chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse via medical records concerning a 17 day old female who was born from a patient with a history of birth control pills, elective termination of a previous pregnancy in 2004 and cervical dysplasia who on 11-MAY-2009 and on 27-JUL-2009 was vaccinated IM with a 0.5 mL first dose (Lot # 661766/0652X) and the second dose (662404/0312Y) of GARDASIL, respectively. It was also reported that on 23-MAR-2010, the patient was given first dose of hepatitis B virus vaccine (manufacturer unknown) (dose, route and lot number not reported) in the hospital at birth. On an office visit on 26-MAR-2010, the patient's weight was 7 pounds and 8 ounces. On 09-APR-2010, the patient's baby was seen again. The patient's weight was 8 pounds and 10 ounces and her height was 20 1/2 inches. Physical examination was normal. Non-Specific Symptoms were detected. Hearing test was passed and the vision was not much crossed. The physician noted that the infant had "eye gunkiness" and watering of right eye and she was treated with erythromycin ointment. The vaccination plan and handouts were discussed with the patient. The diagnosis was a well 2 week old child. The mother's experience is captured in WAES 0909USA02725. Additional information has been requested.
Inflamed skin with increased temperature on the arm around the location of the injection; Affected area is tender to the touch; Inflamed skin with increased temperature on the arm around the location of the injection; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10May2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included diverticulitis, and osteoporosis and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 19Apr2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 11May2021 at 09:30 the patient experienced inflamed skin with increased temperature on the arm around the location of the injection and affected area was tender to the touch. The symptoms continued for three days after vaccine was administered.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events inflamed skin with increased temperature on the arm around the location of the injection and affected area was tender to the touch were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Severe pain in sternum, 8.5/10 on pain scale  It started on the morning after I received the injection; the pain was at a 2.5 when it came on. The pain worsened during an errand with family and caused me to halt my errand so that I could be transported home to rest. 8.5/10 was at its worst on late Tuesday night, and I kept hesitating to even go to the hospital in case it improved. Pain decreased to a slightly more comfortable 6/10 on Wednesday, so I went to work, but still had difficulty being comfortable.  The pain finally subsided on its own on Thursday morning when I woke up at 6:30am.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date in February 2014 the patients were vaccinated with ROTATEQ (lot number and frequency unknown) (dosing regimen and frequency unknown) which had been improperly stored. No concomitant medications were reported. No adverse events were reported. The action taken with ROTATEQ was unknown. No product quality issue was reported. this case is related to case 1403USA007409 and 1403USA008198 via same reporter link. Additional information has been requested.
Swelling and pain at the site and the arm.  Patient flushed and complains of being light headed.
First day: Very strong pain in left arm, all up and down it from the back/shoulder to the wrist Second day: Arm pain continues; fever, chills, strong fatigue, body aches, light head ache
Nausea; Dizziness; tired; fever; unwell; tachycardia; bruised injection site; bruised injection site but it was only mildly tender; This is a spontaneous report from a contactable nurse, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TLC612Y) via an unspecified route of administration in the left arm on 18May2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Nov2020 and the patient did not have any other relevant medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19May2021 at 04:00, 16 hours after the first dose, the patient experienced nausea and dizziness which had gone by 3 hours. On the same day, the patient experienced tired, fever which was resolved with ibuprofen and the patient was unwell, had some feelings of tachycardia similar to when she had COVID. She was still active that day though, 48 hours later she felt fairly well and 72 hours later she felt mostly normal, though she still had occasional feelings of tachycardia and she also had a bruised injection site but it was only mildly tender. Therapeutic measures were taken as a result of fever and included treatment with ibuprofen. The events did not result in any of these doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea and dizziness were resolved on 19May2021 at 07:00, while the clinical outcome of the events tired, fever, unwell, bruised injection site mildly tender were resolved on an unknown date in May2021 and tachycardia was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
She felt a lump under her right armpit; has gotten an MRI and was told it was a lipoma; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, and received dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received two doses of the Pfizer BioNTech Covid 19 vaccine, the first dose was in the right arm, and the second in her left. She was not sure when she noticed it, but she felt a lump under her right armpit, and had read that swollen lymph nodes can be a side effect of the vaccine, and she wanted to know if that was still true. She was not absolutely sure and not positive that it came from the vaccine, but she noticed it after she got her 2nd dose. She had her 1st dose in her right arm, and this lump is under her right arm pit, and then she got her 2nd dose in her left arm. She clarified and said that she was wondering if the location of the vaccine affects the location of the lump under the arm pit. Caller mentioned that she had been to a breast specialist and has gotten an MRI and was told it was a lipoma. The patient underwent lab tests and procedures which included MRI: was told it was a lipoma on an unspecified date. The outcome of events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Information has been received from a physician, via a company representative, concerning a 15 year old female patient, with no pertinent medical history, who on 16-AUG-2007 was vaccinated in the deltoid, with the first dose of Gardasil (Lot #658558/1061U).  There was no concomitant medication.  On 17-AUG-2007, the patient developed nausea, vomiting and diarrhea.  On 24-AUG-2007, she visited her primary care physician, and he advised her to keep herself well hydrated.  No medical treatment was prescribed.  At the time of this report, the patient had not recovered.  Additional information has been requested.
On 8/5/09 pt rec'd KINRIX on L arm and VAX/MMR R side SQ, pt RTC for PPD reading 8/7/09 mother showed me L arm stated "It was worse, starting to get better".  Pt's L upper deltoid area had 4" length x 2" wide red & warm to touch raised bump.  Provider saw patient advised cold compresses to swelling & TYLENOL for pain.  ER precautions given.  RTC if not better.  Doing better per mom.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue Narrative:  resulted in unable to work 1/25/2021 and 1/26/2021  Other Relevant History:
On January 30th before 6 PM, I was laying down watching TV when I started feeling tenseness in my right shoulder and eventually my left shoulder. After about three hours, I started feeling pain in my chest. I couldn't sleep comfortably that night. The next day I was feeling a little better but around 6 PM experienced pain again my chest. The pain was so intense that I decided to go to the emergency room. The doctors ran tests and said I was fine but kept me over night for observations. A nurse told me that it may have something to do with the vaccine, but they discharged me. The pain continued so I went to my primary doctor who recommended me to see a cardiologist. The cardiologists confirmed that I was experiencing a side effect of the vaccine and prescribed me colchicine. I also take CBD to help with the pain.
Information has been received from a certified medical assistant referring to an unspecified number of patient of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# L016429 with expiration date of August 2017; strength, dosage, frequency and route unspecified). The vaccines were exposure in 30F for 20 hours and 53F for 19 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT REPORTED THAT HE WAS VERY FATIGUED THE DAY AFTER THE INJECTION ACCOMPONIED WITH CHILLS, SWEATS, AND LYING IN THE BED.  STATES THAT HIS ARM WAS VERY TENDER TO TOUCH, ITCHING, EDEMA, AND REDNESS.  PATIENT WAS IN CLINIC MONDAY 17 DEC 2012 AND ARM REDNESS MEASURED 7 INCHES X 4.5 INCHES IN REDNESS AND WARM TO THE TOUCH.  DENIES ANY PAIN AT PRESENT BUT STILL REPORTS ITCHING.  DENIES ANY SOB OR SWELLING OF THE TONGUE AND THROAT.
day 1: injection site pain, left neck/jaw area painful lymph node. After 24 hours: swollen lymph nodes. At approximately 30 hours after injection - on face, neck, scalp - burning, blotchy, red rash (item 20 - recovered? yes to rash bcz I took Benadryl. lymph nodes still swollen)
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 06-NOV-2012 at 12:45, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient presented on 10/3/05 with c/o papules/pustules to neck and upper chest wall. Papules and pustules were noted on the chin, neck, upper chest wall and upper arms. Lesions with pruritic. Had small pox vaccination 10 days prior. Order given for Augmentin 875mg q 12 hours with food. RTC if lesions worsen or persist. No follow up was noted.
Red, itchy hives that respond to Prednisone but return after Prednisone taper ends.
Fast heart beat, a little bit of difficulty of breathing, paleness, possible fever, chills, headache, body ache, anxiety.
Right after administration, right deltoid became very warm, and red in color. Next day large hard knot developed with pain and increased warmth. Pt seen in office and tx with antibiotic and prednisone- due to 1 enlarged lymph node.
A registered nurse with a penicillin and sulfa allergy and a history of LASIK surgery who on 29-MAR-1999 was administering the varicella virus vaccine live to a male (WAES00051539) when the needle exited the skin of the male and the vaccine, contaminated with his blood/body fluids, squirted in her face and left eye. On 29-MAR-1999 the pt experienced a stinging sensation that she stated felt like a sunburn and her eye waters frequently. She is also experiencing a tic in the left eye. In the evening of 29-MAR-2000, she saw a Dr who diagnosed her as having a foreign substance in the left eye. The stinging persisted and she used therapy with re wetting solutions approximately every 1-2 hrs and she experienced a headache on that side and a migraine beginning and sinus. On 30-MAR-2000 pm  the stinging was gone and the headache, which had persisted all previous night had worsened and localized to below left eye in sinus area. On 30-MAR-2000 pm experienced gradually building left orbit pain particularly in inner aspect of left eye and with what appear to be muscle spasms in that area every approximately every 20 to 30 minutes. The reporter indicated that during the spasms pain is briefly intense, eyelid partially close without control and the eye tears heavily. On 30-Mar-2000,the reporter indicated that the symptoms persisted but seemed to be lessening gradually.  She saw a ophthalmologist and stated that the symptoms have continued to gradually lessen and the pain is helped by massage to inner eye muscle. The ophthalmologist felt the eye looked good and there was no damage to the surgery. She also stated that he doesn't expect any long term problems from the vaccine and in fact it might boost immunity, he also stated that the discomfort was to be expected-a local reaction to a foreign substance. On 01-APR-2000, she developed a slightly swollen eye and vision problems which she feels is due to yesterday's dilation. On 01-APR-2000 she saw a Dr who diagnosed her as having left eye irritation.  She says she is feeling better; the muscle spasms are infrequent and the orbit pain is very dull, minor. She was treated with Liquid Tears.  She was released from care and could return to work full duty.  She had a hepatitis B core antibody test a hepatitis c virus antibody test, rapid plasma reagin card test, a Western blot HIV-1 and HIV-2 antibody test were all non reactive. Hepatitis B surface antibody and Hepatitis B surface antigen test results unknown. At the time of report the tic of the eyelid persisted. Follow up info received on 01-JUN-2000 indicated that there were no complications noted and the matter was resolved.
Fever in 100-101F range for several hours overnight 11/20-21/2010. Measles rash from head to toe beginning 11/21/2010, still ongoing as of 11/24/2010.
I received the vaccine at 7:30 am on 1/4. At 11 pm, I had electric tingles in my lips and my throat felt ice cold and like mental. At 11:30pm I developed significant tachycardia. My base line resting heart rate is 68-87. I heart rate was 120-130. My rate was pounding out my chest. At 3 am on 1/5, I went to the ER because of the persistent tachycardia and developing chest pain. I has SVT and PVCS.  Tool tylenol 1 g and benadryl 50 mg. By 7am by symptoms resolved. Exhausted the whole rest of the day.
Aortoiliac embolus treated with open aortoiliac embolectomy. Symptoms began 18 days after first injection and included extreme nausea, vomiting, and right leg ischemia.
mom states that early Thursday morning 24AUG95 pt became fussy, irritable, & had a temp fo 103 R; temp went to 104 R today; pt remains irritable & is beginning to eat foods again; mom states pt has been miserable & crying a lot;
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317362, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 58 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as left) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Lt thigh, swelling erythema about 4 x 5 " induration, sl tenderness;
Shooting Neck pain irradiates to my face, rash on my face more concentrated on my eyelids, severe whole body ache, profuse sweating, Dizziness
Red, raised, itchy and warm to touch around and at the site of injection. Also, some tenderness throughout arm. This did not happen until 8 days after injection
Soreness/pain at injection site, 2 months duration at least. Sore nodule at inj site. Severe constipation 1 month duration.
A-Team member stated they didn't feel good this morning and last night after taking the J&J vaccine. Around 8 am looked for the employee health nurse to get medication for nausea and headache. She was then making tea and was noted not to be feeling well and fainted.  Another employee found her on the floor, and her heart rate was 115, and BP was 112/64 with a 100-degree temp Fahrenheit. A couple of hours prior, her temp was 97 degrees Fahrenheit.  She looked diaphoretic, hypoglycemic, and was too weak to get off the floor, there was a maxi lift used to transfer to a wheelchair, and she was very dizzy. The only medicine taken was Pepto Bismol for nausea.
Administered FluMist 20 minutes past administration client had itchy palms and tingling fingers bilaterally with a flushed face and a R sided headache. He was given diphenhydryl PO and acetaminophen, 1hr later symptoms resolved.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Pfizer product on 04/06/2021 and 04/23/2021. They tested positive for COVID-19 on 10/04/2021. They also presented to emergency department on 10/04/2021 with a primary complaint of general weakness. They were admitted to hospital same day (on 10/04/2021). They were found to be having COVID-19 pneumonia and acute respiratory failure. They were discharged to home on 10/17/2021. They died on 10/10/2021. Issued the death certificate but there is a different address on file for the individual and they were tested and cared for in a hospital.
Narrative:  A 96yo male with PMH of Prostatic Carcinoma, Adjustment Disorder with Depressed mood, HTN, Hyperlipidemia, Chronic Low Back Pain, Arthritis, GERD, Hiatal Hernia and other Bursitis Disorder Per Nurse's documentation; He received Pfizer Covid-19 vaccine per policy and protocol without complication First dose on February 20, 2021 and the second dose on March 13, 2021 No ADE was reported Per May 4, 2021 Geriatric Telephone note, the patient passed away on April 24, 2021
facial rash, pruritus 2 hrs after receiving vaccine. treated with benadryl 50 mg po q6h
I received the 3rd Covid Booster on 9/28/2021. On 10/18, i noticed that the left side of my tongue had unusual taste disturbances, and felt as if it were a bit numb. This continued all week, until on 10/22, I woke up that morning to a left sided facial droop. My left eye would not close completely, my mouth could not form a seal, or smile, or pucker. My forehead was frozen anyway because of the Botox recived on 10/15. I started Prednisone 60mgx7 days, then tapering off now for a week and also Famvir 500mg twice daily. The facial droop was determined to be Bells Palsy and as of today has still not resolved.
On day one, I had a runny nose, sinus drainage, and a sore throat. I took a COVID-19 test due to exposure. The result was negative. It felt like seasonal allergies. The next day, the symptoms continued, but they increased in severity. I took another COVID-19 test. The result was positive. On day three, I called the clinic line and left a message for my doctor detailing symptoms and test result. On day four, I was given a prescription for Paxlovid. I started the meds that night. That day, I noticed I was more tired than usual. I finished the prescription. My symptoms didn't get worse while taking it. I went back to work the following Monday.
Presented 2 days after pneumococcal vaccine with 10x10cm induration, warmth, eyrthema at injection site.
After the 1st dose I had a sore arm, and severe fatigue for 2 days followed by 3 days of fibromyalgia flare, sore arm muscles and fatigue, followed by a month of muscle spasams in my neck ,shoulders, back and chest, following the second vaccine immediate  severe unquentable thirst for at least a week post second dose with persistent muscle spasams for the next week and a half in neck, back, pectoral muscles and diaphram and right flank area.  Treated with Flexeril and hydromorphone as needed, finally vistit to ER for muscle spasams in right flank , upper right quadrent abdomen with each breath.  went to ER, treated with Tordal and Tylenol and script for valium and instructions for hydromorphone as needed with tylenol.
Paleness, weakness, loss of appetite (wouldn't nurse). Difficulty breathing, his abdomen was working hard. Breathing treatments were attempted in doctor's office. Since they were ineffective he needed hospitalization/oxygen. Weakened immune system. 9/11/06-DC summary received for DOS 2/1-2/4/02 DC DX: Bronchiolitis. Presented to hospital with congestion, increased WOB, cough x 3 days. Sats at PMD were 88% on RA. Afebrile.  PE: Significant for bilateral rales. Hospital Course: O2, weaned by 2/4/02, Sats 96% on RA. Weakened immune system as evidenced by yeast overgrowth, chronic
This spontaneous report as received from a Licensed Practical Nurse refers to 2 patients of unknown age and gender. On 22-OCT-2013, the 2 patients were vaccinated accidentally with a dose of VARIVAX (merck) (Lot number, expiry date were not reported), 0.5 ml, subcutaneously instead of ZOSTAVAX. No adverse effect reported. Additional information has been requested.