chrisvoncsefalvay/vaers-outcomes huggingface dataset:
That night of the vaccine (07/08/2021) I woke up with debilitating pain. Then the next day on 07/09/2021, I had intense nausea and my lymph nodes were swollen on my collar bone. On 07/11/2021 I had radiating pain up through my neck and jaw. I started shivering uncontrollably and had Lock jaw. I called the hospital (ER) and was told to come in. After I got there my symptoms started slowly subsiding. On 08/10/2021 my period was extremely heavy. Then as time went by I started menstruating every 2-3 weeks. In April of 2022 I had my period for a full 3 weeks. After that 3 weeks, I started sweating profusely and felt so lightheaded and dizzy that I was starting to passing out. I went to a local urgent care on 4/30/2022. My blood pressure was 145/96. I have a tiny fibroid, but it was determined that it wasn't the cause of the bleeding. I've also had several COVID-19 tests and they all came back negative. My menstruation cycles have been sporadic since then. I'm continuously spotting and starting to feel numbing sensations in my abdomen, gluteus maximus, lower back, and feet. My Dr. doesn't think I'm going through Menopause. It's possible that I also had a breakthrough case.
This case was reported by a pharmacist and described the occurrence of nausea in a 46-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included human immunodeficiency virus and hypothyroidism. Concurrent medications included Anti-viral medication and Thyroxine. On 6 May 2010 and 26 April 2010 the subject received 2nd dose and 1st dose of ENGERIX B (40 mcg, unknown). It was noted that within 24 hours of 2nd vaccination with ENGERIX B( administered in the morning), the subject experienced nausea and vertigo. It was suggested that these events occurred with 1st vaccination with ENGERIX B, however no specifics were provided. The events resolved and were considered to be possibly related to treatment with ENGERIX B. At the time of reporting the events were resolved. The pharmacist considered the events were possibly related to vaccination with ENGERIX B.
This case was reported in a literature article and described the occurrence of Bell's palsy in a 63-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), Hepatitis B vaccine, (non-gsk) Yellow fever vaccine and diphtheria tetanus vaccine (non-gsk). Past medical history not reported. On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Hepatitis B vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Yellow fever vaccine (unknown) and an unspecified dose of Diphtheria Tetanus vaccine (Non-GSK) (unknown). 1 day after vaccination with Diphtheria Tetanus vaccine (Non-GSK), Hepatitis A vaccine, Hepatitis B vaccine and Yellow fever vaccine, the subject experienced Bell's palsy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Confirmed that no symptomatic adverse events were reported; Inbound call from nurse calling to report temperature excursion. HCP states that MMR-II may have been administered to patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 31-JUL-2023, the patient was vaccinated with an improperly storage measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) injection, therapy type: rHA, 0.5 milliliter once, valid lot #W022640, expiration date: 15-APR-2024, administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion occurred at 49.26 Fahrenheit (F) for 3 hours and 45 minutes. No previous temperature excursion was reported. No symptomatic adverse events were reported.
7:25 PM pt not feeling well, nausea, BP: 136/84, HR: 84, gave juice and monitored, rest, cool wash cloth  7:35 PM pt laid on floor, dry heaving, BP: 116/87, no respiratory distress, slight dizziness, continued to monitor, provide comfort, water, sprite  7:54PM pt feeling better, BP:130/84, HR: 88, pt requested to go home and felt safe driving 8:10 PM pt called to confirm she arrived at home
Fast heart beat with palpitations; Tightness in chest felt like burning; Tightness in chest felt like burning; Shortness of breath; Extreme nausea; This is a spontaneous report from a contactable other HCP (patient). A 61-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN5318), via an unspecified route of administration on 31Jan2021 at 10:45 in right arm as 2ND DOSE SINGLE for covid-19 immunization. Medical history included asthma, coronary artery vasospasm. The patient took lidocaine and experienced allergies. The patient had received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previous vaccine included first dose of BNT162B2 (COVID Pfizer vaccine, solution for injection; Batch/Lot Number: EN1204) on 10Jan2021 at 10:45 in right arm for COVID-19 immunization. The patient experienced fast heartbeat with palpitations, tightness in chest felt like burning (coded to chest discomfort and chest pain), shortness of breath and extreme nausea on 31Jan2021. Five days later also she had shortness of breath felt like asthma. She also experienced fast heartbeat with palpitations. The events were reported as non-serious. The patient did not receive any treatment for the adverse event. The outcome of all events was not recovered/not resolved.  Follow-up attempts are completed. No further information is expected.
Patient received his first dose of COVID vaccine, Moderna at 1353. Mother noticeda few discrete small and  Slightly pink hives on legs and few on lower back and abdomen at 1405. He appears well in no acute distress. Respiration normal, no hyperventilation, no shortness of breath, no wheezing.  Heart rate to auscultation at 102 per minutes. No lip or tongue or face swelling.  Lead nurse,  RN called station doctor. No new hives noted while waiting for MD. Hives on lower back and abdomen had subsided. Still has light hives noted on thighs, right greater. Dr.  came to assess patient at 1436. Stable. Advised mother to give pediatric dosage of zyrtec once a day in am and benadryl at bedtime as needed hives.  Advise mother to follow up with patient's doctor as needed.
My periods which are normally 23 days became erratic. They were 18 days then 10 days the son days then 10 days.; Hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 (Lot number: EN6205) as dose 1, single and administered in arm right, administration date 03Apr2021 (Lot number: ER732) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies: Sulphate drugs" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 05May2021, outcome "not recovered", described as "My periods which are normally 23 days became erratic. They were 18 days then 10 days the son days then 10 days."; HOT FLUSH (non-serious) with onset 05May2021, outcome "not recovered", described as "Hot flashes". The events "my periods which are normally 23 days became erratic. they were 18 days then 10 days the son days then 10 days." and "hot flashes" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular, hot flush.  Additional information: No covid prior vaccination. No covid tested post vaccination. No other medical history. No other vaccine in four weeks. No other medications in two weeks. Reporters comment: My periods which are normally 23 days became erratic. They were 18 days then 10 days the son days then 10 days. I thought it evened out but now I haven't had one in 49 days the most it's ever been in my life. Also now I am getting hot flashes for the first time ever this week.  Follow-up attempts are completed. No further information is expected
Rash that is itchy and headache. I still have the rash with it being itchy at times.
Left shoulder soreness, redness, swelling, 3/10-12.  Headache, 3/11.  Overall muscle aches, 3/11. Tiredness, 3/11-12
VACCINE WAS ADMINISTER ON 06-06-07.  MOM STATED THAT CHILD HAD ELEVATED TEMP THAT NIGHT 103, AND THAT EVERY TIME SHE TOUCHED THE THIGH THE CHILD CRYED.  BROUGHT TO THE CLINIC ON 06-07-06, THE CHILD WAS STILL HAVING TEMP. MOM TOLD NURSE THE AMOUNT OF TYLENOL SHE HAD GIVEN IN THE AM AND WAS 1/2 THE DOSE TO GIVE AT CHILDS AGE IT WAS IN THE AFTERNOON. ALSO THE LEFT THIGH WAS NOT SWOLLEN BUT WERE THE HIB VACCINE WAS GIVEN CHILD HAD A REDDISH DISCOLORATION THE SIZE OF A DIME FLAT WITH THE SKIN, AREA WAS NOT EXTRA WARM TO TOUCH AND WAS NOT SWOLLEN, CHILD WIMPER WHEN NURSE PALPATED THE AREA.
she tested positive last Monday (22Mar); This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11Mar2021 as single dose for covid-19 immunisation and scheduled on 01Apr for the 2nd dose. The patient medical history and concomitant medications were not reported. Patient said that she tested positive last Monday (22Mar2021). Patient was asking if she can receive the 2nd dose or should she wait. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
ONE OF THREE CHILDREN DEVELOPED BIG, RED, SWOLLEN AREA ON THIGH AND HAD FEVER FOLLOWING IMMUNIZATION.  ALL THREE CHILDREN WERE IMMUNIZED FROM THE SAME VIAL.  VACCINE WOULD NOT DISSOLVE.
Severe fevers and chills lasting 36 hours (101-104 entire time), vomiting, headaches, severe aches and pains (extremely sensitive to touch), heart racing (117 while laying down for hours), feeling of heart about to explode and up in neck area. Heart/blood pressure problems still existing 2-1/2 weeks after injection.  Completely healthy before injection; had BP of 178/100 for my doctor appointment.  I am 5'2", and 145 lbs; had normal BP before this.
Chills, soreness, tingling from shoulder to wrist.  Appears to be moving to other arm.  Joint pain and headache
Information has been received from a registered nurse concerning a male patient who on 18-JUN-2008 was vaccinated with a third dose of GARDASIL vaccine (yeast) subcutaneously (lot number and injection site not reported). Subsequently the patient developed an injection site reaction. The injection site reaction went away and at the time of reporting there was a hard area at the injection site. Additional information has been requested.
She received her first dose on 04May2023 and the second today( with no reported adverse event); Initial information received on 10-May-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 25 years old female patient and she received her rabies (HDC) vaccine [Imovax Rabies] first dose on 04may2023 and the second today ( with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-May-2023, the patient received a dose of suspect Rabies (HDC) Vaccine Powder and solvent for suspension for injection strength, dose: not reported lot V1D643M expiry date: 06-sep-2024 via unknown route in unknown administration site for On 10-May-2023 she also received a dose of the same vaccine for Post exposure dose (immunization).  On an unknown date the patient developed a non-serious she received her first dose on 04may2023 and the second today ( with no reported adverse event) (inappropriate schedule of product administration) (unknown latency) following the administration of RABIES (HDC) VACCINE.  It was reported "She received her first dose on 04May2023 and the second today. He would like to know what's the best course of action to space dose 3 and 4".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event she received her first dose on 04may2023 and the second today( with no reported adverse event).   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 the 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.
At 12:30  i was lying in bed and started getting more and more restless.  I could feel something happening with my body on the inside like a storm.  I got up to use the bathroom and had a syncopal episode about halfway to bathroom. Fell and i came to immediately when my name was called.  I got back into bed.  My lips were white.  I still felt lightheaded but could breathe freely and easily.  There was no noticeable swelling impairing my breathing.  Initially i could not get a reading on my pulse oximeter.  After a few minutes it worked and by then i was at 95%. I suspect the oxygen was quite low prior to that.  For the next day i had a fever and farigue.  The day after that I had some lingering fatigue but no fever.  Right now I am not planning to get the second shot in the series.
post vaccine developed covid symptoms, chest congestion, cough, fever, chills , diarrhea, lost of taste and smell, then proceeded with mild chrons flare with abnormal stools for up to month post vaccine
Pt. is an 80 y/o man with past medical history of HTN, HLD , HFimpEF (2/2 chemo; no h/o hospitalizations), CAD (s/p PCI to LAD 2019), DLBCL (s/p CHOP 2002), hodgkins lymphoma (s/p ABVD 2012), secondary pulm HTN, melanoma (T3bNxM0 Dx 2/2022, scalp, s/p excision), hypogonadism, BPH w/ elevated PSA who presented to my clinic today for hospital follow-up.  He received the flu shot two weeks ago and that night had a first-time lifetime seizure.  He was admitted to the hospital. MRI was unremarkable. EEG was unremarkable. His magnesium was 1.5 which may have contributed. Otherwise no cause has been identified. Of note, he has melanoma so I plan to repeat MRI in 3 months with hopes that this is not an occult brain metastasis that caused this. Other than the above discussion, I do not know a clear cause of his seizure. He was not feeling well that evening, perhaps reasonably due to immune response from the shot.
Shingles; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history includes hearing disability, diagnosed about 3 years ago, so she uses speakerphone so she can hear instead of wearing a hearing aid. Concomitant medications were not reported.  The patient experienced shingles on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Starting on the 8th, I saw signs of blood in urine. It started being extensive and frequent. By Wednesday at 11:30 I had extremely red bloody urine with small clots. I went to ( on Wednesday) Hospital  ER - they performed a handheld exam  - Flomax - to see if I could expel clotting. Late afternoon the next morning, I started expelling clots in very large quantities in very large clots.  It got so bad that I had my wife take me to ER but we were in the parking lot and we called the Urologist - and he said that was what it was aiming for so that it would stretch the Urethra  to pass the clots. So I didn't go to the ER. That night my urine began clearing. It stayed clear until early morning. I had a little blood and then it went away again. Since Friday, after I saw my Primary care doctor, I haven't had any blood in my urine. but I did see the doctor the next morning.  I will see the Urologist tomorrow.
After the 2nd COVID shot I started to experience flu-like symptoms like muscle aches and joint pain. I had bad sciatica and sought medical treatment from my doctor. My inflammation markers were elevated in my blood work. I also have developed a nodule on the left side of my thyroid.
Developed body aches, chills for total of four days after vaccine and symptoms resolved. Then a week after recieving the vaccine she developed arm pain around site of injection, a bright red rash, and swollen, tender lymph nodes at right axillae.
Headache, upset stomach, diarrhea, general malaise within 5 days of shot.
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (had a small patch of Shingles at the time she received the vaccine ).   In October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than 3 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows At the time of vaccination patent was in early 60's. The patient received her first dose of Shingrix in October. She had a small patch of Shingles at the time she received the vaccine but was told by the pharmacist it was okay to receive the vaccine. The patient has not received but the one dose of Shingrix thus far. A few days ago, she developed shingles again.
Water blister at injection site; Itchy rash covering entire upper arm; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route in the right arm on 12Mar2021 at 12:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and complex region pain syndrome (CRPS). The patient was allergic to gluten, latex, band aid and tape. Concomitant medication was not reported. 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. The patient previously took NEOSPORIN and experienced allergies to it. On 12Mar2021 at 16:00, the patient experienced water blister at injection site and itchy rash covering entire upper arm. The patient did not receive any treatment for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of water blister at injection site and itchy rash covering entire upper arm was not resolved at the time of this report.  Information about lot/batch number cannot be obtained. No further information is expected.
PATIENT PRESENTED TO EMERGENCY ROOM ON 8/26/20 STATING THAT WITHIN 24 HOURS OF RECIEVING VACCINE SHE EXPERIENCE TONGUE SWELLING. AFTER TONGUE SWELLING PATIENT EXPERIENCED NO OTHER SYMPTOMS. PATIENT WAS SEEN AS EMERGENCY ROOM AND NO TREATMENT WAS ADMINISTERED. PATIENT WAS RELEASED AFTER BEING SEEN AT EMERGENCY ROOM.
Facial numbing and tingling on left side, followed by severe diplopia and poor depth perception. Labs drawn, MRI of brain with and without contrast. Symptoms gone after about one week
Patient experienced mild nausea and lightheadedness about 10 minutes after her shot. Some alternating warmth and cold feelings.   No chills. No symptoms to suggest allergic reaction. No near syncope or syncope. Symptoms were self limiting and resolved on their own. VSS throughout her stay.   no orthostasis.
10 minutes after the vaccine dose, my lips felt funny.   I could feel them touching my teeth.   At the  20 minute mark,  I was given benedryl.   I could swollow but there was like a resistance in my throat.  About 4 hours after the  vaccine dose, I felt this huge wave of fatigue come over me. My arm was sore from shoulder to elbow.  My PCP referred me to an allergist. I was evaluated by the allergist and was skin tested for the components in the vaccine.  I was given the J & J vaccine by the allergist in the office and was evaluated for an hour.
5 MINUTES AFTER RECIVING INJECTION, PT HAD LIGHTEHEADEDNESS AND ITCHING. NEVER HAD SYMPTOMS TO FIRST DOSE OR TO OTHER IMMUNIZATIONS PRIOR. HE WAS WHEELED INTO OBVS BY WHEELCHAIR, NEEDED NO ASSITANCE TO GET ONTO STRETCHER. WAS OFFERED AND GIVEN SNACKS AND WATER. PT REPORTS IMRPOVEMENT UPON ARRIVAL IN OBVS. VS @ 5:10PM: BP: 124/70 HR:70 RP: 20 O2SAT: 98% ON RA. VS @ 5:20 PM: BP: 132/75 HR: 72 RP: 20 O2SAT: 97% ON RA. VSS AT TIME OF DISCHARGE. NO S/S OF DISTRESS NOTED. PT ESCORTED TO EXIT WITH STAFF, PT REQYESTED TO AMBULATE REFUSED WHEELCHAIR.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 24-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.