chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My son was given the rotavirus vaccine at his 8 week check up.  It is unclear how much of it he even swallowed, as he spit out large amounts and the nurse had a difficult time getting him to take it.  He was crying quite a bit during the administration resisting it.  About 30 min. after the dose he nursed just fine and then fell asleep for several hours. He awoke screaming in pain...certainly not just your typical "I'm hungry,  tired, or want to be held cry".  My baby is typically a very mellow baby, so this was especially concerning to us.  Patient screamed for several hours...he would not nurse or take his pacifier.  He stopped for approximately 3-4 min increments about every hour and then the screaming started again.  His fists were tightly clenched and his toes flexed as he cried.  His belly was very, very tight and I could tell that he was having a lot of abdominal pain.  After approx 3 hours of crying I placed him in a very warm bath and massaged his belly.  This seemed to calm him down a little and he had a small bowel movement, which seemed to relax his tight belly as well.   He ate after that as well.  For the rest of the evening, the screamed continued but did become less in duration and frequency.  Through the night, he would scream about 10 min and then have an enormous bowel movement.....intense diarrhea.  The diarrhea was gone by late the next morning and the screaming and stomach pain stopped as well.   Ironically, my now three year old daughter demonstrated the EXACT same reaction after and course of events after her 8 week dose.  For this reason, we decided NOT to give her the 4 and 6 month doses.
Patient called the pharmacy stating she had hives on her stomach and buttocks and redness and itching on her face.
Partial dose of vaccine was administered rather than full administration. this was caused by some fault in the needle used to inject. following cdc guideance last update 11/3/23, a second half dose was given to equal a full dose. this was all done on the same day. no negative outcome, side effects, or outcomes other wise noted as of the time of this report. Will be following up with pt on Monday.
She received the vaccination, and almost immediately she started getting a numbing feeling on her left side  It started at her face, half her lip and into her jaw, and down her leg on the left side., the upper thigh/leg and the calf, down her feet into her toes.  There was just a slight numbness in her chest, she didn't think much of it as she had family members who had no reactions.  That subsided a little.  The feelings lasted all day Monday, all day Tuesday, got concerned yesterday Wednesday 3/17/21.  She called  the CDC and they transferred her to a nurse who told her to go see her doctor.  She called her doctor and she described her reaction and told her that they did not know if it was stroke-like and they told her to go to the hospital.  She went to the hospital yesterday and they did an exam on her and one of the doctors who consulted with his connections with the CDC and decided that they would have to do an MRI on her to make sure it did not cause a stroke.  She did have the MRI which they looked at it and told her that it looked clear and was not a stroke, however, she is to FU with a Neurologist and her PCP.  The only thing that she was given to try was something for allergies, Benadryl to see if that would help with the reaction.  She still has some feelings of numbness in the same areas as listed above.
Patient vaccinated with first dose of Pfizer with subsequent infection and hospitalization due to COVID-19 infection. Initial H&P reads in part as,  "Patients symptoms began on or around Thursday 3/11 when he began to feel  fatigued. After two days of fatigue, he presented to an urgent care facility on  Saturday 3/13. He was noted to have a fever there and was diagnosed with a  presumed UTI, though patient reports at bedside that he has not had any  dysuria. He was treated with nitrofurantoin and increased his furosemide  temporarily per urgent care's recommendations. He then presented to the ER  on 3/15 with continued fatigue and a low blood pressure at home. We were unable  to clarify the method by which the blood pressure measurement was obtained  and/or if it was repeated. Antibiotics were changed to cephalexin at that time  despite a relatively clear UA. His daughter brought him back to the ER today  (3/18) due to persistent issues with low grade fevers in the 100-100.5 range,  significantly worsening fatigue, anorexia, and oxygen levels of 92-93% on  nonproductive cough. Does not have a home O2 requirement. In addition, he  endorses feeling chilled during the admission evaluation. Denies any chest pain,  nausea, vomiting, fevers, diarrhea, constipation. # Fever Progression of symptoms from Saturday 3/13 may constitute original presentation  of Covid-19. Presentations on 3/13 and 3/15 with dyspnea and fatigue. Initially  thought to be UTI and was treated with nitrofurantoin and cephalexin. UA on 3/15  in ED was negative for leuk esterase and nitrites. Tested positive for covid-19  on 3/18 with lymphopenia, 90-92% on room air. No home O2 req. Given duration  of symptoms and worsening fatigue and fevers, will admit for treatment of Covid- 19. Also considered CHF exacerbation, COPD exacerbation as explanations for  dyspnea. Possible CHF exacerbation as well given 1+ bilateral pitting edema to  mid-shin and JVD to ear lobe. Suspicion for COPD is low given no report of  increased sputum production and questionable history in chart to begin with.  Would be beneficial to clarify history with collateral history 3/19."
our arms (right rear) continues to be very tender; very painful, and our arms (right rear) continues to be very tender and painful 20 hours later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 19:00 (Lot number: FH8027) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 05Nov2021; LANTUS; METFORMIN; EXFORGE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 25Feb2021, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 22Mar2021, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine".  The following information was reported: TENDERNESS (non-serious) with onset 05Nov2021 21:00, outcome "not recovered", described as "our arms (right rear) continues to be very tender"; VACCINATION SITE PAIN (non-serious) with onset 05Nov2021 21:00, outcome "not recovered", described as "very painful, and our arms (right rear) continues to be very tender and painful 20 hours later". Therapeutic measures were not taken as a result of tenderness, vaccination site pain.  Additional information: The patient was vaccinated at the same times and locations for all three doses. The first two doses to let to a mild sore shoulder for her. The Booster injection for BOTH OF US were very painful, and her arms (right rear) continues to be very tender and painful 20 hours later. Also note that we also received our Senior dose Flu shot in the same right (front) arms. This injection site was also a little tender (2 out of 10), but nothing like the Pfizer site (7-8 out of 10)  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101531727 Same reporter/ drug/ event for different patients
Immune thrombocytopenia (ITP); Blisters in the mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia (ITP)) in a 61-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history has not been reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia (ITP)) (seriousness criterion hospitalization) and ORAL MUCOSAL BLISTERING (Blisters in the mouth). The patient was hospitalized on 22-Mar-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia (ITP)) had not resolved and ORAL MUCOSAL BLISTERING (Blisters in the mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Platelet count decreased: (Low) Admitted to the hospital with NO platelet counts.         Patient was not on any concomitant medications before being admitted into the hospital.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
8 d. of moderate - severe body aches & muscle pains, also headaches & fever x 4 days (Tmax 101.9).
11/5/06 emergency room pain in L arm in area where shot administered, 11-9-06 Dr orthopedic doctor Roto cuff impingement?, 11-13-06 started physical therapy  constant pain intense pain, 12-27-06 DR steroid pills, 1-11-07 Dr shoulder injection cortisone, 1-17-07 Dr nerve test on arm and shoulder, 1-23-07 DR, 1-26-07 hospital started physical therapy again still taking it, 1-8-07 MRI at hospital.
SLIGHTLY SORE ARM; This spontaneous report received from a patient concerned an adult female. The patient's weight was 265 pounds, and height was 66 inches.  The patient's past medical history included: infection, and hospitalization (History of hospitalization just 1 time), and concurrent conditions included: polyethylene glycol allergy (The patient had a very severe allergy to polyethylene glycol, the patient found out the allergy to polyethylene glycol accidentally, because the patient was given a samples of Blink eyedrop from doctor, after use patient eyes started swelling up, eyelids swell up like pillows and turned red and closed to the point could not see through them. The ingredient of Blink eyedrops is polyethylene glycol.), chronic asthma (respiratory issues), sleep apnea (respiratory issues), lung scarring, non-smoker (exposed to a lot of second-hand smoke.), obese, autoimmune issues (get sick easily), bipap user, vitamin d3 deficiency (now corrected, but keep taking Vitamin D3, weekly high dose), fatty liver (but they were not concerned liver functions normally.), drug allergy (Albuterol, thimerasol and potassium chromate), latex allergy, sulfa allergy, no alcohol use, nodules on lungs, kidney cyst (they were not concerned kidney functions normally), menopause, degenerative disk disease, arthritis type symptoms (makes it hard to move), gluten allergy, dairy allergy, allergic to potatoes, food allergy (Allergic to green beans), allergic to shrimp, and weight gain (gained weight after menopause), and other pre-existing medical conditions included: The patient had no any symptoms of positive COVID-19 disease prior to vaccination, had no pre-existing acute illness 30 days prior to vaccination. The patient was not a pregnant. The patient had family history of lot of heart issues (on mother's side, and most of mother's side died before 70 due to heart problem) and bad/gasping snoring. The patient experienced fatigue, more reactions, muscle aches and pain in arm when treated with varicella zoster vaccine for prophylactic vaccination, and more reactions when treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-APR-2021 for covid-19 prophylaxis.  The batch number was not reported and has been requested. Age at time of vaccination 59 years old.  Concomitant medications included levosalbutamol hydrochloride for chronic asthma, montelukast sodium for chronic asthma, ibuprofen for pain, and colecalciferol for vitamin d3 severe deficiency.  On 2021, the patient experienced slightly sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slightly sore arm was not reported. This report was non-serious.  This case, involving the same patient is linked to 20220943780 and 20220956151.
Patient received his 2nd Pfizer COVID vaccine on 6/9/2021, did not feel well for 24 hours after the immunization but then improved. Yesterday developed chest pain/heaviness that continued today prompting emergency department evaluation. He was noted to have elevated troponin levels concerning for myocarditis.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 07/20/2021. PATIENT FULLY VACCINATED ON 02/11/2021.
Temp of 103, lethargic, crying, vomiting, information obtained form parent.
This spontaneous report as received from a physician refers to her son of unknown age. On 24-FEB-2014, the patient was vaccinated with the first dose of VAQTA, 0.5 ml, intramuscular (lot number not reported). On 19-AUG-2014, 5 days earlier than recommended minimum interval of 6 months, the patient was vaccinated with the second dose of VAQTA 0.5 ml, intramuscular (lot number not reported). No adverse effects reported. Additional information has been requested.
7 days after the shot i developed shortness of breath and chest tightness with heart palpitations.
Pt recvd MMR vax & w/in 24 hrs pt devel t103 & w/enlargement of occipital lymph nodes; sx resolved next day; approx 10 to 14 days following vax; pt devel small pinpoint rash primarily on chest & trunk; rash cleared w/in 24 to 48 hrs;
Patient reports that she noticed redness and swelling in mirror on 3/20/12.  She is taking cetirizine 10 mg for seasonal allergies, and states that it looks better today (probably due to the cetirizine).  She showed the reaction to me (her pharmacist) and I recommended that she continue taking cetirizine 10 mg and to also take acetaminophen or ibuprofen for swelling and pain.  I also instructed her to contact her physician if it does not continue to improve over the next 3 days.
Patient was accompanied by her mother to receive her covid booster vaccine.  Shortly after she received her vaccination (about 3 to 4 mins).  she started feeling dizzy and lightheaded.  She was sitting down when she felt weak and dizzy. Her skin turned to pale color. we immediately assist her to a laying down position and elevate her legs.  We call 911 right away and continue to monitor her pulse and breathing.  She was sweating a lot and she is alert.  We keep making conversation to her to make sure she did not lose consciousness. EMT arrived and took her vital sign outside and brought her to emergency room. Per patient's mother they stayed in emergency room for about an hour and got discharged. Patient was feeling better after returning to home.
A 18 month old female baby got Pentacel and Acthib same time on 15 Jan 2020, baby accidentally got two doses of ActHIB/No AE; Initial information received on 16-Jan-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a 18 months old female patient who received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and HIB (PRP/T) VACCINE [ACT-HIB] same time on 15-Jan -2020, baby accidentally got two doses of Acthib.  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN) and INFLUENZA VACCINE (FLU).  On 15-Jan-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ053AAA, expiry date: 02-Oct-20 via intramuscular route in the right thigh and HIB (PRP/T) VACCINE lot UJ078AAA, expiry date: 27-Oct-20 via intramuscular route in the left thigh.  It was an actual medication error due to Extra dose administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
51 year old white female admitted with a chief complain of fever after receiving the flu vaccine 10/27/93. Patient had a fever (103.4F) and was found to be hypotensive in the ER. Patient's past medical history includes End-stage cirrhosis (hepatitis B-C), diabetes, asthma, and portal hypertension. Patient also complains of intermittent nausea vomiting and diarrhea for 3 weeks, increased dyspnea on exertion and orthopnea. Patient treat with Ceftriaxone empirically. Chest x-ray no definite infiltrate. Bleeding of left custophrachic angle consistent with left pleural effusion- no change from previous study. Blood culture negative,  urine analysis equal to many bacteria. Patient became afebrile 10/30/98 and discharged.
Pt was inadvertently given pre-drawn Moderna Covid Booster (0.25ml) instead of Pfizer Covid Vaccine #2 (0.3ml).
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient who on 05-NOV-2009 was vaccinated with the first dose of GARDASIL (lot # 663453/0249Y). Concomitant therapy included ADDERALL TABLETS and prenatal vitamins (unspecified). Subsequently the patient was found to be pregnant, with last menstrual period (LMP) 26-OCT-2009, and estimated delivery date (EDD) 20-AUG-2010. On 05-NOV-2009 the patient had Pap smear performed which showed abnormal result of low grade squamous intraepithelial lesion (LGSIL). On 29-DEC-2009, ultrasound was performed for dating scan which showed IVP seen consistent with 6 week and 4 day pregnancy. On 15-MAR-2010, routing pregnancy lab alpha-fetoprotein test (AFP) was performed with normal result. At the time of reporting, the  outcome was unknown. Additional information has been requested.
Mom was feeling fine before she had the Moderna vaccines.    A few weeks later, she became extremely ill.  She died on May 14, 2021.
Sore arm; Developed rash 8-9 days later; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, developed rash 8-9 days later.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Sore arm, Developed rash 8-9 days later.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, developed rash 8-9 days later was unknown.
4x4 swollen, reddened hot & hard around inject site lt deltoid area painful upon palpation & movement;
Suspected Vaccination Failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles before getting the shots).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle shots and got shingles three times since and once before getting the shots. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Case number PHEH2015US017658, is an initial spontaneous report received from a nurse on 09 Sep 2015. This report refers to a 51 year old male patient. Medical history was not reported. Vaccination history included administration of FLUVIRIN (batch number: not reported) two times and the patient tolerated those vaccinations. Concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 157103) pre-filled syringe (PFS) intramuscularly at a dose of 0.5 ml into left deltoid on 08 Sep 2015 at 10:05 hours. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 Sep 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow up received from the nurse on 27 Oct 2015: updated patient demographics, vaccination history, vaccination time, vaccination site and other clinically relevant information in the narrative.
Information has been received from a physician referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot #K009470, expiration date 03-JAN-2016, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 5 minutes after getting shot, patient had extremely rapid heart rate feeling like pounding out of her chest, Patient denies feeling dizzy or faint. Later that day experienced swollen lymph nodes.
Gave flu shot in left deltoid and child had local reaction to injection. Swelling was 2" from point of entry and redness 9" toward elbow from point of entry. 1 ml PO of Benadryl given and father was instructed to ice and give Tylenol if needed. Discussed with MD. Patient is to return to clinic if symptoms worsen.