chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rec'd DTaP #5 and IPV #4 in left arm on 04/05/2005. RTC today with redness, edema from shoulder to near elbow, warm and hard to touch. Mom gave Tylenol 4/5 and 4/6 referred to PMD.
Large, reddish-purple swelling at area of injection, measuring 14 cm. by 10 cm. on Dec. 21 2007.
Shoulder pain, arm pain (feels like nerve pain) along inner arm, numbness/tingling in the hand, weakened grip, all on left side (side of vaccination)
High fever, light headed/faint, no menstrual cycle for 2 months. Constant/everyday PMS cramping. Rapid heartbeat and shortness of breath and lumps in right armpit.
Intense shoulder pain in the back along the scapula, and it radiates towards the spine. 6/10 consistent and constant pain, interrupts daily activites. 8/10 at worst, dull aching pain.
itchy all over body rash, 2 days after vaccine, that cleared and then came back with also ear/lip swelling. patient given prednisone, claritin, benadryl.
Patient received vaccine, was sitting there several minutes and passed out. She was coming out of it, eyes rolled back, and we talked to her to keep her awake. Patient was able to remain awake and have a small drink of water, sugar lollipop, and a cold compress was put on her head. Patient told me that she was nauseated, dizzy, and had blurry vision. I offered to call 911 several times, however the father refused. The patient's mother was in route to pick the child up, however the father left with patient before then. The patient was in the store for 10 minutes after the incident before departing. I also assisted with escorting the patient to the car with her father. She was able to enter the car by herself as well. I told patient to go to the Emergency Room or speak with her PCP. I also told him to report back to us her condition once checked out.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose number, dose, route and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-mintues. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 9 month old patient who on 10-JUN-2014 was vaccinated with improperly stored dose of RECOMBIVAX HB lot#J012567, expiration date 30-JAN-2016 (dose and site of administration not reported). This is one of several reports received from the same reporter. Additional information is not expected.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. The reporter stated that on 10-DEC-2014 a patient who was indicated for ZOSTAVAX inadvertently received a dose of VARIVAX (Merck), 0.5 ml once, subcutaneous injection, (anatomical location was not reported), lot number J000193, expiration date 07-JAN-2015. Other suspect and concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.
swelling around his site of injection on his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling around his site of injection on his arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling around his site of injection on his arm). At the time of the report, VACCINATION SITE SWELLING (swelling around his site of injection on his arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This was an influenza shot for seniors. Pain started night of shot in upper right arm at point of shot, was sporadic at first (about every other night) but since has been every night. It always comes about 3 a.m. or 4 a.m. and goes away shortly after arising in the morning. During the day the arm is a bit sore but no pain. VERY STRANGE PHENOMENON. Ibuprofen makes no difference to this unusual pattern. I have had a flu shot at the same location for several years with no problems. This may be the first year for the 'high dose' shot.
developed patchy red rash in upper arm around injection site.  Area size of orange was swollen; area with it was bumpy, itchy red rash
Pt exp burning @ inject site following vax w/Hep B vax IM; No further details were provided;
Initial soreness went away after 24 hours. Day 6 following the first vaccine my shoulder having joint pain and bicep as well as my armpit has become sore and tender to the touch.
I had an allergic reaction to it; He went to get the second shot the pharmacist on call told him not to receive the second shot and he has not.; Face also started swelling; Lower lip was swollen unbelievably, He states if he had gone out in the rain, he would have drowned. It was so swollen.; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lower lip was swollen unbelievably, He states if he had gone out in the rain, he would have drowned. It was so swollen.), SWELLING FACE (Face also started swelling), HYPERSENSITIVITY (I had an allergic reaction to it) and PRODUCT DOSE OMISSION ISSUE (He went to get the second shot the pharmacist on call told him not to receive the second shot and he has not.) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LIP SWELLING (Lower lip was swollen unbelievably, He states if he had gone out in the rain, he would have drowned. It was so swollen.). In April 2021, the patient experienced SWELLING FACE (Face also started swelling). On an unknown date, the patient experienced HYPERSENSITIVITY (I had an allergic reaction to it) and PRODUCT DOSE OMISSION ISSUE (He went to get the second shot the pharmacist on call told him not to receive the second shot and he has not.). At the time of the report, LIP SWELLING (Lower lip was swollen unbelievably, He states if he had gone out in the rain, he would have drowned. It was so swollen.), SWELLING FACE (Face also started swelling) and HYPERSENSITIVITY (I had an allergic reaction to it) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He went to get the second shot the pharmacist on call told him not to receive the second shot and he has not.) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were provided.  No treatment medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow-up document received include reporter and patient details, suspect drug details additional events.
Swelling in right arm x 3 days. Fever 101 x 2 days, swelling in feet x 2 days, nausea, headache, numbness entire right side, dizziness, weakness and diarrhea x 3 days. Right arm soreness x 10 days.
Vaccine Administration Error. Vaccine given to underage client. Client reports a nausea and queasy stomach but symptoms resolved after 72 hours.
Information has been received from a registered nurse concerning a patient who on 04-DEC-1997 was vaccinated with a dose of VARIVAX (Merck) (lot #, expire date and route not reported). Around 05-AUG-2010 the patient "got chicken pox". The patient sought unspecified medical attention. At the time of the report the patient's outcome was unknown. Follow up information has been received from a registered nurse. It was reported that the 12 year old male patient was vaccinated with a dose of VARIVAX (Merck) (lot number not reported) on 07-DEC-1998. The patient experienced an outbreak of varicella in August 2010. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. No further information is expected.
I had a pulmonary embolism, Er treatment and have been on anticoagulation ever since
This is a spontaneous report from a contactable nurse. An 84-year-old female patient started to receive PREVENAR 13 (Lot # 31685, Exp. Date 30Sep2016), intramuscular at 0.5 ml single dose in the right deltoid on 04May2015. The patient medical history and concomitant medications were not reported. On 05May2015, the patient developed weakness, fever and dizziness. She was seen in the emergency room, at that time, and her temperature was 102.1 degrees Fahrenheit. On 05May2015, she was admitted to the hospital and discharged on 07May2015. Admitting diagnosis was sepsis. Follow up visit 14May2015, at the reporter's clinic, patient was completely recovered.
This case involves a patient (unknown demographic) who had down with the flu for three weeks (influenza) after receiving  INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient's medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious down with the flu for three weeks (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
This subject is a one year old male, who died while enrolled in a Comparative post-marketing safety study of DAPTACEL administered with other recommended vaccines according to the US standard of care. The subject received three doses of study vaccine; the last dose prior to the event was given on 2/20/03. Subject also given PRP T and Prevnar on 2/20/03, lot numbers not reported. The subject expired, 205 days post immunization. The subject was diagnosed with Gangliosidosis, a progressive terminal illnes in January 2003 and expired at home. No autopsy was performed. The events of Gangliodosis and Cardiopulmonary arrest were reported by the investigator as unrelated to the vaccine. Vaccine lot numbers if available, were requested from the investigator.  Follow up on 11/26/03: "From additional info rec'd on 11/18/03 the lot numbers of the suspect products were providec.  ActHib AvP UA775AB/W0522, DAPTACEL C0725AA & PREVNAR LEDERLE 490-901."
Attendee received first dose Pfizer vaccine at 12:00 pm in the left arm.  Lot# FA7485. Attendee was directed to observation area.   At 12:10 voiced complaints of dizziness, pale and clammy.  Attendee's skin was cool and clammy.  Attendee's respirations were not tachypneic or dyspneic. Attendee assisted to the cot to lie down.  Didn't eat or drink prior to vaccination.  Gave him some sugar water.  HR:  51   BP:  92/54   RR:      O2Sat%:  99      12:15 - Attendee stated he felt better, color started to come back.   HR:  53   BP:  100/62   RR:      O2Sat%:  99  12:25 EMS called, as he was not improving.   HR:  48   BP:  90/60   RR:      O2Sat%:  99
Neck stiffness approx 72 after vaccine administration, no signs or symptoms of Guillain Barre.
Pharmacy conducting an onsite vaccination clinic at a school. Student sits down at the nurses station to receive vaccines. The two vaccinators are handed a consent form with first name written on it. The two vaccinators ask the student what her name is and the student points to name on the consent form and says her name. Consent form had documentation of parental consent for meninigitis and tetanus vaccines. Nurse reviews information about meningitis and tetanus vaccines with the student and asks if she has any questions. Student says no so the two vaccinators administer the two shots. The student then gets up to walk away, and the school nurse informs the two vaccinators and the student that the consent form belonged to a different student with the first name. The student  who was just vaccinated was supposed to have received a flu and a COVID vaccine, not meningitis and tetanus. School nurse contacted the mother and explained what happened. Later, the student reported not experiencing any adverse reactions other than soreness at the sites of the injections.
On 1-19-08 mom noticed red sore place on patient's right thigh approximately 2.5cm.  Red, raised hard.  Was seen on 1-20-08 with diagnosis staph skin infection.  ABx only then seen in office 1-28-08 with limping right leg.  ? immunization adverse effect.
left eye swelling; there is a sensation to touch like a little bit of pain; left eye there is some puffiness; harsh soreness around her both temples and her face; Neck pain; Headache/harsh soreness around her both temples; Feverish; Nausea; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-Year-Old Female patient received BNT162B2 (lot number: EH9899, expiration date: Mar2021) on the 21Dec2020 on deltoid left at single dose to prevent COVID 19. Medical history included Hypertension and Rheumatoid arthritis. Concomitant medications included losartan for Hypertension and hydroxychloroquine sulfate (PLAQUENIL) for Rheumatoid arthritis. She was experiencing a few side effects that are on the list. However, the one that is not on there and she have never had them before. She think that it is something with her left eye there is some puffiness and there is a little bit of swelling and there is a sensation to touch like a little bit of pain when you touch it. It actually started yesterday (22Dec2020) and she took the vaccine two days ago (21Dec2020) and it is on the same side as her injection. So it is on her left side on her left eye and the injection was given on her left Deltoid. It seems to be getting a little better now though the sensation by touch is not as much as it was this morning or yesterday. So she think like it is like going away but it is just something that she think may be should be looked at as one of the possible side effect. She did get neck pain, headache, and bit of headache. She think she was a little bit feverish and nausea and joint pain and a lot of fatigue. She had a harsh soreness around her both temples and her face was like when smile or laugh it was sore. Patient took Ibuprofen to help with the soreness and the pain. It was 800mg. The outcome of the events was unknown.
- Brain MRI on 4/23 with multiple small infarcts in both cerebral hemispheres concerning for embolic source - Carotid dopplers without significant atherosclerosis  - No evidence of atrial or ventricular thrombus on TEE - Neurology evaluated, still not certain that patient's neurologic symptoms were from CVAs as these are relatively small and that they might be medication related on admission - Continue ASA and atorvastatin - Started Eliquis 5 mg BID on 4/25 for concern of embolic disease with possible occult afib given severe left atrial enlargement and MRI findings  - Loop recorder placed 4/27 per Cardiology for long term monitoring for occult arrhythmias  - PT/OT/SLP recommending facility based rehab
High pulse rate. Heart rate normally 62-65. 70 at rest today. While making lunch pulse rate 116-130. Slept only 4 hours, feel shaky, and can feel pulse in neck and throat.
This spontaneous report as received from a pharmacist refers to a 63 year old female patient. Medical history was not provided. On 02-JUL-2013 the patient was vaccinated with ZOSTAVAX valid lot # J001692, 0.65 ml, subcutaneous (route not provided). Concomitant therapy was not provided. On 02-JUL-2013, after the patient received the injection, the pharmacist was putting the band aid over the injection site, the patient complained of itching. There was a small red spot which itched and the patient was given BENADRYL. After 20 minutes it continued to get bigger, and appeared to be raised in the center. The pharmacist administered prednisone and 15 minutes later the swelling went down. The pharmacist followed up by calling the patient, after the patient went home and slept for a few hours, the patient reported that the injection site reaction was gone, so patient had recovered the same day on 02-JUL-2013.
-5 min after admin pt feels dizzy. Rested w/husband in waiting area. - 10 min after admin pt said "very dizzy and lightheaded" wanted EMT called. I called 911 pt. responsive and talking until ambulance arrived. EMT did not need further info from me. EMT took pt with them. Per patient, she was given "steroids and an IV" in the E. R.
Developed "paralysis, numbness to right side (arm and hand)" with symptoms improving to arm but not hand. Client reports elevated blood pressure. Symptoms noted since 1/20/2010 or near this date client reports. Reports began taking ARAVA 1/20/2010. Follow-up Information 2/18/2010: Adverse event onset date and time unknown. Client reports having contacted physician, unknown whether or not an actual appointment was made.
c/o severe diarrhea w/abd cramps p/taking each dose x 2 doses;
About 2 weeks after the shot I started experiencing extreme fatigue. During my annual exam my bloodwork showed abnormally high hemoglobin and hemocrit.  I was sent to my oncologist to review. (I had breast cancer 18 years ago and see an oncologist yearly). Bloodwork was taken again, hemoglobin and hemocrit are high normal but immature gram % was above normal.  I don?t have cancer and no other reason for the blood changes other than the vaccine could be identified. The fatigue is abating. Sharing as I am willing to help in research if deemed appropriate.
Worse than normal tinnitus in right ear. Normally have mild tinnitus in both ears, but the right ear became worse after the vaccine
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In January 2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did function as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-JUL-2016, the patient was treated at a medical clinic for a blistering vesicular outbreak, which was diagnosed as a herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I experienced significant pain at time of vaccination and during a prolonged injection time.  Over the next 24-48 hours, there was progressively worsening pain with shoulder movement which led me to contact PCP who recommended MRI.  It was also noted that the injection site was only 1 fingerbreadth below the acromial process.  MRI  was ordered and results are below.   Infectious disease, Dr recommends formal orthopedic eval which is being scheduled presently.  She is  also looking for guidance as to additional vaccine schedule, assuming due to errant and injurious vaccine placement, proper antibody response will not be mounted. Dr states she will get back to me once she has contacted collegaues, CDC, Moderna for formal recommendations.  I was advised to not take NSAIDs due to potential for delayed healing, and to avoid side sleeping.
Initial and follow-up information has been received from a physician and licensed practical nurse concerning a 17 year old female student who is allergic to CECLOR who on 17-APR-2007 was vaccinated IM into the left deltoid with a first dose of GARDASIL vaccine (lot # 657621/0387U).  There was no concomitant medication.  On 21-APR-2007 (also reported as "a day after immunization") the patient developed pain in the left upper arm and shoulder.  There was no swelling or redness.  She was treated with ibuprofen.  It lasted about 4 days.  Subsequently, the patient recovered from pain left shoulder and left upper arm.  Additional information is not expected.
This spontaneous report was received from a physician refers to a multiple patients of unknown age. On an unknown date, the patient was vaccinated with improperly stored (wistar ra 27-3) M-M-R II lot # L040961, 19-OCT-2017. On an unknown date, the patient was vaccinated with improperly stored PEDVAXHIB, M010440, 09-DEC-2018. On an unknown date, the patient was vaccinated with improperly stored oral ROTATEQ, M019708, 25-OCT-2017, L039141 16-AUG-2017, M002252 28-FEB-2017, M006112 16-NOV-2017. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 L043214, 30-AUG-2017. On an unknown date, the patient was vaccinated with improperly stored RECOMBIVAX HB M010212, 21-JAN-2019. Temperature 26 Fahrenheit 5 hours, 52 F 35mins and the vaccine was administered. There was no previous excursion. Additional information has been requested.
Information has been received from a physician concerning a 3-year-old female with a penicillin allergy who in 2004 was vaccinated with her first dose of Varivax. On 23-OCT-2006 the patient received her second dose of Varivax. Following vaccination, the patient experienced redness and swelling at the injection site. The patient was seen in the ER and treated with TYLENOL and ADVIL. At the time of this report, the patient had not recovered. No product quality complaint was involved. No further information is available.
Pt recvd Hep B vax on 0,1,6 mo schedule.According to reporter,"did not seroconvert;"however lab findings indicate "immunity to HBV".Pt told to get 4th & 5th dose.
Patient developed redness at injection site and down left side of abdomen laterally, kept getting hot after intervals, fever later in evening around 5:30 pm developed tightness in throat.  Left arm aching/swollen- went to ER was given ? BENADRYL pill and prescription for antibiotic pills for 7 days.
Per Client approximately an hour after administration of vaccine in R Deltoid she experienced limited range of motion in R arm.
Red papules on face and upper chest. Mother states she has noted similar reaction after he drinks milk (or) eats eggs. Mother treats with Benadryl and they resolve. Her pediatrician told her it was ok to vaccinate him for H1N1 given 25 mg Benadryl elixir po. Mother will observe as in past and call 911 if necessary and possibly give additional Benadryl as she has also done.
Patient experienced racing pulse, sweats and tunnel vision For about 10 - 15 minutes, Then it went away - no after affects
Patient experienced severe syncope episode.  Monitored by onsite EMS - 45 minutes until symptoms resolved.  Patient waited additional 45 minutes. Patient declined transport to ED.
WAS DIAGNOSED WITH BELL'S PALSY 19 DAYS AFTER 2ND DOSE OF MODERNA VACCINE
Shortness of breath, tachycardia in the 120 rate with exertion