chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a PSA before the vaccine. That's where they check your blood for your prostate. After the vaccine, I went and got another report and it had doubled. The only change I had in my life is the vaccine. Now they are saying I have prostate cancer. My PCP doesn't think it's related, but I wanted to let the CDC know just in case. I developed bumps on my left arm. After the vaccine, I went back to work and had soreness in my arm. I noticed it really bad when I started lifting boxes. The doctor prescribed me a new drug, but he said it was a new drug with not a lot of research so I haven't used it. The pain in my arm comes and goes. I can still feel exactly where I received the shot. It's not completely gone at all. I went to the employee nurse and she said there was a couple other people that had the rash come up. We noticed the lot numbers were very close. The nurse said that she could see the bumps compared to my other arm. They just told me I could put ice on it, but I never did. My PCP is with urgent care, but he said he didn't have any answers for me. Just prescribed the medication.
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 28-DEC-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion with 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49.1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335:
Narrative:  Patient reported at his primary care appointment on 6/28/22 that he developed RA after administration of the COVID vaccine the previous year, could not find anything in his chart to confirm a diagnosis of RA.
Second dose High fever- 106 degrees Farenheight. Severe body aches, severe headache
This case was reported by a consumer via call center representative and described the occurrence of weakness of arms in a 46-year-old female patient who received FLUARIX quadrivalent (batch number 45YJ4, expiry date 20th June 2016). Concomitant products included FLONASE, cyanocobalamin and Multivitamin. On 17th October 2015, the patient received FLUARIX quadrivalent (intramuscular) .5 ml. On 18th October 2015, 1 days after receiving FLUARIX quadrivalent, the patient experienced weakness of arms, injection site erythema, numbness in fingers and feeling unwell. On an unknown date, the patient experienced abnormal sensation of limbs and feeling unwell were unknown. The reporter considered the weakness of arms, injection site erythema and numbness in fingers to be related to FLUARIX quadrivalent. It was unknown if the reporter considered the abnormal sensation of limbs and feeling unwell to be related to FLUARIX quadrivalent. Additional details were provided as follows: The reporter reported the report via web site. The next morning, after vaccination the patient experienced weakness of right arm and fingers of right arm were slightly numb (injected arm). During the same day when the events were started, the events were improved but the patient did not feel well and noticed a red mark (oval) on her shoulder at the injection site (injection site redness). In October 2015, less than a week after receiving FLUARIX quadrivalent, the patient's arm was still feeling odd (it had been two days from starting the odd feeling). Also, the weakness of arm was resolved but the fingers were still feeling strange and were very slightly numb. The reporter was called again and reported that, her whole right hand felt weak and finger numbness was specific to right hand. After that, all the weakness was resolved and finger numbness was also resolved but an odd feeling remained. Redness at injection site was resolving which turned to light pink.
Aside from a sore arm and flu like symptoms the first two days, the third day the bumpy skin toned rash that had subsided about 3 weeks after the first vax, came back full force covering the entirety of both legs.  Fourth Day- noticed the bier spots were still there from the first vax. They would come and go. More fatigued than usual.  A familiar rib cage pain that appeared after the first vax lasting 4 days after the first with one more  episode several weeks later after the first, came back. Rib cage pain feels like the tissue between the ribs is sore and bruised. Surround entirety of ribs, front and back. This episode was mild and lasted two days. Week 2 - development of petechiae (went to urgent care for this) under arms, several dots on thighs and and when I scratched my skin for an itch they would develop, along with   the scratch becoming bright red and raised as though I really dug in when I hadn?t. The scratch would last for over 24hrs Also in week 2, developed a sunburned sensation on arms, legs and back. It comes and goes during this time. Week 2 - rib cage pain becomes constant.  Week 2 - far more fatigued than the first week. Bouts of dizziness requiring me to lay down. Excessively sweaty and light headed. Hear makes it much worse  - Heart rate goes from 60bpm while laying down with a normal blood pressure to 110-130bpm within a minute of standing up. Blood pressure remains in the normal zone.  - legs turn red and mottled upon standing  - thighs feel heavy and burn upon standing   Week 3 - rash subsides.                     - skin burning sensation becomes constant now.                     - two nights have experienced very low pelvic cramps. They feel like contractions. I?ve never experienced these cramps before in my life aside from giving birth.  Currently : symptoms continue to persist with the exception of the rash
Mom calling office c/o site where varicella given had a hard knot, warm to touch, whole back of arm swollen, painful to the point that it kept patient up at night. Told mom to do cold compresses and motrin call if symptoms worsen.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (route oral, lot # L048854, expiry date 31-AUG-2017) (strength, dosing details, anatomical location were unknown). No adverse effect was reported. The vaccine was exposed to the temperature of 34 degree Fahrenheit for 53 hours. No digital data logger was involved. No product quality complaint was filed. This is one of the several reports from the same reporter. Additional information has been requested.
Red around injection site, firm to the touch, warm, neck muscle soarness (above  injection site)
8/07 - bladder symptom - later diagnosed as neurogenic bladder; 9/07 - Optic neuritis /Headaches; 10/07 - cognitive decline; Possible diagnosis - Multiple Sclerosis 8/26/08 Reviewed neurologist medical records of 11/1/07-7/14/2008 which included ophtho & PCP medical records. FINAL DX: optic neuritis & MS Records reveal patient experienced left eye dilated, HA w/sharp pains.  Had been seen by ophtho whose records are also included for decreasd color & peripheral vision.  Seen in ER for chest pain, dark vision, dizziness & had passed out x 2.  Had used imitrex & Topamax for HA & then developed chest pain.  Initial neuro consult had been done prior to ER for HA.  ER Dx: adverse effects of medication; vascular HA; chest pain secondary to AE of medication.  D/C to home.  Developed hand/foot tingling & dysuria w/overactive bladder.  By 3/2008 HA had almost completely resolved but continued w/bladder frequency & stress urinary incontinence.  Referred to urogynocologist & dx w/neurogenic bladder.  Referred to second opinion neuro & uro.
Anaphylactic reaction, characterized by mild difficulty breathing, diffuse erythema over body, malaise. Given EPIPEN, SOLUMEDROL, and BENADRYL in office which resolved problem.
to recv vax 11SEP96 & devel shingles rt upper arm 26APR98;
Two and half weeks after the second dose, my daughter had cognitive issues suddenly and couldn?t pass a basic neurological exam at the hospital. She was taken by ambulance - she couldn?t remember her address, phone number and couldn?t make out some words. She was admitted to the hospital and multiple brain scans and other tests were performed ruling out stroke and infection. The doctors don?t know what caused this mysterious cognitive disturbance of a otherwise heathy girl with no previous conditions whatsoever.
The night of vaccine administration, the patient had a high fever and went to the Emergency Room. He also experienced difficulty breathing and nausea. The symptoms resolved in 24 hours and the patient felt better.
This patient did not have any type of allergic reaction to the Moderna vaccine.  The patient was vaccinated on 4/22/2021 and the age at the time of vaccination was 17 years old.  Per advice from Health Department is completing a VAERS report.  Also per direction from DHHS, this patient will be vaccinated with the 2nd dose of Moderna.
Cancer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer". Reporter had a query as they already had the first 2 doses and his wife had cancer and 2 operations, they both would like to get the 3rd dose specifically the Comirnaty vaccine, the fully approved one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First dose Moderna and Second dose Pfizer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna and Second dose Pfizer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna and Second dose Pfizer). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (First dose Moderna and Second dose Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's relevant concomitant medications weren't reported Treatment information was not provided
This case was reported by a pharmacist via call center representative and described the occurrence of faint in a 16-year-old female patient who received TWINRIX adult for prophylaxis. Concurrent medical conditions included woozy. On 28th February 2019, the patient received TWINRIX adult 1 ml. On 28th February 2019, less than an hour after receiving TWINRIX adult, the patient experienced faint (serious criteria GSK medically significant) and inappropriate age at vaccine administration. On an unknown date, the patient experienced off label use. On an unknown date, the outcome of the faint was recovered/resolved and the outcome of the off label use and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the faint to be related to TWINRIX adult. Additional details reported as follows: The pharmacist reported that, in the last evening the 16 years old patient was given a dose of TWINRIX Adult on the left deltoid, which led to off label used and inappropriate age at vaccine administration. The patient was a little woozy before but within 2 minutes after vaccination, the patient fainted and was out for about 30 to 60 seconds.
improperly stored VARIVAX administered to the patient; no additional adverse events were reported; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitants medication were not provided.  On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (lot # W039294 has been verified to be a valid lot number, expiration date: 11-DEC-2024: strength, dose and route of administration were not reported), administered by a health professional (product storage error). The vaccine had been stored under 17.4 degrees Fahrenheit (F) for 2 hours. There was no previous temperature excursion. No additional adverse events were reported.
This case was reported by a physician via sales rep and described the occurrence of myalgia in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was unknown. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was immunized at the pharmacy and experienced significant myalgias. The physician did not have any additional details regarding the patient. The reporter did not agree to receive mails of follow up from the GlaxoSmithKline. This case has been linked with the case US2018GSK082079 reported by the same reporter.
Tinnitus developed four days after receiving second dose of vaccine. No history of tinnitus.
Pt onset with c/o numbness and tingling to lips.  Denied SOB, tongue swelling, difficulty swallowing, itching, or rash.  Denied any other symptoms.  He received Benadryl 50 mg PO at 0922 AM.  Vital Signs:  80-20 137/86  SPO2 96% on room air. At 0935 the patient reports he is feeling better and stated to RN "that Benadryl works fast".  VS HR 87 BP 131/80  SPO2 96% on RA. He left vaccination site ambulatory with two peers in no distress.
Patient reported getting a flu shot and had side effects of chest pain, cold, body aches, he will postpone dosing by a week. No add'l information noted. Patient does not consent to be contacted.
A non-serious spontaneous report of Henoch-Schonlein purpura after FLUMIST has been received from a physician concerning an eight-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 22-Aug-2011. On 10-Oct-2011, the patient was diagnosed with Henoch-Schonlein purpura about six weeks after receiving FLUMIST. The outcome of the event, Henoch-Schonlein purpura after FLUMIST was not recovered.
Client began getting an itchy, raised, red rash on stomach, first noticed in morning of 8-28-08.  Since then, rash has continued to spread down trunk, onto legs, down arms and on face.  Rash continues to be itchy, client taking Benadryl for itching, says it seem to help.  Denies fever, malaise.
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On multiple unspecified dates (after 06-OCT-2016), the patients were vaccinated with doses of improperly stored VAQTA (lot#, expiration date, dose and route were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
07/06/21- Husband and I attended routine cleaning of our teeth.  07/08/21- Husband and I started with symptoms of sore throat, hoarse voice, stuffy/ runny nose, cough, chills, fever.  Then 1 year old daughter started to show symptoms.  Her cough was extremely concerning on 07/16/21, but started feeling better the following week.  She saw her doctor on 07/20/21.  07/14/21- I met with PCP with same symptoms of sore throat, hoarse voice, stuffy/ runny nose, cough, chills, fever. Prescribed Amox-Clav  07/15/21- Amox- Clav filled and taken at 10 pm with allergic reaction of rash and hives  07/16/21- Call to PCP she stopped the Amox-Clav for two days, then prescribed Doxycycline.  Doxycycline did not help the symptoms.  Loss of smell and loss of appetite began.  07/20/21- Test- negative  07/28/21- Urgent Care with same symptoms continuing as listed all above, rapid COVID 19 test- negative, mail out test negative  08/03/21- Doctors appointment, diagnosed with COVID19, no medication presribed / Sometime after this appointment I took Mucinex to help with symptoms and had an allergic reaction for 48+ hours with rash and hives.  Allergy relief OTC medication taken and provided little help.  08/09/21- Still present with cough, stuffy/ runny nose, and itchy skin very few hives
I started breaking out with fever blisters across my mouth. Eventually I developed genital break outs as well. I have a regular prescription for VALTREX for fever blisters but in this case the blisters kept coming back for about 3 weeks before I saw the doctor. It was a herpes simplex. They increased my medication dosage which started to help after about 5 days. Today I still have sores inside my mouth. I have a new doctor taking a look at me now and indicating this is autoimmune. I was prescribed hydroxychloroquine. My symptoms are about the same though.
Dizziness, Headache, swollen on vaccine site, bodyache, fatigue Narrative:
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 20-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
SHINGLES; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included: pancreatectomy, and urinary tract infection, and concurrent conditions included: type 1 diabetes, pancreatic insufficiency, ra (Rheumatoid arthritis), hypothyroidism, hyperparathyroidism, depression, and hypercholesterolemia (Increased cholesterol), and other pre-existing medical conditions included: The patient had no illness at the time of vaccination, no pre-existing acute illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UKNOWN) dose was not reported, administered on 09-FEB-2022 for covid-19 prophylaxis. Age at time of vaccination 62 years old. Concomitant medications included sertraline for depression, levothyroxine for hypothyroidism, ergocalciferol for pancreatectomy, omeprazole for pancreatectomy, pancrelipase for pancreatectomy, insulin aspart for type 1 diabetes, vaccinium macrocarpon for urinary tract infection, and atorvastatin. On 12-FEB-2022, the patient experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious. This case, involving the same patient is linked to 20230107357.
Respiratory distress and failure; Respiratory distress and failure; Hypoxia; Coma; Infection of unknown origins; Rashes and lesions on her skin; Weakness and fatigue; Cardiac injuries; Weakness and fatigue; Rashes and lesions on her skin; extremely high fever; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of an unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 05-JUN-2012, pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).        Within approximately 10 days of receiving zoster vaccine live (ZOSTAVAX) vaccine, on 15-JUN-2012, the pt suffered life threatening injuries which began with extremely high fever (pyrexia) and infection of unknown origins accompanied by rashes and lesions on her skin (skin lesion) and severe weakness (asthenia) and fatigue. The infectious state and fever caused respiratory distress, respiratory failure and hypoxia resulting in admission to Intensive Care Unit (ICU) hospitalization for 10 days in a debilitated/comatose state (coma). She also suffered cardiac injuries (heart injury). All of these injuries were caused by zoster vaccine live (ZOSTAVAX) vaccine. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations (disabling seriousness) not present prior to using the product. Additionally, pt also experienced mental and emotional distress due to this limitations and seriousness of her condition. Pt sustained severe and debilitating personal injuries and in addition, suffered serious, progressive and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, pt also suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, pt was not recovered from the events.  Upon internal review, coma, heart injury, hypoxia, respiratory failure and respiratory distress were considered medically significant events.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients, names and other demographics unknown, who on unspecified dates received an improperly stored dose of ZOSTAVAX (lot # M040144, expiration date 26-DEC-2017) that was reconstituted with properly stored sterile water diluent (STERILE DILUENT) (lot # and expiration date were reported as unknown). The dose was stored at temperatures in the range of 6 degrees Fahrenheit to 14 degrees Fahrenheit for a time frame of 1 hour 30 minutes as identified by a digital data logger. There were no previous temperature excursions. No adverse effects were reported. No additional information was provided. Additional information has been requested.