chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an 18 week old male patient with a history of reflux and umbilical infection when he was born who on 16-SEP-2008 was vaccinated with the first 2 ml po dose of ROTATEQ. On 17-NOV-2008 the patient was vaccinated with the second 2 ml po dose of ROTATEQ (lot # 662618/0925X). Concomitant therapy included PRILOSEC. Subsequently, the patient experienced intussusception and was hospitalized on 20-NOV-2008. On 22-NOV-2008 the patient was diagnosed with intussusception. The physician decided not to administer the third dose of ROTATEQ. Abdominal surgery was performed and was noted by the reporting physician to be an other important medical event. At the time of reporting, the patient had recovered. Additional information has been requested.  3/23/09 MR received for DOS 11/22-24/2008 with D/C DX: Intussusception.  pt presented with several week hx of intolerance to feedings. On 11/20/08 became irritable and fussy, had rust colored urine and vomited large amt. Admitted to local hospital for suspected gastritis. Bilateral hydrocele noted in scrotum with concern for SBO. Transfered to current hospital where abd US confirmed IS.  Attempted reduction with air enema failed. To OR for ex lap and reduction. Did well post-op and d/c.  F/u 12/16/08-recovered.
We left the room after the shot to check out. He said the shot felt weird. While checking out he essesntially fainted but looked like he was paralyzed and having a seizure. I screamed, Drs came. They lifted his legs, grabbed ice, water, crackers. He was out between 1 to 2 minutes. When he came to he did not know why he was on the floor or why his head hurt and all these people were around him. He hit the chair going down and had some knots and one slightly bleeding. He was put in chair and we waited about 15 minutes or more. Drs explained fainting can happen. The nurse nor Drs told us we needed to sit and wait after the shot. Now we know, but it was very scary. So far he just has arm pain where shot was administered.
not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received in March 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-OCT-2023 A pharmacist called to inform that a patient that received the 1st dose of Twinrix in March 2023, had not received the 2nd dose yet. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
My left ear turned bright red, from my left ear to my left wrist was numb for about 2 hours. The injection sight was sore and I continued to have pain in my left wrist. That night I kept waking up with rib pain. In the morning,  May 4th,2021, I woke up with muscle aches all over my body. I had to take pain medication to function. Today, May 5th, 2021, my left arm is still sore and I still have mild pain in my left wrist.
Unclear if related:  3 weeks later diagnosed large posterior encephalocele (i.e. Neural Tube Defect) in 13th week of pregnancy.  ultrasound day of administration appeared normal.
48 year old patient administered fluzone high-dose vaccine, with no reported adverse event; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 48 years old female patient who was administered fluzone high-dose vaccine, with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Aug-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength not reported; lot UJN04AA, expiry date: 30-Jun-2023) via intramuscular route in the deltoid nos for prophylactic immunization.  On 30-Aug-2022, (latency: same day) the 48 year old patient administered fluzone high-dose vaccine, with no reported adverse event (product use issue) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01257338: 01258901: 01258901: 01258919: 01258920: US-SA-2022SA365119:01258924
First adverse event was extreme arm soreness that worsened for the next 5 days to the point that I couldn't lift my arm to shoulder height.  I had a horrible headache starting the evening of the 21st as well as a fever.
Left underarm lymph node swelling appeared on 04/10 (disappeared after 2 days); left ankle peroneal tendonitis that required draining and treatment with cortisone, as well as future follow-up visits and physical therapy
Patient ran fever of 102.7 8 days after having had MMR and Varicella vaccines.
Fainted, sweating, lightheaded, dizzy, tingling all over, felt like bugs were crawling under her skin
POST VACCINATIONS PATIENT SUFFERED SEIZURE LASTING APPROXIMATELY 5 SECONDS EVIDENCED BY POSTURING OF EXTREMITIES, DILATED PUPILS, NONRESPONSIVE TO VERBAL COMMANDS OR PHYSICAL STIMULI, FACE INITIALLY PALE THEN FLUSHED.
81 year-old female patient in otherwise good heath received her first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), administered in right arm on 02/02/2021 (Lot Number EL9264) for COVID-19 immunization.  Concomitant medications include: Losartan and Atenolol.  Vaccine was administered at approximately 5:00 pm at a drive through location.  The vaccination was administered by the County Health Department.  Shortly after receiving the vaccine (but while still at the facility), patient started experiencing a bulging of the right eyelid.  Patient did not immediately recognize that this may have been related to the vaccination. Over the next several days, patient started experiencing additional symptoms including drooping of right side of face, drooping of right eyelid, difficulty closing right eyelid and weakness on the right side of the face.  This was unusual and on 02/10/2021, patient contacted her primary care physician who referred her immediately to Emergency Department for evaluation.  The following tests and procedures were performed by the ER: Basic Metabolic Panel, CBC Hemogram, Troponin, eGFR and CT Head w/o Contrast (reason facial drooping).  Diagnosis: Bell's Palsy, Adult.  On 2/11/21, patient had a follow-up with primary care physician.  On 02/11/2021, the patient received prednisone (10 mg once daily for 5 days) as treatment for the Bell's Palsy.  The reported events required visit to Emergency Room on 02/10/2021 with follow-up at Physician's office on 02/11/2021.  Reporting is delayed because patient understood that the adverse event had already been reported.  At a later date, patient requested a copy of the adverse event report for her records but learned that the adverse event actually had not been reported.  Report is being filed by a contactable family member.
Seizure x2 post immunizations, hospital observation x24hr, started on KEPPRA.
EXHAUSTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exhaustion was not reported. This report was non-serious. This case, from the same reporter is linked to 20211016208.
this may not be related to vax but be of interest.   (around may- June 2021) I began having some intermittent abdominal pain and non specific GI discomfort.  ( this would have been 5 months after my second vax) Then pain severe, vomiting, low grade fever on July 29, 2021, went to ER >> diagnosed with Acute appendicitis.  required appendectomy the next day.
Initial report received from a physician on 09 Jun 2010: This patient with medical history of hypothyroidism, total splenectomy in 2004, fundoplication for reflux oesophagitis in 2004 was vaccinated for with INFLUENZA virus vaccine seasonal (manufacturer unknown) (dose and batch number unknown) intramuscularly in 2006. Following the vaccination, after 01 week the patient experienced rheumatoid arthritis in 2006 and the patient also developed deep vein thrombosis during a 10 month stay at hospital in 2006. The outcome of the events was not reported.
LEG NUMBNESS; ITCHING ON LEGS AND RIGHT ARM; REDNESS ON LEGS; LEGS(FEET TO ABOVE KNEE AREA) HOT TO TOUCH; BURNING SENSATION; RASH ON RIGHT ARM AND BOTH LEGS; 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-APR-2021, the subject experienced leg numbness. On 26-APR-2021, the subject experienced itching on legs and right arm. On 26-APR-2021, the subject experienced redness on legs. On 26-APR-2021, the subject experienced legs (feet to above knee area) hot to touch. On 26-APR-2021, the subject experienced burning sensation. On 26-APR-2021, the subject experienced rash on right arm and both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg numbness, itching on legs and right arm, redness on legs, burning sensation, and rash on right arm and both legs, and the outcome of legs(feet to above knee area) hot to touch was not reported. This report was non-serious.
A red itchy hot and sore rash on the arm, which spread to cover most of the upper arm in the next two weeks. After starting to take allergy medication, it went away and was gone by the time of my second shot on 4/1/2021.
Persistent headache. Little improvement with TYLENOL and ADVIL. Headache lasted over 1 week.
6 straight evenings of evening fatigue, poor concentration, mild malaise, slightly warm feeling, excessive sleeping and the usual sore warm red reaction at a vaccine injection site in L arm  These symptoms did NOT occur each morning through afternoon, but they DID occur each evening and reduce the evening work i can normally accomplish.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding a patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 23-AUG-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # K022993, expiry date: 20-JUL-2016). No adverse effect was reported. Additional information has been requested.
low blood pressure; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPOTENSION (low blood pressure) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078J21A, 011M20A and 078J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOTENSION (low blood pressure). At the time of the report, HYPOTENSION (low blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, Blood pressure measurement: low blood pressure. On 03-Jan-2022, Heart rate: rapid heart beat. On 03-Jan-2022, Oxygen saturation: low oxygen saturation.         No concomitant medications were reported.  Patient received her first booster dose.  No treatment medications were reported.   This case was linked to MOD-2021-249289 (Patient Link).
swelling of underarm and has armpit pain; swelling of underarm and has armpit pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling of underarm and has armpit pain) and AXILLARY PAIN (swelling of underarm and has armpit pain) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced SWELLING (swelling of underarm and has armpit pain) and AXILLARY PAIN (swelling of underarm and has armpit pain). At the time of the report, SWELLING (swelling of underarm and has armpit pain) and AXILLARY PAIN (swelling of underarm and has armpit pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Non significant follow up received on 14-May-2021 contains no new information.
Patient had a delayed reaction "covid arm." Hot to the touch, itchiness, and pain.  It has been a week since she received the vaccination.  I told her to monitor for a few days with IBU and benadryl at bedtime and if no improvement go to the doctor.
patient had no issue at moment of injection.  moved to waiting area in about 2 minutes, he said I think I'm going to pass out.  he then lost consciousness and was not responding to verbal commands.  over the course of the next few minutes, he "came to" and said he sometimes has passing out issues when he gives blood.  we gave water and asked a family member to come and pick him up.
Left sided supraclavicular lymph node swelling x 2, joint pain in hands bilaterally, thumb pain, left thigh pain.
1210PM grandma phoned stating pt had a fever 103-APAP given had already been given @ clinic 1130AM;grandma asked if any other sx she stated none; advised to give APAP;
Six weeks ago, I was at work and I lost control of my bowels for no reason at all. I came home and called Urgent Care. I went there and took different tests. I was recommended to see a specialist. Later I had a colonoscopy and I was diagnosed with diverticulosis.    I had to make dietary changes.
I developed symptoms of bad headache, sore throat, ear pain, fever, chills, and tiredness. Fever and chills lasted one day. I possibly thought it was a sinus infection. I got a COVID test on 12/17/2021 which was positive. My symptoms lasted approximately 3 days. I also did a telehealth visit.
Patient has a knot under the skin in her left upper arm. The skin on the arm around where the shot was given is a ligther color compared to her normal skin color. There is a tattoo present on the arm, as well.
SORENESS IN THE ARM; CHILLS; HEADACHE; EXTREME EXHAUSTION; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included cold prior taking vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced soreness in the arm, chills, headache, and extreme exhaustion. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, extreme exhaustion, chills and soreness in the arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210421193.
This spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (strength, dose, frequency and route of administration were not reported) lot # K009953, expiration date 03-APR-2016 and lot # L001456, expiration date 22-OCT-2016. No concomitant therapies were reported. No adverse effects were reported. This is one of three reports from the same source (MARRS linked cases 1508USA002613 and 1508USA004473). Additional information has been requested.
Raised red rash that lasted 8 hours on hips, stomach. chest and thighs. Not bothersome .No treatment needed.
Information has been received from a pharmacist referring to an approximately 73 years old female patient. The patient had no medical history or drug reactions/allergies. Approximately in March 2015 (reported as "2 months ago") the patient was vaccinated with a dose of ZOSTAVAX (lot # K008886, expire date 20-SEP-2015, dose, frequency were not reported). Concomitant therapy included NORCO. In 2015 the patient had experienced "redness" at the injection site since an unspecified date following the administration. The patient sought medical attention via pharmacy call. No treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. No lab diagnostics studies were performed. Causality was not reported. Additional information has been requested.
Case number PHHY2011US63642 is an initial spontaneous report received from a nurse on 12 Jul 2011 with follow-up. This report refers to a 17 years old female patient. She was given only the MenA lyophilized conjugate component of MENVEO (batch number: A10034) 0.5 mL, reconstituted with sterile water instead of MenCYW liquid conjugate component, intramuscularly 11 Jul 2011. No other adverse reaction was reported. Patient was revaccinated with correct solution. Follow-up report received on 01 Aug 2011: Updated patient demographic and vaccination date.
Acute onset of nausea, fatigue, myalgias, diarrhea and elevated liver function tests within 48 hours of receiving vaccine. Still in recovery.
This spontaneous report was received from a pharmacist referring to an approximately71 years old male patient. Concomitant therapies included methotrexate (manufacturer unknown), MIRAPEX, metoprolol and CELEBREX. Information about concurrent condition and medical history was not provided. The patient had no drug allergies/reactions. On 12-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX (strength: 19400 plaque forming unit (PFU); dose unknown, lot# M035693, expiry date: 07-NOV-2017) subcutaneously for prevention shingles. After vaccination with ZOSTAVAX, the patient had a new prescription for prednisone (manufacturer unknown) 50mg/day for an unknown reason (considered as an adverse event) in February 2017. No lab diagnostics study was performed. At the time of reporting, the outcome of adverse event was unknown. Additional information has been requested.
Soreness in left arm noted following day and night headache throughout - felt like flu 2 days - slept.
This spontaneous case, initially received on 27-Oct-2016, was reported by a health professional and concerns a 24-year-old female patient. Weight: not provided; Height: not provided. Concomitant medication: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 21-OCT-2016 to 21-OCT-2016. Dose regimen: 0.5 ml once, Route of administration: Intramuscular. Batch number: WT54406. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date within 24 hours of injection, the patient experienced tiny red bumps resembling a rash that itched on both arms (outcome: recovering / resolving). Adverse event is resolving. Reporter comments: The healthcare professional considered all events non-serious.
This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow-up information has been received from a physician concerning a 12 year old female with no known drug allergies, plantar warts on hand/fingers at the time of vaccination and a history of gastrooesophageal reflux who on 18-APR-2007 at 16:15 was vaccinated with intramuscularly into the right deltoid with a first 0.5 mL dose of GARDASIL (lot #654535/0960F). Concomitant therapy included VARIVAX given at the same visit using a different site. On 23-APR-2007 at 07:00 (also reported as "a short time after the vaccination"), the patient developed swelling and pain in the fingers of the hand near the pre-existing plantar warts on the hand of the arm in which she received the GARDASIL (also reported as swelling in both of her hands but mostly in the right). The patient sought unspecified medical attention. No laboratory diagnostic tests were performed. The symptoms resolved over 5 days and "are now gone." No further information was provided. No product quality complaint was involved. Additional information is not expected.
on the evening of 12/29/2020:  - headache - nausea - body aches - extreme restlessness  - sore arm  on 1/11/2021 at approximately 12:00PM I noticed a large itchy, and painful to the touch welt where the vaccine was administered.
ALLERGIC REACTION; This spontaneous report received from vaccination coordinator via the VAERS (Vaccine Adverse Event Reporting System)(VAERS ID:) concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sesame seeds allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 13:38 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic reaction was not reported. This report was non-serious. This case, from the same reporter is linked.
Arm soreness until about 15 hours post-vaccine, then chills, hot flashes, muscle/joint pain, fever, hives, extreme fatigue