chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to an approximately 76 years old female patient of unknown age with cardiac issues (also reported as medical history) and allergy to polyethylene glycol. In approximately 2014 (reported as about 2 years ago), the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiration date were not reported). The patient was on unspecified cardiac medications. About 2 weeks after vaccination, the patient started getting large hives on her body which had been an ongoing issue ever since. The patient had sought unspecified medical attention and had been administering unspecified topical products for treatment. The patient did not recover. The causality was not reported. Additional information has been requested.
The day after Flu shot administration the pt developed some swelling of the L pectoralis area, no redness. Had a 1cmX1cm L axillary lymph node.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-JAN-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
pt recv vax 6JUN95 & 2JUN97 pt devel chickenpox w/20 to 25 lesions;
Tinnitus, muffled hearing/ loss of hearing, pressure in both ears. Seen by NP at Couldn?t find cause. Wanted to refer to ENT Dr.
This spontaneous report was received from a registered nurse and refers to a unspecified number of patients of an unknown age and gender. There was information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates in January 2017, reported as between 04-JAN-2017 and 13-JAN-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L040054 with an expiration date 26-DEC-2017 for prophylaxis (dose, route of administration and anatomical location were not reported). Administered doses of GARDASIL 9 experienced temperature excursion of 32.5 degrees Fahrenheit for 3 hours and 23 minutes, on 12-JAN-2017. There were previous temperature excursions which took 5 hours with the temperature of 30.3 degrees Fahrenheit on 04-JAN-2017, 3 hours and 58 minutes with the temperature 31.4 degrees Fahrenheit on 05-JAN-2017, 1 hour with the temperature 32.9 degrees Fahrenheit on 06-JAN-2017, 21 minutes with the temperature 34.7 degrees Fahrenheit on 09-JAN-2017, 4 hours with the temperature 31.8 degrees Fahrenheit on 10-JAN-2016, one hour and 45 minutes with the temperature 32.9 degrees Fahrenheit on 11-JAN-2017. The cumulative time of the temperature excursions was 19 hours and 27 minutes with the lowest temperature 30.3 degrees Fahrenheit. No adverse effects were reported. Data logger was involved (new data logger system in place). Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA012018.
Relapse of nephrotic syndrome/minimal change disease; This is a literature report.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Nephrotic syndrome" (ongoing); "minimal change disease" (ongoing), notes: Achieved complete remission with steroid therapy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, Unknown manufacturer), for COVID-19 immunisation. The following information was reported: GLOMERULONEPHRITIS MINIMAL LESION (medically significant, life threatening), outcome "recovering", described as "Relapse of nephrotic syndrome/minimal change disease". The patient underwent the following laboratory tests and procedures: Biopsy kidney: Minimal change disease; Blood albumin: 3.0 g/dl; Blood creatinine: 10.1; 1.1, notes: 2 weeks after initiation of steroids; Normal; Blood pressure measurement: 152/78 mmHg; Diagnostic procedure: revealed hypertriglyceridemia, normal serum, notes: creatinine; Laboratory test: showed spot urine protein; Protein urine: Unknown results; Serology test: Negative; Weight increased: 10 lbs. Therapeutic measures were taken as a result of glomerulonephritis minimal lesion.  Clinical course: A 63-year-old male, with history of nephrotic syndrome secondary to kidney biopsy proven MCD, who had achieved complete remission with steroid therapy, had follow up labs done that showed spot urine protein: creatinine of 10.1 and albumin of 3.0g/dL. He had received the booster dose of Pfizer-BioNTech SARS-CoV-2 vaccine 2 weeks ago, and endorsed generalized weakness, puffiness over face, edema over upper extremities that appeared within a week after administration of the vaccine, and weight gain of 10 lbs over past week. Blood pressure was elevated (152/78 mmHg). He denied any recent infections, use of Nonsteroidal Anti-Inflammatory Drugs, or antibiotics. Other diagnostic work up revealed hypertriglyceridemia, normal serum creatinine. Serological work up for secondary causes of glomerular diseases was negative. He was initiated on oral prednisone therapy. Spot urine protein:creatinine decreased to 1.1, 2 weeks after initiation of steroids. Vaccination is a recognized trigger for relapse of nephrotic syndrome. mRNA vaccines are expected to produce a higher antibody response as well as increased production of cytokines and chemokines.; Sender's Comments: Based on the available reported information, the causal association between the event and the suspect drug BNT162B2 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.
PT HAD LIGHTHEADEDNESS, DIZZINESS, SWEATING, ANXIETY ABOUT 5 MINUTES AFTER FLUBLOK.  I HAD PT SIT DOWN IN THE VACCINE BOOTH AND GAVE PT BOTTLE WATER.  PT DRANK WATER AND STAYED HYDRATED;    AFTER 20 MINUTES, PT WAS STILL SHOWING THE SAME SYMPTOMS AND ALSO A KNOT IN THE STOMACH.  I ALREADY CHECKED THE INJECTION SITE - NO SWELLING AND NO RASH.  PT DID NOT HAVE ANY RESPIRATORY DISTRESS.  I CHECKED EVERY FEW MINUTES FOR ANY ALLERGY SIGNS, BUT NO ALLERGY SIGNS DETECTED.;   I ASKED PT IF HE WANTS TO LIE DOWN, BUT HE SAID HE WILL JUST SIT, BECAUSE HE FELT LIKE IF LIED DOWN, HE'LL BE TOO DIZZY TO GET BACK UP.  PT HAD A FRIEND WITH HIM WHO CAN DRIVE HIM TO ER OR URGENT CARE, SO I ASKED FOR THIS FRIEND'S HELP.;  PT'S FRIEND HELPED ME MONITOR THE PT WHILE HE WAS SITTING IN THE VACCINE BOOTH.;  I ASKED PT FRIEND TO DRIVE PT TO URGENT CARE OR ER.  PT SAID HE WILL GIVE US A CALL WITH ANY UPDATED, QUESTIONS, CONCERNS.
PATIENT WAS GIVEN A BOOSTER DOSE WHEN SHE WAS NOT ELIGIBLE FOR A BOOSTER AS PATIENT IS ONLY 17 YEARS OLD WITHOUT ANY NOTATION TO BEING IMMUNOCOMPROMISED.
No immediate reactions.  14 Oct 2022 upset stomack, cold flashes, runny nose.   At home Coved Test positive.   Oct 20 another at home Covid Test positive.  Sypmptoms getting worse.   Cannot hold down energy drink or water.  Continuous Headached and stomach ache.   Oct 21, Taken to Hospital by ambulance.   ER put me on Zofran IV with Benderyl.  After four hours Nauseau had passed.  Sent home with 10 mg Metoclopramide.    However, continuous coughing  continues to 11/28/2022
disorientation; Achiness; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientation), PAIN (Achiness), CHILLS (chills) and FATIGUE (tiredness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DISORIENTATION (disorientation), PAIN (Achiness), CHILLS (chills) and FATIGUE (tiredness). At the time of the report, DISORIENTATION (disorientation), PAIN (Achiness), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was not reported. No treatment medication was not reported
Began with a tickle in my throat that progressed to non stop coughing. After seeing the pulmonologist on 12/12/13 was given steroids, antibiotics and breathing treatments, fever of 101.3, body aches and continued coughing non stop. NOTHING relieved the cough except Benadryl. After steroids and antibiotics completed coughing continued and pulmonologist called in another round of both. After steroids completed cough continues and the only relief is Benadryl or Zyrtec. This is violent coughing causing severe loss of bladder control. Only minimal mucous produced in the beginning.
Left arm with development of 3cm x 5cm patch of edematous and hyperemic skin patch with sharply delineated borders. Mild tenderness and papular texture. Plan: Reassure, apply ice, MOTRIN prn.
Missed period. It should have started on 4-26-21. I am presently 15 days late. I have never missed a period, except with my two pregnancies, and I am not pregnant. I have always had a very regular cycle.
I had the first vaccine I had horrible reactions.  I got coat-hanger syndrome.  My neck felt like it was ripped out.  I contacted my doctor and he advised to go home and take Tylenol.  It went away after a few days.  After the second vaccine I did not have many symptoms.  A few months after I started to have red and painful legs and arms.  The doctor say that he thinks I have small fiber neuropathy.  I am having biopsy?s done tomorrow to see if I do.  I am having symptoms Chronic diffuse burning sensation, numbness in hands and feet and face, Stabbing pain, Gastroparesis, Temperature Di circulation, Tachycardia, shortness of breath. Orthostatic hypertension is what I had before the vaccines but the doctors think all this has been brought on because of COVID they think I had in the earlier part of the year.
Lips tingling, tongue tingling, throat closed. 50 mg Benadryl taken. Epi given in doctor office. Transported to add for more epi and steroids. Sent home with steroids. 5 days later and still experiencing throat thickness and difficulty swallowing.  Have to follow up with doctor for further treatment.
Pain up to left side of face, down to wrist, throat felt cold, headache, nausea, myalgias significant enough to keep patient awake.
This spontaneous report as received from a medical assistant refers to a 12 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 28-SEP-2017 the patient was vaccinated with improperly stored doses of GARDASIL 9 lot # N015087 expiry date 20-OCT-2019 by intramuscular route for prophylaxis.  No adverse events reported. The call was made due to a digital data logger. The vaccine was exposed to a temperature of 50.5 degrees Fahrenheit for a time frame of 1.5 hours. There was no previous temperature excursion involved. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1711USA004678: US-009507513-1710USA000490: US-009507513-1711USA004680: US-009507513-1711USA004676: US-009507513-1711USA004677.
I received the vaccine on Friday, February 26th, 2021, around 10:20am.  I was fine throughout the day. I was also fine all day on Saturday, February 27th, 2021. Sunday, February 28th, 2021 at 1:30am, I woke up from sleep with double vision, dizziness, and lightheadedness. I went to use my bathroom, and began to feel week. I was still very lightheaded, and weak. I felt as though I was going to faint. My ears started to feel really warm, and I then vomited. I started feeling lightheaded and weak once again, and then suddenly had diarrhea. I was so dizzy, but managed to head to my bed to sleep. Every single day since, I have been dizzy and losing my balance. I wake up, walk around, and sleep dizzy. Then on Friday, March 5th, 2021 I developed a large lump directly under my armpit. I could not take the dizziness any longer and I went to the ER on Monday, March 8th. I was then diagnosed with vertigo and told that I most likely had lymphodenopathy.  Till this day, I am still having dizziness and will be seeing an ENT doctor. I also still have the lump under my armpit. My next dose is, March 19th, 2021.
Within 2 weeks of getting vaccine autistic behavior increased. More self harm, more aggression against others, more melt downs.
Information has been received from a registered nurse concerning a 10 year old female with no allergies and medical history who on 10-APR-2007 was vaccinated IM with 0.5 ml first dose of VAQTA. There was no concomitant medication. On 11-APR-2007 the patient developed a 7x5 mm raised, red itchy area around injection site. Unspecified medical attention was sought. No diagnostic laboratory test were performed. A product quality complaint was involved. Additional information has been requested.
Fever; throwing up; Feel very weak and sore; Feel very weak and sore; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25May2021 at 17:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included lung scarring, irregular heartbeat and heart murmur. Concomitant medications included levetiracetam (KEPPRA) from unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021 the patient had a fever for two days and was still on going and he had throwing up, and just feel very weak and sore. This was only the first dose and the patient worried about the second dose. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event fever was not recovered and of the event throwing up, just feel very weak and sore was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient visited pharmacy a few days after administration to report slight redness and irritation. Pharmacist informed patient to apply ice and take Tylenol or Ibuprofen to help with redness/swelling. Patient called today 03/16/2021 to state that the redness spread to the upper and under arm. Patient is still experiencing pain/discomfort from vaccine. Pharmacist suggested patient to seek medication attention and to inform us of outcome.
At the beginning of January, I just began feeling sniffly. I had a runny nose and cold like symptoms. I took an at home COVID-19 test and it was positive. I called my family doctor who prescribed Paxlovid. The next time I had to have blood work done at the doctor after that, my liver counts were elevated. We did follow up blood work a month later and the numbers for my liver were back down in a normal range.
This spontaneous report was received from a 76 year old female patient, reporting on herself. The patient's concurrent conditions included allergy to penicillin and sulfa. The patient had no pertinent medical history and concomitant medications. On an unspecified date in October 2009, the patient was vaccinated with PNEUMOVAX 23 in an unspecified arm (strength, dose, route, lot # and expiration date were not provided) for prophylaxis. On the same date, reported as "that evening" after receiving the vaccine, the patient began to "swell at the wrist which spread to the elbow and then to the shoulder and to the breast" (breast swelling) (peripheral swelling) (joint swelling). The patient went to the physician's office on the next day, however no laboratory diagnostic studies were carried out and no treatment was given for the events. The events resolved 1 to 1 and half days later. The causality between the events breast swelling, peripheral swelling and joint swelling and therapy with PNEUMOVAX 23 was unknown.
Fever started 6 days after vaccines - lasted 3 days; Temp 104.8 degrees no other symptoms but of above from mother
Upper left part of my back was very sore and achy to the point that it went up to front of chest and made sharp pains that interfered with sleeping and daily activities. I went urgent care on 09/23/2022 they did an EKG and stated that my heart and lungs looked good if worsens go to hospital. It continued to get worse and so I went to the hospital on 09/25/2022 they preformed an EKG, blood work and an x-ray everything came out normal they stated it must be and adverse reaction they prescribed me a muscle relaxer and stated to use ice pack. As of today I do have the same symptoms but it is primarily in the evenings.
Information has been received from a physician concerning a male patient with no medical history and no drug reactions/allergies who on an unspecified date ("many years ago") was vaccinated with a dose of MMR (dose frequency, route, lot# not reported). No concomitant medications were reported. The physician reported that this patient only had one dose of MMR and now has a negative or low titer to Rubella. The titers for measles and mumps were adequate. No symptoms reported. There was no product quality complaint. No further information is available.
Chills, fever of 100.1, body aches, sore throat, phlegm, bottom of feet burning, arm pain where injected.
Severe allergic reaction to hair coloring including chemical burns, oozing, and open sores on scalp with no previous reactions prior to injection.    Bacterial infection in blood and skin requiring now 2 rounds of antibiotics and steroids.
Information has been received from a nurse practitioner referring to an unspecified number of patients. Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of improperly stored ROTATEQ (lot# M038846, expiry date: 26-APR-2018; lot# M031807, expiry date: 02-APR-2018) were administered to unspecified number of patients. The vaccines experienced a temperature excursion between 32F and 36F for 17 hours 25 minutes. No adverse effects reported. Data logger was involved. This report is one of the reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006086: US-009507513-1703USA000376: US-009507513-1703USA006085.
This spontaneous report concerning a 62 year old female patient was received from the patient herself via an unspecified source. Her pertinent medical history and concurrent conditions were not reported. Notably though, she had no known drug reactions/ allergies. On 29-SEP-2016, the patient was vaccinated with ZOSTAVAX, intramuscularly, for prophylaxis (the dose, frequency, lot # and indication were unknown). Her concomitant therapies included an unspecified thyroid medication. Subsequently, on 03-OCT-2016, the patient began experiencing a tiny rash around her left eye and around the upper and lower lash area. The rash was itchy as well. Hence, she visited a physician who prescribed hydrocortisone and acyclovir (reported as "acyclozir"). The events resolved for a while, but returned. At the time of reporting, the events remained unresolved and the patient was consistently seeing the physician for a lasting treatment. Reportedly, no laboratory diagnostic studies were performed. The patient also failed to provide an explicit causal relationship between the events, and the vaccination with ZOSTAVAX. Additional information has been requested.
7.5 days after first round of Covid vaccine, I got a red circle around where the injection was. It?s hot and a bit itchy.
swelling on face, rash, shortness of breath, diarrhea, chills, fever, nausea.
pain in his jaw; Joint pain; Face actually look a little swollen one side; This is a spontaneous report from contactable consumer. The reporter reported for her husband. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown, Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were none. On an unspecified date, the patient experienced severe pain in his jaw, joint pain and face actually looks a little swollen one side. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
4 DAYS AFTER RECEIVING FIRST VACCINE I STARTED HAVING PALPATATIONS AND RACING HEART, WHICH INCREASED IN SEVERITY AS DAYS PASSED. ONE WEEK AFTER THE VACCINE I ENDED UP IN ED BECAUSE OF PALAPATATION, INCREASED HEART RATE AND ELEVATED BLOOD PRESSURE. PRIOR TO THIS I HAVE NEVER EXPERIENCED THESE SYMPTOMS
Pt recvd 1st dose of vax w/no noted problem; Pt recvd 2nd dose of vax on 18AUG92 w/in an hr following the vax pt exp sore arm w/pain @ inject site; sx resolved w/in 24 hrs; No further details were provided;
Patient reports pain at injection site traveling to back of neck and head, dizziness and almost fainting.
Fever, muscle aches, runny nose, sore throat, loss of taste and smell, headache, fatigue, cough, chest pains, diarrhea
03/02/2023 - I started experiencing symptoms of a UTI.  I went to the ER and was given a prescription for a Diarrhetic, and Antibiotics. Both of the prescriptions made me feel worse and followed up with my Physican. I had a Bladder CT scan and was diagnosed with Hydronephrosis. I have a follow up visit for a bladder scan next week.