chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid 24Apr2023; tested positive for Covid 24Apr2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 62 years intramuscular for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EH9899), on 13Jan2021 as dose 2, single (Lot number: EL1283), on 29Oct2021 as dose 3 (booster), single (Lot number: EW0169) and on 10Aug2022 as dose 4 (booster), single (Lot number: FP7137), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: Crab" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Apr2023 at 09:30, outcome "recovering" and all described as "tested positive for Covid 24Apr2023". The event "tested positive for covid 24apr2023" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2023) Positive, notes: at 9:30 am. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300171842 same patient, different drug, different events;
Information has been received from the authors of a published literature article concerning a 6 month old female with gastroesophageal reflux and reactive airway disease and a history of frequent respiratory illnesses who on an unspecified date was vaccinated with her second dose of HIB conjugate vaccine. Concomitant therapy included ranitidine, fluticasone propionate, and albuterol. Subsequently, the patient developed cough and fever and was given amoxicillin/clavulanic acid and prednisolone. Three days later, she was hospitalized with chest radiograph confirmed pneumonia and fever to 38.9 degrees C and was treated with ceftriaxone. Blood cultures from admission and hospital day 2 grew H. influenzae type a, which was subsequently determined to be beta-lactamase-negative and sensitive to amoxicillin/clavulanic acid. She completed 6 days of ceftriaxone treatment, followed by 4 days of amoxicillin/clavulanic acid treatment, and returned to her baseline state of health. Four months later, the patient was again evaluated for cough and fever. Chest radiograph revealed bilateral upper lobe infiltrates. She was treated with oral clindamycin and albuterol. Three days later, she was hospitalized with cough, fever, poor oral intake, and non-bilious vomiting. She later became lethargic and developed a bulging fontanel. Cerebrospinal fluid analysis showed 9750 mm^3 white blood cells (with 68% segmented neutrophils and 32% lymphocytes), protein 248 mg/dL, and glucose <20mg/dL. She was treated with vancomycin, ceftriaxone, and dexamethasone. Cerebrospinal fluid cultures grew H. influenzae type a, and she was treated with ceftriaxone. After IV antibiotic treatment was started, her neurological status returned to normal in 2 days, and her fevers resolved in 6 days. She completed 10 days of ceftriaxone treatment and was well at the time of discharge. The patient was subsequently evaluated by a immunologist and found to have normal values of immunoglobulin (IgG), immunoglobulin A (IgA), immunoglobulin M (IgM), component C3 and C4, and a normal neutrophil oxidative burst test. No further information is available. A copy of the published literature article is attached as further documentation of the patient's experience.
Dizziness, "tired/droopy" eyes.  Administered Benedryl waited 20 mins, Patient left for 15 minutes, came back with significant other and were advised to go to urgent care.  Significant other drove patient to urgent care.
Patient asked for 3 vaccinations (FLUAD, PREVNAR, SHINGRIX) at same time. I advised patient if he has a reaction, would not be able to determine which vaccination caused. He still preferred to get the 3 together. Patient's wife called the following morning and said patient's right arm (FLUAD AND PREVNAR) was extremely sore and difficult for him to lift it and he had a hard time sleeping. I explained soreness is common, but if he's unable to lift arm suggested he contact his MD. She also informed me he has Parkinson's Disease (not noted on consent form).  She will follow up with MD.
Information has been received from a licensed practical nurse and a registered nurse concerning a 13 year old female, with no pertinent medical history, who on 09-JUL-2007, while seated, was vaccinated IM in the left deltoid with a first dose of Gardasil (lot # 656371/0181U). There was no concomitant medication. Two minutes after the vaccination the patient stood up and fainted. She also experienced tachycardia, diaphoresis and felt lightheaded everytime she tried to sit up or stand. The patient laid on the floor with her feet up over a chair, and was monitored for abut 40 minutes post vaccination. Subsequently, the patient recovered from fainting, tachycardia, diaphoresis and lightheadedness. About 1 hour after the vaccination the patient left the office. No laboratory or diagnostic tests were performed. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 8/14/2007. Additional information is not expected.
acute hypoxemic respiratory failure; hypeoxemic; multifocal pneumonia; COPD exacerbation; shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported.      On or around 12-JAN-2017 the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).        Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered severe cough and shortness of breath. The patient was hospitalized and diagnosed with acute hypoxemic respiratory failure, multifocal pneumonia and chronic obstructive pulmonary disease (COPD) exacerbation. Shortly after hospitalization, the patient suffered from a severe rash on her chest and right flank. The patient was diagnosed with shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to the vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries (disability) Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was not resolved. The causality assessment was related. The reporter considered the events to be disabling.   Upon internal review, acute hypoxemic respiratory failure and multifocal pneumonia were determined to be medically significant.  Additional information has been requested.
very smelly urine for a few days   A friend with the COVID shot had the same reaction.
Fever. Loss of appetite. Regression in verbal and nonverbal communication - Babbling & is a eye contact.
pt recv vax 12AUG96 10AM & mom noticed rash like area around site;13AUG96 soreness @ site;no itching;heat @ site;moist heat encouraged, DPH if itching;
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from pharmacist. This case is linked to case 2018SA286240, 2018SA286241, 2018SA286243, 2018SA286245, 2018SA286233, 2018SA286242, same reporter. This case involves Adult female patient who experienced local redness and swelling that warm to the touch, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI982AA, expiry date not provided via unknown route at unknown administration site. On unknown date, the patient developed a non-serious local redness and swelling that warm to the touch 48 hours following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. (Other relevant tests included no lab data.) Final diagnosis was local redness and swelling that warm to the touch. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovering for local redness and swelling that warm to the touch. Follow up information was received on 12-Oct-2018 from pharmacist. Outcome was updated. List of documents held by sender- none.
pt recv vax;devel red rash on abd,neck,trunk 5 days p/ vax;
Beginning day after injection, aches and pains, dry cough. Two days after injection developed additional "cold-like" symptoms including stuffy nose, sneezing, coughing and tightness in chest.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient came to pharmacy on tuesday 09/09/2022 presenting with redness, swelling and warmth on her left forearem.  I sent patient to see her MD. MD diagnosis with cellulitis and  prescribed Bactrim DS 1 tablet twice a day for 14 days. Patient picked up medication day of.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 21-JUN-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) PROQUAD injection (lot# M001152, expiry date 05-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant referring to 20 unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in March 2015, the patients were vaccinated with improperly stored doses of M-M-R II recombinant human albumin (rHA) lot # K018965 and expiration date 15-OCT-2016, (dose and route were not reported). It was stated that the temperature excursion was 74 degrees F for 37 minutes. No previous temperature excursions were reported. It was stated that the call was made because a data logger. No adverse effects reported. There was not a product quality complaint (PQC) involved. This is one of two reports from the same source. Additional information has been requested.
Palpitations and anxiety. Resolved by the time she sought treatment in the ED. No rash, swelling.
Employee c/o tingling in both hands Benadryl 25mg given at 1646. V/s 122/80 99% 91 p. Tingling subsided at 1700. Ending v/s o2 99% P:73.
we are all sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "we are all sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
extreme fatigue, head ache, chills, left knee pain could hardly bend it, rt hip pain, extreme neck pain,  difficulty walking. nausea, symptoms were much worse than the first dose, the symptoms have continued now for 3 weeks a few good days  and walking is often difficult. I still get days of nausea, foggy head feeling. neck pain it will come in waves some times during the day it will be hard to walk and other times it eases up.  it has been 21 days since 2nd dose.   These doses were mandated by my employer not voluntary, it has triggered a auto immune response.
When he woke up 10 days after shots, he was listless/less responsive, seem to be staring. He never had fever/rash/other signs of illness. He remained less active/responsive all day, though it did gradually improve over the day. By next day he was normal again.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported. No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 72, 47 and R. The storage criteria was  refrigerator (R). This is one of several reports received from the same source.
Rapid Covid test on 05/23/21 at 2259 with positive result PCR test was negative on 05/24/21 at 1530
Allergic reaction in form of body rash. Full body itching. Covered up to 80% of body in rash. Medical help sought 10/28/13. Tx: KENALOG 40mg IM on 10/28/13, Prednisone dose pak 10/29, OTC BENADRYL.
On 7/6/2021 while on vacation, I started developing sharp tingling feeling in my left leg. I then nearly had a syncopal episode, had trouble speaking and was leaning to the right. My wife had to hold me up. My brother in law had to carry me to the car as my left leg was not working at all. I was taken by ambulance to the nearest hospital and was worked up for possible CVA (which was ruled out). I was also checked for DVT of lower extremities which was negative. I am still having residual numbness and tingling to my left leg. I am still having symptomatic bradycardia with near syncope.
Day 1 of symptoms (April 5)  stomach ache and pains April 6 stomach pains constant and sometimes sharp, mild flu symptoms April 7 severe stomach pain, flu symptoms. Took rapid covid test which came back negative.  In the afternoon temp hit 104 and I went To ER. After CT scan, appendicitis was confirmed and went into emergency surgery. Appendix ruptured. April 9 - released from hospital  as of 4/28 most symptoms are gone but BM are not consistent and stool is soft. Energy level is low. Slight lower stomach pain at times and muscle soreness
Four days, post vax, the pt had a seizure. He had a stomach bug, 1 days prior, but had no fever. Several hours later, at the hospital, he had another seizure. Cause as yet unknown.
heart arrythmia; PVCs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Lot number: EP7534) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand= pfizer,, Prev dose lot number=EN6203,, Prev dose dose number=1), administration date: Feb2021, for COVID-19 immunization. No known allergies. The following information was reported: VENTRICULAR EXTRASYSTOLES (disability) with onset May2021, outcome "not recovered", described as "PVCs"; ARRHYTHMIA (disability, medically significant) with onset May2021, outcome "not recovered", described as "heart arrythmia". The events "heart arrythmia" and "pvcs" required physician office visit. PVCs have steadily increased and have had to start medication to treat. Therapeutic measures were taken as a result of arrhythmia, ventricular extrasystoles, treatment includes Beta Blocker and now Calcium Channel.  No follow-up attempts are possible. No further information is expected.
Atypical tachycardia, Left upper lymph node enlargement, Left axillary soft tissue edema
Oral/vaginal ulcers-recurrent since shortly after 1st HPV-has seen numerous specialists-on Colchicine.
received Infanrix instead of Boostrix; 11 year old received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th March 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 15th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and adult use of a child product. On an unknown date, the outcome of the wrong vaccine administered and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-APR-2022 Reporter's Comment: The reporter consented to follow up. Additional Supportive Information:The reporter reported that a patient received Infanrix instead of Boostrix (dtap instead of tdap),which led to wrong vaccine administered and adult use of child product. The case had been linked to US2022051794,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022051794:Same reporter
Starting in January of 2022 lot of inflammation in the body. Inflamed chest wall and Bursitis in both hips. Doctors put me on a combination of Steroids and pain medicine to get the inflammation down. Painful to sneeze, cough, hiccup, laugh or anything that causes the chest wall to expand. The pain starts in the chest and moves down my arm to my finger tips.
(PLEASE NOTE PATIENT RECEIVED MMR 1ST DOSE, VARICELLA 1ST DOSE AND PCV 13 4TH DOSE ALL ON 7/10/17). Mom states patient had a few small pink pimple-typed bumps at her face about 20-30 minutes after the vaccines, and 6 hours later patient woke up from a nap with large red itchy blotches and welt-type rash over her face and neck. Mom called our clinic and was advised to start oral BENADRYL, which she did and the rash went away. The rash has not returned. Mom states the patient has been fussy at night and is screaming and crying as if in pain for past 2 nights. Did take her to the emergency room last night and instructed to use NSAIDS for pain.
Less than 24 hours following the immunizations, patient started experiencing hives and and itchy red rash covering her entire body. Both injection sites swelled up and became red. She began having hot flashes/sweating, and then becoming cold and clammy. She began vomiting and having nausea. She then noticed that her throat started to swell. She went to the emergency room where she recieved a steroid shot. The doctor also noticed that she had red blisters all over her uvula and streaks running down her throat so he ran a strep test which came back negative, thus attributing to the reaction.
Stomach pain, chills, low grade fever, body aches, joint pains, headache, hot flashes, fatigue
Admission for cycle 6 of carboplatin desensitization. Hospital admission within 6 weeks of receiving the COVID vaccine.
Woke up this morning feeling achy took some reg strength tylenol which seemed to help temp  was 97.3   later after an eye doctor appointment i was starting to get achy again and had the chills. When I got home I took my temp about 3 hours after my eye appointment and it has been consistently 100 now. I have taken 2 more tylenol just now and temp is 99.7 at this time
There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Hyperlipidemia. Concurrent medical conditions included Penicillin allergy, Hypertension, COPD and Alcohol abuse. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], SIMVASTATIN, LISINOPRIL, GABAPENTIN and TRAZODONE for an unknown indication.    On 03-Sep-2021 at 2:09 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-328706 (Patient Link).
peri orbital itching that traveled to right ear, itching and redness traveled to left ear, per client  trachea began to constrict, patient administered her Spiriva inhaler, followed with her albuterol inhaler at 2:20, patient had some improvement at 2:40 patient administered  DOH epi injection to left thigh .  EMS  called per DOH policy.  Per patient itching stopped, trachea felt better.  Patient refused EMS care when they arrived.  Patient doing better, no s/s of difficulty breathing.  Patient left at 3:15.  Patient called call center at 3:30 to thank everyone and let us know she felt good and was home.
Immediately after had a warm chill, swelling, and soreness at injection site. On the next day after taking medicine to sleep and for pain, stayed painful and annoying. Sleepiness and tired all the time (napped multiple times during the day) Flu like symptoms started without temp. OTC treatment self care. 2-3 weeks and only small issues for a week more after that.
8/12/2021 left sided chest pain 8/14/2021 UTI with continued left chest pain 8/14/2021 abdominal CT showed left lower lobe necrosis and admitted. 8/15/2021 CT angiogram of chest showed left lower lobe pulmonary emboli with left lower lobe pulmonary infarct. Pt anticoagulated. 8/18/2021 Discharged on Eliquis.
Began with tightness in muscles across the shoulders and down the opposite arm from the injection site; lost partial use of left arm by 11/2/2010, diagnosed with Brachial Plexitis by neurologist on 11/4/2010.  Treated with methylprednisolone dosp. #21, hydrocodone 5mg/apap 500mg, diclofenac 75mg, cyclobenzaprine 10mg, meds ineffective.
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. On an unknown date these unspecified amount of patients were vaccinated with ROTATEQ (lot #, dose not reported, default route: oral) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.