chrisvoncsefalvay/vaers-outcomes huggingface dataset:
focal seizures, onset of which occured 3 days after her 3rd dose of Pentacel, PCV 13, Hepatitis B and Rotateq vaccines Patient also received Influenza vaccines Seizures are described as tilting of the neck to the left with jerky movements of the left arm and head This has occured multiple times, daily, 3-10 episodes per day Patient has been referred to pediatric neurology for further evaluation.
Pt devel malaise & fever approx 4 days p/vax was administered; When examined on 22OCT91 pt had palpable purpura; Skin biopsy performed currently on Pred;
Pt came back into clinic on 3/16/2021 to ask if we would submit an adverse event request. Pt waited 15 minutes and had no reaction in clinic and then on drive back home pt states that his face became flush, he began having shortness of breath, and palpitations. Pt states that he pulled of onto side of road and waited approximately 15 minutes and then symptoms began to dissipate. Pt has had no further symptoms and the symptoms he states that he had were unwitnessed by medical staff at clinic. Once again pt waited till 3/16/2021 to report this to the clinic.
Felt fatigued and weak while taking routine daily walk (cold, clear, sunny weather).  Had to stop once to rest (almost never happens). Then nearing end of 2-mile walk, knees buckled and fell down on sidewalk. (Did not trip).  Hurt arm, scraped face.   Went home, put ice on face, laid down, rested.
Developed high fever (102) on 8FEB followed a few days later 14FEB w/rash which started on his face & spread to the body; Seen by MD 18FEB tx DPH for a "poss rxn to MMR 2 wks later chid was well w/no rash; F/U 7MAR91
Initial report received from a health care professional via Health Authority (HA reference: 132167) on 13 Jan 2011: This patient was vaccinated with MENVEO (batch number M10094) intramuscularly and INTANZA (other manufacturer, batch number G9732-1) intramuscularly on 14 Dec 2010 at 13:05 and 13:00 hours respectively. On the same day she developed cervico-cephalgic meningeal inflammation with pain at motion of the head. She also developed reddening and swelling at the injection site. Outcome of the events was not reported. The events were assessed as non-serious by the reporter.
Redness, warm to touch, slightly raised LT from Vaccine. KINRIX. Tx: Was seen By Dr today (02 JUL 2010 @ 1315) and advised to apply cold compress. Childrens MOTRIN TID PRN for swelling and pain. Monitor for increase swelling, redness, warm, Pain, and itchiness and immobility and to go to ER if other symptoms persist.
pt recvd vax & exp paresthesia in feet & ankles then noticed tingling in hands; seen by a cardiologist; pt indicated was on Niacin & discontinued thinking that whay may have caused it; off Niacin for 5 wks & still persistent tingling;
This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 78-year-old female patient who received Influenza vaccine Quadrivalent. In December 2016, the patient received Influenza vaccine Quadrivalent. In January 2017, 30 days after receiving Influenza vaccine Quadrivalent, the patient experienced loss of consciousness (serious criteria hospitalization and GSK medically significant), fall (serious criteria hospitalization) and sickness (serious criteria hospitalization). On an unknown date, the patient experienced cough. On an unknown date, the outcome of the loss of consciousness, fall and sickness were recovering/resolving and the outcome of the cough was not recovered/not resolved. It was unknown if the reporter considered the loss of consciousness, fall and sickness to be related to Influenza vaccine Quadrivalent. The reporter considered the cough to be probably related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was reported by the patient's son. The specific brand name of the flu vaccine received by the patient was unknown. The patient experienced a barking cough following administration of vaccine. Also, the reporter initially stated that patient was currently sick. He further specified sick as meaning that patient slipped on ice and fell a week before reporting date. She was knocked out. Due to the event, she was hospitalized. The batch number of the flu vaccine was unknown. This case had been linked with case US2017014925, reported by the same reporter.
c/o don't feel as though I can breathe and feel funny.  Offered Benadryl 50 mg PO.  RR 18, Room air 98%, HR 76, BP 129/72.  Rechecked 10 minutes later and vitals were within normal limits. NO reaction with first dose.  Observed for a total of 30 minutes.  able to be released.
Headache for 9 days after receiving the shot.  Got nauseated a Lil and very fatigued and a high heart beat, numbness and passing out spells
pt recv vax 19JAN96 & 28JUL96 pt exp a raised red rash w/itching & 30-50 lesions on trunk, chest & extremities;pt suspected flea bites;also devel swollen lymph nodes, low grade fever of 99, n/v;to MD dx w/breakthrough chickenpox;
PT STATES HER ARM BEGAN TO SWELL THE NEXT DAY AFTER VACCINE, PT MADE APPT TO SEE DR ON 6/28/18. LEFT ARM RED, SWOLLEN, ITCHING AND WARM TO TOUCH . DR PRESCRIBED OTC BENADRYL.
A few hours after receiving first dose of vaccine, developed extreme leg weakness (unable to stand). This persisted for two days and pt was sent to emergency room. Initial evaluation at ER revealed leg weakness only. After 24 hours observation, it was noted that the patient had left sided weakness and slurred speech. MRI confirmed acute infarct in right pons area.
Cold symptoms (stuffy head, sore throat), fever 101 degrees Fahrenheit, joint pain, severe headache (4-5 days). Taking Benadryl, Ibuprofen.
Ankle Joint Pain; This is a spontaneous report from a contactable physician (patient).  A 54-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm from 26Dec2020 14:00 to 26Dec2020 14:00 as SINGLE DOSE for COVID-19 immunization.  Medical history included hypertension and allergies.  The patient's concomitant medications were not reported.  On 28Dec2020, the patient experienced ankle joint pain.  On 31Dec2020, the patient was tested for COVID-19 post vaccination via nasal swab and tested negative. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Client had syncopal event after the administration of GARDASIL (HPV) vaccine. Client issue was resolved almost immediately. Client was instructed to lay down to rest and given cool washcloth to apply to forehead as needed and water to drink until he felt good enough to leave.
Headache, Myalgia, chills, fatigue Narrative:  Received 2nd vaccine on 2/1/21, experiencing body aches, chills ha, fatigue. The side effects started at 3 am 2/3/21. Is taking acetaminophen and ibuprofen for pain, is feeling better at this time. Reports tested covid positive in  January 2021. Advised that these signs and symptoms should reside in afew days but if become worse to follow up with PCP.
pt recv vax & wk later pt exp urticaria that lasted 4-6 wk;
Arthralgias, non-inflammatory and right grip weakness- chronic since Anthrax vaccine, 6th series.
4 months later when I woke up in the morning I had black floaters on my right eye, black spots, clot on the back of my eye; since the clot moved and I had vision problems on the right eye, but it's getting better. Next week I am going for a Coronary artery exam because all the tests I have had shown that I had a blockage on the artery on the neck in the Carotid Artery.
Swollen bottom lip, raised bumps that itch up from the center of spine down to the crack of his butt
p/ vax pt devel fever 104.8 w/ croup like cough, severe bronchitis, and weakness. accor. to mother pt was delerious because of fever.  pt saw md. pt treated w/ antibiotics. mother says child still weak and has cough.  see worm...
This spontaneous report was received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-JUL-2015, the patient was vaccinated with a dose of an improperly stored (Oka/Merck) VARIVAX, lot number K021486, expiration date 03-NOV-2016 (dose and route were not reported). No adverse effects were reported. There was no concomitant medication reported. This is one of several reports from the same source. Additional information has been requested.
Patient reported they were not feeling well. No other information was provided; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 2 (unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 1 (unknown manufacturer), for COVID-19 immunization.  The following information was reported: MALAISE (non-serious) with onset 28Sep2022, outcome "recovering", described as "Patient reported they were not feeling well. No other information was provided". It was unknown if therapeutic measures were taken as a result of malaise.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 09:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. The patient previously took Aspirine and experienced drug allergy. The patient did not take any medications within two weeks prior to vaccination. Prior to the vaccination, the patient was 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. On 10Apr2021 at 14:00, the patient experienced eyes itching and thy numbness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events eyes itching and thy numbness was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
About 6:00pm on 4/1/21 (8hrs after 2nd vaccine) the bones in my torso began to hurt - hips, spine, shoulders - at level 3 [on 10pt scale]. Pain increased rapidly from onset level 3  to level 6 in next 2 hrs until 8pm, and spread to leg bones, knee joints, neck. Bone pain kept increasing for 2-3hrs to level 7 and my arm bones, elbow joints, hand and foot bones, and skull finally hurt too, all at level 7-8  around 10pm and for the next 12-13hrs. Pain dropped to level 6-7 about 10:30am 4/2/21 and remained at that level for about 18hrs, or until 4:30am on 4/3/21, when it began to drop rapidly to level 0 by 10:am. I felt achy and exhausted from lack of sleep and had a level 4 headache until 4/4. Not muscle pain.
Information has been received from a physician concerning a female patient who entered an unspecified study and was vaccinated with VARIVAX (Merck) on an unspecified date. (Lot #, and dosing information was not provided). The patient did not seroconvert to the vaccine. No further information is available.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient said that she feels chest tightness(mild), sweating, blurred cision (mild) light headed.\r\nPatient on Amphetamine 15 and 30mg
pt recv vax;while standing in front of the counter, passed out & fell backward ;sec later,woke up & complained about neck & chest pain; rushed to hosp;
HUGE swollen lump on arm, about the size of a large baseball (width), purple, RED, FEVERISH!!!, achy, sore, painful to touch. Also caused headache, tummy ache, possible diarrhea, and had to leave school early the day after.
While in her 15 min. observation she became diaphoretic, nauseous, notable wheezes.  Stated she was having a difficult time breathing.  Pt. was given 1 dose of epi.  Has a hx of COPD and had her albuterol inhaler with her.  She took 2 puffs.  EMS was notified and transported pt. to ER.  2:20PM O2 sat 97% HR 110 BP 148/112.  2:25PM O2 sat 96% HR 110 BP 200/120.  2:32PM EMS arrived and transported pt. to ER. Pt. appeared less diaphoretic and breathing was less labored when EMS arrived.
Patient stated she had a sore arm for two days after her first dose, but it subsided. Then, a week after her first dose, she stated she couldn't move her neck. She saw her PCP who sent her to the ER. They gave her a muscle relaxer, which she said helped. She said the pain lasted until Sunday (which was yesterday).
febrile by 4PM on 17FEB93 by 8PM fever of 103.6 not responding to APAP; pt begin to devel runny nose, cough, irritable, sx of URI; skin dry on lt leg; lump palpable in rt leg;
21JAN91 pt vax w/MMR; exp soreness at inject site for 2 days. 27JAN91 exp gen malaise & arthralgia.  01FEB91 sx subsided.
patient was diagnosed with COVID-19; fever; fatigue; diagnosed with covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid-19) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 021A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced COVID-19 (diagnosed with covid-19) (seriousness criterion medically significant). On an unknown date, the patient experienced DRUG INEFFECTIVE (patient was diagnosed with COVID-19), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, COVID-19 (diagnosed with covid-19), DRUG INEFFECTIVE (patient was diagnosed with COVID-19), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, SARS-CoV-2 test: positive (Positive) Patient was diagnosed with COVID-19.         Concomitant product information was not provided.  Treatment information was not provided.  Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information and lack of scientific plausibility for the occurrence of the event causal relationship is considered unlikely related to mRNA-1273.
Soreness at the injection site, nausea, tingling in hand, fever, chills, sweats, headache, backache, and stomach pain.
10/9/99 felt 'under the weather,' had soreness all over, 'flu-like symptoms.' By the evening was experiencing chills/fever, sweating, and redness over shoulder, deltoid area. Pt took Tylenol. Shoulder very sore to the touch.
large, 4  by 5 inch area,  red itchy rash developed nine days after rash on arm below injection site.
Within 1 hour of her receiving Td/PPD Pt has ? syncopal/?sx episode while standing in ine in restaurant- Fell to floor with 'trembling" in extremities, unresponsive x 30 seconds. Evaluated in local ER with IV fluids Then sent home.
Had a 2cm local reaction raised area over arm with erythema (Varicella right arm).
Information has been received from a pharmacist referring to 5 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 20-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
All died within the 5 weeks after there first shot; This is spontaneous report from a contactable consumer. This the second case out of six cases.   An elderly male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021 as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. On unknown date the patient died within the 5 weeks after the first vaccination. It was not reported if an autopsy was performed. The patient was in a residential home with 5 other elderly residents. He/she died in sleep.  Information related Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021617030 same reporter, same vaccine, same adverse event, different patient.; Reported Cause(s) of Death: Unknown cause of death
Night after getting the vaccine, legs, and arms numb and tingling, heavy feeling, lasted 2 days and nights like this, got better and became less intense until about 13 days in then became very concerning. I couldn't sleep at night because I would be awake not being able to feel my arms and legs. During the day the numbness went from my right toes all the way up to my hip, my left foot and calf were numb, my hands and lower arms up to be elbow were numb and heavy. I went in to see Dr. who put me on a medicine to help me sleep, I saw a spinal surgeon the next week and went over MRI, both Dr. and the spine specialist said this was due to the vaccine, not my spine. It's been 7 weeks now and my right leg is still. numb, very heavy feeling, sometimes I trip, my left foot tingling and numb. At least once a week I am awake all night with my arms and legs feeling numb.
first vaccine 5 years ago. then it became unavailble; This case was reported by a consumer via call center representative and described the occurrence of product availability issue in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 5 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product availability issue. On an unknown date, the outcome of the product availability issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient self-reported the case and stated that, he/she had first Shingrix vaccine at the age of 65 years. Then the vaccine became unavailable in his/her area for many months, which led to product availability issue. By then, the patient was very much involved in caring for a seriously ill family member. The patient did not receive 2nd dose and asked if he/she could get 2nd dose now or need to start over.
Started having eye pressure pain swelling and a sty developed inside lower left eye next morning pain got worse every day  by 3 day the eye was was like infected and the stye was pushing to the outside with lots of pain this took place over the holiday so couldn't call anybody till the 6th day to get a medicated drop from my doctor
Narrative: She notes having developed difficulty breathing (described as increased WOB/heaviness) a/w throat and chest tightness about 10 minutes after the vaccination. She was able to ambulate w/o difficulty to an examination room down the hall from the other vaccination waiting area. The throat tightness was not a/w difficulty swallowing or swelling. It may have been a/w the feeling of spasms, but was persistent for about 3-5 minutes prior to spontaneously resolving. The chest tightness/heaviness occured along the same timeline and resolved spontaneously. It was localized to the sternum and did not radiate, was not a/w the sensation of pain. The feeling of increased WOB had greatly improved upon resolution of these sx, but was not completely resolved by the time the patient left clinic (>40minutes after vaccination). She was offered more time to rest/relax in the clinic, but felt comfortable to depart. She denied past similar reaction to other vaccine. Only known other allergy is to sulfa drugs (hives). The patient denied urticaria, flushing, swelling, confusion/disorientation, dizziness/lightheadedness, weakness, shortness of breath/wheezing, tachycardia/palpitations, nausea, abdominal cramping, or feeling the need to vomiting/have diarrhea. O: HR initially 50s on pulse ox with manual in 70s. Repeat pulse ox placement 70s BP manual 142/96 RR initially 20s, improved to ~14-15 during the examination SpO2 97-98% on RA during exam Gen: non-toxic, distress dissipated during exam, answering questions appropriately, speaking in full sentences w/o increased work of breathing HEENT: atraumatic/normocephalic, PERRL, no swelling Neck: no swelling or stridor CV: regular rate and rhythm, normal S1/S2, no murmurs Pulm: clear to auscultation bilaterally with no wheezes Ext: moves all 4 spontaneously, no edema Skin: no obvious lesions or urticaria Neuro: CN II-XII grossly intact, 5/5 strength UE and LE Psych: appropriate, thoughts linear A/P: reaction s/p 2nd Moderna vaccination. Likely vasovagal with potential concern for immediate allergic reaction component given throat and chest tightness. Both throat/chest tightness resolved w/o intervention.
Shoulder pain and limited range of motion. Onset 2 hr. post injection, lasting 7+ mos. Capsulitis, bursitis, humeral head bone erosion. RX = PT, NSAIDS.
Pt received flu vaccine. Pt at baseline for approximately 5 minutes after administration and standing in exam room. Pt had syncopal event and became unresponsive for 1.5 minutes with decreased BP and oxygen saturation. Returned to baseline and transferred to ED for evaluation.
ED to Hosp-Admission Discharged  3/23/2021 - 4/6/2021 (14 days)    Last attending ? Treatment team Hypoxia Principal problem        * (Principal) Hypoxia Yes      Ambulatory dysfunction Yes     Comorbid MS, diabetic polyneuropathy      Type 2 diabetes mellitus  Yes     Goal A1c<8.0% (due to comorbidities)    Diagnosis: Multiple sclerosis, peripheral neuropathy, multiple orthopedic issues Specialists: neurology  consider physical therapy if x-ray comes back without significant issues  Scheduled: pregabalin As-needed: acetaminophen, baclofen    COVID-19 Yes      Hypoxemia Yes
Pt vaccinated with MMR developed fever of 102-103, rash covering entire body 5 days after vax. MD checked child prescribed Tylenol for fever and Benadryl elixer for rash.