chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-OCT-2011, the patient's healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 19-MAY-2015, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Headache throat dryness/scratchiness, parasthesias, skin feels like bubbling all over, jittery, site pain, feels like index finger pressing on left sternum Narrative: 1. First ONE minute - pain at and around site 2. 5 MINUTE parasthesias on injected arm hand/fingers 3. 30 MINUTE dullness, soft headache 4. LESS THAN 3 HOURS vacillating pains, headaches (which moves and varies in intensity) Has had hives previously from an unknown source in the past. "This feels like I am on a drug." stomach upsets jutteriness
patient bring observed for 30 minutes post vaccine. hx of seizures and has service dog hx of anaphylaxis to bee stings and antibiotics. uses epi pen ,not available with patient   10 minutes post vaccine sudden onset cough and c/o itching throat, followed by wheezing nurse stat called.  patient stated feels like passing out, within 1 minute started having seizures. was conscious but not responding patient lowered to floor  stat team present eejrosepatient lifted to stretched, 100% NRB applied. patient taken to ER. patient conscious and responding
COVID 19 BREAKTHROUGH: 69 y/o female presents to the ED at Hospital with the CC of: Severe weakness. Patient with PMH of HTN, HLD, CKD, and PMR presents today due to Severe weakness. Pt states she has had cough, congestion and SOB for about a month now and was treated for a sinus infection 1 month ago. Pt states she woke up this morning around 0500 due to cough and the cough was so severe that it made her vomit. Pt denies any CP, fever, nausea or diarrhea associated. Pt is fully vaccinated for COVID-19. In ED CXR completed and revealed bilateral opacities, concerning for atypical  pneumonia. Abnormal labs included; k 3.3, Co2 22, bun 27,  wbc 17.87, plt 376, bnp 2754, troponin 197 Pt given decadron in ED.
The caller states that she currently has a urinary tract infection and is taking an antibiotic to treat this infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "The caller states that she currently has a urinary tract infection and is taking an antibiotic to treat this infection". Therapeutic measures were taken as a result of urinary tract infection. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
LOST NIGHT VISION; HAD A SHARP PAIN IN THE SIDE OF HEAD; HURT SHOULDER; HAD A SHARP PAIN IN THE SIDE OF JAW; SLIGHT CHEST PAIN; CHEST HEAVINESS; STABBING PAIN IN BACK; LIGHT-HEADNESS; PAIN IN HIPS; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included blood clots, and other pre-existing medical conditions included sick for at least 6 weeks, started with a fever for several days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced difficulty breathing. On APR-2021, the subject experienced slight chest pain. On APR-2021, the subject experienced chest heaviness. On APR-2021, the subject experienced stabbing pain in back. On APR-2021, the subject experienced light-headness. On APR-2021, the subject experienced pain in hips. On 10-APR-2021, the subject experienced hurt shoulder. On 10-APR-2021, the subject experienced had a sharp pain in the side of jaw. On 10-APR-2021, the subject experienced had a sharp pain in the side of head. On 11-APR-2021, the subject experienced lost night vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty breathing, and stabbing pain in back, and the outcome of pain in hips, had a sharp pain in the side of head, had a sharp pain in the side of jaw, lost night vision, slight chest pain, chest heaviness, light-headness and hurt shoulder was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Day 1: within 30 min  - severe sharp temporal headache (worst of my life); developed within a couple hours in this sequence: cold hands/feet, chills (no fever), much worsened vision, slight confusion/dizziness, weakness (had to lay down), both knee joint pain, swollen neck glands, moderate nausea and intestinal cramps, complete loss of smell/taste; all night - severe acidic stomach pain (barely relieved with anti-acids). Day 2: residual headache (50%), tiredness, weakness, sweating if doing things, residual knee joint pain, sense of smell/taste returned and heightened. Day 3: residual headache (25%), still not 100%, residual knee joint pain. Day 4 (today):  residual knee joint pain (comes and goes). I realize that these are not symptoms of an allergic reaction, but severe side effects.
Fatigue  Chills Headaches Pain in legs Feeling loopy Arm hurts a lot
Information has been received from a physician concerning an 8 year old male who on 06-AUG-2002 and 06-APR-2004 was vaccinated with the first and second doses of MMR II. On 07-DEC-2009 the patient experienced mumps. On 19-NOV-2009 the patient had the first blood work, serum immunoglobulin G was 2.11, serum immunoglobulin M was negative, serum amylase was 53. On 19-Nov-2009 the patient was diagnosed with Mumps. The patient had no fever. At the time of this report the patient's status was unknown. Follow up information from the physician indicated that the patient experienced mumps on 15-DEC-2009 (previously reported as 07-DEC-2009) . On 16-DEC-2009 the patient was diagnosed with Mumps. The patient had a headache and lower jaw pain for 1 day. On 17-DEC-2009, a first blood work was performed. Additional information has been requested.
No adverse reaction happened that we know, we just wanted to report it in case anything came up. Pt had a flu shot at pulmonology on 9/27/13 and we didn't know. She was revaccinated on 10/4/13.
Basically I had a cough from Covid that manifested itself and I kept coughing, coughing, and coughing. I had a hematoma in my chest. I was held overnight for observation and I believe this to be a side effect from Covid.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A 17-year and 10 month-old patient of unspecified gender and ethnicity received TRUMENBA on unknown date at single dose. Relevant medical history and concomitant medications were not reported. After the vaccination, the patient passed out took about 15 minutes to come around-elevated legs. The patient recovered from the event on unknown date. No follow up attempts possible. No further information expected.
Potential trigger of new onset automimmune condition, PANS. Debilitating psychiatric symptoms.
I wasn?t an ulcerated colitis flare but still going to work every single day and living life as usual. I had a sigmoidoscopy the morning before my first Moderna shot. The next morning my flare went absolutely horrible. I was defecating massive amounts of blood several several times a day. I started missing work as I was having trouble walking and functioning. I also became violently ill throwing up etc. I went to the emergency room and was hospitalized within three weeks for three days. People thought maybe it was a fluke thing and then I still should get my second vaccine is maybe I had nothing to do with it. I was in the hospital When I was supposed to get the second one so when I was released I got the second one in March and the day after I became even more violently ill. Within a week of that one I was hospitalized for five days. No medication?s including prednisone and IV steroids even touched me. I had to get three blood transfusions. I had scheduled surgery to help with my colon removed because it was so bad. I?ve had Ulcerative colitis 16 years and this was the worst thing that ever happened to me. I was out of work for nine months. Suddenly things started to turn around in October. It?s not perfect but I am doing well now And things started to turn around around the time I started getting emails about getting a booster. No way! I know this exasperated my flare and this was the worst and I almost lost my colon because of this. Below when asked about hospitalizations I am just putting down the first place and first time. The second time was after the second vaccine and that was in Hospital for 5 days.
With mom for shots, left to stay with dad for next 2 days.  When mom saw arm on Wed, L arm was red from shoulder to elbow, hot to touch with raised rash noted over area.  Very tender to touch & to use.  Gave Tylenol & put ice on area. Next day swelling was down & child feeling better.  Unable to report what happened while staying with dad.
Patient now Deceased.  Patient admitted to hospital due to COVID-19.   Per hospital documentation patient was fully vaccinated.   (no access to vaccination records)   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Pneumonia due to COVID-19 virus [U07.1, J12.82] Acute hypoxemic respiratory failure (HCC) [J96.01]   HOSPITAL COURSE: presented to ed with identified significant  hypoxia . Tested positive for covid . History of him being fully vaccinated . Was started on decadron and Remdesivir tx and was continued . Over course of stay progressively became more hypoxic and required increasing amounts of oxygenation ultimately requiring high flow nasal cannula . He later was transferred to icu for trial of cpap due to worsening hypoxia. This only improved oxygenation mildly . Family meeting held with decision made to make him comfort care measures . Cpap removed and low dose morphine as well as anxiolytics given. He passed comfortably in thi icu with family at his side.  Discharge Disposition:  Deceased
pain on her  teeth and gum; pain on her  teeth and gum; She can't chew, it hurts with warm or cold water; pain on the side where she had the vaccine; This is a spontaneous report received from a non-contactable consumer (mother). A female patient (daughter) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 17Apr2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that her daughter received the first dose do the Pfizer Covid-19 vaccine on Saturday 17Apr2021 and by Monday 19Apr2021, she started experiencing a terrible pain on her nerves, teeth and gum; like when you have a root canal. She can't chew, it hurts with warm or cold water. Stated that she has the pain on the side where she had the vaccine. She would like to know if there is available information regarding this side effect and if there is a recommended cure for this. The events were reported as non-serious. The outcome of the events was unknown.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Tingling and burning up and down back/for Tingling in face, side of right cheek; Tingling and burning up and down back; Headache; Warm at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 09:30 (Lot number: EW0162, Expiration Date: 31Jul2021) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing), notes: Tylenol every once in while for headaches in the last 2 week. Concomitant medication(s) included: TYLENOL taken for headache. Vaccination history included: Meningitis a (Route: injection, Anatomical Location: right arm), for immunisation. The following information was reported: PARAESTHESIA (non-serious) with onset 22Apr2021 09:45, outcome "not recovered", described as "Tingling and burning up and down back/for Tingling in face, side of right cheek"; BURNING SENSATION (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Tingling and burning up and down back"; HEADACHE (non-serious) with onset 22Apr2021, outcome "recovered" (22Apr2021), described as "Headache"; VACCINATION SITE WARMTH (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Warm at injection site". Therapeutic measures were not taken as a result of paraesthesia, burning sensation, headache, vaccination site warmth.  Additional information: The patient had tingling and burning up and down her back, neck and tingling in her face. Had the vaccine 9:30 this morning. It started almost as soon as she had it. Also had a headache that went away. The patient was told to wait the 15 minutes to see if there were any side effects. When she left, she started feeling the burning sensation in her back. When she got home, she felt the tingling, like acupuncture. It was still burning and felt the same way. Has not gotten any worse, its the same. Tingling in face, side of right cheek: Is by her nose on the right side. Started about an hour or 2 ago. Still feels the same.  No follow-up attempts are possible. No further information is expected.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 37-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.  The subject's past medical history included two previous pregnancies resulting in normal births of two full-term infants with no defects.  Concurrent medical conditions included gestational diabetes mellitus under diet control.  The subject had not been using contraception before becoming pregnant.  On 31 August 2011, the subject received a booster dose of Boostrix (.5 mL, intramuscular, right deltoid), and experienced vaccine exposure during her third trimester of pregnancy.  The conception was reported to be normal.  The subject was approximately 36 weeks gestation at the time of vaccination.  Date of last menstrual period was 22 December 2010 and estimated delivery date was 28 September 2011.  Ultrasound on 10 May 2011 and maternal serum alpha-fetoprotein on 20 April 2011 had revealed no defects.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 10 May 2011 and maternal serum alpha-fetoprotein on 20 April 2011 had revealed no defects.
pt recvd vax on 15JUN93 seen in clinic 18JUN93 w/induration/redness measuring 10x20 w/blistering effect measuring 20x30mm; pt c/o pain extending for axillary region to finger tips on rt arm; temp today 100.8;
As soon as needle was injected, before injection of the vaccine patient arm jerked quickly knocking the needle out of her arm.  She stated it was an involuntary jerk and immediately after no pain etc.
2-4-21 2000 Nausea/upset stomach 2-5-21 0100 Fever/chills, HA, injection site pain, joint pain, muscle pain, tiredness, nausea/upset stomach, loss of sense of taste and smell 2-6-21 HA, injection site pain/swelling, joint pain, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, nausea/upset stomach, loss of sense of taste and smell 2-7 -21 HA, injection site pain/swelling, joint pain, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, nausea/upset stomach, loss of sense of taste and smell 2-8-21 HA, injection site pain/swelling, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, loss of sense of taste and smell 2-9-21 HA, injection site pain/swelling, muscle pain, tiredness, nausea/upset stomach, lymphadenopathy, diarrhea 2-10-21 Fatigue, lymphadenopathy, vertigo 2-11-21  Fatigue, lymphadenopathy, vertigo 2-12-21  Fatigue, lymphadenopathy, vertigo 2-13-21  Fatigue, lymphadenopathy, vertigo 2-14-21  Lymphadenopathy, vertigo 2-15-21 Lymphadenopathy, vertigo 2-16-21 Lymphadenopathy, vertigo 2-17-21 Lymphadenopathy, vertigo
I had the 1st shot in my right arm. However, I developed a very small rash in the crease of my LEFT arm; a few slight bumps in the crease of the right arm within a week of the 1st shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Jun2021 14:15 (Lot number: EW0181) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing), notes: Anemia (I'm vegetarian), some history of high blood pressure; "High blood pressure" (unspecified if ongoing), notes: Anemia (I'm vegetarian), some history of high blood pressure. Concomitant medication(s) included: IRON. Past drug history included: Isoniazid, reaction(s): "Known Allergies: Isoniazid". The following information was reported: RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "I had the 1st shot in my right arm. However, I developed a very small rash in the crease of my LEFT arm"; BLISTER (non-serious) with onset 2021, outcome "recovered" (2021), described as "a few slight bumps in the crease of the right arm within a week of the 1st shot.". Therapeutic measures were not taken as a result of rash, blister.  Additional information: She had the 2nd shot in the left arm. This time, She did not develop any rash in the right arm, but about one to two weeks after the 2nd shot, she noticed the area on her left arm had become dark in the same place where the 1st rash presented. Over the next few days, that area became red, itchy & inflamed. It started out as a dark spot about the size of a dime & grew in size to cover the entire arm crease and an area 1.25 inches above and below the crease. Initially, she put 91% alcohol & iodine on it to prevent an infection & left it alone, thinking it would go away just like the 1st rash did after the 1st shot. However, this 2nd rash had become more pronounced & she realized she needed to inform someone. Adverse event start date was reported as 09Aug2021. No covid prior vaccination. Covid was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Upset stomach and nausea  came on suddenly about 30 minutes after shot. I day later, stomach still upset.
The pt had a temperature and was vomiting a large amount of fluid. The child cried at times but was alert. The parent was told that if the vomiting continues, get the baby to an urgent care facility.