chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling in hands, legs, feet, also feeling of legs and hands falling asleep without any cause I.e. just sitting comfortably in a chair, legs uncrossed would cause the feelings of numbness and tingling.  This had nothing happened before and was happening often during the day. Saw physician who ran a few blood tests and Vitamin B6 came back a low normal, three months later B6 went even lower and shows deficiency . Currently, taking B complex vitamin to I rease B6 levels my B 12 was within normal limits. Tingling sensations and numbness subsided after about 1 week and occasionally still occurs but not with the intensity it did before, the physician did not think it was related to the Moderna shot but I waited an extra week to get my second dose on 3-19-21, versus sooner just in case.  I will be getting  my Moderna booster soon since it is only half the initial dose, I am less hesitant.  If it were the full dose which is higher than the amount of vaccine in Pfizer, I wouldn?t be getting it. I am very sensitive to, medications and normal only take half doses of any script I am given.
after 2 and a half hours of getting the vaccine, my throat got irritated.  As I mention before I do at times get sinuses nasal drip, but I didn't have it at the time of the vaccine.
increaed SOB   24/7 A-Fib; Heart failure with high decreae in blood flow from heart. EF dropped to 25%
This spontaneous report was received from a medical assistant, and refers to an adult patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and drug reactions/allergies was not provided. On 22-OCT-2018, the patient was vaccinated with a dose of PROQUAD (lot # N025923 with an expiration date in 18-MAR-2019), subcutaneously, for prophylaxis (strength, dose and frequency were not provided). Concomitant therapies included sterile diluent. No adverse effects were reported.
Current legal guardian reported to this nurse that 2 days after administration of vaccines patient developed a possible reaction to one of the vaccines. Aunt reports that patient had a red circular area with blisters in center of red circle to her Right leg near where the bandaid was placed. Aunt did not bring patient to a doctor due to issues with the insurance company. Advised patient to please follow up with a private doctor to determine if reaction was from the vaccine or not. Aunt voiced understanding.
Gave pediatric dose (10 mcg) instead of the adult dose (20 mcg)
After about 10 minutes of sitting in observation, patient reported his tongue was tingling. Gave patient benadryl to treat symptoms. at about 4:51 he reported his face was tingling.  Checked injection site and it looked normal, no redness. We continued to monitor patient until 5:30 than the Patient stated he was starting to feel better and had arranged a ride home and someone to stay the night with him and left the pharmacy.
Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 23 months (also reported 1 year 11 months 25 days) old female patient who was vaccinated with an expired dose of ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PEDIARIX; PREVNAR; and PROQUAD. On 22-Feb-2019, the patient received a dose of 0.5 ml suspect HIB (PRP/T) Vaccine) (Lypholized Powder: Lot: UI895AA, 27-Oct-2019, Diluent: Lot: U6001AA Exp date: 21-Feb-2019, Package: Lot: UI895AAA, Exp date: 21-Feb-2019) (dose in series and route was not reported) in the right thigh. It was a case of actual medication error due to expired vaccine used as ACTHIB was given on 22-Feb-2019 and the Diluent expired on 21-Feb-2019. 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 holder's 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. List of documents held by sender: none.
Pfizer BioNTech COVID-19 Vaccine EUA. Patient states she received vaccine on 4/27/2022. On the following Monday she was walking around her house and suddenly her right foot "felt like it was hit with a lightening bolt." States her right foot was hot to touch and she was unable to walk without crutches. States she "treated at home" until Wednesday (5/4/2022) when she called her primary care doctor. States went to see PCP on Friday (5/6/2022) and was diagnosed with gout. States she is now able to bear weight on right foot without assistance of aids and no longer has symptoms. States PCP prescribed steroids and uric acid.
pt recv vax; saw MD; hives, red face, eyes swollen shut; tx w/ dph & 5 days prednisone therapy;
redness / at injection site; swelling at injection site/ small amount of swelling; injection site  / area was hot as well; Raah; This case was reported by a consumer and described the occurrence of injection site erythema in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received on 13th June 2019, also experienced injection site erythema and injection site warmth, refer case US2021029258).   On 4th December 2019, the patient received the 2nd dose of Shingrix. On 4th December 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. In December 2019, the patient experienced injection site warmth and rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and rash were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and rash to be related to Shingrix.  Additional details were reported as follows: The patient received the dose in the right arm.  The patient had redness and swelling at injection site presented that same day. It was described as a large red circle and progressed up to the shoulder and down past the elbow with a small amount of swelling.  The area was hot as well.  She sought medical attention on 6th December 2019, medication was provided.  The symptoms were resolved within 10 days. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021029258:same reporter
Anaphylaxis.  High temp, swollen face, throat, eyes, chills,   Required ER visit
This spontaneous report was received from a consumer refers to a multiple patients (age and gender unknown). On an unknown date, the patients were vaccinated with MMR II. Concomitant medication was not reported. On an unknown date, the patient experienced neurological disorder, autism, attention deficit/hyperactivity disorder (ADHD) and developmental disorder. At the time of the report, the outcome of neurological disorder, autism, ADHD and developmental disorder was unknown. The reporter considered neurological disorder, autism, ADHD and developmental disorder to be related to MMR II. Additional information has been requested.
The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their off-label studies they provided via PDF file, they are not able to support the temperature excursions that occurred. As per CDC guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
This spontaneous report as received from a health care worker refers to a 46 year old adult female patient. No information about medical history, concurrent conditions was reported for the patient. On 01-SEP-2015 46 year old adult patient was vaccinated with PROQUAD, (Lot L010140, expiration date 24-SEP-2016) 0.5 ml, subcutaneously. The reporter documented that first digit in the lot number L010140 could be read as I or lower case 'L' and was unable to confirm the lot number at the time of call. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Information regarding a case in litigation has been received from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the male patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the ZOSTAVAX (date unknown), the patient suffered a painful zoster rash, followed by vision problems which ultimately resulted in him losing his vision in his right eye. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, 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. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, loss of vision in his right eye was determined to be medically significant. Vision problems, loss of vision in his right eye, and painful zoster rash were considered to be disabling. Additional information has been requested.
Patient was given what was thought to be her first dose of Moderna vaccine when she had actually already had her first dose on 1/19/2021. This was discovered when EVMS was accessed shortly after she received her vaccine. This 2nd dose of Moderna was given at 23 days after the first one inadvertently.
April 7, 2006 broke out with 15-20 lesions, febrile, supportive treatment recommended.
Information has been received from a healthcare worker of unknown age referring to herself. The patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date the patient started ZOSTAVAX vial (Lot# L034726 with expiration date of 09-DEC-2016 dose/frequency/indication was not reported). On 17-DEC-2015, the patient had an intravenous infusion of REMICADE in the top portion of her left hand which might cause her "to be immunocompromised". On 18-DEC-2015 when the patient was opening a box of ZOSTAVAX (Lot# L034726 with expiration date of 09-DEC-2016), one of the vials in the box was broken and she was topically exposed to the ZOSTAVAX powder. Some of the powder leaked out of the broken and got on the palm of both of her hands. No adverse effect was reported. Medical attention was not sought. Additional information has been requested.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information regarding concomitant medication, medical history or drug reaction/allergies. On unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L051123 with expiration date 13-OCT-2018, lot # M014926 with expiration date 17-FEB-2019; dose and route were not reported). It was reported that the vaccine was improperly stored at 33.6 (unit not provided) for 89.5 hours and then was back in range. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received their second dose of the vaccine in a recliner from a physical therapist at approximately 08:50am. Pt reported Hx of vasal vagal response with shots in general. A RN took over monitoring  the pt. The pt reported feeling light headed. Vitals were obtained and showed the patient was hypotensive. The team lead was notified and 911 was called.  Pt vitals were obtained frequently, water was provided, and feet were elevated. EMS arrived at 09:07 and took over. Pt refused EMS care and went home after waiting an additional 10 minutes.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LARISSIA, start date: 03Feb2018. Past drug history included: Ceclor, reaction(s): "known allergies: Ceclor", notes: known allergies: Ceclor.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AE reported; HCP reported PNEUMOVAX 23 (PFS) was administered after a temperature excursion to a patient.; This spontaneous report has been received from a medical assistant (healthcare professional (HCP)) regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 06-JUL-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U003306, expiration date: 15-OCT-2022, administered once for prophylaxis (dose, route of administration and anatomical location were not provided) after temperature excursion of 62 Fahrenheit (F) for 5 hours 12 minutes (which occurred on 12-APR-2022) (product storage error). There was no previous temperature excursion. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of four reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA010789: US-009507513-2208USA010861: US-009507513-2209USA000730:
PT received two covid vaccines at drive through on 3/16/2021 and 4/6/2021. Pt admitted for inpatient observation. Chief Complaint: Chest pain off and on for a while, worse with exertion: Reason for Consultation- Covid; History of Present Illness: patient is a pleasant 50-year-old lady with a past medical history of hypertension, depression who works as a daycare employee who received 2 doses of vaccination in April this year present to the hospital chief complaint of chest pain and shortness of breath.  She mentions  2 kids in the daycare for sick with Covid.  She mentions she also had an infection of Covid earlier this year. Complains of tightness in her chest and chest pains.  Denies any fevers complains of shortness of breath on deep inspiration denies of any abdominal pain diarrhea or dysuria.  In the emergency room she was tested positive for Covid.  She did have a CT chest negative for pulmonary emboli.  She is currently on room air.
Experienced low grade fever, joint aches, headaches. Considered normal.  Injection site redness, hot to touch, tenderness. Slight swelling.  Considered normal.
I had severe headaches; Nausea; Inability to walk; Fever; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6206) via an unspecified route of administration on 15Mar2021 as dose number unknown, single for COVID-19 immunization (at the age of 74-year-old). Medical history included thyroid disorder and hormone therapy. Concomitant medications included levothyroxine taken for thyroid disorder; estradiol taken for hormone therapy, start and stop date were not reported. The patient experienced i had severe headaches, nausea, inability to walk and fever on 18Mar2021. It was reported that, patient had the Pfizer vaccine, week ago today, she had an undiagnosed case of Covid and when she was checked with 7 different doctor's they all said there was nothing wrong with her, then she came down with long-hauler syndrome for months and quite miserable that there was nothing wrong with her, she would up getting the same symptoms 3 days after, had the injection Monday, she had severe headaches, nausea, Inability to walk, fever those were the main things. Patient still had the headache and got low grade fevers. The patient did not receive any treatment for the events. The outcome of the event fever was recovering, severe headache was not recovered and for nausea and inability to walk was unknown.  No follow-up attempts are possible. No further information is expected.
Arm is swollen, red, warm to touch, itching. Per allergist took Zyrtec, singular and applied Trimacinoline cream I also had body aches and fatigue for 48 hours.  I took Tylenol for aches and discomfort
pt recvd vax & had inconsolable high pitched crying x 4 hrs; swelling of lower extremity where vax adm fr thigh to ankle;
sore arm at injection site, lethargic.  I have an IUD and have had an IUD for 6 years (I am currently on my second IUD).  Ever since having the IUD, I usually just spot for my periods and the color of blood is light pink or brown. Ever since I received the vaccine my periods are very heavy and the blood is bright red.   My breasts have been swollen and sore. I have been getting radiating pain starting from under my armpits and going down the sides of my breasts.  My nipples have been swollen on and off since receiving the vaccine.  I also have noticed increased acne on chest area.
I was administered the 2016 flu vaccine Friday, November 11, 2016 around Noon (Pharmacy).  About an hour later I developed the anticipated mild pain in my right arm.  I also developed pain in the left side of my back.  This pain grew and was persistent, keeping me awake at night. I also noticed a few minor red marks on the left hand side of my back and inner left thigh.  I went to the doctor November 17.  The doctor was unsure of a diagnosis at that time.  The doctor thought that I might have a urinary tract infection.  He prescribed an antibiotic and sent my urine specimen to be tested by a lab.  On Friday November 18, I developed a painful rash on the left side of my body. On Monday, November 21, I returned to my primary care physician's office. Dr.  diagnosed my illness as Shingles and prescribed Gabapentin and Valacyclovir HCL 1. Dr. stated that my urine specimen was negative, and that I did not need to continue with the antibiotic.  I have been in significant pain which began about an hour after the flu vaccine. Unfortunately the Valacyclovir HCL 1 and the Gabapentin have done little to reduce the pain which continues to grow.  I realize that the 2016 flu vaccine did not give me Shingles, however, I do believe that it triggered the virus.
Information has been received from a registered nurse concerning a female who on unspecified dates, was vaccinated with two doses of GARDASIL vaccine (yeast) from another unspecified provider. The nurse reported that recently the patient underwent a Papanicolaou test (PAP smear) that was positive. At the time of the report the patient had not recovered. The patient sought medical attention with an office visit. No further information is available.
No pain or soreness in arm on November 13, 2021. On November 14, 2021, I woke at 1:00 am with chills, fever and joint pain all over my body. By the evening of November 14, 2021, chills, fever and joint pain subsided, except for the joint pain in my hands and wrists. I have had moderate-to-severe pain in my wrists and hands ever since.
This case was reported by a lawyer and described the occurrence of arthralgias in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (Unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced arthralgias, myalgias, swollen joints, foot pain, wrist pain, stiffness, gastrointestinal problems, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. He also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow-up information was received on 13 April 2009 via medical records. On 08 July 2000, the subject received lumbar epidural injection for disc herniation and stenosis at L2-3 and L3-4. It was reported that the subject underwent an operative procedure of decompressive laminectomy, with partial facetectomies and foraminotomies, L2-4 in August 2000. For this, the subject was admitted overnight. Later in August of 2000, the subject underwent L2-3 and L3-4 laminotomy, foraminotomy and diskectomy of L2-3.
This spontaneous report was received from a health care worker regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 18-JAN-2016, the patient was orally vaccinated with an improperly stored dose of ROTATEQ (dose not reported, lot # L013188, expiration date 02-NOV-2016). There was no adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.