chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Twitching, ear infection, stimming. Loss of words and all verbal communication. Neurological and developmental delays. Autism from 18 mos - 22 mos onset. Low protein. Currently takes LEVOCARNITNINE and CO Q 10 for possible metabolic disorder. Follow-up 1/21/10 Seizures, tics, autism, developmental delays.   8/5/08 Reviewed psychologic examination report of 2/22/2008. FINAL DX: autism spectrum disorder Records reveal that patient experienced recurring otitis media abeginning at 15 mo that seemed to trigger a developmental regression beginning with his 1st ear infection but most apparent after 3rd ear infection approx 19 mo when he became very hyperactive.  Language loss began approx 22 mo & began stereotypical repetitive behaviors.  Had PE tubes placed & adenoids removed 10/2007 & ear infections resolved however found to have mild hearing loss.  Also medically found to have metabolic disorder & eczema, picky eater, loose stools, hyperactive, difficulty falling asleep, loss of speech.  Had been receiving ST/OT.  6/20/08 Reviewed PCP medical records for 12/18/06-8/2/2007. FINAL DX: Records reveal patient experienced recent URI & was teething on day of vaccination otherwise in good health.  Returned to clinic 12/28/06 w/vomiting, diarrhea, fever, cough, congestion, lethargic & decreased appetite. Dx w/URI & ROM, treated w/antibiotics.  Returned 2/23/07 w/runny nose, cough, congestion, fever, decreased sleep.  Dx wLOM & URI, treated w/antibiotics.  Returned 3/9/07 w/questionable seizure night before with shaking while in highchair.  Exam revealed resolved OM & neuro eval WNL.  Referred to neurology for EEG.  Had additional OM & URI, loss of speech.  Referred to ENT for hearing test.  Neuro did not feel had seizures.  No documentation of autism in PCP records received.   7/4/08 Reviewed developmental peds medical records of 8/23-9/26/2007. FINAL DX: autistic disorder Records reveal patient experienced hyperactivity, paroxysmal twitching behaviors, abnormal repetitive play, toe walking, not responsive to name, sleep difficulties, toy/activity fixations, finicky eating, stereotypical repetitive behaviors, Receiving ST/PT/OT from early intervention program at time of evaluation.  An addendum of 2/2008 notes that parents reported regression to the point of having no recognizable words.
Two hours after the administration of the vaccine, at 12:00 pm on the 29th of July, a small bump started to form on the Patient's Lt deltoid near the administration site. The next day, the Mother of the Patient noticed that it was becoming larger, and that the bump was red and warm to the touch. The mother of the Patient reported the patient was given Motrin for her fever of 102 degrees Fahrenheit, and a warm compress for the pain and swelling. Bump on arm was 5x3 cm in area, on the 31st of July. Plan of action is to continue the care given by the mother. If it continues to become larger, the patient is recommended to seek further medical care.
This spontaneous report as received from a other health professional refers to an unspecified patients of unknown age and gender. On 10-JUL-2017 and 11-JUL-2017, the patients were vaccinated with improperly stored doses of M-M-R II (dose, route of administration and were not reported). Data logger was involved (temperature excursion: 47-77  Fahrenheit degrees).      Additional information has been requested.
05/09/2021 brought to Hospital by EMS, with weakness & 104.6F fever; PMH HTN, CAD, afib an dvt on eliquis, DM II, hypothyroid, CKD, diagnosed with COVID in January 2021; discharged home on 05/11/21 Home with Skilled Home Care.
There is a 4" by 5" raised red patch around the injection site. The patch presents with a higher temperature than the rest of the arm, is raised, as well as causes itching.
sore arm; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 06Feb2021, at single dose, for COVID-19 immunisation. Medical history included pain in hip and ongoing asthma. Concomitant medications included ibuprofen (MOTRIN) and paracetamol (TYLENOL) both for pain in hip. The patient experienced sore arm (non-serious) on an unspecified date with outcome of unknown.    The information on the lot/batch number has been requested.
cough, malaise and fatigue. He states that he started to have symptoms about 3 days ago with chills, subjective fevers, cough, anosmia. He also had some chest pain that he states was left sided/substernal and felt like squeezing/heavy pain. It started yesterday morning and comes and goes. He has some SOB and he also has had a very poor oral intake.
Freezing Cold; Shaking; Weak; Upset Stomach; Lethargic; Not feel well; being in bed; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019 15:00, the patient received the 1st dose of Shingrix. In July 2019, 3 days after receiving Shingrix, the patient experienced feeling cold, tremor, weakness, upset stomach, lethargy, feeling unwell and bedridden. On an unknown date, the outcome of the feeling cold, tremor, weakness, upset stomach, lethargy, feeling unwell and bedridden were unknown.   It was unknown if the reporter considered the feeling cold, tremor, weakness, upset stomach, lethargy, feeling unwell and bedridden to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient felt fine on saturday and sunday.  On 22nd July 2019, at around 8:00am, 2 days 17 hrs. after vaccination when the patient woke up, she did not feel well. The patient was freezing cold, shaking, felt weak, and had a mild upset stomach. She got back into bed and has been there ever since.  At the time of reporting the patient was feeling better but still in the bed and felt lethargic. Unable to obtain additional information. The reporter gave permission to follow up.
Allergic skin rash on trunk and arms.  Treating with Benedryl and cortisone creme
patient arrived in ventricular tachycardia via EMS, but responsive. deteoriarated to pulseless ventricular tachycardia, PEA and ultimately death.
Fever 102 Fahrenheit; Severe leg and foot pain; Short of breath; Headache; Chills; This is a spontaneous report from a contactable other HCP (Patient). This 51-year-old female patient (who was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an Intramuscular route, administered in Arm Left, on 20Jan2021 at 09:00 AM (at the age of 51-year-old) as a single dose for COVID-19 Immunization, at hospital. Patient's medical history was not reported. Patient had no Known allergies. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC), lamotrigine (LAMICTAL) and ergocalciferol (VITAMIN D); which were administered within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an Intramuscular route, administered in Arm Left, on 31Dec2020 at 09:00 AM (at the age of 50-years-old), as a single dose for COVID-19 Immunization. Patient did not receive other vaccines in four weeks of vaccination. Patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID since post vaccination. On 20Jan2021, at 09:00 PM, the patient experienced Fever 102 Fahrenheit, severe leg and foot pain, short of breath, headache and chills. No treatment was given for the events. Outcome of the events was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Was a bit fatigued in the evening of 5/11. Starting about 4pm. Woke up 5/12 at about 6 am to severe body aches and pains. Very weak and Sever chills. Now have a fever of 102.3. Have been taking Tylenol for fever and pains
first dose in June 2019, plan dose 2 as soon as possible; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in June 2019 in an unknown arm intramuscularly).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose in June 2019, plan dose 2 as soon as possible). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-May-2023 The pharmacist reported that the pharmacy planned to give the patient's Shingrix dose 2 as soon as possible. The reporter did not ask the patient for permission to contact health care professional. The patient did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Provider's Notes for 4-10-2021 visit:  29 y/o F presents to Urgent Care with c/o possible side effects after receiving 1st dose of Pfizer BioNtech COVID-19 vaccine yesterday evening. Reports to feeling pruritis in R arm at time of vaccine administration but this resolved within few minutes. However, pt admits to waking up with headache and R sided body pain. Husband noted erythematous rash behind pt's ear; pt denies warmth, pruritis or tenderness at rash site. Symptoms of generalized body aches and chills have developed in the last few hours (similar to symptoms of cold). Took excedrin with relief to headache and myalgias.   Denies recent use of antihistamine but adds that she was prescribed cetirizine and diphenhydramine by PCP for hx of random rashes that occur after being outdoors. Pt also states that she was recently prescribed cyclobenzaprine, meloxicam and norco for R "trapezius" pain. She was referred to physical therapy by specialist recently. Last use of pain medication was 1 week ago.   Denies arthralgias, numbness, tingling, rash or pruritis at injection site (does have soreness), fever, sore throat, dysphagia, facial/neck swelling, chest pain, SOB, nausea, vomiting, diarrhea, inner or external ear pain, discharge from ear, rhinorrhea, post nasal drip, persisting headache, hx of anaphylactic reaction to meds or vaccine in past.   Adverse reaction to vaccine product Due to acute onset of symptoms after recent vaccine administration (onset within 12hrs), pt's symptoms of myalgias, acute onset rash, chills are likely mild adverse reaction to the recent COVID-19 vaccine. No current signs of anaphylaxis and pt was reassured. She opted to take cetirizine while at clinic. PO or IM steroids will be avoided to reduce risk of suppressing intended immune response to vaccine. May apply topical hydrocortisone or topical benadryl if rash becomes pruritic. RTC if symptoms worsen or persist. ER precautions discussed for acute worsening. Pt and her husband voiced understanding.   Start cetirizine 10 mg tablet 1 tablet as needed  On examination - erythematous rash See above recs. Cellulitis is low in ddx due to acute onset of symptoms, bilateral distribution, and lack of tenderness. Monitor closely.   Muscle pain Can continue acetaminophen or NSAIDs with food as needed. RTC if symptoms worsen or persist.
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date in 2013, the patient was vaccinated with the first dose of GARDASIL, then the patient received the second dose of GARDASIL about 3 months later on an unspecified date and finally, on 19-JAN-2016 (reported as today), the patient was vaccinated with the third dose of GARDASIL, (dose, route, anatomical location, lot number and expiration date were not reported for the vaccines above described). No adverse effect was reported. There was no concomitant medication reported. Additional information has been requested.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 011F21A, 007B21A and 023M20A) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included COVID-19 (Patient had 4 Covid episodes -one before getting any of the vaccines). Concurrent medical conditions included Hypertension, High cholesterol and Asthma (from time to time).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient had 3 COVID-19 episodes in between the 2nd doses and the other succeeding doses and its symptoms included feeling tired. Treatment information was not provided.   This case was linked to MOD-2023-715619 (Patient Link).
Pt left office after immunizations, called back approx 10 minutes later & stated left eye was swollen. Returned to office & was examined by Physician. " Returned after 30 minutes with dramatic left periorbital swelling, more of the inferior lid than superior. Some musocal swelling at the lateral margin, too."
severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; severe systemic itching, facial swelling; hives on back; flushing on chest; face; arms; hands; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Mar2021 10:30 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient medical history was not reported. Concomitant medications included chlorthalidone; diltiazem; doxepin; famotidine (PEPCID AC); fexofenadine hydrochloride (ALLEGRA). The patient experienced severe systemic itching, facial swelling, hives on back, flushing on chest, face, arms, hands on 18Mar2021 10:45. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment received for the adverse events included diphenhydramine (BENADRYL) and steroids. The outcome of events was recovered in 2021.   Information on the batch number has been requested.
Reports within a few hours after vaccine started to feel "ill" by 1900 11/4/14 was "cold and achy" pt reports the chills were severe. By noon on 11/5 she was better and WNL on 11/6/14.
Really dizzy; Can barely stand; Feels room is spinning; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Really dizzy), DYSSTASIA (Can barely stand) and VERTIGO (Feels room is spinning) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 026B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ALLOPURINOL for Product used for unknown indication, DILTIAZEM HCL, FINASTERIDE, ROSUVASTATIN, TAMSULOSIN and IRBESARTAN for an unknown indication.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced DIZZINESS (Really dizzy), DYSSTASIA (Can barely stand) and VERTIGO (Feels room is spinning). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Really dizzy), DYSSTASIA (Can barely stand) and VERTIGO (Feels room is spinning) outcome was unknown. Not Provided
Within 5 days of the vaccination,  I developed skin thickening on the tips of the smaller toes on both feet.  This progressed over several weeks to ulcerations and severe pain which precluded the wearing of shoes.  Subsequently, the affected toes developed discoloration suggestive of severe bruising .  At that time, the fingers of both hands showed a cyanotic appearance of the distal two thirds and   a pale appearance of the proximal third.
persistent screaming episodes lasting 1-1 1/2 hrs (timed by parents); episodes alternate w/episodes of sleeping for varying amounts of time; episodes resolved @ 0500 27OCT93;
mother called on 06/26/2020 at 10:37 am to advise the patient had been vomiting and had a fever of 103.0 at 4:00 am. Mother called back on 06/26/2020 at 2:35 pm and states that patient had held some water and a half of a sandwich down. Fever is now at 99.0 to 100.0 mother stated that she will continue to monitor and push fluids to the patient.
Dull chronic headache - started 15 hrs after vaccination, ongoing for > 4 months  Bilateral tinnitus - started several days after vaccination, ongoing for > 4 months
About ten minutes after the shot, my heart suddenly started pounding, I was panting, and I got very hot.  Then tingling went all over my body, even in my lips.  At one point, I felt close to fainting.  The pharmacist lady gave me cold water (I asked for it), and I just sat there for quite a while.  Gradually my heart rate came down, and I got cold, but the tingling kept going, and I felt somewhat weak.  Since I didn't want any epinephrine (it affects my heart), and I didn't think I was so bad that I needed an ambulance, after being there nearly an hour my husband drove me home.  There I took some liquid Benadryl, and that seemed to help with the tingling.  I just took it easy after that.  Considering my reaction tothe first dose, I will NOT be getting the second one.  I don't need to consult with a doctor to decide that.  It was somewhat frightening because I didn't know how bad it was going to get.
Fever of 101-103 degrees through 07/14/14.  Spotty rash appears heavy on lower abdomen, groin and spreads to belly, back and neck.
Information has been received from a registered nurse referring to an 11 year old patient of unknown gender. On 30-JUN-2015 the patient was vaccinated with GARDASIL (lot # K008931, intramuscular, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I received the first dose of the vaccine on January 11th.  By January 21, I developed extreme itching on the scalp between my ears, which later developed into several bumps. Using a prescription shampoo for3 weeks did not seem to help. Then I received the 2nd dose of Moderna on February 8th.  A couple of days later, I began itching in some places of my body, such as the elbows, underarms, and buttocks.  Soon hives accompanied the itching.  The hives and itching spread over most of my body.  I was prescribed antihistamines and took those for a month before it even started to get a little better.  Then, after another month, I was still itching all over, but the hives were not as bad.  On April 20th, the itching was still not much better, so I went to an allergist.  He prescribed that I take one 24 hour Allegra in the morning, and one at night.  In a week, the itching improved quite a bit.  Now I'm on 1 Allegra a day, and it seems under control. The allergist said that my immune system response to the vaccine may have played a role in triggering the chronic urticaria.
Vaccine was given on 7/26/22 but expired on 7/7/22. No adverse events reported.
Bad migraine after 1st dose on 9/22/21.  Extreme migraine after 2nd dose on 10/13/21
On 07/28/2022 in the morning I had fever, tiredness and body aches. I tested positive for COVID-19 on 07/29/2022. I did a telehealth with my doctor on 08/01/2022. They prescribed me with cough depressant and other medications but I didn't take it. I didn't take any medications at all.
Patient was present with dad while vaccine administration, after receiving 7 out of the 9 vaccines, patient reports not feeling well, and experienced seizure with decorticate posturing manifested by eyes rolling upward, legs becoming straight and and arms flexing upward with clenched fists holding close to chest.   I had the patient lay down flat on the exam table with head turned to the side. Seizure lasted approximately 5 seconds, and afterwards patient became alert and responsive. Father was at patient's side. V/S were checked. BP 122/73, HR 94, RR 20, Temp 98.1. Patient recovered right away as soon as she lay down on the exam table. Patient was due to also get Hep B and HPV vaccines, which was held d/t this event. Father was advised to F/U with patient's PCP for further vaccine administration.
several days after shot 1, itchy rash appeared away from injection site on neck, forearms, and back of hands and subsided without treatment prior to shot 2; within 24 hours of shot 2, rash reappeared in same locations; visited PCP and then dermatologist 6 weeks later because of itchy lesions especially on back of hands (worst on right hand); was prescribed Triamcinolone 0.1% ointment which reduces itching but lesions on hands still a problem as of 05/01/21.
Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Numbness along right arm for 1 day,k then numbness along right leg and foot for 2 weeks
we already discussed possible side effects that were to be expected BUT she stated she had slight fever (over 100.1 for over 72 hours) and nausea.
Patient is 18 years old and 11 months. He was given the adult dose instead of the pediatric dose.
Red, swelling to both RA, LA treatments known are BENADRYL and BACTRIM, massaging to area.
LIGHT PAIN; DIZZINESS; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included no known allergies. no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 12-APR-2021, the subject experienced light pain. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from light pain, fatigue, dizziness, and nausea. This report was non-serious.