chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced severe local swelling, to the extent she could not put on a sleeve, redness and heat at the injection site. No throat invovement, or difficulty breathing. Patient was seen by her cardiologist for an unrelated issue, whom referred her immediately to her primary care provider.  Dr. diagnosed her as having cellulitis and prescribed an antibiotic.
My right arm became swollen, felt numb, back of arm became blue  & purple, arm felt heavy, extreme pain & veins showing through skin. Hospital visit on 11/08/2021 concluded I have 3 blood clots in my right arm.
SEVERE whole-body chills lasting approximately 2.5 hours, followed by mild fever, fatigue, and entire body ache.  This lasted until approximately 48 hours after the injection.
On December 21st I got my first Pfizer Injection.  Had minimal side effects, that included a weird headache (I have migraines and this was unlike any migraine I ever had), it was like a halo above my ears and around the crown of my head.  I also had a sore arm.  No other issues.  On January 11th I got my second dose.  Again sore arm, nothing terrible.  This time I was prepared and over hydrated to prevent the headaches.  On day 2 after my shot I noticed both my shoulders starting to hurt and complained to my best friend I felt like a bus ran me over.  I said maybe it?s the shot but we shuffled it off to I slept funny.  2 weeks went by, same thing still going on; except some days my shoulders hurt so bad I couldn?t take my clothes off.  About 4 weeks post injection my knees also started to hurt.  I visit my chiropractor every 2-3 weeks regularly since having my daughter 12 years ago because my pelvis rotates out of place; her and I discussed what was going on and she said she had a couple other patients complain of similar things and it typically gets better after 6 weeks.  So I give it a few more days, decide to message my family care doctor just to let her know what?s going on.  She checks me for Rheumatoid Arthritis- that?s negative.  Checked my CRP-  which were elevated to basically say I was having an inflammatory response.  (I knew all these things already lol you don?t just wake up at 38 with RA with no family history but whatever).  Another week went by and I am at work and can?t stand up to walk- like crying in pain my knees and arms hurt so bad.  One of the anesthesiologist gives me a Decadron injection.  An hour later it was like magic, I actually had relief.  Unfortunately less than 48 hrs later the pain came back.  I went to my family doctor and had a conversation about all of this.  They put me on a tapering dose of Prednisone for 10 days- because unfortunately the max dose for Decadron is 6 days we decided to do Prednisone so I could have more days.  I started with 100 mg a day of Prednisone and tapered it down for 10 days.  I finally felt back to normal and it was amazing!!  Then 5 days after the last dose of Prednisone the pain came back yet again in my knees.  It hasn?t come back as bad in my shoulders but it?s definitely worse in my knees.  My family doctors recommendation is for me to see a rheumatologist; which I am waiting on an appointment for now.
eye pressure is rising; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a 70 year old female patient started to receive exemestane (AROMASIN, Coated tablet, strength: 25 mg) via unknown route of administration from an unknown date at an unknown dose and frequency for Malignant neoplasm of unspecified site of right female breast and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unknown route of administration on an unknown date as dose number unknown, single for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Patient stated her eye pressure was rising. Also, stated she had received the Pfizer Covid shot and is very happy so far. The action taken in response to the event with exemestane was unknown. The outcome of the event was unknown.
The day after receiving the vaccine (Wednesday 3/3/21) I noticed extreme sensitivity to sunshine while driving, even while wearing shades.  Remind me of when I get my pupils dilated by the ophthalmologist.  Also muscle pain, chills, and fatigue.  All these symptoms disappeared by the next day, but the fatigue remained through the weekend. Today, 3/8/21 I feel back to normal. I had Covid 19 in May 2020, so I recognize some of the symptoms, except for the light sensitivity, which scared me.  I will consult with my ophthalmologist before my second dose scheduled for 3/23/21.
A mother who is also a nurse, reported that her 4 year old daughter received an injection of Prevnar on 12/12/00 and 2 nights later, awakened complaining of "shivers" but denied being cold. Her mother noted intermittent, involuntary jerking motions of her daughter's body. The mother reported that her daughter was afebrile, alert and oriented. Her symptoms resolved approx. 6 hours later. Additional information received on 1/25/01, from the physician indicated that the pt has had no subsequent jerky movements or episodes of altered awareness.
Approx. 1 AM on 10/2/21 noticed throat was itching and tongue felt full.  Self administered 2 benadryl and went back to sleep. Awakened at 3 am with lip, tongue and throat swelling and called for assistance.  Epinephrine 0.3 mg IM administered and prednisone 60 mg  orally administered with improvement of throat swelling /tongue swelling . Lip swelling improved however continued to be mild for an additional 8 hours.  Patient given prednisone taper and  benadryl q4 hours along with certirizine 10 mg bid and famotidine 20 mg bid prescribed for 1 week. By approx  6 pm on 10/2/21 all symptoms had resolved .
herpes zoster, damage to her optic nerve; permanent loss of vision in right eye; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). On an unknown date, reported as after received zoster vaccine live (ZOSTAVAX) vaccine, suffered from herpes zoster, damage to her optic nerve resulting in permanent loss of vision in her right eye (ophthalmic herpes zoster and blindness unilateral). As a result of these symptoms, patient was seen and treated by healthcare providers. As direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, patient had resulted in physical limitations did not present prior to used the vaccine. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient condition. Patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffered, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Patient had suffered and incurred damages, included medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of ophthalmic herpes zoster and blindness unilateral was not recovered. The reporter considered ophthalmic herpes zoster and blindness unilateral to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, ophthalmic herpes zoster and blindness were determined to be medically significant events.
reconstituted  with 0.7mL of sterile water; reconstituted  with 0.7mL of sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2021, the patient received the 2nd dose of Shingrix. On 16th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reports that a pharmacy technician reconstituted Shingrix with 0.7mL of sterile water instead of the supplied AS01b adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have further patient information or dose lot number or expiration date. The reporter consented to follow up.
5 days after Tdap right deltoid site swollen tenderness about golf ball size swelling, right arm sore pain 5-7, complain generalized warmth feeling hot, temp 98.
ALT was really high/A couple days ago had blood work and ALT was like super high; This is spontaneous report from contactable female consumer (patient). A 21-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in arm left on 16May2021 15:00 (at the age of 21-year-old) at a 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was taking unspecified thyroid medications. No family history was reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took flu shot and thought she had adverse reaction because the patient like passed out or something. The patient experienced alt was really high/a couple days ago had blood work and alt was like super high on 28May2021. Patient asking for advise following her first Pfizer vaccine she is scheduled this Sunday for the 2nd one. Patient stated, On Friday, she got blood work, went to see my primary care physician, ALT was really high. Patient was not taking anything other than thyroid medication, thinking maybe it is the vaccine. They were going to repeat the blood work in 6 weeks. Had tests done 4 or 5 months ago and were fine. The patient was a consumer reporting she had not received the second dose Pfizer Covid Vaccine and was scheduled to receive the second dose Pfizer Covid Vaccine on Sunday, 06JUN2021. The patient stated she received the first dose Pfizer Covid Vaccine. A couple days ago had blood work done and ALT was like super high: A couple days ago the patient had blood work done and the patient's ALT was like super high. The patient stated this was her liver she guessed. The patient went to her primary care and the primary care stated maybe the vaccine caused the ALT to go up so high. The patient stated she was not taking any medications or anything or doing anything differently. The patient was wondering if she should still receive the second dose Pfizer Covid Vaccine. The patient underwent lab tests and procedures which included ALT was like really high on 28May2021. Therapeutic measures (unspecified) were taken as a result of alt was really high/a couple days ago had blood work and alt was like super high. Outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Iodiopathic Transverse myelitis; Ascending paralysis c/w transverse myelitis; This is a literature report for the following literature source(s):   A 73-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, 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: ASCENDING FLACCID PARALYSIS (medically significant) with onset 26Feb2021, outcome "unknown", described as "Ascending paralysis c/w transverse myelitis"; MYELITIS TRANSVERSE (medically significant) with onset 26Feb2021, outcome "unknown", described as "Iodiopathic Transverse myelitis". The patient underwent the following laboratory tests and procedures: CSF cell count: elevated; CSF glucose: low; CSF protein: elevated; Culture: negative; Gram stain: elevated.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported events Myelitis transverse, ascending flaccid paralysis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article;drug/different patient;
Retinal Necrosis; This is a literature report.  A 62 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chickenpox" (not ongoing). The patient's concomitant medications were not reported. The following information was reported: NECROTISING RETINITIS (medically significant), outcome "unknown", described as "Retinal Necrosis". The patient underwent the following laboratory tests and procedures: intraocular pressure test: 53 mmHg; 16 to 23; investigation: notable for vitreous cells, occlusive retinal, notes: vasculitis, large  retinal hemorrhages, and three quadrants of peripheral areas of  retinal whitening; optical coherence tomography: demonstrated scattered vitreal debris,, notes: intraretinal edema, and areas of full thickness disruption of retinal architecture with increased hyperreflectivity; visual acuity tests: 20/125, notes: left eye.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Necrotising retinitis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I am a registered  nurse at  hospital.  On 12/25,   seven days after  receiving the  shot  I started to get right lower leg pain and I kept complaining about it till New Years Day. I had no symptoms of a DVT.  I triaged on 1/1/21 and the doctors  ordered  labs/imaging  and the results were  as followed: D-Dimer  biomarker  (+) , Ultrasound of the Rt lower leg ( - ) ,  CTA showed a PE (segmental right upper lobe pulmonary artery consistent with pulmonary embolus). I  was discharged on  Xarelto and advised to follow  up with a hematologist. On 1/5/2021,  I went to hematology and they did a whole bunch of labs. I was sent to get a  ultrasound   of the leg because the pain persist and they found  a clot hidden by my soleus. The plan is to continue on the Xarelto for 6 months. Come back in 3 weeks to scan my leg again and get my lab results.  On 1/12/2021, I received the 2nd shot of the Pfizer vaccination.
I got first and second dose of vaccines of Pfizer, First dose november 14, and second dose December 05, 2021.  On December 2021 after two days of my vaccines I got my period, it was spotting for 4 days, After  that, In January, I dont have period at all, by February I only got spotting for 9 days, Its was weird because for many years I always have period. By March for some reason I got heaviest period in my life, I feel the blood its like pee, it last for 15 days, because I took advil to help it decreased.  By end of April my period start again, but at first I got spotting at like 3 to 4 days before actual period start April 24 to May 10, its like 17 days bleeding, I know it was not normal at all Im taken advil for this also to help me stop the bleeding. In May I went to have check up the doctor advice me to get a transvaginal ultrasound,  and I'm glad it went, normal result. That time, the doctor prescribed me a traxenemic acid. In June, It seem it was lighter and I have 9 days period but in the 7th day, I took traxenemic and stop in 9 days.  So I thought,  and hoping by July will go back to normal  but it wasnt.  In July I got my period again start July 04 to July 18, its 15 days bleeding,  before the period start, I had spotting again by 4 days before start, this time my period, has a lot of clots and there are some days i'ts lighter and for some reason the next day it will be heavier. I took the traxenemic and advil, I only allowed 5 days for traxenemic so when its end after a day, I took advil. So  in August I got my period.I didnt spotting but my period start August 17 but stop for 2 days. And then August 20 start again, its lighter some days, and next days it heavier its been like 12 days up to now it didnt stop. For many years I never experienced this before I got the vaccine. I have only like 4 days of period and like 28  days of cycle before. I'm hoping that one day it will go back to normal,  i'ts been like almost 6 months, and I still dealing with it. I dont have any cramps, but I do have like more clotty period,  and heavier some days, some days lighter, and for some reason I feel it won't stop unless I took some medication.
Patient had severe demyelination in the brainstem following the vaccination and presented with weakness, parasthesia, paralysis of eye muscles, jaw clonus, double vision, severe ataxia and inability to swallow and trouble breathing.
PUI is unsure of her symptom start date as since the beginning of the month she has been having coughing and congestion due to allergies. PUIs daughter was monitoring her 02, was hopping between 95 and 84, went on 9/19 and was admitted. PUI got an xray, EKG, EEG, and CT scan which showed pneumonia but no complications, said she has a release date set for 9/24 so she can have the 5 days of antibody infusion treatment. PUI has type 2 diabetes, AFIB, and hypertension. Patient is fully vaccinated.
Dizziness, lightheadedness, headache, difficulty breathing. These symptoms only lasted a couple of minutes and then they passed. I've had a headache all day since the vaccination and have had on-and-off lightheadedness.  No treatment received
I experienced hives, itching, and put cortisone cream on it when it happened. The raised hives have been recurrent daily since 12/17/21. I began taking Allegra per my doctors suggestion which helps with discomfort and the hives, but they are still occurring daily. This is a new thing for me which only started after my vaccination. I have been referred to an allergist and my appointment is on 4/29/22.
Injection site became itchy; Injection site became red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site became itchy) and VACCINATION SITE ERYTHEMA (Injection site became red) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site became itchy) and VACCINATION SITE ERYTHEMA (Injection site became red). At the time of the report, VACCINATION SITE PRURITUS (Injection site became itchy) and VACCINATION SITE ERYTHEMA (Injection site became red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
PATIENT WAS GIVEN BIVALENT AS A PRIMARY SHOT. PATIENT DID NOT RECEIVED PRIMARY SERIES PREVIOUSLY.
A spontaneous report was received from a consumer (age and gender unknown) who received Moderna's COVID-19 vaccine first dose and experienced Covid-19 test positive.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection.   On 06 Jan 2021, one day after receiving the vaccine, the patient was tested positive for Covid-19.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event is Recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PATIENT LEFT THE PHARMACY FEELING PERFECTLY FINE. HE WAS IN THE VITAMIN AISLE AND FAINTED. ANOTHER CUSTOMER HELPED HIM UP AND BROUGHT HIM BACK TO THE PHARMACY. HE SAID HE FELT LIGHT HEADED PRIOR TO FAINTING. I PROVIDED HIM SOME WATER, CHECKED HIS BLOOD PRESSURE, AND EVENTUALLY HE FELT FINE. HE MENTIONED HE DID NOT EACH MUCH, DRINK ENOUGH WATER, AND HAS BEEN WORKING LONG HOURS. HE LIVES CLOSE TO US AND WAS GOING HOME TO EAT SOME PIZZA AND GET SOME REST. WE OFFERED TO CALL 911 BUT HE STATED HE WAS FINE.
Wheezing started 3/17/14 with cough. Hypoxia noted in ER despite treatment with DUONEB and admitted to hospital. Discharged home 3/20 on inhalers with diagnosis of RSV (-) bronchiolitis. CXR read as normal. Had initial admit to PICU x 1 day.
expired Ipol was administered to the patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse.  This case is linked to case 2020SA357294 (same reporter).  This case involves a female patient of unknown age who received a 0.5ml standard dose of an expired IPV (VERO) [IPOL] (lot number: P1F491M and expiry date: 30-Nov-2020) once via intramuscular route in the right deltoid for prophylactic vaccination on 03-Dec-2020 (Expired product administered).  Medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination .  This was an actual medication error case due to expired vaccine used (latency: unknown).  At the time of reporting, no adverse event was reported.  Reporter asked for any recommendations regarding dosing and administration of expired product.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.