chrisvoncsefalvay/vaers-outcomes huggingface dataset:
de novo Minimal change disease; This is a literature report for the following literature source(s):  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "edema" (unspecified if ongoing), notes: 4-week history. Concomitant medication(s) included: AMLODIPINE; IRBESARTAN. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: GLOMERULONEPHRITIS MINIMAL LESION (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "recovered", described as "de novo Minimal change disease". The patient underwent the following laboratory tests and procedures: Anti-glomerular basement membrane antibody: Negative; Antineutrophil cytoplasmic antibody: Negative; Antinuclear antibody: Negative; Biopsy: MCD EM normal but proteinuria, notes: already resolving by time of biopsy; Biopsy kidney: Unknown results, notes: On the 2nd day of hospitalization; Blood albumin: 2.0 g/dl; Blood creatinine: 0.81 mg/dl; Blood fibrinogen: Negative; Blood immunoglobulin A: Negative; Blood immunoglobulin G: Negative; Blood immunoglobulin M: Negative; Blood pressure measurement: 116/42 mmHg; Complement factor C1: Negative; Complement factor C3: Negative; Negative; Complement factor C4: Negative; Negative; Glomerular filtration rate: 71.0, notes: Units: mL/min/1.73m2; Hepatitis B virus test: Negative; Hepatitis C virus test: Negative; HIV test: Negative; Immunohistochemistry: Negative; kappa: Negative; Negative; 0.10; Microscopy: showed no extensive, notes: foot process effacement, deposits, or basement membrane abnormalities; There were no significant findings; showed no significant glomerular abnormalities,notes: and electron microscopy showed no extensive foot process effacement, deposits, or basement membrane abnormalities; Protein urine: resolving, notes: proteinuria; Urinary sediment: showed no red cells; Urine protein/creatinine ratio: 9.1, notes: units: g/g; 0.62, notes: decreased; Weight: 7 kg, notes: increase. Therapeutic measures were taken as a result of glomerulonephritis minimal lesion. Clinical Course: He had received 2nd dose of Pfizer/BioNTech vaccine 2 days before the onset date of edema. Units: 71.0 mL/min/1.73m2 (Modification of Diet in Renal Disease). Spontaneous remission from nephrotic syndrome was observed approximately 6 week after the onset of symptoms.; Sender's Comments: Based on available information, a contributory role of BNT162B2 to the event  glomerulonephritis minimal lesion cannot be fully 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.
Information has been received from a registered nurse concerning an unknown number of patients who on unknown dates, might had been vaccinated with a dose of ROTATEQ at a longer interval than indicted, (routes and lot numbers not reported). It was unknown if the patients sought medical attention. No adverse effect reported. Follow up information has been received via telephone call from the registered nurse who stated that she could not provide any patient identifiers as the patients had been switched from ROTATEQ to a different vaccine. The patient's were switched from ROTATEQ to another vaccine because the parents had a "tough time" getting their child in on time for the ROTATEQ series of vaccinations. Follow up information has been received from the registered nurse who stated that they had not had any adverse reaction or issues of any kind with ROTATEQ to the best of her knowledge. The nurse thought there was some miscommunication during a phone call with a marketing agent. No further information is available.
receiving extra doses of Hib and Hepatitis B Vaccine; medication error due to a 4-year old male patient received VAXELIS instead of QUADRACEL; This non-serious spontaneous safety report, with reference number 2023SA268652, was received by the partner on 01-SEP-2023 and forwarded to company on 04-SEP-2023, from a health professional.     Due to the nature of the event, the causality between the events "receiving extra doses of Hib and Hepatitis B Vaccine" and "medication error due to a 4-year old male patient received VAXELIS instead of QUADRACEL" and Vaxelis was not applicable.  Further information is expected.
The whole day I had a headache lingering. In the evening I felt like I was having an allergic reactions. My nose was irritated and my eyes were burning. The rest of the evening I wasn't able to get a full breath. I did take a a COVID-19 test but it came back negative. I did take Zyrtec and Advil. It did help my symptoms aside from the breathing which was still labored. The next morning my headache was back and my throat was hurting really bad. The back of my throat was really red. I was still having trouble breathing. I called my Primary Care Physician because I thought I had Strep Throat. 05/10/2022 I did another test and it came back positive. I was prescribed Paxlovid and started it on 05/12/2022. Paxlovid did help. I did use a pulse ox monitor and I didn't have anymore episodes of low oxygen. I tested again on Monday 05/16/2022 and it came back positive. I tested on 05/17/2022 and it came back negative. I did take another test on 05/20/2022 to make sure it was still negative and it was. I am still experiencing trouble breathing when I exert myself. I still feel fatigue and have allergy like symptoms.
Pt was given pre-kindergarten immunizations while seen for well child exam on 09/08/09. Pt then returned 09/10/09 and was seen by Dr. with c/o induration & redness reaction in R deltoid area. Pt denies fever or pain in affected area. Physical exam by Dr.: R arm from mid biceps up to mid deltoid muscle laterally shows erythema and also significant amount of induration. No tenderness noted to area, but slightly warm to touch. Dr. then explained induration & erythema reactions to vaccines in entity to parents. Pt parents were instructed to watch for any symptom of secondary infection and to contact our office as needed.
- within 24 hours post vaccination my daughter developed fever and local symptoms: pain, redness and swelling (12-15cm in diameter) -antipyretics administered for fever management and cold ice-packs applied to reduce swelling and redness
Patient began having symptoms of sore mouth. She said it feels like a sunburn in her mouth, lots of irritation. She is unable to eat normally, and the skin in her mouth feels tight. Was told by Dr. that she had Lichen Planus- is seeing an ENT to have a biopsy to confirm LP. She is concerned as to the possibility of future squamous cell carcinoma secondary to the LP that she believes was the result of the flu vaccine. She reported this to me on 10/29/18.
knees began itching, developed hive in lower extremities during the night (1/13) s/s resolved in the morning 1/14 1/14 evening elbows began itching, then hives to both upper extremities and back and down into lower extremities, and both hands took Advil/Benadryl 1/15 intermittent itching in various areas
Vaccinator had a reverse needlestick. Vaccinator did not realize that he was stuck first. Vaccinator was scratched on his left hand then gave the vaccine to the patient's arm. After giving the vaccine, vaccinator realized that his left 2nd digit was scratched and saw a little bit of blood.   Treatment: Washed the wound site with soap and water. Reported incident to supervisor. Sought medical treatment to nearest ER for patient and staff member.   Outcome: Both patient and staff member has no other symptoms. not in distress. Awaiting for lab results.
lacey rash on legs and arms. non-raised rash very itchy took Benadryl and put calamine on the rash rash still present on 3/10 @ 1pm   but itch is gone
Had flu shot at 3 PM - worked till 7:30 PM. Went to a 2 hour dance class then home and to bed. At 3 AM - woke up with a headache and unable to move arms or legs. Admitted to hospital.
Herpes outbreak; Herpes outbreak; This is a spontaneous report from a contactable consumer or other non hcp.   A 37-years-old female non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included herpes simplex, erythema multiforme. Concomitant medication(s) included cannabis (CANNABIS). The patient had Known allergies Tetracycline & erythromycin. Age at the time of Vaccination: 37 years. The patient was not pregnant at the time of vaccination The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. On 23Aug2021, 07:45 PM the patient experienced, After the first vaccine she had a Herpes Outbreak After the second vaccine, fainted within 2 minutes of receiving the shot & have had mental confusion ever since.1 week after the second shot, now had an outbreak of Erythema Multiformae, a secondary condition related to Herpes. Currently, the RA is investigating a connection between the Vaccines and activin Herpes and Erythema Multiformae outbreaks after Vaccines. The outcome of the events was not recovered. Therapeutic measures were taken Anti-Viral Medication as a result of herpes outbreak (disease recurrence), herpes outbreak (herpes virus infection).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient received vaccine on 8/14/21 and on 8/16/21 had a syncopal episode that was ultimately diagnosed as a deep venous thrombosis and pulmonary embolism on 8/17/21
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. In August 2013 the patient was vaccinated with a dose of ZOSTAVAX dose, route and lot # not reported (also reported that patient might have received ZOSTAVAX. On an unknown date the patient experienced lightheadedness. The outcome of lightheadedness was unknown. The relatedness between ZOSTAVAX and lightheadedness was not reported. Additional information has been requested.
On  09/28/2021 I took BP it was 174/105 I contacted my dr and she stated take it everyday. 09/29/2021 Tried Lisinopril for 5 days, that did not help, on 10/04/2021 she changed me to Clonidine, currently still on and it seems to be helping.
1/21/21 covid vaccine 1/23/21 covid positive test at work 1/31/21 hospitalized - remdesivir, dexamethasone.
Reports getting a rash that "Goes down both side of my back,"started on Saturday 10/24/2020. Reports "rash painful and occasional itching." Injection site has no issues.  Seen PCP,  who feels its a fungal infection, gave her an injection of Ketortalac and recommended that she continue to monitor it and contact the health department to report Adverse reaction. Dr. referred her to dermatology which she has an apt scheduled for 12/22/2020.  "I get my flu shot every year and never have had issues in the past."
ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/2/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/2/2021 ATRIAL FIBRILLATION, PAROXYSMAL HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 6/2/2021 ATRIAL FIBRILLATION, PAROXYSMAL
3/18 - received shot 3/19-21 - no symptoms other than mild soreness at injection site 3/22 - evening: Enlarged lymph nodes and significant swelling on left side collar bone, tender to touch, fatigue. 3/23 - morning: Enlarged lymph notes and significant swelling on left side collar bone, under arm left arm and upper rib area on right side. Fever of 99.4 (i am always 97.7). fatigue. Visit to doctor, blood work taken for labs.  3/24 - morning, all same symptoms as day prior with headache. Doctor called, lab results normal. Took ibuprofen to for headache and anti-inflammatory.   evening: Swelling of lymph areas reduced a little.  3/25 - morning; swelling reduced by half.  Very tender under right arm and lymph glands still hard and tender in right side of neck /shoulder area and under arm. No fever or headache but I am taking ibuprofen.
Received PCV13 on 2/3/15 and developed bruise and rash on right arm below injection site. Area on right arm was itchy, approx. 6cm x 4cm of red raised rash with small bruise noted at injection site. Pt developed rash 2/5/15.
Redness around injection site (left arm); It itches around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness around injection site (left arm)) and VACCINATION SITE PRURITUS (It itches around injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 036AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin) and Drug allergy (Daypro).   On 25-Feb-2021 at 7:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021 at 7:25 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021 at 7:00 AM, the patient experienced VACCINATION SITE ERYTHEMA (Redness around injection site (left arm)) and VACCINATION SITE PRURITUS (It itches around injection site). On 06-Mar-2021, VACCINATION SITE ERYTHEMA (Redness around injection site (left arm)) had resolved. On 28-Mar-2021, VACCINATION SITE PRURITUS (It itches around injection site) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE ERYTHEMA (Redness around injection site (left arm)) and VACCINATION SITE PRURITUS (It itches around injection site) to be related.    Treatment details included Benadryl cream.   This case was linked to MOD-2021-105088 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Patient demographics, event start date and time, event stop date, event outcome, allergies and causality updated
Mondor's disease penile; Peripheral penile vein swelling appeared, with little uncomfort and pain; Peripheral penile vein swelling appeared, with little uncomfort and pain; This is a spontaneous report from a contactable pharmacist (patient).  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 16May2021 at 15:15 (Batch/Lot Number: EW0177) as single dose 2 for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, hypercholesterolemia, and hypothyroidism. The patient has no known allergies. Concomitant medications included metformin; atorvastatin calcium; levothyroxine sodium (SYNTHROID); all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included BNT162B2 given on 18Apr2021 for COVID-19 immunization at the age of 60 years old (brand: Pfizer, lot number: EW0169, administration time: 3:15 PM, dose number: 1, vaccine location: left arm). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately 20 days after receiving the second dose, peripheral penile vein swelling appeared with little uncomfort and pain. Ibuprofen helped when taken. Event was ongoing. The patient believed it was Mondor's disease penile. The reporter was curious if COVID19 vaccine causes this disease. All events occurred on 01Jun2021 with outcome of not recovered. Treatment received for the events was ibuprofen. The events were reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the limited in formation provided and due to an unsuitable temporal association, the company, at the present time, deems there is not a reasonable possibility that the reported Mondor's disease, with associated signs and symptoms, are related to BNT162B2 administration. The impacts 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.
Fever to 105 degrees F evening of vaccination, rash on legs next arm 7/19. Fever resided after Tylenol, rash resolved with Benadryl. Ok 7/19 per father at 3:30 pm.
Suspected herpes zoster in a 2-dose varicella vaccine recipient. Painful rash on left thigh and left lower back. Clustered patches. He was limping. No antivirals prescribed. Lasted about a week. No history of varicella. Medical record does not differentiate between varicella and herpes zoster, but based on pain and rash location, I am reporting it as a suspected case of herpes zoster. Visited facility on 7/1/2016.
PER PATIENT REPORT: 2 WEEKS AFTER VACCINE PATIENT HAD LOSS OF FUNCTION IN ARMS AND EXTREME FATIGUE. THE PAIN CONTINUED TO INREASE IN HIS JOINTS UNTIL AT 4 WEEKS IT WAS INPACTING HIS SHOULDERS, HIPS AND WRISTS. AT ALMOST 8 WEEKS POST DOSE, HE WAS JUST RELEASED FROM THE HOSPITAL. HE WAS ADMITTED DUE TO INABLILITY TO WALK. HE HAS LOST 27 POUNDS IN 5 WEEKS. HIS CURRENT THERAPY OF PREDNISONE HAS HELPED HIM REGAIN USE OF HIS LEGS BUT HIS ARMS ARE STILL WEAK
Blood seen in stool the night of the vaccine. Same thing happened to older brother 2 days after receiving Rota vaccine.
Vaccination received at health department sponsored immunization outreach conducted at the mall. 10/20/11: tolerable pain on Right deltoid 10/21/11: itching, swelling on Right Arm (RA) 10/22/11: swelling, redness, warm on RA 10/23-26/11: redness spread, warm to touch. No function loss to RA. Temp  (oral) 98. BP 140/70 Left arm.  TX 10/26/11 Warm compress 2X with improvement.
Burning pain traveling from left arm to heart around a minute after injection.  A burning/heartburn feeling in chest.  Hypotension (nurse took vitals, it was ~106/65).
syncope; POTS; fatigue; dizziness; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 15-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), syncope, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
pt recv vax 3OCT95 & 18OCT95 pt devel swollen glands in neck, joint pain, gen rash all over body, body aches, gen feeling of illness & temp 99.2 to 100;
skin rash on upper left arm, painful to touch,  body aches/discomfort, shivers, fatigue
Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, at approximately 74 years of age, the patient was administered the ZOSTAVAX by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at an urgent care for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Mild confusion short episode followed by clogged ears and loud ringing in both ears for about an hour before sleep. I took ibuprofen. Ringing is better this  morning but still noticeable.
She started developing a rash in different parts of her body, following the vaccination/It is on her legs, her elbows, chest, upper and low back, both front and back of the neck.; Rash has gotten worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "not recovered", described as "She started developing a rash in different parts of her body, following the vaccination/It is on her legs, her elbows, chest, upper and low back, both front and back of the neck."; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "Rash has gotten worse".  Additional Information: Rash is on her legs, her elbows, chest, upper and low back, both front and back of the neck./She explained that this rash has been moving from one part to another since it started developing.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax & 1wk later started w/a few pox;next day has several lesions all over body;home visit on 7MAR97 of PHN;has several lesions on all of body;only a few vesicles around scabed-several erythema macular;also littler fever;
Rash noticed on right arm beginning at 48 hours.  Spread to back and chest.  Also present on inner thighs.  Lacey and red.  Slightly raised.  Does not itch.
The patient presents with shortness of breath. 56 year old male presents to ED complaining of sob, secondary to COVID-19 infection. Pt reports his O2 saturation drooped to 85% PTA. He discussed this concern with his PCP, who advised him to visit the ED. Pt is COVID-19 positive. PT PRESENTS TO ED FROM HOME VIA EMS FOR CO SHORTNESSOF BREATH. PT TESTED POSITIVE FOR COVID A WEEK AND A HALF AGO. PT WAS AT 87% ON RA UPON EMS ARRIVAL. when pt arrived to the ED he was placed on 4L NC and his sat was 88%.