chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Autoimmune patient with highly sensitive immune reaction and severe COVID-19 survivor having illness and malaise following all 3 rounds of the Pfizer-BioNTech vaccine. No immediate reaction, but debilitating illness for 1-3 weeks afterward with illness ramping for several days starting ~12 hours after injection, then very slowly tapering off over the course of weeks. Symptoms include debilitating gut pain, diarrhea, headaches, debilitating muscle aches, joint pain, swelling at the injection site, pain and soreness of the injected arm, redness as the injection site, debilitating fatigue. No adverse reaction requiring emergency care and no immediate reaction in the first 4 hours following injection. The patient's physician noted that autoimmune patients of this type should ideally receive a reduced dosage for boosters of this vaccine to still gain benefit but suffer less debilitating illness, however, no such option has been cleared at this time. The full-dose booster and subsequent illness was judged to be less dangerous than risking re-infection of COVID-19, but the wear on the patient if multiple boosters per year are required over the course of years is a significant concern. Allowing autoimmune patients to receive an adjusted dosage of the adult formulation or a standard child's dose of the child formulation for an adult autoimmune patient would go a long way towards addressing this concern so that future boosters could be recommended without hesitation.
Right leg and right foot have been numb for one week. Arms are numb sometimes but not continuously. Sore arm. Sore belly. Right ear hurts inside. Lymph nodes on neck hurt. Headaches.
p/recv second dose of lymerix 2-3 days later pt exp general join pain, fatigue, joint stiffness, pain since chronic recurrent, w/severe joint pain hands & rt foot
Large local reaction right thigh. Fever 103.5 on day of vaccine for 3 days. Vomiting two times; no dehydration.
Decrease coordination and ability to concentrate. Weakness in left arm and left leg. Headache decrease hearing in left ear. head MRI Nov 5 2009 normal
Per participant 04/10/2021 15 to 20 minutes post injection , rash started on neck and chest. By the time patient arrived home +/- 20 min, rash had spread to both legs. Onset lower extremity edema occurred in L/R ankle, L/R leg, L/R feet.  Took Benadryl  04/11/2021  swelling and rash no longer present. Slept  most of the day, did get up to eat dinner, experienced diarrhea in the evening, notices no change in appetite.  Rotating Tylenol/ Ibuprofen 04/12/2021 fatigue, light headiness, dizziness, headache, chills, nausea, diarrhea, jaw/mouth pain, sore throat 04/13/2021 sob, severe fatigue, nausea   Rotating Tylenol/Ibuprofen
Pain/swelling at and around injection site (lasting 7 days), nausea (lasting 2 days).
Patient had been to local ED on 7/21/13 for bee sting and was treated with prednisone and famotidine tablets. On 7/22/13, patient received zoster vaccination. Patient waited in clinic for over 30 minutes with no reaction. Several hours later, patient contacted clinic with complaints of rash developing. Patient opted to hold prednisone and contact office if any further problems. Patient did not contact office, no further issues reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported) and M-M-R II lot # reported as L027434, expiry date 22-JUL-2017 (dose, route and site of administration were not reported) for the same indication. No adverse effects were reported. Administered vaccines experienced the temperature excursion of 6 degrees Fahrenheit for 1.5 hours. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.
6 days of issues. Started with headache, nausea, tired, weak, off/on feverish,   body aches and left arm hurt and tingled from shoulder to finger tips all 6 days.  Still feel some off and on tingling where I received shot as of today's date.
Hives ? within 24 hours after receiving Nasal Flu vaccine '12-'13 and HPV #2. ? 24 - 36 hours by chart review.
24 hours after vaccination -stinging, burning eyes with excessive tearing, and couldn't stand bright light. Wasn't able to read or watch TV due to  tearing & light. Awful runny nose. Symptoms were better on September 22.
My period was 45 days late; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 21Mar2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had allergies to bees and bay shrimp. The patient last menstrual period was on 07Feb2021. Concomitant medications included cholesterol meds. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced (delayed periods) and felt that she was not sure if this was related to vaccine. However, her period was 45 days late. She did not go to her doctor thinking she was going through menopause due to her age. However, she was confused that her period just stopped them, her period started back up 45 days late. The period came again on 22Apr. The clinical outcome of delayed periods was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
12/4 - 11am started feeling like I needed to sit down; kinda dizzy like I was going to pass out or vomit; cold chills; sweats; hives 12/5 - still struggling to stand up for long periods; same symptoms; hives got worse before bed; covered full torso; 12/6 - 6:30am woke up w/ hives around my neck; clothes felt uncomfortable (like sandpaper on a sunburn); itching; exhausted
5 days after vaccine booster (#3 ) (1 moderna on 2/10/21, 2nd vaccine moderna on 3/10/21) developed chest soreness and leg swelling. Admitted to hospital on 10/29/21 with diagnosis of pulmonary embolism.
When administering medications, wrong syringe was grabbed and Tdap was given IV instead of IM. No adverse reaction noted up to an hour and a half later.   Doctor notified and patient notified.
Pt is 14 years old on 12/08/2021 gave pediatric Pfizer ages 5-11 yr as a 1st dose. Today 12/26/2021 gave the 2nd dose of Pfizer  but the 12yr + dose.
Patient had itching at the injection site and rash to hands bilatearlly with itching  to hands and arms bilaterally
Developed Bells Palsy on 12/1/2021 Face paralysis on right side.  Neck, ear and eye pain on right side.  Mri shows neck/spine swollen
Fever 101-102, body aches, dry cough, nausea.  Started 1 day after Pneumovax and lasted 5-6 days.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 08-JUL-2014 the patient was vaccinated with expired dose of M-M-R II (albumin status HSA, vaccine vial, subcutaneous, lot#H011898, expiry date: 25-JUN-2014). No adverse effects was reported. Additional information has been requested.
pins and needles and tingling down her left arm and into left breast area; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in arm left on an unspecified date as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient stated, it just feels like pins and needles and tingling down her left arm and into left breast area and she wants to know if that is normal and how long will that last. it seems like that is what it came from, but it happened after the vaccination and she is still experiencing it five weeks later. The outcome of event was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax & devel rash on cheeks, nose, top lip & had inc t of 100.5;
Next day in the evening arm started feeling very sore pain through elbow and down to hand. That 7 o?clock ran a slight temp of 101.6. I took Advil and I was back to 100.4 within 1/2 hour.  Woke up about 5 AM  the next morning fever free.  At about 8 AM my under armor got very swollen and painful. I took Advil every six hours through the next morning. The swelling went down after about 30 hours and the pain itself was gone by the third day.
Reporting system showed patient in need of FLU, Hep A, MMR, Varicella, Tdap, and IPV.  Post vaccine administration mother presented staff with written vaccine record to enter today's vaccines.  It was discovered patient had vaccines administered prior at a clinic never reported to the state immunization reporting system therefore did not show up in the reports pulled prior to vaccine administration.  Doses have been entered as historicals.  Parent aware of extraneous doses and advised to return to clinic for any reason or adverse reaction or to call Emergency.
Information has been received from a physician concerning a 4 month old birth twin whonon 09 Feb 2007, 30 Mar 2007 and 06 Apr 2007 was vaccinated with the first, second and third doses, respectively, of Rotateq. It was unknown if medical attention was sought. No symptoms were noted. This is one of several reports received from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007.  Information has been received from a physician concerning a 17-week-old male premature birth twin who on 09-FEB-2007, 30-MAR-2007 and 06-APR-2007 was vaccinated with the first, second and third doses, respectively, of ROTATEQ.  There was no illness at the time of vaccination.  No laboratory/diagnostic tests were performed as medical attention was not sought.  No symptoms were noted.  This is one of several reports received from the same source.  Additional information is not expected.
The patient did not disclose on his intake form that he has received any dose of the covid vaccine, After the patient received the vaccine and we were entering the patient information into database it was when we discovered that the patient had had 2 doses of COVID and his second dose was on October of 2021.
Information has been received from a registered nurse (R.N.) for the Pregnancy Registry for GARDASIL regarding a 15 year old female who on 14-AUG-2007 was vaccinated intramuscularly with her first dose of GARDASIL (Lot #, and site not reported). Concomitant therapy included a first dose of MENACTRA. On 27-SEP-2007, the patient was vaccinated with a second dose of MENACTRA was received in error. On 16-OCT-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot #, and site not reported). On 22-FEB-2008, the patient was vaccinated with her third dose of GARDASIL (Lot # 655165/1425F, site not reported). ON 10-APR-2008, the patient was vaccinated intramuscularly with her fourth dose of GARDASIL (Lot #655165/1425F, site not reported). The patient received the fourth dose of GARDASIL in error. Concomitant therapy included Tylenol. On an unspecified date the patient took a urine pregnancy test which was positive. The patient "thinks she became pregnant in the first week of November 2007" (LMP approximately 10-OCT-2007). On an unspecified date, the patient had an ultrasound (not further specified). The patient had no symptoms. The patient sough unspecified medical attention by seeing the nurse. No further information is available. Follow-up information was received on 03-NOV-2008 from the R.N. and a physician indicating that the patient is with ) previous pregnancies. The patient had no significant past medical history or concurrent medical conditions. It was reported that the third dose of GARDASIL (Lot #655165/1425F) was under bad storage and the dose was therefore repeated on 10-APR-2008. Other medication used during this pregnancy included occasional prenatal vitamins for nutrition and Zithromax (initialized on 05-MAY-2008), 250 mg, daily for an unknown infection (it was also reported that the patient had no infections or illness during pregnancy). The outcome of the infection was not reported. An ultrasound performed on 05-MAY-2008 was normal. On 11-AUG-2008, 40 weeks from her LMP, the patient delivered a normal female baby, weighing 3 kg. The patient's length was 48 cm. There were no congenital anomalies. There were no other complications or abnormalities. The patient had no complication during pregnancy or labor/delivery. Additional information is not reported.
Significant chest congestion and coughing. Heavy sinus and nasal congestion and sneezing. The worst symptoms lasted 5 days. On days 7 the worst of the symptoms were minimal. I was not given any medications but advised to take vitamins.
Vaccine site red, hot and hot to touch no streaking or fever. C/O itch.
Swelling of the lips and tongue, numbness and tingling of the mouth, sweating of the lips and mouth. Patient refused to be seen by EMS
Tested positive for covid. ER visit - fever, swelling, coughing, runny nose, headache, dizziness, disorientation, fogginess cognitively, moody, lack of appetite, excessive thirst, tightness in chest, difficulty with full lung breathing, heavy feeling on chest with muscle spasms, arthritic flare up.
Patient complained lost of vision (blacked out) for a second, then was drenched with sweats & feeling hot. After laying down for few minutes, patient is back to normal again when paramedics came. Patient stated no history of allergic reactions from past flu vaccines and no history of diabetes.
After getting the 2nd dose of the vaccine on 1/27/2021, participant felt extreme fatigue which lasted several days.  On 2/12/2021 participant got a severe headache which she describes as "phenomenal and excruciating pain." On a scale of 1-10 , she rated it 10+.  She treated it with ice and ibuprofen. She also went to see her doctor the next day who sent her to get a COVID 19 test. She got a nasal COVID test on 2/13/2021 which was negative.  She also went the next day 2/14/2021 and got a saliva COVID 19 test. Results also negative. She self treated with ice, Tylenol and ibuprofen .  After 2 weeks, the headaches went away.
Pt states that from time she received the injection on 10/10/10 she has had pain at injection site. The pain is worse at night when she lays on it or puts it in a certain position.
day of vax pt had high pitched, abn crying, screaming-intermittently x 6 hrs, 1 hr was longest cont;
My problems began with a bad case of diarrhea, fever and high blood pressure of 170. I could not walk and unfold my hands. I lost strength in my legs , arms, and hands.  My most severe problems lasted for two weeks.  I  laid in bed and took aspirin. After  about  two weeks , the most severe problems subsided. I currently fill weak and stiffness., and tightness in my chest.. My doctor has taken me off the blood pressure medication because pressure is down. My doctor has advised me to report problem to VAERS. I'm waiting  your response.
Caller stated her great grandson got autism from a vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "Caller stated her great grandson got autism from a vaccine".  Clinical information: Caller stated she is a doctor. Caller wanted to know why Pfizer is insisting and pushing that children 6 months to 5 years get the Pfizer covid vaccine. Caller stated that doctors said the children did not need it. Caller stated babies have their natural immunity especially if they are breastfed.   Caller asked if Pfizer is that greedy. Caller stated her great grandson got autism from a vaccine. Caller stated Pfizer is the one that makes the vaccine and should stop making it. Caller stated Pfizer should stop pushing this. Caller stated she is trying to help babies that do not need it. Caller said this is getting out of hand. Caller stated Pfizer will be sued.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and 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.
Wheezing after 50 hours of vaccination, admitted in the hospital, responded to Topiver almovir, went home on 10/22/2005.
Severe "covid arm. Under arm  and neck nodes are the size of tennis balls and I can barely move my left  arm. High fever( 101-102) with tylenol, vomiting, aches everywhere and drop in blood pressure (80/39)
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 13-NOV-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated at a hospital for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient stated after receiving vaccine, the next day she woke up with arm red, area of where vaccine was placed was swollen, and itchy. Patient stated swelling lasted 2 days.
The evening the patient received the injections the patient experienced a lot of redness that looked like bad sunburn on his upper arm. It looked very swollen as well. The redness and swelling was on the same arm he received injections in, but it was not near the deltoid, but more on the back of the arm, almost toward the armpit. These symptoms, along with very extreme fatigue, and watery mouth almost as if he were going to throw up, occurred the evening of 8/23/17 and the redness and swelling were still visible on 8/26/17 upon presentation to the pharmacy. On 8/26/17 he no longer felt fatigue or watery mouth, so appeared to be getting better. No treatment was needed at that point, but he was instructed to visit his doctor's office if it was not getting better in the next day or so.
2-3 days after oral vaccine, patient developed bloody stools and was found to have intussusception.
This is a spontaneous report from a contactable physician via a Pfizer Sales representative. A patient of unknown age, gender and ethnicity received on an unspecified date first dose of TRUMENBA at 0.5 ml single dose. Concomitant medications and medical history were not reported. After use of product, the patient had a rash in both forearms that lasted for a couple of days. Outcome was not reported. Follow-up (16JUL2016): Follow-up attempts are completed. No further information is expected. Follow-up (16Aug2016): This is a follow-up spontaneous report form a contactable Physician. This Physician reported for a 23-year-old female patient in response to HCP letter sent that included: Did the patient provide information to you regarding the reported adverse event(s) with the use of the product: Yes If yes above, do you consider the Pfizer product had a causal effect to the adverse event: No Are you willing to be contacted again by Pfizer on the reported averse event (s): Yes Suspect vaccine: Suspect vaccine name and/ or generic name: TRUMENBA Bat/Lot #: J28923 Expiration date: 30Jun2016 Route of administration: IM Indication: vaccine Time vaccination was given (hour: minute - 24 hour clock): 18Apr206 15:14 Anatomical location of the administration of the vaccine: L Deltoid Did any of the AEs require and emergency room or physician visit: No Adverse event: Was the patient admitted to hospital: rash forearms Event onset date: 21Apr2016 Causal relationship: (Is there a reasonable possibility that the event is related to suspect product/s): Unknown Dechallenge/Rechallenge? Did reaction(s) recur on re-administration: No Were specific test and/or treatment required: No Relationship to patient: Vaccine provider, Patient/parent Vaccinated at: Private Physician's office/hospital Vaccine purchased with: Private funds Illness at time of vaccination (specify): None Have you reported this event previously: No May we contact you to request additional information if needed: Yes Follow-up attempts completed. No further information expected.
DEVELOPED A COUGH, RHINORRHEA, CHEST TIGHTNESS, HOARSENESS, SNEEZING, ON 6/6/2021.
L arm erythematous 13x11.5 cm dia, warm tight, tender 23.25 circumference, R arm 20.5 cm circumference, RX Atarax, Ibuprofen/Tylenol Keflex.
Breakthrough case admission after 2 vaccines Moderna 3/12/21 Lot# 038A21A;  Moderna 4/9/21 Lot# 040B21A
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-OCT-2015, the patient was vaccinated with improperly stored GARDASIL injection (lot # L014415, exp. date: 25-JUL-2017) (route, dose and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
3 days after second injection of Moderna COVID vaccine my tinnitus increased in volume to a level I could barely hear and never experienced before.  It was difficult to sleep.   By morning the ringing had decreased in volume, more like I normally have.  I thought it might have been a coincidence, however my wife has now had a similar reaction to J&J vaccine and I have seen others reporting the same issue. My prior reaction to the first and second shots were soreness at the injection site which resolved after 4-5 days.