chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up; Lack of drug effect; Impaired quality of life; Difficulty sleeping; Drug specific antibody present; Breakthrough pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4238973-00.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number: unknown) to 2021 at (40mg/0.4ml) for rheumatoid arthritis. Relevant medical history included: "Allergic Rhinitis Unspecified" (unspecified if ongoing); "Gastro Esophageal Reflux Discharge without Esophagitis" (unspecified if ongoing); "Opoid use unspecified uncomplicated asthma" (unspecified if ongoing); "Unspecified disturbances of skin sensation" (unspecified if ongoing); "Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement" (unspecified if ongoing); "Intervertebral disc degeneration thoracic region" (unspecified if ongoing); "Sulfacetamide allergy" (unspecified if ongoing); "Bactrim Allergy" (unspecified if ongoing); "Ibuprofen Allergy" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL; FLUTICASONE; ALBUTEROL SULFATE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; TYLENOL; ACETAMINOPHEN;HYDROCODONE; IBUPROFEN. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; DRUG INEFFECTIVE (non-serious), outcome "not recovered", described as "Lack of drug effect"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "not recovered", described as "Impaired quality of life"; INSOMNIA (non-serious), outcome "not recovered", described as "Difficulty sleeping"; DRUG SPECIFIC ANTIBODY PRESENT (non-serious), outcome "not recovered", described as "Drug specific antibody present"; BREAKTHROUGH PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Breakthrough pain". The patient underwent the following laboratory tests and procedures: laboratory test: unk. The action taken for adalimumab was dosage permanently withdrawn on 2021. Clinical information:  The reporter's causality for Pfizer biontech covid-19 vaccine (tozinameran) and HUMIRA 40mg/0.4ml (ADALIMUMAB), for the event(s) of affecting quality of life, unable to sleep, rheumatoid arthritis/ worsened/ flare up, Humira not working due to formation of antibodies unknown onset and breakthrough pain was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect vaccine BNT162B2 cannot be excluded.
chills, fever +3 degrees, joint aches, muscle aches, headaches ,fatigue starting 20 hr after injection.  fever lasted 20 hours, headache lasted 36 hr, everything resolved in 48 hr.
05-25-2017 at 10:30 AM: Received KINRIX IM in (R) VL and PROQUAD (R) thigh. Patient left office. Returned at 11:30 C/O swollen throat, itching, cough and chest hurting with wheezing. BENADRYL PO given and EPI PEN JR given IM.
3-4 hrs after injection, pt developed a lot of pain followed by redness and swelling that evening along with chills. c/o deep ache down her left arm to left hand the next morning. Will use ice, Tylenol, Benadryl.
Onset 1 day after booster. Chest pain, palpitations, shortness of breath, fatigue lasting 4 days, plus residual chest pain on day 5. Treated at home by mom. Self resolved. (Treatments included electrolytes and Prussian Blue).
INTENSE PAIN FOR 5 HOURS STRAIGHT IN LEFT OVARY LESS THAN 24 HOURS LATER TO THE POINT THAT MOVING AND WALKING WERE VERY DIFFICULT. CHRONIC MIGRAINES CONTINUOUSLY SINCE VACCINATION. PAIN IN RIGHT OVARY ON DAY 4.
12/5/2011 Received shingles vac 11/29/2011. Started to break out with rash in Right Lumbar 1 dermatome. Started to blister approximately 48-72 hours ago and started having pain last night. No fever or other alert symptoms. No immunocompromise risk factors. Well nourished, healthy appearing, no distress. Has red welts band-like fashion right Lumbar 1 dermatome--very confluent and starting to breakout in multiple blisters.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-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 EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. On 26-Sep-2021, the vial was placed in the refrigerator. The vial did not had any temperature excursion and the patient had no adverse event. No Treatment medication reported.
Pt reported severe dizziness 1 week after receiving PPSV-23 vaccine.
Headache, Myalgia,  INJECTION SITE PAIN AND SWELLING  Narrative:  Other Relevant History:
11 hrs p/vax pt exp sudden onset uncontrollable shivering, severe joint pain all extremities; sx lasted into following day when was seen in medical 8AM, still shaking; missed 2 work days; no tx given; sx subsided by end of 48 hrs;
LEFT EYE BLURRY; FELT SLIGHT DISORIENTATED; SLIGHT DOUBLE VISION; SMALL RASH ON THIGH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced small rash on thigh. On 28-MAY-2021, the subject experienced left eye blurry. On 28-MAY-2021, the subject experienced felt slight disorientated. On 28-MAY-2021, the subject experienced slight double vision. The action taken with covid-19 vaccine was not applicable. The patient recovered from slight double vision on 28-MAY-2021, had not recovered from left eye blurry, and felt slight disorientated, and the outcome of small rash on thigh was not reported. This report was non-serious.
PM p/recving shots had a high fever - "almost 105" (mom); took to hospital where they put ice packs on pt; under observation for 4hrs & sent home; during fever was "limp, not crying or drinking anything";
Rash on abdomen, hives on upper left thigh. 5ml of Benadryl given. Rash developed within 2 hours of receiving vaccines, patient came back into office. Vital signs were stable. Provider saw patient.
This spontaneous report as received from a pharmacist refers to a 70 years old female patient with codeine allergy. On 27-SEP-2012, the patient was vaccinated with, 0.5 ml PNEUMOVAX23 Lot # H009826 Exp date: 11-FEB-2014. Pharmacist reported that on 27-SEP-2012, the patient experienced very swollen arm after receiving PNEUMOVAX23 and complained of difficulty moving the arm. The patient did not received any treatment for the event. The patient sought medical attention by spoke to pharmacist. The outcome of adverse events was unknown. The relatedness for adverse events was unknown for PNEUMOVAX23. Additional information has been requested.
COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4487476-00.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for crohn's disease. The patient had no relevant medical history. No Known Allergies. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Apr2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Apr2022) Positive, notes: On 01Apr2022, the patient experienced COVID. The action taken for adalimumab was dosage not changed. Clinical course as follows: Solicited report from the USA by a consumer of a 77-year-old male with events of covid with Humira (Adalimumab). On 01Apr2022, the patient experienced COVID. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. he said he didn't know whether if it the Humira that's caused Covid. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab), The reporter's causality for the event covid was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of covid is related to Humira (Adalimumab). Causality for Pfizer BioNTech Covid-19 Vaccine for event COVID-19, Causality as per reporter was Possible.  The reporter considered "covid" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and covid 19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201110935 same patient/vaccine different dose and AE;
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA 9/3/2022 -- RECURRENCE OF SAME SYMPTOMS
Approximately 24 hours after Hep A and PREVNAR given in left upper thigh, red firm area developed-continued to spread. Afeb no other symptoms. Eval'd at our office on 3/20/19 - 4.5x2.5cm red, warm, ERM, irregular even on (L) thigh. Rx'd AUGMENTIN.
This is a spontaneous report from a contactable Physician (patient) reporting for himself. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6203), intramuscularly, administered in Left arm on 25Feb2021 14:45 at the age of 56-years-old as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were none. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809), intramuscularly, administered in Left arm on 04Feb2021 15:45 at the age of 56-years-old as single dose for covid-19 immunisation. Relevant tests were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 25Feb2021 at 20:00, the patient experienced arm soreness, headache and fatigue. No treatment was received for adverse events. Seriousness criteria for events was reported as non-serious. The outcome of events was recovered on an unspecified date in 2021. No follow attempts are possible; No further information is expected.
I don?t have a doctor at the moment but called health services and spoke to a nurse. There is still swelling at the injection site and it has a knot along with stinging and itching. It feels like an infected mosquito bite. Bruised with speckles on skin and warm to the touch. It is now 7 days and feels the same.
Patient received the vaccine on 4/5/21.  On 4/8 a strong pain developed in her opposite arm and migrated to her chest.  She couldn't even pull up her pants when going to the bathroom.  On 4/11 she developed chest pain and struggled to breath until 4/13.  On 4/13 she developed a strong pain in her right thigh which subsided on 4/15.  On 4/17 she started with a rah on the back of her left thigh which continued to spread onto her torso, arms, legs, neck and chin.  On 4/18 she went to the ER and was given steroids.  She followed up with her family doctor on 4/19 and while at the MD office her throat, tongue and lips started to swell.  She was sent back to the ER on 4/19 and received more steroids.  She  went back to her family doctor after leaving the ER on 4/19 and completed blood work which came back on 4/20.  All the blood work (specifically allergen marker) indicated this was not an allergic reaction to any of her known allergies (as the ER MD assumed).  At that point, her family doctor recommended she visit an ER at another town to get additional help.  She went to the ER, on 4/20 and was given more steroids and told she had vasculitis.  The rash continued to spread all over her body.  The rash started as a blistery red and then shifted to red and purplish, black.  On 4/22 she saw her MD once again who diagnosed her with HSP.  She is certain this was a reaction to the covid vaccine, as she has only been to the md twice in the last two years; once for a pap smear and once for a flu shot.  She is a very healthy person with no illnesses until this vaccine.  Her skin is now peeling where the rash was.  She is also struggling with a severe mental fog.  She struggles to remember conv ersations.
Pain at the top of my spine - was severe the first couple days after shot Almost felt like I had slept funny or twisted my neck Two months later it's not as severe but I still notice it Wanted to report to see if other people have reported a similar symptom; it's not disruptive to life but it is noticeable
got their first dose over a year ago and has not received the 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date a over year ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The health care professional asked if a patient got their first dose over a year ago and had not received the 2nd dose, did they need to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Injection 02/08/04.  Severe swelling and erythema left deltoid.  This was his 5th Anthrax, not infected.
severe pain, no strength in lt arm, trouble moving arm, hand feels numb-hand shakes when holding something;
vomiting w/in 1 hr of vax; mom called hlth dept & then pvt MD; by noon temp had went up to 102.7 ax; c/o h/a;
Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/30/2023 Discharge Date: Feb 7, 2023  PRESENTING PROBLEM: Septic shock [A41.9, R65.21] Cellulitis [L03.90]   HOSPITAL COURSE: Patient is a 67 year old woman with PMH significant for DLBCL s/p chemotherapy in remission, RA on chronic prednisone, HFpEF, asthma, history of VTE in the setting of factor V Leiden on Eliquis, hypothyroidism, bipolar disorder, hyperlipidemia, and rheumatoid arthritis who presented to our institution on 01/30/2023.  She was diagnosed with septic shock secondary to left lower extremity cellulitis and admitted to the intensive care unit.  She was started on intravenous Vancomycin and Zosyn as well as stress dose steroids. MRI of LLE shows cellulitis with no osteomyelitis. The wound care team was asked to follow for chronic left lower extremity wound. Blood cultures showing corynebacterium on one of two sets no susceptibilities studies available.  Repeat blood cultures collected on 02/02/2023 revealed no growth. On 02/03/2023 antibiotics were deescalated to unasyn, and subsequently changed to Augmentin in preparation for discharge.  The patient required pressor support briefly while in intensive care as well as stress dose steroids, upon transfer out of the intensive care unit on 01/31/2023 stress dose steroids were discontinued and her home dose of prednisone 10 mg daily (as part of her rheumatoid arthritis therapy) was resumed. The patient was on 2l of oxygen via nasal canula prior to admission has been weaned off nasal oxygen to room air through this admission.   Noted pulmonary hypertension history, pulmonology team felt likely group 3 and group 4 with history of VT and factor 5 laden and recommended continuation of Eliquis twice daily   On 02/06/2023 the patient was determined to be medically stable to transfer back to these skilled nursing facility from which she came, however they were unable to accommodate transportation on this date and therefore she was discharged on 02/07/23  with labs and vitals stable condition and instructions to follow-up with her primary care physician within 1 week to monitor potassium and volume status.
I was diagnosed with "Myocarditis" last Monday 12/06/21 following the chest pain that I had. Prior to this, I never had any health issue.
pt recv vax & devel swelling in both the rt arm & testicles the following morning;no further details were known as of reporting date;
patient developed redness and swelling and warmth at the site.  Dr. prescribed patient Acetaminophen and Benadryl.
This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 12 days after receiving Shingles vaccine, the patient experienced injection site rash, fever, chills, general body pain and headache. On an unknown date, the outcome of the injection site rash was unknown and the outcome of the fever, chills, general body pain and headache were recovered/ resolved. It was unknown if the reporter considered the injection site rash, fever, chills, general body pain and headache to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient self-reported the case. The patient got all the side effects after the vaccine. On an unknown date, less than a day after vaccination the day when patient got the vaccine, the patient came down with a fever (102 degree Fahrenheit), chills, overall body ache, headache for 24 hours. At the time of reporting patient mentioned that 12 days later the patient had a rash at the site of injection. The patient asked was this normal. The follow-up would not possible as no contact details were available.
T 103 (AX) for 1/2 day following DTP inject 7Nov91, limpness, paleness, high pitched crying,crying > 3 hrs, approx 1 hr /p following injection
Pt had varicella vaccine 08/21/97. 07/12/02 child diagnosed wit varicella.
This spontaneous report as received from a registered nurse. The nurse was also an 11 years old male patient aunt. The patient was given his third dose of GARDASIL (injection; 0.5ml) on 23-JAN-2013 (the dates of the first 2 vaccinations were unspecified). On 27-JAN-2013, the patient developed "hand print sized red spots all over his body and smaller spots on his face." He was brought to the emergency room (ER) of an unspecified hospital but the representative did not know if the patient was admitted. No other vaccines were given at the time of this vaccination. There was no AE with the first 2 doses of GARDASIL. BENADRYL was given for AE. The outcome of events was unknown. The patient was sought medical attention. Additional information has been requested.
Patient had first Moderna vaccine on 3/14/2021.  The day after he started having a lot of pain in his shoulders arms and hands, this is spread to general myalgias and he is very miserable.  He is on oxycodone chronically.  His wife is with him and very concerned as he cannot seem to get comfortable. Patient's pain distribution involving his hip girdle and shoulders is consistent with polymyalgia rheumatica.  Further supporting this diagnosis are the significantly elevated ESR and CRP markers, he is also had imaging which did not show any specific arthritic findings.  Given the timing of the polymyalgia rheumatica developing following his Covid vaccine this may be an adverse effect to the vaccine.  Finally his quick response to prednisone is further evidence of polymyalgia rheumatica.  He does not have any evidence of visual loss, or severe headache to suggest temporal arteritis presents.
Patient received 2nd dose of COVID-19 vaccine on 5/6/21 therefore was fully vaccinated.  Patient presented to clinic 8/25/21 with symptoms of COVID and tested positive for COVID-19 8/25/21.
Shingles. Skin pain in right leg, hip, back then blisters on right thigh. Pain started several days after vax, blisters appeared approximately 10 days after vax.
Patient started complaining of difficulty breathing, difficulty swallowing and nausea. Wheezing noted, epi administered. Patient stated that her symptoms improved following epi. EMS called and patient transferred to the hospital.
Mom felt the child was warm on Friday night, June 1st but never measured temperature until Sunday evening, June 3rd when the temp was up to 103 F, pain on R leg and tenderness at vaccine site. The duty nurse recommended Tylenol and fever came down. Temperature 103 F at noon on Monday June 4th and given Tylenol then came to clinic for a follow up. Patient active and in good spirit.