chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUX
Symptoms: Fatigue, Irritability, Off label use, Overdose, Product preparation error
Clinical narrative: Patient received a dose Pfizer Covid 19 vaccine for 6 months -4 years old, the vaccine was not diluted prior administration. Client was observed for 15 minutes after vaccination as recommended, no signs or symptoms of an allergic reaction noted. The med error was discovered after the patient had left clinic. The family was notified and reported the child had no signs of an allergic reaction. A follow up call was made later in the evening, there had been no changes.  Family encouraged to monitor child closely.
Age: 3.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLUX
Symptoms: Product use issue, Vaccination site pain
Clinical narrative: Patient received a dose Pfizer Covid 19 vaccine for 6 months -4 years old, the vaccine was not diluted prior administration. Client was observed for 15 minutes after vaccination as recommended, no signs or symptoms of an allergic reaction noted. The med error was discovered after the patient had left clinic. The family was notified and reported the child had no signs of an allergic reaction. A follow up call was made later in the evening, there had been no changes.  Family encouraged to monitor child closely.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Ear pain, Headache, Nausea, Pyrexia
Clinical narrative: 104.2 fever 2am-5am Fever 1am -8am  Skin felt like it had paper cuts all over  Nauseas  Headache  Ear pain  Chills
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin irritation
Clinical narrative: 104.2 fever 2am-5am Fever 1am -8am  Skin felt like it had paper cuts all over  Nauseas  Headache  Ear pain  Chills
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary pain, Diarrhoea, Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness approximately nickel sized. Redness began 09/30/2022. Injection site swelling approximately nickel sized in diameter at time of reporting 10/01/2022 . Swelling began 09/30/2022. Pain in right arm pit as of Saturday 10/01/2022. Diarrhea. Began 10/01/2022.
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue and arm soreness
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigue and arm soreness
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pain in extremity, Vision blurred
Clinical narrative: Aches Sore arm Blurred vision
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Cerebral disorder, Computerised tomogram normal, Dysgraphia, Electroencephalogram abnormal
Clinical narrative: Extreme headache with severe aphasia, could not speak more than one word together.  Could not write more than one letter.  Rushed by ambulance to hospital to rule out stroke.  Admitted into hospital for 2 days for monitoring.  MRI, CT Scans taken, all normal.  EEG taken, focal slowing observed.  Follow up EEG 3 months later did not show focal slowing.  Epilepsy ruled out.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging normal, Speech disorder
Clinical narrative: Extreme headache with severe aphasia, could not speak more than one word together.  Could not write more than one letter.  Rushed by ambulance to hospital to rule out stroke.  Admitted into hospital for 2 days for monitoring.  MRI, CT Scans taken, all normal.  EEG taken, focal slowing observed.  Follow up EEG 3 months later did not show focal slowing.  Epilepsy ruled out.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hallucination
Clinical narrative: Extremely vivid memories bordering on hallucinations.  Lasted nearly an hour.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Drug screen, Full blood count, Hallucination, visual, Headache
Clinical narrative: Vaccine details unknown, lot number, bivalent, etc. fever, headache, arm pain, visual hallucinations ED evaluation mild leukocytosis otherwise unrevealing Patient discharged home for outpatient follow up
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza virus test, Laboratory test, Lumbar puncture, Metabolic function test, Pain in extremity
Clinical narrative: Vaccine details unknown, lot number, bivalent, etc. fever, headache, arm pain, visual hallucinations ED evaluation mild leukocytosis otherwise unrevealing Patient discharged home for outpatient follow up
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Urine analysis
Clinical narrative: Vaccine details unknown, lot number, bivalent, etc. fever, headache, arm pain, visual hallucinations ED evaluation mild leukocytosis otherwise unrevealing Patient discharged home for outpatient follow up
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Nausea
Clinical narrative: 9/28, took 2 Tylenol,  9/29, 16 hrs after injection, severe aches, joint pain, fever headaches,  nausea, left arm pain, fatigue, no strength. Lasted until 9/30 8:00 am, except the nausea lasted until bedtime at 11pm. and aches in right leg lasted till around 12 pm, when I laid in the recliner where it stopped hurting.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: 9/28, took 2 Tylenol,  9/29, 16 hrs after injection, severe aches, joint pain, fever headaches,  nausea, left arm pain, fatigue, no strength. Lasted until 9/30 8:00 am, except the nausea lasted until bedtime at 11pm. and aches in right leg lasted till around 12 pm, when I laid in the recliner where it stopped hurting.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Condition aggravated, Pallor, Syncope
Clinical narrative: Patient has history of vasovagal syncope. Patient became pale, was perspiring and experienced syncope. Patient was given ice packs and recovered fully  in about 10 minutes.
Age: 32.0
Sex: F
Vaccine: COVID19-2, FLUR4, HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out after getting their vaccination for flu, Covid and Gardasil 9 and followed Company policy for CODE WHITE AND CALL 911. Medic arrived and took her to the hospital. Store is filling out store  Incidence report and I am filling out SCRT and VAERS. Pateint passed out for couple of minutes and helped her to lay down on the floor until Ambulance arrived at the store.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: Chills, pain in the body.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Asthenia, CSF glucose increased, CSF protein normal, CSF white blood cell count negative, Guillain-Barre syndrome
Clinical narrative: admitted to hospital on 9/26/22 and diagnosed with Guillain-Barre after evaluation by neurologist in the hospital. Starting 9/24/22 patient reported numbness/tingling of feet/hands, weakness with walking and weakness with raising her head above her shoulders. started IVIG on 9/28/22 for 5 days
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging spinal normal, Paraesthesia
Clinical narrative: admitted to hospital on 9/26/22 and diagnosed with Guillain-Barre after evaluation by neurologist in the hospital. Starting 9/24/22 patient reported numbness/tingling of feet/hands, weakness with walking and weakness with raising her head above her shoulders. started IVIG on 9/28/22 for 5 days
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm very painful can't move arm
Age: 71.0
Sex: M
Vaccine: COVID19-2, FLU4, PNC20
Symptoms: Chest pain, Flank pain, Flatulence
Clinical narrative: Pt reported chest and side pain to the pharmacist following immunizations. Pain started within the hour of receiving the immunizations and resolved within 10 minutes after it started. Pharmacist followed up with patient about an hour after the pain and he said he was still feeling all right. He believed the pain to be gas pain.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt received vaccination/dosage under the approved age.  No adverse  symptoms reported by mother/physician.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted
Age: 73.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Patient received 0.5ml of the (NDC 80777-0279-05) Moderna vaccine for 6 months to 5 years instead of the Moderna Bivalent 0.5 mL dose Since this wsa the monovalent vaccine at the appropriate dose (still 50 mcg), we are waiting 2 months and if the patient still wants, giving the Moderna Bivalent vaccine.  Patient reports that her arm hurts really bad.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Extra dose administered, Fatigue, Headache, Inflammation
Clinical narrative: I did receive the newest Covid Booster, #5 for me,  about a week prior to getting the Shingrix vaccine.  I had no side effects from the Covid Booster at all.  After receiving the Shingrix, My temperature started to rise within a few hours.   After two days, my temp went up to 99.8.  Today is day 4 and my temp is down to 98.4 which is still up form my usual 97.2.  The most important thing that I want to report is that on day 3,  I started having very severe dizziness and nausea.  I have had probably every vaccine including the Hep B due to being in the dental field and I have never had anything throw me totally out of commission.  I could not move my head without experiencing vertigo.  I also had muscle aches and pains as well as fatigue and a constant headache, but those symptoms do not alarm me.  Although I am not supposed to take NSAIDS, I have been taking Aleve since I read that the Shingrix can cause inflammation in the sensory system.  I am seeing my neurologist on Monday and I will be discussing this with him since I have never had vertigo until now.  I am thinking that the risks of taking the second Shingrix do not support the second dose.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Vertigo
Clinical narrative: I did receive the newest Covid Booster, #5 for me,  about a week prior to getting the Shingrix vaccine.  I had no side effects from the Covid Booster at all.  After receiving the Shingrix, My temperature started to rise within a few hours.   After two days, my temp went up to 99.8.  Today is day 4 and my temp is down to 98.4 which is still up form my usual 97.2.  The most important thing that I want to report is that on day 3,  I started having very severe dizziness and nausea.  I have had probably every vaccine including the Hep B due to being in the dental field and I have never had anything throw me totally out of commission.  I could not move my head without experiencing vertigo.  I also had muscle aches and pains as well as fatigue and a constant headache, but those symptoms do not alarm me.  Although I am not supposed to take NSAIDS, I have been taking Aleve since I read that the Shingrix can cause inflammation in the sensory system.  I am seeing my neurologist on Monday and I will be discussing this with him since I have never had vertigo until now.  I am thinking that the risks of taking the second Shingrix do not support the second dose.
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4, PPV
Symptoms: Biopsy, Pemphigus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Painful, itchy red rash that crusted over
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4, PPV
Symptoms: Scab
Clinical narrative: Painful, itchy red rash that crusted over
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Deafness, Dizziness
Clinical narrative: When I got out of bed in the morning I started to walk across the room to the bathroom but instead took off at a run to the left, only stopping when I ran into the dresser.  I scheduled an appointment with an ENT doctor, who I saw on 09/27/2022.  He found no ear infection.  He made an appointment for an inner ear exam on 10/05/2022.  I also had a hearing exam on 09/27/22 at Dr. office, showing loss of hearing, with a hearing aid presentation scheduled for 10/12/2022. My existing hearing loss is worse after the 09/10/22 incident, as is my existing unsteadiness on feet.  I also have some dizziness that comes and goes.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in right arm. Intermittent. Started noticing after initial vaccine soreness went away. Persistent. Undergoing physical therapy.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site mass, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Patient had a fever the night of her injection and then developed a lump at the injection site with tenderness down into the armpit. Site is also warm to touch. As of today she is still experiencing these symptoms minus the fever.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Covid-19: diarrhea, sore throat, cough, headache, head and chest congestion, vertigo, fatigue, brain fog, sinus pressure. Started morning of 9/22 like a mild sinus infection. Quickly increased or flu-like symptoms by afternoon or 9/23. Took 2 rapid tests that were immediately positive.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Influenza like illness, Oropharyngeal pain, Paranasal sinus discomfort, Respiratory tract congestion
Clinical narrative: Covid-19: diarrhea, sore throat, cough, headache, head and chest congestion, vertigo, fatigue, brain fog, sinus pressure. Started morning of 9/22 like a mild sinus infection. Quickly increased or flu-like symptoms by afternoon or 9/23. Took 2 rapid tests that were immediately positive.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sinus congestion, Sinusitis, Vertigo
Clinical narrative: Covid-19: diarrhea, sore throat, cough, headache, head and chest congestion, vertigo, fatigue, brain fog, sinus pressure. Started morning of 9/22 like a mild sinus infection. Quickly increased or flu-like symptoms by afternoon or 9/23. Took 2 rapid tests that were immediately positive.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: The Moderna Bivalent was inadvertently administer as a 2nd dose instead of the Moderna Monovalent.  Pharmacy contacted patient and he will come back to the pharmacy to get the Moderna Monovalent per CDC recommendation.  No adverse event reported by patient.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient received the original Pfizer covid vaccine instead of the bi-valent Pfizer covid vaccine by mistake.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was inadvertently administered the Pfizer Bivalent as the 2nd dose instead of the Pfizer Monovalent.  No need for redosing per CDC.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient received the original Pfizer covid vaccine instead of the bi-valent Pfizer covid vaccine by mistake
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Five minutes post vaccination pt became light headed, sweaty, pale.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe Hives and itching  Took Antihistamine to relieve the symptoms
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Injury associated with device, Skin discolouration
Clinical narrative: CMA pocket her index finger with an EPI PEN . she was training one of the New CMA at out office, trainer epi are in a specific drawer . She grab it she put her index finder in the top and pocked her self. Finger turned completely white  she got admitted to the ER
Age: 73.0
Sex: M
Vaccine: COVID19-2, FLU4, PNC20
Symptoms: Back pain, Cold sweat, Dizziness, Flushing, Respiratory tract congestion
Clinical narrative: AFTER ABOUT 3 MINUTES AFTER THE LAST IMZ- MODERNA-B BOOSTER THE PATIENT SAID HE WAS HAVING A REACTION, HE SAID HE WAS LIGHT HEADED, GONGESTED, PAIN IN BACK FLUSH AND CLAMY. HE SAT AND WE GAVE HIM WATER, AND A COOL RAG. HE STARTED FEELING BETTER AND GAVE HIM A LOLLYPOP JUST IN CASE HIS BLOOD SUGAR WAS LOW. HE FELT BETTER AND WAS ABLE TO LEAVE WITH HIS WIFE
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: 10/1/2022 - Patient given Pfizer-BioNTech COVID-19 Vaccine first dose  2y <5y: 0.2mL drawn from vial prior to dilution and given to patient. Contact mother to report this error. Mother reports patient is doing fine 38 minutes post administration. Mother was advised about increase risk of side effects and given return to clinic/ER precautions.
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Chills, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: Severe chills, headache, Nausea, Muscle Aches. Fatigue as well as severe swelling, reddening, in large part of left forearm starting about 12 hours after injection and lasting to some degree for 48-72 hours after.
Age: 37.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Nausea, Peripheral swelling
Clinical narrative: Severe chills, headache, Nausea, Muscle Aches. Fatigue as well as severe swelling, reddening, in large part of left forearm starting about 12 hours after injection and lasting to some degree for 48-72 hours after.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia
Clinical narrative: 102 fever at 11:30 a.m. 01-October-2022 - no treatment 104 fever at 7 p.m. 01-October-2022 - treated with 10 mL children's acetaminophen
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was to receive Pfizer Bival (12 yr & up) but gave Pfizer (12 yr & up ) instead. I mistakenly took the wrong bottle out - they look exactly the same with the difference of omicron coverage.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, COVID-19, Deafness, Hyperacusis, Menstruation irregular
Clinical narrative: A few hours after 2nd Covid vaccination (Pfizer), experienced left inner ear spasming lasting approx. 1 minute, followed by daily tinnitus for 4 months.   Some mild hearing loss is also suspected to present.  Also began experiencing chronic migraines 8 days after - lasting until present time (October 2022).   Chronic migraines are often noise induced, or begin upon waking, with light and sound sensitivity.  Frequency was generally 5-12 days per month, treated with Imitrex or Nurtec, until July 2022, when frequency began to reduce significantly.  Notably, first Covid infection occurred May 2022, with a complicated course followed by post-Covid secondary infections.   Also, heavy menstrual bleeding ceased after 2nd Covid shot, with a prior history of uterine fibroids.   All subsequent menstrual periods were light through September 2022.  First "normal" heavy menstruation returned October 2022.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle spasms, Photophobia, Tinnitus
Clinical narrative: A few hours after 2nd Covid vaccination (Pfizer), experienced left inner ear spasming lasting approx. 1 minute, followed by daily tinnitus for 4 months.   Some mild hearing loss is also suspected to present.  Also began experiencing chronic migraines 8 days after - lasting until present time (October 2022).   Chronic migraines are often noise induced, or begin upon waking, with light and sound sensitivity.  Frequency was generally 5-12 days per month, treated with Imitrex or Nurtec, until July 2022, when frequency began to reduce significantly.  Notably, first Covid infection occurred May 2022, with a complicated course followed by post-Covid secondary infections.   Also, heavy menstrual bleeding ceased after 2nd Covid shot, with a prior history of uterine fibroids.   All subsequent menstrual periods were light through September 2022.  First "normal" heavy menstruation returned October 2022.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was to receive Pfizer Bival (12 yr & up) but gave Pfizer (12 yr & up ) instead. I mistakenly took the wrong bottle out - they look exactly the same with the difference of omicron coverage.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product packaging confusion
Clinical narrative: Patient was to receive Pfizer Bival (12 yr & up) but gave Pfizer (12 yr & up ) instead. I mistakenly took the wrong bottle out - they look exactly the same with the difference of omicron coverage.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was to get Pfizer Bival (12 yr & up) but I gave Pfizer (12 yr & up) instead. Contacted patient & left a voicemail for patient to call back
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Anticoagulant therapy, Arteriogram coronary abnormal, Blood culture negative, Blood immunoglobulin M normal
Clinical narrative: Suspected KD with cardiac sequelae  Per mom, he began having cold symptoms including runny nose and cough prior to 9/13. Rapid COVID test was negative. He received his second dose of COVID vaccine (Moderna) on 9/13.   On 9/18, mom noticed right cervical lymphadenopathy that was nontender and non-erythematous. On 9/19, began having a fever that persisted until 9/26 (about 1 week). Fevers were as high as 103F around the clock. Rapid COVID tests were negative for first 3 days of fever. Other associated symptoms included conjunctival injection, several episodes of vomiting after meals, low appetite, and increased tiredness/lethargy.    He did not have mucous membrane changes, changes to the lips or tongue, swelling or changes of hands/feet, or rash. He did not have abdominal pain, headaches, mental status changes other than tiredness/lethargy, difficulty breathing, or sore throat/voice changes.    Went to PMD on 9/20 and rapid strep was negative.  Was prescribed Augmentin which he took BID for 8 days.  Right neck lymphadenopathy resolved after 3 days of Augmentin, but he continued to have fevers and conjunctivitis.    He re-presented to PMD on 9/26 and labs were notable for CRP 96.4 (range 0-9mg/L), RVP negative for viral infections, CBC with WBC 14.6, Hgb 11.3, Plt 602, and EBV negative. PMD referred him to cardiology for possible atypical Kawasaki Disease. Echo (9/28) was notable for LAD dilation and possible thrombus. He was referred to LPCH CVICU urgently. Repeat echo (9/28) notable for severe, diffuse dilation of left main coronary artery, left anterior descending, and right coronary arteries. CT angiogram 10/1 with fusiform aneurysmal dilatations of the left main coronary artery extending to the level of the mid left anterior descending artery, as well as the right coronary artery until it gives rise to the PDA. No thrombosis. He has received IVIG , methylprednisolone, aspirin and clopidogrel for treatment of suspected sequelae of KD.     Since 9/26 he has had no fevers, no limitations in activity, no apparent SOB or swelling/edema, no syncope and has overall had improved energy, improved appetite, and normal UOP  Sister with rapid COVID positive on home test 9/19 and fever/URI symptoms. SARS-COV-2 RNA negative on respiratory test on admission 9/28. Due to lower concern but to evaluate for MIS-C, COVID-19 antibody tests sent prior to IVIG and have so far resulted as IgM negative, IgG pending.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, COVID-19, Cardiac disorder, Conjunctival hyperaemia, Conjunctivitis
Clinical narrative: Suspected KD with cardiac sequelae  Per mom, he began having cold symptoms including runny nose and cough prior to 9/13. Rapid COVID test was negative. He received his second dose of COVID vaccine (Moderna) on 9/13.   On 9/18, mom noticed right cervical lymphadenopathy that was nontender and non-erythematous. On 9/19, began having a fever that persisted until 9/26 (about 1 week). Fevers were as high as 103F around the clock. Rapid COVID tests were negative for first 3 days of fever. Other associated symptoms included conjunctival injection, several episodes of vomiting after meals, low appetite, and increased tiredness/lethargy.    He did not have mucous membrane changes, changes to the lips or tongue, swelling or changes of hands/feet, or rash. He did not have abdominal pain, headaches, mental status changes other than tiredness/lethargy, difficulty breathing, or sore throat/voice changes.    Went to PMD on 9/20 and rapid strep was negative.  Was prescribed Augmentin which he took BID for 8 days.  Right neck lymphadenopathy resolved after 3 days of Augmentin, but he continued to have fevers and conjunctivitis.    He re-presented to PMD on 9/26 and labs were notable for CRP 96.4 (range 0-9mg/L), RVP negative for viral infections, CBC with WBC 14.6, Hgb 11.3, Plt 602, and EBV negative. PMD referred him to cardiology for possible atypical Kawasaki Disease. Echo (9/28) was notable for LAD dilation and possible thrombus. He was referred to LPCH CVICU urgently. Repeat echo (9/28) notable for severe, diffuse dilation of left main coronary artery, left anterior descending, and right coronary arteries. CT angiogram 10/1 with fusiform aneurysmal dilatations of the left main coronary artery extending to the level of the mid left anterior descending artery, as well as the right coronary artery until it gives rise to the PDA. No thrombosis. He has received IVIG , methylprednisolone, aspirin and clopidogrel for treatment of suspected sequelae of KD.     Since 9/26 he has had no fevers, no limitations in activity, no apparent SOB or swelling/edema, no syncope and has overall had improved energy, improved appetite, and normal UOP  Sister with rapid COVID positive on home test 9/19 and fever/URI symptoms. SARS-COV-2 RNA negative on respiratory test on admission 9/28. Due to lower concern but to evaluate for MIS-C, COVID-19 antibody tests sent prior to IVIG and have so far resulted as IgM negative, IgG pending.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery aneurysm, Coronary artery dilatation, Cough, Decreased appetite, Echocardiogram abnormal
Clinical narrative: Suspected KD with cardiac sequelae  Per mom, he began having cold symptoms including runny nose and cough prior to 9/13. Rapid COVID test was negative. He received his second dose of COVID vaccine (Moderna) on 9/13.   On 9/18, mom noticed right cervical lymphadenopathy that was nontender and non-erythematous. On 9/19, began having a fever that persisted until 9/26 (about 1 week). Fevers were as high as 103F around the clock. Rapid COVID tests were negative for first 3 days of fever. Other associated symptoms included conjunctival injection, several episodes of vomiting after meals, low appetite, and increased tiredness/lethargy.    He did not have mucous membrane changes, changes to the lips or tongue, swelling or changes of hands/feet, or rash. He did not have abdominal pain, headaches, mental status changes other than tiredness/lethargy, difficulty breathing, or sore throat/voice changes.    Went to PMD on 9/20 and rapid strep was negative.  Was prescribed Augmentin which he took BID for 8 days.  Right neck lymphadenopathy resolved after 3 days of Augmentin, but he continued to have fevers and conjunctivitis.    He re-presented to PMD on 9/26 and labs were notable for CRP 96.4 (range 0-9mg/L), RVP negative for viral infections, CBC with WBC 14.6, Hgb 11.3, Plt 602, and EBV negative. PMD referred him to cardiology for possible atypical Kawasaki Disease. Echo (9/28) was notable for LAD dilation and possible thrombus. He was referred to LPCH CVICU urgently. Repeat echo (9/28) notable for severe, diffuse dilation of left main coronary artery, left anterior descending, and right coronary arteries. CT angiogram 10/1 with fusiform aneurysmal dilatations of the left main coronary artery extending to the level of the mid left anterior descending artery, as well as the right coronary artery until it gives rise to the PDA. No thrombosis. He has received IVIG , methylprednisolone, aspirin and clopidogrel for treatment of suspected sequelae of KD.     Since 9/26 he has had no fevers, no limitations in activity, no apparent SOB or swelling/edema, no syncope and has overall had improved energy, improved appetite, and normal UOP  Sister with rapid COVID positive on home test 9/19 and fever/URI symptoms. SARS-COV-2 RNA negative on respiratory test on admission 9/28. Due to lower concern but to evaluate for MIS-C, COVID-19 antibody tests sent prior to IVIG and have so far resulted as IgM negative, IgG pending.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Epstein-Barr virus test negative, Fatigue, Full blood count abnormal, Haemoglobin decreased, Immunoglobulin therapy
Clinical narrative: Suspected KD with cardiac sequelae  Per mom, he began having cold symptoms including runny nose and cough prior to 9/13. Rapid COVID test was negative. He received his second dose of COVID vaccine (Moderna) on 9/13.   On 9/18, mom noticed right cervical lymphadenopathy that was nontender and non-erythematous. On 9/19, began having a fever that persisted until 9/26 (about 1 week). Fevers were as high as 103F around the clock. Rapid COVID tests were negative for first 3 days of fever. Other associated symptoms included conjunctival injection, several episodes of vomiting after meals, low appetite, and increased tiredness/lethargy.    He did not have mucous membrane changes, changes to the lips or tongue, swelling or changes of hands/feet, or rash. He did not have abdominal pain, headaches, mental status changes other than tiredness/lethargy, difficulty breathing, or sore throat/voice changes.    Went to PMD on 9/20 and rapid strep was negative.  Was prescribed Augmentin which he took BID for 8 days.  Right neck lymphadenopathy resolved after 3 days of Augmentin, but he continued to have fevers and conjunctivitis.    He re-presented to PMD on 9/26 and labs were notable for CRP 96.4 (range 0-9mg/L), RVP negative for viral infections, CBC with WBC 14.6, Hgb 11.3, Plt 602, and EBV negative. PMD referred him to cardiology for possible atypical Kawasaki Disease. Echo (9/28) was notable for LAD dilation and possible thrombus. He was referred to LPCH CVICU urgently. Repeat echo (9/28) notable for severe, diffuse dilation of left main coronary artery, left anterior descending, and right coronary arteries. CT angiogram 10/1 with fusiform aneurysmal dilatations of the left main coronary artery extending to the level of the mid left anterior descending artery, as well as the right coronary artery until it gives rise to the PDA. No thrombosis. He has received IVIG , methylprednisolone, aspirin and clopidogrel for treatment of suspected sequelae of KD.     Since 9/26 he has had no fevers, no limitations in activity, no apparent SOB or swelling/edema, no syncope and has overall had improved energy, improved appetite, and normal UOP  Sister with rapid COVID positive on home test 9/19 and fever/URI symptoms. SARS-COV-2 RNA negative on respiratory test on admission 9/28. Due to lower concern but to evaluate for MIS-C, COVID-19 antibody tests sent prior to IVIG and have so far resulted as IgM negative, IgG pending.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Intensive care, Kawasaki's disease, Lethargy, Lymphadenopathy
Clinical narrative: Suspected KD with cardiac sequelae  Per mom, he began having cold symptoms including runny nose and cough prior to 9/13. Rapid COVID test was negative. He received his second dose of COVID vaccine (Moderna) on 9/13.   On 9/18, mom noticed right cervical lymphadenopathy that was nontender and non-erythematous. On 9/19, began having a fever that persisted until 9/26 (about 1 week). Fevers were as high as 103F around the clock. Rapid COVID tests were negative for first 3 days of fever. Other associated symptoms included conjunctival injection, several episodes of vomiting after meals, low appetite, and increased tiredness/lethargy.    He did not have mucous membrane changes, changes to the lips or tongue, swelling or changes of hands/feet, or rash. He did not have abdominal pain, headaches, mental status changes other than tiredness/lethargy, difficulty breathing, or sore throat/voice changes.    Went to PMD on 9/20 and rapid strep was negative.  Was prescribed Augmentin which he took BID for 8 days.  Right neck lymphadenopathy resolved after 3 days of Augmentin, but he continued to have fevers and conjunctivitis.    He re-presented to PMD on 9/26 and labs were notable for CRP 96.4 (range 0-9mg/L), RVP negative for viral infections, CBC with WBC 14.6, Hgb 11.3, Plt 602, and EBV negative. PMD referred him to cardiology for possible atypical Kawasaki Disease. Echo (9/28) was notable for LAD dilation and possible thrombus. He was referred to LPCH CVICU urgently. Repeat echo (9/28) notable for severe, diffuse dilation of left main coronary artery, left anterior descending, and right coronary arteries. CT angiogram 10/1 with fusiform aneurysmal dilatations of the left main coronary artery extending to the level of the mid left anterior descending artery, as well as the right coronary artery until it gives rise to the PDA. No thrombosis. He has received IVIG , methylprednisolone, aspirin and clopidogrel for treatment of suspected sequelae of KD.     Since 9/26 he has had no fevers, no limitations in activity, no apparent SOB or swelling/edema, no syncope and has overall had improved energy, improved appetite, and normal UOP  Sister with rapid COVID positive on home test 9/19 and fever/URI symptoms. SARS-COV-2 RNA negative on respiratory test on admission 9/28. Due to lower concern but to evaluate for MIS-C, COVID-19 antibody tests sent prior to IVIG and have so far resulted as IgM negative, IgG pending.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: N-terminal prohormone brain natriuretic peptide normal, Nasopharyngitis, Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Suspected KD with cardiac sequelae  Per mom, he began having cold symptoms including runny nose and cough prior to 9/13. Rapid COVID test was negative. He received his second dose of COVID vaccine (Moderna) on 9/13.   On 9/18, mom noticed right cervical lymphadenopathy that was nontender and non-erythematous. On 9/19, began having a fever that persisted until 9/26 (about 1 week). Fevers were as high as 103F around the clock. Rapid COVID tests were negative for first 3 days of fever. Other associated symptoms included conjunctival injection, several episodes of vomiting after meals, low appetite, and increased tiredness/lethargy.    He did not have mucous membrane changes, changes to the lips or tongue, swelling or changes of hands/feet, or rash. He did not have abdominal pain, headaches, mental status changes other than tiredness/lethargy, difficulty breathing, or sore throat/voice changes.    Went to PMD on 9/20 and rapid strep was negative.  Was prescribed Augmentin which he took BID for 8 days.  Right neck lymphadenopathy resolved after 3 days of Augmentin, but he continued to have fevers and conjunctivitis.    He re-presented to PMD on 9/26 and labs were notable for CRP 96.4 (range 0-9mg/L), RVP negative for viral infections, CBC with WBC 14.6, Hgb 11.3, Plt 602, and EBV negative. PMD referred him to cardiology for possible atypical Kawasaki Disease. Echo (9/28) was notable for LAD dilation and possible thrombus. He was referred to LPCH CVICU urgently. Repeat echo (9/28) notable for severe, diffuse dilation of left main coronary artery, left anterior descending, and right coronary arteries. CT angiogram 10/1 with fusiform aneurysmal dilatations of the left main coronary artery extending to the level of the mid left anterior descending artery, as well as the right coronary artery until it gives rise to the PDA. No thrombosis. He has received IVIG , methylprednisolone, aspirin and clopidogrel for treatment of suspected sequelae of KD.     Since 9/26 he has had no fevers, no limitations in activity, no apparent SOB or swelling/edema, no syncope and has overall had improved energy, improved appetite, and normal UOP  Sister with rapid COVID positive on home test 9/19 and fever/URI symptoms. SARS-COV-2 RNA negative on respiratory test on admission 9/28. Due to lower concern but to evaluate for MIS-C, COVID-19 antibody tests sent prior to IVIG and have so far resulted as IgM negative, IgG pending.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory symptom, Respiratory viral panel, Rhinorrhoea, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: Suspected KD with cardiac sequelae  Per mom, he began having cold symptoms including runny nose and cough prior to 9/13. Rapid COVID test was negative. He received his second dose of COVID vaccine (Moderna) on 9/13.   On 9/18, mom noticed right cervical lymphadenopathy that was nontender and non-erythematous. On 9/19, began having a fever that persisted until 9/26 (about 1 week). Fevers were as high as 103F around the clock. Rapid COVID tests were negative for first 3 days of fever. Other associated symptoms included conjunctival injection, several episodes of vomiting after meals, low appetite, and increased tiredness/lethargy.    He did not have mucous membrane changes, changes to the lips or tongue, swelling or changes of hands/feet, or rash. He did not have abdominal pain, headaches, mental status changes other than tiredness/lethargy, difficulty breathing, or sore throat/voice changes.    Went to PMD on 9/20 and rapid strep was negative.  Was prescribed Augmentin which he took BID for 8 days.  Right neck lymphadenopathy resolved after 3 days of Augmentin, but he continued to have fevers and conjunctivitis.    He re-presented to PMD on 9/26 and labs were notable for CRP 96.4 (range 0-9mg/L), RVP negative for viral infections, CBC with WBC 14.6, Hgb 11.3, Plt 602, and EBV negative. PMD referred him to cardiology for possible atypical Kawasaki Disease. Echo (9/28) was notable for LAD dilation and possible thrombus. He was referred to LPCH CVICU urgently. Repeat echo (9/28) notable for severe, diffuse dilation of left main coronary artery, left anterior descending, and right coronary arteries. CT angiogram 10/1 with fusiform aneurysmal dilatations of the left main coronary artery extending to the level of the mid left anterior descending artery, as well as the right coronary artery until it gives rise to the PDA. No thrombosis. He has received IVIG , methylprednisolone, aspirin and clopidogrel for treatment of suspected sequelae of KD.     Since 9/26 he has had no fevers, no limitations in activity, no apparent SOB or swelling/edema, no syncope and has overall had improved energy, improved appetite, and normal UOP  Sister with rapid COVID positive on home test 9/19 and fever/URI symptoms. SARS-COV-2 RNA negative on respiratory test on admission 9/28. Due to lower concern but to evaluate for MIS-C, COVID-19 antibody tests sent prior to IVIG and have so far resulted as IgM negative, IgG pending.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test negative, Troponin normal, Urine output, Vomiting, White blood cell count increased
Clinical narrative: Suspected KD with cardiac sequelae  Per mom, he began having cold symptoms including runny nose and cough prior to 9/13. Rapid COVID test was negative. He received his second dose of COVID vaccine (Moderna) on 9/13.   On 9/18, mom noticed right cervical lymphadenopathy that was nontender and non-erythematous. On 9/19, began having a fever that persisted until 9/26 (about 1 week). Fevers were as high as 103F around the clock. Rapid COVID tests were negative for first 3 days of fever. Other associated symptoms included conjunctival injection, several episodes of vomiting after meals, low appetite, and increased tiredness/lethargy.    He did not have mucous membrane changes, changes to the lips or tongue, swelling or changes of hands/feet, or rash. He did not have abdominal pain, headaches, mental status changes other than tiredness/lethargy, difficulty breathing, or sore throat/voice changes.    Went to PMD on 9/20 and rapid strep was negative.  Was prescribed Augmentin which he took BID for 8 days.  Right neck lymphadenopathy resolved after 3 days of Augmentin, but he continued to have fevers and conjunctivitis.    He re-presented to PMD on 9/26 and labs were notable for CRP 96.4 (range 0-9mg/L), RVP negative for viral infections, CBC with WBC 14.6, Hgb 11.3, Plt 602, and EBV negative. PMD referred him to cardiology for possible atypical Kawasaki Disease. Echo (9/28) was notable for LAD dilation and possible thrombus. He was referred to LPCH CVICU urgently. Repeat echo (9/28) notable for severe, diffuse dilation of left main coronary artery, left anterior descending, and right coronary arteries. CT angiogram 10/1 with fusiform aneurysmal dilatations of the left main coronary artery extending to the level of the mid left anterior descending artery, as well as the right coronary artery until it gives rise to the PDA. No thrombosis. He has received IVIG , methylprednisolone, aspirin and clopidogrel for treatment of suspected sequelae of KD.     Since 9/26 he has had no fevers, no limitations in activity, no apparent SOB or swelling/edema, no syncope and has overall had improved energy, improved appetite, and normal UOP  Sister with rapid COVID positive on home test 9/19 and fever/URI symptoms. SARS-COV-2 RNA negative on respiratory test on admission 9/28. Due to lower concern but to evaluate for MIS-C, COVID-19 antibody tests sent prior to IVIG and have so far resulted as IgM negative, IgG pending.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Fatigue, Headache, Incorrect product formulation administered
Clinical narrative: Patient was supposed to have graded challenge with by bivalent COVID vaccine. By mistake she got monovalent COVID 19 vaccine. I wrote the orders but I actually did not check the vial itself.  After administration of the second dose of graded challenge (0.05 cc+0.25 cc) I discovered that the patient got more monovalent Pfizer vaccine (she already had 2 original vaccinations+2 boosters) instead of bivalent COVID vaccine.   Patient was not suppose to receive monovalent COVID 19 vaccine since it is not recommended as a booster anymore.   Patient was observed for 2 hours.  Understandably she was very upset but stable.  I contacted Pfizer safety department and obtained information what to do in case of an error and how to report it. I contacted her on October 1st. She complaints of headache and fatigue, but otherwise stable.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Paraesthesia
Clinical narrative: Erythema, swelling and severe pain of left upper arm with paresthesias
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mechanical urticaria, Pruritus, Skin irritation, Urticaria
Clinical narrative: Roughly two weeks after receiving the booster, any slight irritation of the skin that occurs began to cause a break out in hives. The symptoms are synonymous with dermatographia urticaria. I am constantly itchy without antihistamines.   This happened the first time I received the booster (December 2021) but at the time I did not know it was related to the vaccine. Now that it has occurred twice after receiving the covid vaccine, I know it isn't a coincidence.  The first time it occurred the side effects lasted two months.
Age: 87.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: *** ONLY reporting incident of non-indicated repeated dose of Fluzone high dose at Pharmacy on 10/1/22 *** Report is being submitted on Day 1 ; no adverse reaction on Day 1
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Acute sinusitis, Biopsy, Chronic sinusitis, Computerised tomogram head abnormal, Computerised tomogram neck
Clinical narrative: 1. Asymptomatic cervical lymphadenopathy first detected and diagnosed 2/15/22, four months after first Covid booster. Not detected at doctor visit just prior to booster or in months following booster by the patient. 2. Chronic sinusitis also diagnosed at 2/15/22 visit. Severe sinus congestion required several ENT visits. Successfully treated with multiple drugs. Finally diagnosed as acute sinusitis by ENT doctors in visits March-April, 2022. He believes Covid booster was linked to reactive lymph nodes, sinusitis, worsened excema and a new case of psoriasis, ("Covid booster could have sensitized your immune system. The lymph node was then more prone to react to a skin thing.") Skin conditions treated by dermatologist. 3.  6/16/22 exam showed "Left posterior adenopathy still present but significantly reduced in size." All other skin conditions resolved and back to pre-booster status. Sinusitis resolved.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Endoscopy abnormal, Lymphadenopathy, Psoriasis, Scan with contrast abnormal, Sinus congestion
Clinical narrative: 1. Asymptomatic cervical lymphadenopathy first detected and diagnosed 2/15/22, four months after first Covid booster. Not detected at doctor visit just prior to booster or in months following booster by the patient. 2. Chronic sinusitis also diagnosed at 2/15/22 visit. Severe sinus congestion required several ENT visits. Successfully treated with multiple drugs. Finally diagnosed as acute sinusitis by ENT doctors in visits March-April, 2022. He believes Covid booster was linked to reactive lymph nodes, sinusitis, worsened excema and a new case of psoriasis, ("Covid booster could have sensitized your immune system. The lymph node was then more prone to react to a skin thing.") Skin conditions treated by dermatologist. 3.  6/16/22 exam showed "Left posterior adenopathy still present but significantly reduced in size." All other skin conditions resolved and back to pre-booster status. Sinusitis resolved.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Peripheral swelling
Clinical narrative: i slowly developed muscle weakness and swelling in my hands muscle weakness from my knees up to my shoulders
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Sensation of foreign body, Urticaria, Vitamin D
Clinical narrative: Hives all over body. Feeling of lump sensation in throat. Symptoms persists for 5 weeks now  Medication taken -Prednisone 7 day course 40mg -Allegra -Benadryl
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Adverse reaction, Body temperature increased, Chills, Feeling abnormal, Gait disturbance
Clinical narrative: Adverse symptoms occurred after I had gone to bed and were noticed when I got up to use the bathroom.  I had a temperature, chills, and had difficulty walking, felt unstable. Also had erratic tremors in my jaw and hands that I couldn't control.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: Adverse symptoms occurred after I had gone to bed and were noticed when I got up to use the bathroom.  I had a temperature, chills, and had difficulty walking, felt unstable. Also had erratic tremors in my jaw and hands that I couldn't control.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose normal, Dizziness, Headache, Nausea
Clinical narrative: After 5 minutes received Pfizer bivalent covid vaccine, patient claimed dizziness, headache, nausea, no SOB or chest pain. Rph called 911 and paramedic checked her BG 93 & BP 99/60.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Musculoskeletal stiffness, Pain, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: My boyfriend and I believe we were given the wrong flu vaccine at a pharmacy based on our paper work saying Fluzone. Fluzone is marked as approved for 65 and older only on the manufacture site however my boyfriends and I  who received the vaccine are both under 65. I am pharmacy technician at a different chain and the pharmacist at my store say it is not  approved for those under 65 which matches what I found on the CDC website. We are both having body aches the night of getting the vaccine. I am also experiencing muscle stiffness and tirdness.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Scintillating scotoma
Clinical narrative: Scintillating scotoma, both eyes, <1 hour.
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sensitive skin
Clinical narrative: Skin hypersensitivity over the right (opposite) site of the body, on fingers, hand, back, hip areas. Symptoms started ~84 hours after injection. Symptoms have lasted 36 hours and have not subsided. Severity does not vary during the day.