abnormal, Pain, Pulmonary embolism
Clinical narrative: Pulmonary embolism. Awoke Monday 11/7 with pain and difficulty breathing. Labwork done by doctor on 11/7 was abnormal. Extremely difficult to breathe the night of 11/7 with intense pain, admitted on 11/8 mid morning
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angular cheilitis, Condition aggravated, Rash, Rash erythematous, Rash pruritic
Clinical narrative: 10/29/22 spouse noticed red rash on lower half of scalp, which continues to the day I am reporting this on 11/15/22. In retrospect, I think the rash appeared at least by 10/22/22 and maybe earlier based on memories of periodic itching. I saw a primary care nurse practitioner on 11/10/22 who prescribed ketoconazole shampoo which I started using daily on 11/11/22. On 11/10 or 11/11/22 I developed angular cheilitis which I've treated with ketoconazole ointment that I had on hand. I got a flu shot on the same day as the COVID booster, but I don't know what flu shot it was so I can't add it to this form.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine instead of bivalent vaccine
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chest discomfort, Cough, Feeling hot, Headache
Clinical narrative: It started out with headache, slight cough, felt hot, tightness in chest, and running nose. I tested positive for COVID-19 at home. Then I went to the urgent care to confirm and, I was positive. My doctor prescribed me PAXLOVID when I called. I started taking that yesterday. Today I have a sore throat and a more serious cough.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: It started out with headache, slight cough, felt hot, tightness in chest, and running nose. I tested positive for COVID-19 at home. Then I went to the urgent care to confirm and, I was positive. My doctor prescribed me PAXLOVID when I called. I started taking that yesterday. Today I have a sore throat and a more serious cough.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Breast pain, Injection site pain
Clinical narrative: I counseled patient on possible adverse effects and asked her if she had any problem with previous Moderna and she said "no." She only indicated she has bad rashes on right arm due to eczema which led to me suggesting administering on her left arm instead which she agreed. I administered into right deltoid intramuscularly, no where close to the shoulder. Patient called 2 hours later saying she is experiencing some sharp pain on her left shoulder bone and pain on the underfold skin on her left breast. She confirmed it's not chest pain, no shortness of breath. I counseled her on taking Tylenol which is her usual pain med for her pain. Go to ER if she experiences any chest pain, SOB or irregular heartbeat. Follow up with MD the next day if she continues to feel pain.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine instead of bivalent vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Tinnitus
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine instead of bivalent vaccine
Age: 54.0
Sex: M
Vaccine: COVID19-2, FLUC4
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: Developed a rash on right arm, chest, neck, and face with redness and small raised bumps.
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain, Wrong product administered
Clinical narrative: Pt came in asking for the flu shot and covid vaccine, but only wanted flu shot that day. He received covid 19 booster instead-- per pt he experienced body aches that evening
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral, Anticoagulant therapy, Blood test, Cardiac disorder, Cardiac dysfunction
Clinical narrative: Pt had a clotting stroke in left frontal lobe of brain on 5/23/2022, he woke up in the am unable to speak, we went to the hospital and CT scan of brain and MRI of the brain confirmed a clot in left frontal lobe of brain.  He was placed on statin drug, high dose aspirin, and blood pressure medication, 6 weeks later pt. had a second clotting stroke in the cerebellum of the brain.  He was then started on Eliquis along with other medications mentioned above with the addition of Plavix after 6 weeks.  He was seen by multiple doctors who could not determine the cause of pt.'s strokes.  During this process he was also found to have irregularities with his heart which is ongoing and continues to see a cardiologist with decrease in heart function with unknown cause.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Catheterisation cardiac, Cerebral thrombosis, Cerebrovascular accident, Computerised tomogram head abnormal
Clinical narrative: Pt had a clotting stroke in left frontal lobe of brain on 5/23/2022, he woke up in the am unable to speak, we went to the hospital and CT scan of brain and MRI of the brain confirmed a clot in left frontal lobe of brain.  He was placed on statin drug, high dose aspirin, and blood pressure medication, 6 weeks later pt. had a second clotting stroke in the cerebellum of the brain.  He was then started on Eliquis along with other medications mentioned above with the addition of Plavix after 6 weeks.  He was seen by multiple doctors who could not determine the cause of pt.'s strokes.  During this process he was also found to have irregularities with his heart which is ongoing and continues to see a cardiologist with decrease in heart function with unknown cause.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Full blood count, Lipids, Magnetic resonance imaging head abnormal, Metabolic function test
Clinical narrative: Pt had a clotting stroke in left frontal lobe of brain on 5/23/2022, he woke up in the am unable to speak, we went to the hospital and CT scan of brain and MRI of the brain confirmed a clot in left frontal lobe of brain.  He was placed on statin drug, high dose aspirin, and blood pressure medication, 6 weeks later pt. had a second clotting stroke in the cerebellum of the brain.  He was then started on Eliquis along with other medications mentioned above with the addition of Plavix after 6 weeks.  He was seen by multiple doctors who could not determine the cause of pt.'s strokes.  During this process he was also found to have irregularities with his heart which is ongoing and continues to see a cardiologist with decrease in heart function with unknown cause.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial necrosis marker, Scan myocardial perfusion, Speech disorder, Ultrasound Doppler
Clinical narrative: Pt had a clotting stroke in left frontal lobe of brain on 5/23/2022, he woke up in the am unable to speak, we went to the hospital and CT scan of brain and MRI of the brain confirmed a clot in left frontal lobe of brain.  He was placed on statin drug, high dose aspirin, and blood pressure medication, 6 weeks later pt. had a second clotting stroke in the cerebellum of the brain.  He was then started on Eliquis along with other medications mentioned above with the addition of Plavix after 6 weeks.  He was seen by multiple doctors who could not determine the cause of pt.'s strokes.  During this process he was also found to have irregularities with his heart which is ongoing and continues to see a cardiologist with decrease in heart function with unknown cause.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Toothache, Vomiting
Clinical narrative: Began the next day after my vaccine my teeth began to hurt after I threw up. I had severe nausea I sought medical through a telehealth visit and prescribed REGLAN. My mouth continues to hurt, prescribed gabapentin and lidocaine mouth rinse.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient should have received Pfizer for 5-11 year old 0.2ml but received adult pfizer 12+ 0.3ml , Mother reported no adverse effects at this time.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Dermatitis
Clinical narrative: Have since developed dermatitis and alopecia
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Body temperature increased, Chest discomfort, Chills, Cough, Feeding disorder
Clinical narrative: I have been really sick since Friday 10/28- with what I can only assume is a reaction to the vaccine. Symptoms include:  intense headaches, stuffy nose, congestion, vomiting on day 1- intense sweats, chills 24/7 temp was 102.4- unable to eat. Day 2 symptoms were better, still had headaches,  less chills, still had stuffy nose, able to eat some ritz crackers and have drank 7x 28fl oz Gatorade ( so far) Day 3 Intense night sweats  the night before, bedding was saturated Now it is predominantly headache, queasy stomach but still able to eat the crackers Sore throat, congestion, coughing and tightness in chest.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Hyperhidrosis, Malaise, Nasal congestion, Nausea
Clinical narrative: I have been really sick since Friday 10/28- with what I can only assume is a reaction to the vaccine. Symptoms include:  intense headaches, stuffy nose, congestion, vomiting on day 1- intense sweats, chills 24/7 temp was 102.4- unable to eat. Day 2 symptoms were better, still had headaches,  less chills, still had stuffy nose, able to eat some ritz crackers and have drank 7x 28fl oz Gatorade ( so far) Day 3 Intense night sweats  the night before, bedding was saturated Now it is predominantly headache, queasy stomach but still able to eat the crackers Sore throat, congestion, coughing and tightness in chest.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Night sweats, Oropharyngeal pain, Respiratory tract congestion, Vomiting
Clinical narrative: I have been really sick since Friday 10/28- with what I can only assume is a reaction to the vaccine. Symptoms include:  intense headaches, stuffy nose, congestion, vomiting on day 1- intense sweats, chills 24/7 temp was 102.4- unable to eat. Day 2 symptoms were better, still had headaches,  less chills, still had stuffy nose, able to eat some ritz crackers and have drank 7x 28fl oz Gatorade ( so far) Day 3 Intense night sweats  the night before, bedding was saturated Now it is predominantly headache, queasy stomach but still able to eat the crackers Sore throat, congestion, coughing and tightness in chest.
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Herpes zoster
Clinical narrative: -shingles activation near chest. Never had a shingles episode before, had chickenpox as a child
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: pt noted onset of itching about one day after vaccine and then developed hives which lasted 10 days
Age: 44.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Electrocardiogram ambulatory, Heart rate irregular, Lymphadenopathy
Clinical narrative: Irregular/abnormal heartbeat which was not present prior to vaccination. (Unresolved) Extremely enlarge lymph node under arm that lasted more than one month. (Mostly resolved)
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient got the  Pfizer bivalent booster on 10/14/2022 and then came to the clinic for another one on 11/4
Age: 27.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Chills, Decreased appetite, Fatigue, Pain, Pyrexia
Clinical narrative: 101 degree F fever. Chills, severe fatigue, body aches. Low appetite. Lasted for 36 hours.
Age: 87.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given Pfizer Mono-valent instead of Pfizer Bivalent due to pharmacist's mistake. Patient already notified and okay. Pharmacy apologized for the error and informed patient to come back after 2 months.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT REPORTED.  GAVE VACCINE THAT WAS 1 DAY BEYOND THE 10 WEEKS BEYOND USE DATE AFTER THAWING THE PFIZER COVID VACCINE
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Back pain, Bladder dysfunction, Death, Diplopia
Clinical narrative: Patient was a healthy (not overweight and no known medical issues), functioning man that worked out regularly, excelled in his career and was always active. 3 days after Patient received his 2nd Covid vaccine he started with severe back pain, that led into slurred speech,  breathing issues (difficulty breathing at night especially-started to use a C-pap machine), vision issues- double vision, became unsteady on his feet, which then resulted in on and off paralysis, loss of bowel and bladder control. It appeared that he had a stroke, but they could not find any evidence. They also found a cancerous tumor on his kidney, which was removed surgically and he did not need additional treatment. However, he did later have issues with his kidney leaking fluid and had a tube placed in his back to drain the fluid. He was hospitalized 3-4 times, went to a skilled nursing facility twice. Received OT and PT to assist in gaining any functionality back. He was tested for MS, ALS, various other diseases  and autoimmune disorders and was finally given a diagnosis of Transverse Myelitis and then auto immune encephalomyelitis. He recently received an infusion of rituximab in October 2022.  His suffering was endless and he ultimately passed away on 11/9/22, we are awaiting results of the autopsy because cause of death was not obvious.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drain placement, Dysarthria, Dyspnoea, Encephalomyelitis, Functional gastrointestinal disorder
Clinical narrative: Patient was a healthy (not overweight and no known medical issues), functioning man that worked out regularly, excelled in his career and was always active. 3 days after Patient received his 2nd Covid vaccine he started with severe back pain, that led into slurred speech,  breathing issues (difficulty breathing at night especially-started to use a C-pap machine), vision issues- double vision, became unsteady on his feet, which then resulted in on and off paralysis, loss of bowel and bladder control. It appeared that he had a stroke, but they could not find any evidence. They also found a cancerous tumor on his kidney, which was removed surgically and he did not need additional treatment. However, he did later have issues with his kidney leaking fluid and had a tube placed in his back to drain the fluid. He was hospitalized 3-4 times, went to a skilled nursing facility twice. Received OT and PT to assist in gaining any functionality back. He was tested for MS, ALS, various other diseases  and autoimmune disorders and was finally given a diagnosis of Transverse Myelitis and then auto immune encephalomyelitis. He recently received an infusion of rituximab in October 2022.  His suffering was endless and he ultimately passed away on 11/9/22, we are awaiting results of the autopsy because cause of death was not obvious.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Infusion, Laboratory test, Myelitis transverse, Neurological symptom
Clinical narrative: Patient was a healthy (not overweight and no known medical issues), functioning man that worked out regularly, excelled in his career and was always active. 3 days after Patient received his 2nd Covid vaccine he started with severe back pain, that led into slurred speech,  breathing issues (difficulty breathing at night especially-started to use a C-pap machine), vision issues- double vision, became unsteady on his feet, which then resulted in on and off paralysis, loss of bowel and bladder control. It appeared that he had a stroke, but they could not find any evidence. They also found a cancerous tumor on his kidney, which was removed surgically and he did not need additional treatment. However, he did later have issues with his kidney leaking fluid and had a tube placed in his back to drain the fluid. He was hospitalized 3-4 times, went to a skilled nursing facility twice. Received OT and PT to assist in gaining any functionality back. He was tested for MS, ALS, various other diseases  and autoimmune disorders and was finally given a diagnosis of Transverse Myelitis and then auto immune encephalomyelitis. He recently received an infusion of rituximab in October 2022.  His suffering was endless and he ultimately passed away on 11/9/22, we are awaiting results of the autopsy because cause of death was not obvious.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paralysis, Positive airway pressure therapy, Renal cancer, Renal disorder, Renal tumour excision
Clinical narrative: Patient was a healthy (not overweight and no known medical issues), functioning man that worked out regularly, excelled in his career and was always active. 3 days after Patient received his 2nd Covid vaccine he started with severe back pain, that led into slurred speech,  breathing issues (difficulty breathing at night especially-started to use a C-pap machine), vision issues- double vision, became unsteady on his feet, which then resulted in on and off paralysis, loss of bowel and bladder control. It appeared that he had a stroke, but they could not find any evidence. They also found a cancerous tumor on his kidney, which was removed surgically and he did not need additional treatment. However, he did later have issues with his kidney leaking fluid and had a tube placed in his back to drain the fluid. He was hospitalized 3-4 times, went to a skilled nursing facility twice. Received OT and PT to assist in gaining any functionality back. He was tested for MS, ALS, various other diseases  and autoimmune disorders and was finally given a diagnosis of Transverse Myelitis and then auto immune encephalomyelitis. He recently received an infusion of rituximab in October 2022.  His suffering was endless and he ultimately passed away on 11/9/22, we are awaiting results of the autopsy because cause of death was not obvious.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: pt 11 should have had peds dose, got adult dose (error thinking pt was 12)
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received primary COVID Pfizer dose on 9/30/22. Returned for dose #2 and was inadvertently given COVID BIVALENT booster on 10/21/22.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea
Clinical narrative: Onset of watery diarrhea 2 days after injection of Covid and flu vaccines. Diarrhea has persisted 16 days with no improvement.   I also received Fluzone HD 65 t PF2022-2023 inj.  .7 ml at the same time.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Eyelid disorder, Hypersensitivity, Skin reaction
Clinical narrative: Allergic skin reaction first on creases of neck for about a month. No treatment.  Followed by similar skin reaction on eyelids with one being significantly worse than the other.  Started 1.5 to 2 months after vaccine and progressively worsened over a 3 month period ending in mid October.  Visited ophthalmologist who concluded allergic reaction to "something".
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: CAUSED MY BLOOD PRESSURE TO GO EXTREMLY HIGH WITH POSITION CHANGES.  ESPECIALLY SITTING TO STANDING. I REACHED OUT TO MY DOCTOR(S) - MY MEDICACTIONS HAD TO BE ADJUSTED.  - STOPPED MY FLUDROCORTIZONE.    ( WAS ON 1.5 TABLET 6AM AND 1 TABLE 6 PM.  REDUCED DOWN TO NONE.  BUT THEN MY BP WAS TOO LOW, SO RESTARTED ON FRACTION OF DOSE.)    INCREASED PROPRANOLOL FROM 120eR TWICE A DAY TO 160 er TWICE A DAY.
Age: 32.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity, Swelling
Clinical narrative: swelling all over the left side of her body which is the side she got it on. She went and saw her PCP who gave her a steroid pack and told her to take Advil and Benadryl. She is still having problems today with arm pain. They are saying that there is possibly nerve involvment
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Areflexia, CSF cell count normal, CSF protein increased, Fatigue, Gait disturbance
Clinical narrative: On October 4, 2022 at 13:00 PM, I received the Influenza vaccination Flucelvax Quadrivalent Vaccine (Manufactured by Seqirus; Lot #942394; Product ID No. 31342) 0.5 cc administered IM to my left arm, as part of employee influenza vaccination at hospital.  Day after the vaccine, I developed headaches, neck pain, and fatigue for 2 weeks.   On October 28, 2022, I suddenly developed numbness and tingling of bilateral fingers and toes.  This ascended to bilateral wrists and ankles followed by progressive muscle weakness.  This culminated with inability to climb stairs, difficulty walking without assistance or a walker, and arm weakness.    I was admitted to Hospital from 11/04/22 to 11/09/22 with MRI, lumbar puncture, neurological exam, and lab work confirming a diagnosis of Guillain Barre Syndrome (GBS).  Workup for other triggers of GBS syndrome has been negative.    I responded to 5 days of IV IG with return of muscle function.  I was admitted to Rehab on 11/09/2022 and discharged 11/14/2022 with referral to outpatient rehab.  Follow-up with Neurology pending.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Guillain-Barre syndrome, Headache, Hepatitis B DNA assay negative, Hepatitis C antibody negative, Hypoaesthesia
Clinical narrative: On October 4, 2022 at 13:00 PM, I received the Influenza vaccination Flucelvax Quadrivalent Vaccine (Manufactured by Seqirus; Lot #942394; Product ID No. 31342) 0.5 cc administered IM to my left arm, as part of employee influenza vaccination at hospital.  Day after the vaccine, I developed headaches, neck pain, and fatigue for 2 weeks.   On October 28, 2022, I suddenly developed numbness and tingling of bilateral fingers and toes.  This ascended to bilateral wrists and ankles followed by progressive muscle weakness.  This culminated with inability to climb stairs, difficulty walking without assistance or a walker, and arm weakness.    I was admitted to Hospital from 11/04/22 to 11/09/22 with MRI, lumbar puncture, neurological exam, and lab work confirming a diagnosis of Guillain Barre Syndrome (GBS).  Workup for other triggers of GBS syndrome has been negative.    I responded to 5 days of IV IG with return of muscle function.  I was admitted to Rehab on 11/09/2022 and discharged 11/14/2022 with referral to outpatient rehab.  Follow-up with Neurology pending.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Immunoglobulin therapy, Influenza virus test negative, Laboratory test abnormal, Laboratory test normal, Lumbar puncture abnormal
Clinical narrative: On October 4, 2022 at 13:00 PM, I received the Influenza vaccination Flucelvax Quadrivalent Vaccine (Manufactured by Seqirus; Lot #942394; Product ID No. 31342) 0.5 cc administered IM to my left arm, as part of employee influenza vaccination at hospital.  Day after the vaccine, I developed headaches, neck pain, and fatigue for 2 weeks.   On October 28, 2022, I suddenly developed numbness and tingling of bilateral fingers and toes.  This ascended to bilateral wrists and ankles followed by progressive muscle weakness.  This culminated with inability to climb stairs, difficulty walking without assistance or a walker, and arm weakness.    I was admitted to Hospital from 11/04/22 to 11/09/22 with MRI, lumbar puncture, neurological exam, and lab work confirming a diagnosis of Guillain Barre Syndrome (GBS).  Workup for other triggers of GBS syndrome has been negative.    I responded to 5 days of IV IG with return of muscle function.  I was admitted to Rehab on 11/09/2022 and discharged 11/14/2022 with referral to outpatient rehab.  Follow-up with Neurology pending.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness, Neck pain, Neurological examination abnormal
Clinical narrative: On October 4, 2022 at 13:00 PM, I received the Influenza vaccination Flucelvax Quadrivalent Vaccine (Manufactured by Seqirus; Lot #942394; Product ID No. 31342) 0.5 cc administered IM to my left arm, as part of employee influenza vaccination at hospital.  Day after the vaccine, I developed headaches, neck pain, and fatigue for 2 weeks.   On October 28, 2022, I suddenly developed numbness and tingling of bilateral fingers and toes.  This ascended to bilateral wrists and ankles followed by progressive muscle weakness.  This culminated with inability to climb stairs, difficulty walking without assistance or a walker, and arm weakness.    I was admitted to Hospital from 11/04/22 to 11/09/22 with MRI, lumbar puncture, neurological exam, and lab work confirming a diagnosis of Guillain Barre Syndrome (GBS).  Workup for other triggers of GBS syndrome has been negative.    I responded to 5 days of IV IG with return of muscle function.  I was admitted to Rehab on 11/09/2022 and discharged 11/14/2022 with referral to outpatient rehab.  Follow-up with Neurology pending.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Paraesthesia, Respiratory viral panel, Romberg test positive, SARS-CoV-2 test negative, Walking aid user
Clinical narrative: On October 4, 2022 at 13:00 PM, I received the Influenza vaccination Flucelvax Quadrivalent Vaccine (Manufactured by Seqirus; Lot #942394; Product ID No. 31342) 0.5 cc administered IM to my left arm, as part of employee influenza vaccination at hospital.  Day after the vaccine, I developed headaches, neck pain, and fatigue for 2 weeks.   On October 28, 2022, I suddenly developed numbness and tingling of bilateral fingers and toes.  This ascended to bilateral wrists and ankles followed by progressive muscle weakness.  This culminated with inability to climb stairs, difficulty walking without assistance or a walker, and arm weakness.    I was admitted to Hospital from 11/04/22 to 11/09/22 with MRI, lumbar puncture, neurological exam, and lab work confirming a diagnosis of Guillain Barre Syndrome (GBS).  Workup for other triggers of GBS syndrome has been negative.    I responded to 5 days of IV IG with return of muscle function.  I was admitted to Rehab on 11/09/2022 and discharged 11/14/2022 with referral to outpatient rehab.  Follow-up with Neurology pending.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Fall, Presyncope
Clinical narrative: Patient temporarily experienced a vagal response resulting in gently falling to ground, within minutes after receiving vaccine injection. This occurred 10 seconds of ambulating after vaccine receipt. She opened her eyes per parent report within 3 seconds of the event, and was responsive. I evaluated her as a provider within a few minutes after the event.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Blood follicle stimulating hormone increased, Blood luteinising hormone increased, Blood oestrogen decreased, Blood test
Clinical narrative: After breastfeeding my daughter for 7 months I never got my period back so when she turned 1 year old in March 2022 I went to my OBGYN to get some bloodwork done (2 rounds of testing done in April and May) only to learn that my estrogen was super low and my FSH and LH were very high (this has never been a problem for me before and I had no issues getting pregnant with my daughter - I have also always had a regular period for as long as I can remember).  She said it could be indicative of premature ovarian failure and from there I went to see a fertility clinic who did more tests and said it could be low ovarian reserve or premature ovarian failure). I also got back on birth control since my estrogen was so low in July and then got off of it after 3 months (I did get my period while on my BC which I was told is uncommon if you are in the menopausal category which I thought was interesting)  to see if I was able to get my period back on it's own.  Unfortunately I didn't get my period in September and went to another fertility clinic for a second opinion who did more blood tests after I had been off my BC for a month. I am waiting for the final set of test and lab results from them.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Oestradiol
Clinical narrative: After breastfeeding my daughter for 7 months I never got my period back so when she turned 1 year old in March 2022 I went to my OBGYN to get some bloodwork done (2 rounds of testing done in April and May) only to learn that my estrogen was super low and my FSH and LH were very high (this has never been a problem for me before and I had no issues getting pregnant with my daughter - I have also always had a regular period for as long as I can remember).  She said it could be indicative of premature ovarian failure and from there I went to see a fertility clinic who did more tests and said it could be low ovarian reserve or premature ovarian failure). I also got back on birth control since my estrogen was so low in July and then got off of it after 3 months (I did get my period while on my BC which I was told is uncommon if you are in the menopausal category which I thought was interesting)  to see if I was able to get my period back on it's own.  Unfortunately I didn't get my period in September and went to another fertility clinic for a second opinion who did more blood tests after I had been off my BC for a month. I am waiting for the final set of test and lab results from them.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Dose of 0.3ml mistakenly administered.  Should have been 0.2ml.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: HIV test negative, Hepatitis B test negative, Hepatitis C test negative, Hypertransaminasaemia, Laboratory test abnormal
Clinical narrative: Received 2nd dose in series as low Hep B antibody levels and  employment places higher risk of exposure. Second dose as above with labs through PCP with Transaminitis. Repeat labs 2 weeks later better but still high. Third set of labs through occupational health better / resolving. Two sets of viral tests run including Hep b, Hep c and HIV all negative. Liver US normal. No major medical history otherwise. Felt to be related to Hep B vaccine.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Liver function test, Ultrasound liver normal, Viral test
Clinical narrative: Received 2nd dose in series as low Hep B antibody levels and  employment places higher risk of exposure. Second dose as above with labs through PCP with Transaminitis. Repeat labs 2 weeks later better but still high. Third set of labs through occupational health better / resolving. Two sets of viral tests run including Hep b, Hep c and HIV all negative. Liver US normal. No major medical history otherwise. Felt to be related to Hep B vaccine.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: 0.3ml administered.  Should have been 0.2ml for pfizer bivalent 5-11.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Inadvertently gave high dose Fluzone to an adult 19 yrs of age.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects noted.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Pruritus, Pyrexia
Clinical narrative: My whole body turned red and itchy, I had a fever, I had a severe headache, and I couldn't sleep at night because of the chills.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: My whole body turned red and itchy, I had a fever, I had a severe headache, and I couldn't sleep at night because of the chills.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Idiopathic angioedema, Immunisation reaction, Mast cell degranulation present, Presyncope
Clinical narrative: Near syncope day of injection while at rest in seated position. Subsequently recurring idiopathic angioedema in several months following injections. I did do series and had second injection 2/2/21 from same lot number at same location/site, but without alternative explanation for these symptoms I did discuss it with my allergist who felt like more than likely related to mast cell destabilizing effects of that particular vaccine.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bradycardia, Dizziness, Electrocardiogram, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: I immediately felt dizzy. RN observeors said that I lost all color and looked spacey.  The room was whirrling. Dr. was there along with an retired ER RN and a couple of the nurses from the Health department started taking my vitals.  I was extremely light headed for over an hour and my heart rate ranged from 43 - 54 during the event. Dr. at that time felt it necessary to call 911.  By the time the paramedics arrived, I was feeling better.  They told me that my rhythm was bradycardia but that my rate was is in mid to high 50's and felt that I would be okay.  They did not transport.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pallor, Vertigo
Clinical narrative: I immediately felt dizzy. RN observeors said that I lost all color and looked spacey.  The room was whirrling. Dr. was there along with an retired ER RN and a couple of the nurses from the Health department started taking my vitals.  I was extremely light headed for over an hour and my heart rate ranged from 43 - 54 during the event. Dr. at that time felt it necessary to call 911.  By the time the paramedics arrived, I was feeling better.  They told me that my rhythm was bradycardia but that my rate was is in mid to high 50's and felt that I would be okay.  They did not transport.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram, Diverticulitis, Flank pain
Clinical narrative: I began having pain on October 5 in my lower back and left side. I went to the ER on October 7 and was diagnosed with diverticulitis. I do not believe it was related to the vaccine.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus, electric static-type sound in my right ear. Same sounds appeared after booster #3.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Pain and redness at injection site x 4 days, tiredness x 3 days, nausea x 2 days
Age: 70.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Dizziness, Fatigue, Muscular weakness, Pyrexia, Walking aid user
Clinical narrative: Narrative: 70 yo M received flu shot and covid booster on same day. Reports feeling fatigue, lightheaded, and feverish. Symptoms resolved on own, Remained afebrile since presenting to hospital. Given reported leg weakness prior to  vaccination, unlikely Guiilen barre. Patient reported resolution of fatigue and lightheadedness 24 hours later and feels capable of ambulating with walker.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Acute respiratory failure, COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: Narrative: Hospital, acute resp failure, cough. Remdesivir, dex, azithromycin, ceftriaxone, oxygen, d/c to home. Covid +, moderna x 4
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: Narrative:  Patient recently established care with clinic in August 2022. During initial PCP visit on 8/24/22, an allergy assessment was performed and patient reported experiencing urticaria after receiving the Twinrix vaccine. this adverse reaction was documented in system at this time. Per chart, patient received at lead 3 doses of Twinrix hepatitis A/B vaccine series outside of the clinic from an unknown provider. These dates were 5/21/2007 (dose 1), 2/28/2008 (dose 2), and 6/16/2010 (dose 3). It is unclear whether the reaction took place with all vaccines within series, or just one. It is unclear whether additional medical interventions were necessary,
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: Bronchial stent insertion, COVID-19, Hypoxia, Lung neoplasm malignant, Pulmonary angioplasty
Clinical narrative: Narrative: Hospital, Moderna x 3, Covid+, Lung CA with mass in right lung-stent and balloon placed, increased hypoxia, increase oxygen demand, cefipeme and doxy
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: Pulmonary mass, SARS-CoV-2 test positive
Clinical narrative: Narrative: Hospital, Moderna x 3, Covid+, Lung CA with mass in right lung-stent and balloon placed, increased hypoxia, increase oxygen demand, cefipeme and doxy
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Fatigue, Headache, Nasal congestion, Oedema peripheral
Clinical narrative: Headache CHILS, FATIGUE, ONE NOSTRIL STUFFED, SWOLLEN ARM, TENDERNESS IN ARM, LUMP NEAR VACCINE SITE, BUT IMPROVING Narrative:  if arm continues with edema and tenderness, told to contact PCP
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Tenderness, Vaccination site mass
Clinical narrative: Headache CHILS, FATIGUE, ONE NOSTRIL STUFFED, SWOLLEN ARM, TENDERNESS IN ARM, LUMP NEAR VACCINE SITE, BUT IMPROVING Narrative:  if arm continues with edema and tenderness, told to contact PCP
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, MMRV
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was stored in refrigerator, not freezer. Then given after the 30 day expiration.
Age: 5.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was stored in refrigerator, not freezer. Then given after the 30 day expiration.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19-2, COVID19-2
Symptoms: COVID-19, Cervical vertebral fracture, Fall
Clinical narrative: Narrative: Hospital, transferred from Medical Center, pt fell C1-C2 fracture. D/c to NH, dx with Covid, Moderna x 3
Age: 1.75
Sex: F
Vaccine: COVID19, HEPA
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine was stored in refrigerator, not freezer. Then given after the 30 day expiration.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Pain in shoulder vaccinated
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-2-22. Bivalent booster authorized by FDA on 8/31/22. Patient contacted, will return for bivalent booster in 2 months.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-1-22. Bivalent booster authorized by FDA on 8/31/22. Patient contacted, will return for bivalent booster in 2 months.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-1-22. Bivalent booster authorized by FDA on 8/31/22. Patient contacted, will return for bivalent booster in 2 months.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-1-22. Bivalent booster authorized by FDA on 8/31/22. Patient contacted, will return for bivalent booster in 2 months.
Age: 4.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child was inappropriately vaccinated at with Pfizer Age 5-11 in Nov. 2021 when child was 4 yrs old.
Age: 64.0
Sex: M
Vaccine: COVID19, FLUC4, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-2-22.  Bivalent booster authorized by FDA on 8-31-22. Patient contacted, will return for bivalent booster in 2 months.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-2-22.  Bivalent booster authorized by FDA on 8-31-22. Patient contacted, will return for bivalent booster in 2 months.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-1-22. Bivalent booster authorized by FDA on 8/31/22. Patient contacted, will return for bivalent booster in 2 months.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-2-22.  Bivalent booster authorized by FDA on 8-31-22. Patient contacted, will return for bivalent booster in 2 months.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-1-22. Bivalent booster authorized by FDA on 8/31/22. Patient contacted, will return for bivalent booster in 2 months.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-2-22. Bivalent booster authorized by FDA on 8-31-22. Patient contacted, will return for bivalent booster in 2 months.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-1-22. Bivalent booster authorized by FDA on 8/31/22. Patient contacted, will return for bivalent booster in 2 months.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-2-22. Bivalent booster authorized by FDA on 8-31-22. Patient contacted, will return for bivalent booster in 2 months.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent vaccine administered for a booster on 9-2-22. Bivalent booster authorized by FDA on 8-31-22. Patient contracted, will return for bivalent booster in 2 months.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Fatigue, Vaccination site pain
Clinical narrative: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3247), in right arm, on 15Feb2021 as dose 2, single (Lot number: EL3247), in right arm and on 14Oct2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 25 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes".  Additional information: Since the vaccination, the patient had not been tested for COVID-19. Device Date reported as 10Nov2022. Dose 4 Pfizer administered on 10Nov2022 at 10:30 AM by Intramuscular in Right arm.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3247), in right arm, on 15Feb2021 as dose 2, single (Lot number: EL3247), in right arm and on 14Oct2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 25 years, in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes".  Additional information: Since the vaccination, the patient had not been tested for COVID-19. Device Date reported as 10Nov2022. Dose 4 Pfizer administered on 10Nov2022 at 10:30 AM by Intramuscular in Right arm.
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2, FLU4, VARZOS
Symptoms: Blister, Fatigue, Malaise
Clinical narrative: 10/12/22 and 10/13/22:  seen in clinic for chest wall pain and extensive shingles rash / pain Rt anterolateral chest and axilla day after vaccines, then spread to back in following week. 10/24/22 Seen in ER for : Weakness, fatigue, dizziness, dehydration, medication side effects, discharged home.  11/1/22 Seen in ER for:  Weakness, fatigue/malaise, orthostatic hypotension 11/1/22 -11/4/22 Admit to hospital ACF inpatient  - MD suspicious of pt developing Parkinson's like disorder d/t hand tremor at rest, cogwheel rigitity, flat facies, slow shuffling gait and changes in handwriting - referral to neurologist, PT, OT, ST were made. 11/7/22 Follow up with PCP, Dr.  11/16/22 Follow up with FNP,
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLU4, VARZOS, COVID19-2, FLU4, VARZOS
Symptoms: Adverse drug reaction, Asthenia, Axillary pain, Back pain, Bradykinesia
Clinical narrative: 10/12/22 and 10/13/22:  seen in clinic for chest wall pain and extensive shingles rash / pain Rt anterolateral chest and axilla day after vaccines, then spread to back in following week. 10/24/22 Seen in ER for : Weakness, fatigue, dizziness, dehydration, medication side effects, discharged home.  11/1/22 Seen in ER for:  Weakness, fatigue/malaise, orthostatic hypotension 11/1/22 -11/4/22 Admit to hospital ACF inpatient  - MD suspicious of pt developing Parkinson's like disorder d/t hand tremor at rest, cogwheel rigitity, flat facies, slow shuffling gait and changes in handwriting - referral to neurologist, PT, OT, ST were made. 11/7/22 Follow up with PCP, Dr.  11/16/22 Follow up with FNP,