chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child developed Guillain Barre Syndrome approximately three weeks after influenza vaccine with ascending muscle weakness. He required non-invasive ventilatory support for 3 to 4 days, NG tube feedings and received 5 doses of IVIG. He has recoved some muscle strength especially of his respiratory muscles (breathing room air with no support) and his upper arms. He is also tolerating full diet (well chopped). He is receiving physical therapy and is anticipated to be discharged home in the next week. 1/20/09-records received for DOS 10/26-11/12/08-DC DX: Acute infective polyneuritis.Presented to ED with C/O muslce weakness and gait abnormality, vomited and diarrhea prior to admission. Weakness and urinary incontenence. Weakness and difficulty breathing, autonomic instability. Constipation. Treated with IVIG. Blood pressure instability treated with antihypertensives.
Had significant swelling and pain starting 4 hours post vaccination.  Swelling subsided about 72 hours later. Now 8 days later arm is significantly swollen and itchy.
Pt reported 102.5 F fever with Nausea/Vomiting/Diarrhea, syncope, sweating. Area around PNEUMOVAX injection site was reported blistered, swollen, and hot to the touch. The area around the flu shot had mild bruising.
Caller is a pharmacist asking about the second dose of Comirnaty for her child, who is sick; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (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: ILLNESS (non-serious), outcome "unknown", described as "Caller is a pharmacist asking about the second dose of Comirnaty for her child, who is sick". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: The pharmacist wanted to know about the second dose of Comirnaty for her child, who is sick. Her child has was not diagnosed with anything, but she wanted to know if there was information about getting the second dose with a current illness.  Follow-up (20Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient stated that the morning after he got the shot his arm started hurting (~ 4 weeks now).  Patient states his right arm constantly hurts and that he cannot lift his arm.  He is also having trouble sleeping because of the pain.
No adverse event verbalized by clients family.  1-year old child was given nasal spray out of fda recommended age
Fatigue- On going body aches Muscle pain-Torso Headache- On going - Head aches when moving around chills- 3 hours
Ran a fever all night of 102 that wouldn't go down. Up all night. Signs of sore throat. (Wouldn't take bottle or pacifier). Symptoms of a cold onset. Runny nose, cough, and sneezing. Fever finally broke around 6am. Threw up between 6am and 10am several times.
BOOSTRIX given 10/8/09. Cares records previous TDAP 11/17/2007. 10-13-09 spoke to pt-she reports no problems from immunization.
Experienced malaise within two days.  The side effects got progressively worse and on the 5th night had 6 vaccine related adverse events- chills, low-grade fever, headache, nausea, GI upset, shallow breathing.  Been in bed for 24 hours and limited relief.  I would categorize all these side effects as mild-moderate.
Patient received 2 doses of Shingrix vaccines at the same time. Muscle ache, bone pain, fatigue
1 MONTH AFTER THE BOOSTER VACCINE, MY LEG WAS SWOLLEN FOR A COUPLE OF WEEKS, THEN AFTER THE PAIN CAME. ONE WEEK LATER WENT TO GET DOPLER OF LEG FOUND BLOOD CLOT IN MY RIGHT LEG FROM MID CALF TO MID THIGH. WENT STRIGHT TO EMERGENY ROOM WHICH THEY FOUND 4 BLOOD CLOTS IN MY LUNGS.  DOCTORS AFTER THIS EVENT THAT I HAVE TO SEE..... HEMATOLOGIST, CARDIOLOIST, VASCULAR, PULMONOLOGIST, RHEUMATOLOGIST.  SPENT OVER 5,000 DOLLARS ON MEDICAL BILLS.
fatigue, headache, dizziness, swollen glands, body aches ( 5+ days all symptoms)
This spontaneous report as received from a company representative refers to a 14-year-old female patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 04-APR-2018, the patient was vaccinated with a second dose of GARDASIL 9, 0.5 ml, intramuscularly (lot# and expiration date were not provided), for prophylaxis. On 05-APR-2018, the patient was acting different than normal, walking differently, and exhibiting different characteristics. It was not specified which characteristics were different. Her mother took a video of the patients and was going to show the doctor during their appointment. No diagnostic test were performed. The outcome of the events was unknown. The causality assessment was not provided. This is one of two reports received from the same reporter concerning siblings.; Sender's Comments: US-009507513-1804USA010586:
3 inch oval round, hot, red, rash at injection site 24 hours after injection. She took Benadryl and rash went away after 2 days.
she felt the vaccine run down her arm, when the needle was pull; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported for a female patient of an unknown age received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 02Feb2021 as an Unknown, Single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient had the vaccine yesterday (02Feb2021), she felt the vaccine run down her arm, when the needle was pull. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
12/27: headache, slight tiredness   12/29: post workout(cardio)?- not abnormal in daily/weekly routine for workout?- 0500 smell of nickels/metallic smell. 0600?tickle in throat, constant need to clear throat, lungs CTA but chest feels like there is congestion and unable to clear throat or cough anything up. Metallic smell dissipated to barely noticeable by 1000.
Received 2nd dose of Vaccine and developed numbness in his feet with tingling and shaking of his knees. Admitted for observation (initial concern for Guillain-Barre). Patient slept all night and discarged the following day with no symptoms.
Hemoptysis.  On 06/05, a one-time event (old, dark clots) occurred.  On 06/06, there were several instances, some older clots, some lighter/fresher blood.  Then 4 days of no blood, but "normal" (usual) infected sputum colors (preexisting lung infection; see continuation page).  Then on 06/11 beginning @ 7:57am, fresh (light) blood streaks/tinged sputum, which occurred a number of times over the span of approximately 5 hours, until "normal" pale yellow infected sputum was expectorated.  Then on 06/12 beginning @ 9:30am, fresh blood again, which again occurred a number of times over the span of about 5 hours until the usual infected colors of sputum were expectorated. Additional information for Item 18: I have a history of MAI/MAC infection and resultant hemoptysis since 2006.  However, until the first Pfizer dose, it had been 2 years since the last incident of hemoptysis, which was due, at least in large part, to malnutrition spanning a couple of months, for reasons unrelated to the lungs.  I believe my most recent hemoptysis episodes are a result of my immune system being distracted by the Covid-19 vaccine, thus allowing the Mycobacterium avium (and/or other) to more effectively attack my lung tissue.  There was no hemoptysis yesterday (06/13), but this has me concerned about the second dose causing additional, possibly worse, problems for my immune system, as it needs to be concentrating on my lung infection full-time; it has been keeping the MAC (and/or other) generally under control, assuming hemoptysis is a good indicator, which my X-rays over the years of monotherapy with Ethambutol suggest is the case.  I discontinued Ethambutol on 06/15/2012, with no further hemoptysis until 04/26/2019, and then no hemoptysis until 11 days after the first Pfizer Covid-19 dose. It seems reasonable to conclude that the vaccine led to these latest hemoptysis events and perhaps allowed the preexisting bacterial infection to cause additional lung damage.The physician noted above is my current pulmonologist.  I was to have follow-up lung CT scan and lung function tests, but did not do so in 2020 because of Covid-19 concerns.  I had planned to see Dr. and my other doctors after being fully-vaccinated, but since lung function tests cannot be performed on patients with active/recent hemoptysis, this may cause an even further delay in my obtaining appropriate diagnostics and treatment.
Patient came in 15 days later to inform me that day after receiving PREVNAR-13 he had experienced lower back pain (pelvic area), spasms, that are getting better. The patient did mention having back surgery years ago.
This spontaneous report as received from a medical assistant via a company representative refers to a 73 year old female patient with a penicillin allergy. The patient's medical history included breast cancer. On 08-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (single dose, 0.5 ml, intramuscular, in the left deltoid, lot number reported as: K009106, expiry date reported as: 25-FEB-2016). Concomitant therapies included NOVOLOG FLEXPEN. On 09-OCT-2014 the patient experienced redness, swelling, pain in the left deltoid at the injection site and developed a 101.2 (units not provided) fever. At a follow-up visit (in October 2014, date unspecified) the patient's fever had gone down at 99.3 (units not provided) and the adverse event was 80% resolved but the elbow was by that time still tender. The patient was given CELEBREX 200 mg, bid for five days and hydrocodone 10-325 as a treatment for adverse events. The patient sought medical attention (unspecified). The outcome of events was reported as recovering. The relatedness between events and PNEUMOVAX 23 was not reported. Additional information has been requested.
I exp body aches, fever (102.7 lasting an hour or 2) headaches and fatigue. I followed up with the nurse line was advised if fever got over 103 to seek medical attention.
Rash below injection site down to elbows; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 497D9, expiry date 11th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient experienced rash below injection site down to her elbows after receiving Shingrix. The reporter consented to follow-up.
dT given first. Hep B given second. Immediately after second immunization stated he felt dizzy then had tonic stiffening of upper and lower extremities, both eye dilation and enuresis. Episode lasted about 60 seconds. Watched in office about 30 minutes after episode. Sent for labs. EEG arranged. None with Rx for diastat.
Information has been received from a registered pharmacist concerning a female patient, who in 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). The pharmacist reported that on 12-SEP-2010 the patient was diagnosed with shingles. The pharmacist reported that the patient's lesions were dried up and the patient had minimal pain. The patient sought unspecified medical attention. At the time of the report the patient was recovering. No further information is available.
Started something like car exhaust 2 days after vaccination. The car exhaust smell is what was bothering a lot.; Have swollen tender axillary lymph nodes.; Had tender axillary lymph nodes.; Had extreme fatigue fever chills for 1 day after vaccine.; Had extreme fatigue fever chills for 1 day after vaccine.; Had extreme fatigue fever chills for 1 day after vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Other medical history not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced started something like car exhaust 2 days after vaccination, the car exhaust smell was what bothered her a lot. The patient experienced swollen tender axillary lymph nodes and had extreme fatigue, fever and chills for 1 day after vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen tender axillary lymph nodes and started something like car exhaust was unknown at the time of this report. The clinical outcome of the events extreme fatigue, fever and chills was resolved on an unknown date, after the duration of 1 day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tinnitus both ears; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 26Feb2021 at 09:30 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included zolpidem tartrate (AMBIEN) and amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN95212) via an unspecified route of administration in the left arm on 05Feb2021 at 09:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 24Mar2021 at 00:00, the patient experienced tinnitus both ears. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included treatment with steroids antibiotics. The clinical outcome of the event tinnitus both ears was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Redness, swelling, and "hot to touch" in Right arm.  No pain in arm or other symptoms.  Mom states it is about the size of a baseball.
Within 5-6 hours arm became extremely sore and painful to move.  Fatigue body ache and headache followed.
gave Menveo to a 13-year-old pt who had been vaccinated with Menveo 2 years and 5 months ago; This case was reported by a non-health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date 28th February 2023) for prophylaxis.   Previously administered products included Menveo (1st dose received 2 years and 5 months prior to the reporting).   On 16th June 2022, the patient received the 2nd dose of Menveo (intramuscular) .5 ml. On 16th June 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2022  Reporter's comment: Caller was the store manager calling on behalf of the pharmacist on duty. Caller reported her pharmacy technician gave a Menveo vaccine on left arm to a 13-year-old patient who had previously been vaccinated with Menveo 2 years and 5 months prior to reporting. The pharmacist to MI for further instructions. The reporter consented to follow up. Additional supportive information: The patient received Menveo 2nd dose which led to extra dose administered.
The injection site is bright red, swollen, hot to the touch, itchy, and feels hard. There is some pain in the area and it hurts to lift my arm, and underneath in the armpit region.  This is the first day this has happened since getting the injection.
On 06/05/2000 the patient started to develop a diffuse papular-pustular rash. On 06/06/2000, the patient was seen by a physician and diagnosed with chickenpox that consisted of "many lesions on his back, arms and chest with no fever. Follow up information from a physician's office indicated that no action was taken and the patient subsequently recovered.
Dizziness, oncoming headache, sore throat. BP 157/93. O2 sat 98%.
Patient c/o symptoms to vaccinator approx 7 weeks after vaccination. Symptoms of disabling pain in (L) shoulder joint for over 7 days. Pt had limited movement and swelling.
stable patient on warfarin began having seizures after receiving first dose of vaccine and INR going low after second dose of vaccine. Required a dose adjustment to correct the issue.
mom states on last shot 27may94 immed after inject pt "went out"; came to in a few min but remained sleepy for 12-18 hrs;
Received vaccine at 7PM, and by 1:30AM had severe chills/shivering; Fever reached 103, and continued throughout the day. Finally dropped to 99 by 3PM the next day. Continued throughout day to have body aches, head ache, chills. Around 3PM had hives on both sides
The patient was vaccinated with 1 dose of varicella virus vaccine live in 1998. In approximately September 2000, the patient experienced chickenpox. He was covered with chickenpox. The patient's brother had a similar experience following vaccination with varicella virus vaccine live. Medical attention was sought. No further information is available.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Additional Details: a few minutes after the patient took the vaacine she started getting lightheaded and she came to the pharmacy counter and passed out there.  i carried the patient and sat her straight in a chair.  i gave her water and orange juice.  patient was confused and not aware of her surrounding and said she barely could hear. once she drank the OJ she felt better.  took her vitals everything was fine.  pt said she felt all good
Severe head and neck pain, stiff neck, 104 degrees and fever could not walk due to pain and weakness in entire body, dizzy. Received shot at 3 pm, next day symptoms started at 7 am. Required emergency room treatment (MD office advised to take to ER) about 4 pm till 10 pm (high blood pressure, meds for pain).
Raised area near administration site; soreness. Raised area 3 inches, itching, red. Feeling flu-like symptoms continuing 2 days post injection.
There was no adverse reaction.  This is to report an administration error of an accidental second Janssen dose to this patient.
Vaccine received at 215pm on 12/30/20. Arm pain 8PM. Chills and aches at 10PM. Awoke at 115AM on 12/31/20 with heart rate of 150 beats per minute and chest pain persisting for 30+ minutes. Went to ER at 2AM. Heart rate recorded at ER was 124. Hydroxyzine and fluids given. Patient sent home from ER.
Menstrual Cycle stopped after shot on 12/5/02 and as of now, 1/21/03. Hypertension from 1/6/03 through 1/20/03, to now.
Additional information received on 7/12/02 provided the Strep pneumoniae serotype. A pediatrician reported that an 11 month old male, who had a medical history of congenital diaphragmatic hernia, reactive airway disease and numerous colds, received his first dose of Prevnar on 6/27/02. Concomitant therapy included Pulmicort (budesonide), Kopenex (Levalbuterol) and Singulair (montelukast sodium). In 5/02, he was treated for bronchiolitis and otitis media with amoxicillin. Two days post vaccination, on 6/29/02, he was taken to the pediatrician's office because he was shaking. His temperature was 104.9 deg F; he was transported to the hospital. On admission, it was noted that he had experienced seizures. Laboratory studies yielded the following results: WBC 18,000; platelet count 514,000; blood culture positive for Strep pneumoniae (serotype 22F). A lumbar puncture was not performed. A diagnosis of septic shock was made and intravenous ceftriaxone was administered. He expired later that day following resuscitative efforts. Autopsy results are pending. The reporter submitted this directly to VAERS. Per F/U 7/23/02, on arrival at ER, pulse-198; RR-45; hemorrhaging at IV spots and given fresh frozen plasma and platelets with resolution of his bleeding. He was also given a unit of packed red blood cells. His abdomen became quite distended thoughout this resuscitation attempt. He began to have red frothy sputum from his endotracheal tube and his CXR showed a developed bilateral white-out of his lungs. He was transferred to ICU where his oxygen sats dropped into the 70's. He remained hypotensive. He died at 18:51. DX: ascites; bilateral pleural effusions; bilateral adrenal hemorrhage.
Information has been received from a registered nurse concerning a 35 year old female with penicillin allergy and cefuroxime axetil (Ceftin) allergy who on 04/25/2002 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Concomitant therapy included tuberculin purified protein derivative (PPD TINE TEST).  On 04/27/2002 the patient complained of a jittery feeling and developed a lump on the left side of her head located between the ear and neck.  The lump measured "about 40mm in size."  On 04/30/2002 the patient developed a fever of 101 degrees F, and vomiting and experienced joint stiffness and neck pain.  The patient went to the emergency room.  On approximately 04/30/2002 a /CAT scan and MRI were negative.  The patient was last seen in the office on 07/16/2002.  The reporter stated that the tremors are gone but the patient continued to suffer from memory loss, pain at the site of the lump, and sleep loss.  The reporter stated that the lump comes and goes.  The reporter stated that "at the ER, this was documented as a reaction to MMR".  The patient sought unspecified medical attention.  Additional information has been requested.
On 2/22/2021 My mom felt very tired. On 2/23 EMS was called at 530 am to report that my mom could not walk or stand. My mother is not incontinence but she had urinate her bed. EMS took her to ER they kept her for 24 hrs released her on 2/24/2021 around 2:00 pm. still could not stand right. On 2/30/2021 EMS called again patient could no longer stand went back to ER there until moved on to Rehab on 2/24/2021. Her Dr reported to the family place her for  couple of weeks to get her strong. Patient is still no longer walking.