chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up on July, noticed hearing deficit in left ear muffled, congested. Thought it was odd. Let it go a couple days thinking it would clear up on its own. Within a week I developed tinnitus. Ringing in left ear. Made an appointment with ENT on 7/26/21, and placed on prednisone and diuretic Triamterene. Cranial MRI 8/2 - neg results. Also noticed a fatigue or weakness in thighs, when walking going up/down stairs (not ENT related), so 8/2 saw PCP. He sent me to an endocrinologist 24hr cortisol test - normal. 8/9 - back started hurting around both sides where kidneys are. Would start in am and go until around 5pm and dissipate. Also during this time noticed I was experience numbness and tingling in my legs. 8/18 - back numbness/tingling began ascending and went up into my arms. 8/25 - weakness in legs/thighs had moved up into my arms 9/16 - saw a neurologist. Ordered blood work, A1C slightly elevated, EMG, EKG, inconclusive but peripheral neuropathy and early onset diabetes diagnosis. Muscular Dystrophy, ALS, Parkinsons, Cervical MRI - all neg. Genetic testing for other neurological/ hereditary problems - all neg Biopsy tests for neuropathy still pending.10/3 - weakness now predominantly moved into shoulder and neck and jaw muscles. 10/5 spread into lower legs/shins and front of arms. All of above are still present. In the last 30 days have had more ear problems. Now have tinnitus in right ear, as well as left.  Returned to ENT. Treating for eustachian tube disorder. Oral and nasal steroids prescribed. Lisinopril for possible fluid in my ears. When I squat and stand up get light headed, dizzy. I also see a chiropractor that specializes in peripheral neuropathy, and is treating me with laser therapies. I have been doing cupping and acupuncture with another holistic MD
Initial unsolicited report received from nurse on 05-Oct-2018. This case is linked with case 2018SA279699. This case involves a [9 months old] unknown gender patient who was vaccinated with a 0.5 ml dose of IPOL (Batch number: N1K92, expiration date: 14-NOV-2019, route: subcutaneous and site of administration: left thigh) on 14-Sep-2018. The patient's medical history was not reported. Concomitant medication includes DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. It was an actual medication error due to incorrect product storage (vaccinated with an IPOL multi-dose vial that was out of temperature range for 30 minutes). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Narrative: Admission date: Oct 10,2021 Discharge Date: Oct 22,2021 Condition of patient at discharge: DECEASED Primary Diagnosis during Admission/Treatment: Acute Hypoxic Respiratory Failure (AHRF) secondary to COVID Pneumonia 80 year old male with a history of CAD s/p PCI to LAD, HFrecEF (51% 12/2020, prev 35% 5/2020) s/p BiV-ICD 9/2020, HTN, and hypothyroidism presented to the Emergency Department (ED) with shortness of breath, cough, and weakness onset 2 weeks prior to the ED visit. Pt stated that he had progressively felt more fatigued and SOB with minimal exertion over the past two weeks and was encouraged to come to the ED by his nephew. He had greenish-yellow sputum production. He also admitted to 2 episodes of non-bloody, nonbilious emesis this morning. He denied any recent CP, lower extremity edema, or subjective fevers at home. In the ED, pt was afebrile, initially satting in the 80's on room air, BP 129/89, tachypneic RR 28. He tested positive for COVID-19 despite 2 doses of Moderna Covid vaccine on 1/11/2021 and 2/8/2021, and had notable labs of Cr 1.45, WBC 18.2, CRP 31.74, ESR 86, procal 1.75, ddimer 2.13. CXR showed mild atelectsis in left lower lobe otherwise clear. CTA PULMONARY ANGIOGRAPHY showed diffuse bilateral peripheral predominant areas of groundglass opacity and crazy paving in the lungs. VBG was 7.44/33.5/13. He was started on CAP coverage rocephin/azithro, given solumedrol 125mg and admitted to the ICU. The patient was started on 10-day course of steroids, remdesivir, and was given antibiotics to cover for possible bacterial co-infection during hospitalization. He started on High Flow Nasal Cannula (HFNC) on maximum settings with oxygen saturations that continued to drop below 88%. Patient was advised to self-prone, but stated that he was not able to do secondary to posture-related back pain. Remdesivir was discontinued after 2 days due to acute rise in liver function tests. Over the next few days, the patient began requiring a non-rebreather on 100% in addition to 60L 100% FiO2 HFNC to maintain oxygen saturation. On the morning of 10/22/21, patient began to decompensate with 75% oxygen saturation on 60L 100% HFNC with 100% non rebreather. After reviewing code status with the patient, he requested to be intubated, understanding the risks, benefits, and alternatives. Shortly following successful intubation with 100% FiO2 and PEEP of 14 and arterial line placement, patient continued to decompensate with HR near 130 and hypotension. Despite initiation of vasopressor and optimizing ventilator settings, patient declined and passed away on 10/22/2021 at 10:48am.
Circular area of approximately 1 - 1/2 inches around injection site red,  swollen, and painful. Armpit of same arm swollen approximate size of grapefruit and painful. Lasted 4 days.
Chills, headache, body aches, pain at injection site, general feeling of malaise, sweats, loss of appetite. Took Tylenol with minimal results. Resolved after about 30 hours
Received the shot friday 8/20, saturday experiences nausea dizziness, cognitive impairement, site shot arm pain. Sunday: chest and back pain, palpitations, panic attack, hot & cold flashes, cognifitive impairement or extreme brain fog: trouble focusing on completing daily tasks including walking and talking, nausea, fatigue, site shot pain, tingling in arms and legs Monday: chest and back pain, palpitations, panic attack, hot & cold flashes, cognifitive impairement or extreme brain fog: trouble focusing on completing daily tasks including walking and talking, nausea, fatigue, site shot pain, tingling in arms and legs Tuesday: still shaky and unsteady mentally and physically, able to work desk job only a few hours a day. appetite started to return. Wed-Sunday: something felt different inside of me. including: involuntary muscle twitches all over my body: arms, legs, chest, back, stomach, unable to workout, shortness of breath. Since then i have experienced what you would call waves or flare ups or episodes every day, sometimes multiple times a day: site shot arm pain, muscle twitches/spams, extreme brain fog (cognitive imparement), elevated heart rate while stationary, panic attacks, chest pain, joint pain, unable to workout like i used to- cardio workout triggers heart palpitations. motor skills and reflexs are delayed. quality of life is NOT the same. I had never had a panic attack just minor anxiety until after the shot. it has excercarbated my anxiety 100X. I had mild work related anxiety prior to the shot but left a stressful job in march and from march to aug had no anxiety until after the shot. pain in my right leg (suspect blood clot). i will NOT be taking the second or any subsequent doses. would please beg you grant medical exceptions.  I have had TWO major episodes where i felt i was going to pass out, high heart rate spikes while laying in bed, uncontrolled shaking, clenched jaw like i was going to have a seizure. only benzodiazepines helped calm the episode down. I am scared of what long term effects this will result in. Please please stop the mandates. it does not work the same for everyone. i have research my Lot number and found 250 adverse VAERs reported during same timeframe. Please tell me these symptoms will go away someday.
pt stated he woke up about 4:00 in the morning after having the covid vax and felt nauseous and felt the need to use the bath room.  Stated he broke out in a sweat with chills.  Pt stated he and wife both were having symptoms so called 911.  EMS arrived and monitored his vitals for about 30 minutes.  Pt stated symptoms subsided after about 20  minutes.
Patient is an 82 year old  male with a history of PAF on Eliquis, CKD-III, cognitive impairment,  tested positive for COVID-19 on 9/16/23, who presented to Hospital 9/18/23 with weakness, cough and confusion with reported recent fall. Managed for COVID infection. Course complicated by confusion.    1. COVID 19 with Hypoxia: symptom onset and positive home test on 9/16/23. Confirmed on admission. CXR non acute. Started on Decadron and Remdesivir. On RA as of 9/20/23. Remdesiver stopped. Special Isolation precautions. 2. Acute Metabolic Encephalopathy: Likely related to above with know cognitive dysfunction-> delirium. Patient being followed at Senior ceneter. Steroids contributing.AAO x 3 at the time of admission.CT brain non acute. Placed on PRN haldol and scheduled depakote. Behavioral Health followed.  3. Reported Fall: per ED documentation. Patient denied. No evidence of major trauma. CT head on admission nonacute. PT/OT recommended HHA PT/OT on discharge  4. Atrial Fibrillation/Atrial Flutter: per history. s/p ablation 2013. Follows with Dr. (Cardiology). Continued home Eliquis. Rate controlled Atrial Fibrillation  on admit ECG.  5. CKD stage 3a: Baseline Cr ~1.4-1.6. Stable on admit.   6. Pituitary Adenoma: Diagnosed 2015 incidentally. Follows with Dr (Endocrinology). On Cabergoline  7. Cognitive impairment : Noted cognitive deficits at baseline but no formal dementia diagnosis. Continued follow up at Senior center recommended  8. Code status: Full code.
Patient was given pfizer covid 19 omicron vaccine for ages 6 months - 4 years instead of pfizer covid 19 omicron vaccine for ages 5year - 11years.
10/18/2016  Client reports onset of rash to bilat upper extremeties, posterior neck within approx. 20 minutes of received vaccines on 9/16/2016; lasted x approx. 2 hours with resolution; denies respiratory symptoms/distress.
Episode of extreme crying, went limp, unresponsive and drowsy thru back to baseline 3 minutes in duration. 10/2/06 Received medical records from provider which included hospital records & revealed patient experienced prolonged irritability episode w/o evidence of apnea with a period of screaming then becoming pale, limp & unresponsive.  Taken to ER & monitored overnight.  Exam was WNL & d/c home./ss
avoid lifting my arms very high; pain at they gave me the shots / pain is not as sever; avoid lifting my arms very high and they hurt enough to make me wait up in night; make me wait up in night; This case was reported by a other health professional via interactive digital media and described the occurrence of injected limb mobility decreased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site pain, pain in arm and sleep disturbance. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, pain in arm and sleep disturbance were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, pain in arm and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, received 2nd dose in may 2020 and had pain where dose gave. The reporter stated that, the pain was not as sever but the patient had to avoid lifting arms very high and hurt enough to make the patient wait up in night. The patient asked, would the pain gone away.
diarrhea; This is a spontaneous report from a contactable consumer (mother of the patient). A female patient of an unspecified age (age: 66, units: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that her daughter (age 66) got a little sick after she got her vaccine. She was sick in stomach, diarrhea really bad. She didn't eat breakfast just had coffee. She had a hamburger after the vaccine and made a mess at the consumer's house. So the consumer was worried. Outcome of the event was unknown. Information on the lot/batch number has been requested.
4 hrs post inj arm swelling, increased pain, fingers numb and lower arm numbness. Saw Dr next day received IBU. Pt still experiencing finger numbness in 3 fingers cannot bend index finger.
no adverse reaction  expired vaccine was administered. Lot expired on 7/12/2020 and was administered 8/13/2020  contacted Merck to report and was given following case number and asked to record on VAERS: 01679927
This spontaneous report received from a health care professional concerned multiple patients of an unspecified sex, age, race and ethnic origin. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  "Reporter (Health Care Professional) stated that, on an unspecified date, one of his clients had done a antibody testing (COVID-19 antibody test) to all of their employees. From that testing, 'multiple people' that took J&J tested negative for antibodies (suspected immunological vaccine failure). It was unknown how long after vaccination testing was done". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211017208, 20210445531 and 20211007061. This report was associated with product RA: 90000196841.; Sender's Comments: V0: 20211017311-COVID-19 VACCINE AD26.COV2.S-suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient had a booster dose ( 3rd shot) of Moderna vaccine, broke in hives after 2 weeks,  some chest pain,  fullness in throat.
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-JUN-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1807USA003177: US-009507513-1807USA003068: US-009507513-1807USA003067: US-009507513-1807USA003066: US-009507513-1807USA003065: US-009507513-1807USA003064: US-009507513-1807USA003063: US-009507513-1807USA003062: US-009507513-1807USA003061: US-009507513-1807USA003060: US-009507513-1807USA003059: US-009507513-1807USA003058: US-009507513-1807USA003057: US-009507513-1807USA003056: US-009507513-1807USA003055: US-009507513-1807USA003054: US-009507513-1807USA003053: US-009507513-1806USA012857.
Data exchange was not properly working in EHR. Office procedure did not include reconciliation of immunizations. Causing extra dose to be given.
Flu like symptoms for 4 days, severe burning on soles of feet resulting in unbearable pain could not walk. Blisters broke out over entire body, hands and fingers swollen and could not close them.
I woke up with a rash on my stomach that were very itchy. They spread to chest, arm pit, forarm &  inner thighs.
Sore at the injection site; injection arm stiff; Welt; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Herniated disc" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Muscle tightness" (unspecified if ongoing); "Muscle spasms" (unspecified if ongoing); "Polycystic ovarian disease" (unspecified if ongoing); "Gastric reflux" (unspecified if ongoing); "Anaphylaxis" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Emphysema" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Sinusitis(Frequent)" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Adenoids" (unspecified if ongoing); "Orthopedic surgery" (unspecified if ongoing); "Tonsils" (unspecified if ongoing). Concomitant medication(s) included: PERFOROMIST; IPRATROPIUM BROMIDE AND SALBUTAMOL SULFATE; TRAMADOL; BUDESONIDE;FORMOTEROL FUMARATE; LISINOPRIL; METHOCARBAMOL; METFORMIN; PANTOPRAZOLE; CETIRIZINE HCL. Past drug history included: Pneumovax. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "unknown", described as "Sore at the injection site"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 09Apr2021, outcome "unknown", described as "injection arm stiff"; URTICARIA (non-serious) with onset 09Apr2021, outcome "unknown", described as "Welt".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a 19 months 8 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
On 3/21/08, child developed a fever of 102.2 which lasted for 3 days.  On 3/24/08, fever broke and child broke out with a red rash over entire body.  Rash was slightly raised.  Rash was gone by 3/27/08.  Was seen by provider on 3/24/08 and doctor thought it might be related to getting vaccines.
inappropriate age/ 6 month old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The Medical assistant reported the case. The patient received a dose of Kinrix at 6 months of age, which led to inappropriate age at vaccine administration. No symptoms reported.  The reporter consented to follow up.
pt recvd vax & was not feeling well; was achy all over; HA, swollen, red, hard arm shoulder to elbow; cellulitis;T100.4
Jaw chattering chills started roughly 12hrs after injection.  Fever associated with chills. Both chills and fever subsided by 24hrs post injection. Severe Muscle aches and joint point set in on day 2.
Information has been received from a healthcare worker via a company representative referring to "one or two" unspecified patients. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength, lot#, expiration date, dose and route were unknown). On an unknown date "about a year later", the patients came back to received a second dose of GARDASIL (strength, lot#, expiration date, dose and route were unknown). The physician decided to "restart" the GARDASIL series (due to the amount of time that elapsed between the 1st and 2nd dose) therefore "one or two" unspecified patients received 4 doses of GARDASIL (all on unspecified dates). No adverse effect reported. Additional information has been requested.
Swelling and lots of pain in left arm at injection site, radiates up to left side of neck, left inner ear and left side of back of my head. panful headaches, pain in all  my bones, vomiting, feverish , extremely tired and in bad mood. Chills and  numbness on the left side of  my face, including left side of my mouth and left eye making me almost lethargic and extreme bad mood.  Light bother me a lot,  feel nauseas.  I am extremely weak when walking and have to make a great effort to walk since is extremely painful and I don't have much strength.   Everything hurts, especially when I walk, I feel very weak.
Related to Rotateq, case of Rotavirus infection. Vomiting 4/14/23 on day of vaccination. Diarrhea since 4/14/23- multiple times a day. Needed office visit and phone call follow ups. Pedialyte recommended and smaller feeds. Symptoms resolved by 4/20/23.
tested COVID positive; tested COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 55-year-old male patient (weight was lean to average) received BNT162b2 (COMIRNATY), in Feb2021 as dose 1 single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 11Apr2022, outcome "unknown" and all described as "tested COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive. Symptoms were mild and did not require hospitalization. The patient traveled very frequently.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.