chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The infant had an instant scream with administration of Prevnar (IPV 1st, Prevnar 2nd, Hib 3rd). The infant became pale, diaphoretic, hypotonic, hyporesponsive, turned bluish across the eyebrows with circumora.. His eyes deviated sharply to the upper right side held there about 30 secs. When his eyes returned to normal position he responded to painful stimuli to ear lobes then to mandibular joints. Cry resulted in color of skin normalization after 15:20. The patient was left clonic. The DTaP was administered to the infant he turned slightly pale, but quickly recovered with mother consoling. The infant firmly began to suck his bottle. The doctor Administered 0.4 ml of APAP med for fever precaution. The mother instructed in what to watch for in the infant behavior for immunization reaction and seeking emergency help. The mother expressed understanding via spanish interpretation. When the infant left the clinic he had good color and was sleeping in the infant seat about 4:50 pm. No oxygen was ever needed, as the infant was treated the doctor responded very quickly. The infant maintained respiratory and heart rate; CPR not needed.
having some itching at the injection site; patient was given a vaccination of MMR II intramuscularly; This spontaneous report as received from a pharmacist refers to a non-pregnant female patient of unknown age. The patient's historical condition included asthma. The patient was not having any breathing problems. No information regarding the patient's concomitant medication, drug reactions and allergies was provided.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), albumin status of recombinant human albumin (rHA), injection, 0.5 milliliter, intramuscularly in the right deltoid, lot # R015163, expiration date 29-MAY-2020, which was diluted in a sterile diluent (DILUENT MRK) injection, intramuscularly in the right deltoid (dose, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced itching at the injection site. At the time of the report, the patient not recovered from the event of itching at the injection site.  The relatedness between itching at the injection site and suspect therapies was not provided.
5OCT91 itchy; wheals, felt hot & cold; 6OCT91 taken to ER rx Pred & DPH; also exp muscle aches; no energy;
Information has been received from a Licensed Practical Nurse concerning an unspecified numbers of patients. On an unspecified date, the patients received a batch of improperly stored M-M-R II (dose, strength, route and lot# were not reported). No adverse effects reported. This case was one of the three reports received from the same reporter. (Other two products captured in case 1503USA003160 and case 1503USA003159). Additional information has been requested.
Complaining of itchy legs. In tears each morning about her legs being itchy and feeling uncomfortable. Not characteristic behavior prior to vaccination. Going on day 6. Hoping the itchy and uncomfortable and emotional upset will clear in coming days.
Information has been received from a health professional concerning a 4 month old infant who on 20-Oct-2006 was vaccinated with an oral first dose of Rotateq (lot 655175/0849F). The patient was not experiencing any known symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Moderate abdominal pain/distress, Moderate fatigue  Nausea  Body aches  Headache,  feeling not well
DIARRHEA; SHAKING; DRY MOUTH; BODY ACHES; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and  expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced shaking. On APR-2021, the subject experienced dry mouth. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, shaking, body aches, nausea, dry mouth, chills and headache was not reported. This report was non-serious.
Chills, Headache, Feeling unwell,  injection site pain Treatment : Acetaminophen
nose felt blocked off; runny nose and eyes; sudden high fever; headache; whole right arm painful including fingers and palm; This spontaneous case was reported by a patient and describes the occurrence of NASAL CONGESTION (nose felt blocked off), PAIN IN EXTREMITY (whole right arm painful including fingers and palm), RHINORRHOEA (runny nose and eyes), HEADACHE (headache) and PYREXIA (sudden high fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation, Arthritis (arthritis in her right thumb) and Shoulder discomfort (has a shoulder problem in her right arm).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (whole right arm painful including fingers and palm) and HEADACHE (headache). On 10-Mar-2021, the patient experienced NASAL CONGESTION (nose felt blocked off), RHINORRHOEA (runny nose and eyes) and PYREXIA (sudden high fever). On 08-Mar-2021, HEADACHE (headache) had resolved. On 09-Mar-2021, PAIN IN EXTREMITY (whole right arm painful including fingers and palm) had resolved. At the time of the report, NASAL CONGESTION (nose felt blocked off) and PYREXIA (sudden high fever) outcome was unknown and RHINORRHOEA (runny nose and eyes) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication heat applied to sore arm. No concomitant medication details was reported.
CDC reports: 2 mo infant had fever to 101, generalized body rash & screaming episode lasting > 3hrs following DTP/OPV immun; Duration of illness 2 days.
lt arm swollen (3"), sore, pain radiating under lt ax toward lt breast & lt hand; lt hand stiff; this lasted for 1 wk; pt advised to use DPH & advil;
Numbness began in toes an progresses up legs over a week before diagnosis of Guillain-Barre Syndrome at Hospital on June 9, 2016.
Developed "splotchy rash" on abdomen and inner thigh, puritis, runny nose. No temp.
arm was a little stiff; warm; This case was reported by a consumer and described the occurrence of stiffness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On 22nd October 2021, the patient received the 2nd dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced stiffness and skin warm. On an unknown date, the outcome of the stiffness and skin warm were unknown.   It was unknown if the reporter considered the stiffness and skin warm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, after vaccination arm was a little stiff and warm to the touch.
Information has been received from a physician concerning a male patient over 65 years old, who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Lot # was not provided). The patient experienced a herpes zoster rash. The patient developed the rash on his lumbar or his chest. The patient sought medical attention. There was no product quality complaint. Additional information is expected.
The morning of woke feeling like I was getting a small head cold. I was okay all day until about 6pm. My throat was starting to get sore, and I had a few body aches. A couple hours later my head started to hurt, my knees were bothering me. They hurt to walk. By 11pm I was running a 99.2 fever. Everything was hurting from head to toe. By 12:30AM my temperature went up to 101.9. I couldn't get comfortable. By 6 in the morning my fever broke, and I was still feeling bad, so I called my doctor, and we went in, and I ended up testing positive for COVID-19. They prescribed me Azithromycin 250mg and cough syrup. I was antibiotics for 5 days. A few days ago, I started getting fatigued.
Extreme pain in arm after shot, could not move for several days; pain went away in arm but stayed in shoulder; better with aspirin, pain with movements like putting on jacket, putting on deodorant; lateral arm movements. Saw school nurse but not PCP.
1st - pain at site, nausea, swollen lymph node, fatigue, muscle soreness 2nd - headache, shortness of breath, fatigue, muscle/joint soreness, fatigue
Massive heart attack: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:  A patient (no qualifiers provided) 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Massive heart attack".  Clinical course: The caller also mentioned that one of his friends took the shot and had a massive heart attack. They also recently found out they have stage 4 cancer of the prostate. Caller said that he called Pfizer because of a problem with the approved Comirnaty. Caller stated that he hasn't seen a bottle or label for Comirnaty, but over Labor Day weekend it went Bivalent. Caller said that instead of putting 2 in front of it, they used Bivalent. Most people don't know what the word Bivalent means. Caller said they said it is for two different variants, but it isn't, it's for 5 different variants. Caller stated that bivalent means double the dose and basically Pfizer doubled the dose over Labor Day weekend, and then RSV started. The information on Product strength and count size dispensed, Additional lot numbers, Packaging sealed and intact was not willing to verify or clarify any information provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient got light-headed, and was unable to stand without assistance. Patient remained conscious, but said he felt like he was going to pass out. He was pale and said he was hot. The patient was seated, his color came back relatively quickly. His mother gave him a drink and he seemed to feel better relatively quickly.  His mother reported that this has happened previously with doctor visits and he gets nervous with vaccines. A follow-up call was made to his mother and she reported he was completely fine.
Patient is fully vaccinated.  COVID + 12/22/2021.  Hospitalized on 12/18/2021.  Admitting dx: neck pain, back pain, knee pain, fall COVID-19.  Pulmonary empolism. Treatment:  Lovenox given,  The patient is a 72y.o. female with history listed below presenting to the ICU for acute hypoxic ventilator dependent pneumonia secondary to covid.Started on broad spectrum antibiotics, decadron, albuterol nebulizer, remdesivir. On 1/2/2022 ICU was called for Unresponsive with agonal respiration while on bipap with continued hypoxia. Palpable pulse but unable to get blood pressure. Anesthesia at bedside for intubation. 2L bolus started in both patent IVs. Emergent CVC placed in right fem. Multiple pressors along with levophed, epinephrine, and pushes of neo give prior to intubation. Patient was intubated, CVC placed, and on 4 vasopressors including vasopressin and phenylephrine drip. Per family request, patient was terminally extubated and expired.
administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine) in a 96-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Reporter stated that no treatment was given to patients.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
pt recv vax & 9SEP97 pt exp soreness & a raised area @ the inj site;10SEP97 pt telephoned to report swelling & redness @ the inj site w/o any real pain;
Left arm pain on first 2 days; extreme fatigue; chills/ All night chills; flu like illness; This is a spontaneous report from a contactable Physician (patient himself). A 40-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm on 18Dec2020 11:45 at single dose for Covid-19 immunisation in a hospital. Medical history included High cholesterol. Concomitant medication included influenza vaccine (FLU). Prior to vaccination the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 post vaccination. The patient experienced left arm pain on first 2 days (21Dec2020) 12:00, had extreme fatigue, chills described as all night chills and flu like illness on 21Dec2020 12:00. The patient took Tylenol as treatment. The outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Prominent localized swelling at injection site immediately after injection was given (swelling = size of walnut). No other immediate adverse reactions noted by pt. or observed. Ice applied to site x 15 minutes and swelling resolved. I spoke with pt on 11-16-07 and he stated that after flu injection, he had gradually increasing (L) arm pain and swollen lymph nodes over next few days which prompted him to visit his physician on 11-13-07. Physician prescribed Keflex x 10 days and will continue to follow.
Fever, extreme chills and physical shaking, dizziness, sensitive skin hot to the touch, painful to touch skin, headache, sinus pressure, metallic taste in mouth, body aches - took Tylenol and ibuprofen as needed - all occurring within 24 hours of vaccine. Starting to fade off but still having a headache and body aches 48 hours after.
This literature marketed report has been received from the authors of the literature article entitled as stated above concerning to 52 3-18 year old patients of unknown gender. The patients were under methotrexate (manufacturer unknown) for atopic dermatitis, psoriasis or morphea. On unknown dates, the patients were vaccinated with RECOMBIVAX HB (lot#, expiration date, dose and route were not reported) for prophylaxis. These patient were confirmed to have completed the recommended hepatitis B (HB) vaccination series. On unknown dates, the patients' anti-HBs titers were analyzed, showing the results of less than 10 milli international unit (mIU)/ml. These 52 patients had no anti-HBs protective levels and were considered as non-responders for RECOMBIVAX HB. The outcome of hepatitis b surface antibody negative and therapy non-responder was unknown. The reporter considered, in the patients with atopic dermatitis and psoriasis, these immunogenetic factors or excessive inflammation due to underlying disease might contribute to the increased rate of those without anti-HBs protective levels.
pregnant and has had both vaccines; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant and has had both vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant and has had both vaccines). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant and has had both vaccines) had resolved.            No concomitant medication was reported.  No treatment details were provided.   Reporter did not allow further contact
This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. No adverse event was reported. This is one of the two reports from the same source. Additional information is not expected.
Subject reports receiving AVA vaccine #1 on 10/8/07.  She states she started having pain at the injection site on the evening of 10/9/07.  Complained of slight injection site swelling and injection site warmth.  Denies any systemic effects.  10-17-07 subject reports that symptoms resolved as of 10-12-07.
Left leg weakness and limp, beginning one day after receiving MMRV and DTaP/IPV (B75MY) left arm
Injection site soreness; fatigue; body aches; nausea; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EN6206) via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 17:15 (at the age of 30-years-old) as single dose for covid-19 immunisation. The patient's medical history includes known allergies shellfish, endometriosis, pelvic floor myalgia, depression, PMDD and asthma. The patient underwent lab tests and procedures which included sars-cov-1 test: negative on 28Feb2021 Nasal swab. The patient's concomitant medications included acetaminophen, ibuprofen, ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) and melatonin. It was reported that on 10Mar2021 at 18:00, the patient experienced injection site soreness, fatigue, body aches and nausea. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
PATIENT EXPERIENCING SORENESS MORE THAN USUAL FEW HOURS AFTER INJECTION AND SORENESS PERSIST EVEN UNTIL NOW.
broke out in hives roughly 30 hours after injection given. No relief with benadryl.
No symptoms until 9:00 PM. Left cheek broke out into red/white, thick and bumpy hives. He complained that his left eye hurt. At 9:15 the hives quickly spread to his forehead, the right side of his face, and both eyelids. We took him to the hospital at 10:30 (arrived there). The hives became worse and his left eye was completely swelled shut. There were tiny red dots on his arms and back, some on front of neck. My son also had a cough along with all of this. After he was given a steroid shot and Benadryl, the hives went away within the hour and his swelling went down some. The swelling was not gone until Sat. afternoon. The swelling covered his entire face, not just his eyes. When we got home, we gave him Benadryl every 6 hrs. Prednisolone 2 times a day and eye ointment 4x day.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 21Feb2021 as dose 1, single (Lot number: 002A21A), in right arm, on 25Mar2021 as dose 2, single (Lot number: 037A21B), in right arm and on 22Jan2022 as dose 3 (booster), single (Lot number: 047F21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CALCIUM VITAMIN D3 [CALCIUM;COLECALCIFEROL], start date: 16Sep2009; SIMVASTATIN, start date: 15Sep2020, stop date: 07Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 07Aug2023 to 12Aug2023 for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300277719 same patient different drug/event;
I had three occasions where I had tightness in my head followed by goosebumps. I experienced weakness on a scale 1-10 would be a 2 (quite mild). After Dose 3, it was maybe 2 weeks after I experienced the same symptoms. The morning of November 17, 2021, I went walking a mile as my daily routine. I had a sensation in my head followed by a weakness that lasted 1 min-1 1/2 min. Then later me and wife went to get breakfast. I had a mini sensation in my head and weakness. At that time my wife called the physician and was seen 2 hours later. I explained to him what happened he stated I didn't have a stroke or TIA. He wasn't able to classify what happened. I went home later that evening standing in the kitchen totally blanked out, no weakness. My wife called 911 went to ER had a MRI, CT Scan and EEG. I was hospitalized for 2 days for observation. On November 20,2021 I started taking Keppra 500 mg twice daily haven't experience any more episodes.
returned to clinic approx 1hr p/vax w/generalized hives, given DPH in clinic;note: child was also in feeding clinic, several new foods on face & in mouth;
There was no place for me to list the date of my second shingrex vaccine which was 7/7/2020.  For both doses, I experienced similar reactions.  For the first one I had pain at the injection site for 3 days, I awoke the morning after the vaccine and nearly fainted from lightheadedness, I felt extreme fatigue for a few days, and I had swollen and painful lymph nodes under the armpit of the side I received the injection for three days.  For the second dose, I again still have pain at the injection site two days later, extreme fatigue, and painful lymph nodes under the armpit of the side I received the injection as well as pain that extends down the inside of my arm towards my elbow.
Temp 105.6 3 hrs. after PENTACEL; symptomatic treatment; resolved 24 hrs.