chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At around 11:35am, I (pharmacy tech) gave patient a COVID 19 shot (Pfizer dose 1: Lot: EW0153, Exp: 07/21) in the left deltoid. Prior to vaccinating, we discussed a myriad of side effects as well as the risk of anaphylacticreaction. Patient's mother mentioned a penicillin allergy and peanut allergy but nothing raised any red flags. Approximately 3 minutes after injecting, we heard mother screaming. Patient had gone limp and seemed to be out of it and was pale in color. Motherasked to inject Epipen which was injected in left thigh. After injecting Epipen, color returned and we started to monitor blood pressure. First reading came back at 112/82. Checked multiple times, patient was co
pt recv vax  18MAY98 & reportedly became stiff, non-responsive & lt eye went to side of eye for about 1min;half hr prior to above APAP given for fussiness;
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Mild
Pt complained of local reaction, golf ball sized know at injection site, redness and soreness up to right shoulder.
get sick; Initial information was received on 24-Nov-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Regulatory Authority (under reference number - US-SA-SAC20211130000274).  This case involves patient of unknown age and gender who experienced get sick (illness), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, concomitant medication(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 an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious get sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Syringe Use; Underdose; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2463118-1. The original narrative from the sender is the following:  Patient received half of the dose as about half of the dose squirted out the syringe around where the needle is screwed onto the syringe. Consulted with MD and patient did not receive additional dose.  Due to the nature of events the causal relationship between Vaxelis and "Syringe use and Underdose" was not applicable.  No further information is expected.
PT'S wife reported to the pharmacy that he was very tired after the vaccine on thursday and friday, he did not wake up on saturday, he passed away.
Patient rolled out of bed morning after vaccine and fell off the bed with mattress on top and was there for a whole day prior to being found, Pt was hospitalized  04/28/2021- 04/30/2021
42 days after 2nd vaccine, I began having left leg pain. It started in the shin, then calf, thigh & remained mostly in the knee. It was excruciating & I could not sleep at night nor put weight on it. I was unable to bend it even 5 degrees & it locked at times. I never had any issues whatsoever prior to 6/29. I am a very active, healthy person. I had appts with my chiropractor (who I had not seen since 2013) on 7/16, 7/19, 7/21, 7/23, 7/26, 7/28, 8/2 & 8/4. I had a left knee x-ray at the hospital on 7/19. I had appts with my family physician on 7/28 & 7/30 to rule out Lyme, etc. I went to another medical facility on 8/6 and had weight-bearing x-rays that showed arthritis, bone on bone. I have an appt scheduled with an ortho surgeon on 8/27. Also, 1 week after 1st vaccine, my hair fell out in clumps for 3 full months. Once again, I NEVER EVER had issues with my knee or anything arthritic.
Devel 104(R), shaking, leg swollen to toes-"normal" color, unable to wear shoe; sl redness @ inject site; Slept a lot; Shaking; Screaming when wt bearing & cont x 24 hrs; very irritable; Not seen on date of rxn, but seen on 7MAY advised DT;
a patient received FLUZONE QUADRIVALENT PFS, but in actuality desired to have Fluzone High-Dose PFS with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 73 years old male patient where reporter reported patient received influenza quadrival a-b vaccine [fluzone qiv] but in actuality desired to have influenza usp trival a-b high dose subvirion vaccine [fluzone high dose] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included tozinameran (Pfizer biontech covid-19 vaccine) for Prophylactic vaccination.  On 23-Oct-2023, the patient received 0.5 ml dose of suspect influenza quadrival a-b vaccine Suspension for injection (lot- U8192AA and expiration date- 20-Jun-2023) via intramuscular route in the left deltoid (strength: not provided) for Immunisation (wrong product administered) (latency- same day).  On an unknown date, the patient received a dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation.  Action taken- 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.
Large, red rash extending 3 inches in diameter from injection site and persisting for 7 days. Maximum fever of 102.5 degrees F persisting for 2 days following vaccination. Tylenol taken for fever.
Pt complaining of ringing in left and right ears. Worse in left. Both sound plugged, runny nose. Had same symptoms 1 month prior when received 1st Twinrix. Stopped 1 week before 2nd Twinrix. Pt did not report this to RN. Pt had MD appt on Fri 10/31/2014, cancelled appt even though symptoms remain. TC 11/05/2014 as followup. Ringing in ears continue, left worse than right. Recommended going to MD for followup.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications were not reported.  It was reported that 51 doses from Lot AS7140C and 60 doses from Lot AS7148B were administered. No treatment information was provided.   This case was linked to MOD-2022-690817 (Patient Link).
Approx. 5-6 hours, post vax, child complained of fever, cough and nausea which continued until the next morning. Fever was 103F and then broke with Advil and resolved within 24 hours. Other ill children in home.
Post third vax, pt reported that she experienced shooting pains form elbows down to hands. This was continued on occasion. The pain reportedly continues to be sharp shooting pain and a stiff arthritic pain.
received flu shot on 11/1.  Saturday 11/3 began developing a hive-like rash on abdomen which increased in intensity through Thursday 11/8 covering entire torso and arms. Was taking benadryl OTC dose.   Notified PMD on 11/8 and was put on Bendadry 50mg po q6hrs and topical cortisone cream.  On 11/9 felt that symptoms were under control at least not progressing.
felt like crap; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt like crap". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had big rash/welch in the forearm where he got the injection 2 days after getting vaccinated that lasted for at least 2 weeks.
Patient had complaints of nausea and fatigue. Patients arm was red and swollen at site of injection which caused patient to come in and be examined. This was patients right arm.
This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "allergy induced asthma" (unspecified if ongoing); "known allergies: eggs" (unspecified if ongoing); "known allergies: gluten" (unspecified if ongoing); "known allergies: soy" (unspecified if ongoing); "known allergies: coconut" (unspecified if ongoing); "known allergies: environmental allergens" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: Mar2016. Past drug history included: Tetanus, reaction(s): "known allergies: tetanus"; Morphine, reaction(s): "known allergies: morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "not recovered" and all described as "tested positive for Covid 28Jul2022 with symptoms starting 27Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Positive; (06Aug2022) Negative; (08Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PF-07321332, ritonavir (PAXLOVID) with treatment start date: 29Jul2022, treatment stop date: 03Aug2022. No  follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Uveitis Vision loss Blurred vision Decreased vision Eye pain - excruciating Facial pain Eye pressure Facial pressure Light sensitive - severe Photophobia - extreme Light intolerance Hemorrhage in eye Swelling around eye Periorbital swelling Inflammation in eye Red eye Ocular hyperemia Lid closure Visual impairment Eye irritation Acute visual impairment Visual field loss Visual acuity deficit
Had a hoarse voice, only could speak at a high pitch. I went the paramedics and waited it out while they checked my vitals. Voice came back after 15 minutes. At first I could only talk with a deep voice and then it all went back to normal.  Benadryl was taken once I got home.
Day1: General fatigue and vertigo Day2: Overwhelming fatigue, muscle cramping, fascillations Day3-4: Generally Ok, but not "well" Day5: Extreme fatigue, muscle weakness, bowel issues Day 6: Bells Palsy, Emergency room visit, Neurology consult and full stroke work up (neg) Day 7: FMRI at specialist HCF to look for any occlusions or bleeds intracranial
Made appt with Dr., 2 weeks in advance, for 11/01/18 to. Imply with CDC guidelines for special populations of >50 and chronically immunosuppressed due to exogenous steroid injections. At the last minute Dr. refused care. Told me to go to Pharmacy. Pharmacy unable to administer vaccine due to medical complexity. Again requested treatment by my PCP, Dr.
24 hours after vaccine administration, child felt sick, went to bed early. Awakened in AM with arm pain, swelling, redness increasing so much that couldn't raised her arm for lacrosse game. Re seen day 2 after vaccine with (R) upper arm swelling, heat and erythema approx 6 inches around vaccine injection site, pain with adduction - raising arm -  with additional pink streaking to prox upper forearm. Started on antibiotics for early cellulitis.
Arm felt like beaten, intense pain, headache, hurt almost all the way to shoulder but mainly lower down, swelled up, turned red progressively. Patient received the Fluzone HD in the same arm.
patient called to state that within 10 hours of vaccination, "all my muscles started attacking me"; reports muscle aches, headache, fever, "even my teeth hurt"; reports that it wasn't as bad as his first shot where he felt he had the flu for three days, but he was unable to sleep last night at all because he couldn't get comfortable; reports NO injection site pain
A pharmacist reported that a female received an injection of Pnu-Imune 23 on 10/6/00 and subsequently, developed an injection site reaction characterized by pain, erythema and hardness. As of 10/13/00, the pain persisted. The reporter indicated that 2 females experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Additional information received from the physician's office on 11/20/00, indicated that the pt is a 68 year old female, immunized on 10/5/00. On 10/6/00, she developed a fever, enlarged axillary glands, itching, skin peeling and shoulder pain. She recovered.
Severe abdominal, spinal and leg pain. Unable to sit. Severe weight loss (down to 102# from 140#). General Weakness. Severe pain especially when eating.
Pt stated she felt faint and "hot" and stated she felt she had passed out for a few seconds. Upon arrival, Pt was conscious, A&Ox4, appearing diaphoretic, with a rapid pulse. Pt symptoms relieved with supine positioning and rest, and pt has recovered. Pt stated prior history of fainting with vaccines and blood draws, and stated her symptoms felt the same. Pt denied falling, hitting head, or other injury or illness.
Had headache, Temperature of 100.3 degrees F took Tylenol 650mg Temp down to 99.7 degrees F. Also experienced Nausea, No vomiting. 12/19 in the evening Temperature was 99.6F. Called Primary MD and advised to rest.
Woke up at 1:30am the following morning shaking, freezing, and all of my joints throbbing. I layed there for an hour not knowing what was going on, crying in pain because I literally never get fevers. It finally occurred to me at 2:30am that I was sick and asked my husband to get me a thermometer. He did and it was 100.6 degrees. I called out of work. My fever got higher and higher and I felt worse and worse. My fever got over 104 degrees when my fever reducers were wearing off. I had a fever for 2 days and my knees felt like they were broken, my husband had to physically carry me to the toilet because of my knee pain and weakness from the fever. I had no fever on Thursday, but I had the worst neck pain and migraine of my life for the next 3 days going from a sitting to standing position made me feel like my head was going to split into 2 and I verbally screamed a couple times from the head pain because it was such a searing pain that I have never experienced. My neck was so swollen and sore that I felt like I couldn't hold my head up.  I never feel like I fully recovered from getting sick. I have not experienced fatigue like this since I got mono when I was 19, I take 3-4 hour naps after work everyday because I barely have enough energy to stay up for my shifts let alone get through a whole day.  I am running shorter distances and slower miles and I can not run without napping first and my knees hurt when I walk/run/ and when on my feet at work. I have never experienced knee pain before I got sick from the vaccine and now it won't go away.
Daughter vomited 7 times within 6 hours. She had a low fever and was given acetaminophen. She complained of neck pain. She was not able to keep water down until after 7pm. She was misereable, tired and weak.
Pt said he only had a sore arm for a few days after the first dose, which subsided. However, he developed chills, nausea, and headache two weeks later. This lasted for one night.
This spontaneous report as received from a nurse refers to a 5 months 27 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
vertigo, onset at 14 days after first vaccine. has not gone away yet. tried home epley maneuver, but did not resolve issues
Approx 20 mins after vaccination, just after leaving observation, pt began to complain of itching at scalp. She mentioned this to one of the vaccination nursing staff. This author arrived as discussion was taking place.  Itching increasing to torso, began coughing. Denies dyspnea.  Placed in wheelchair and taken to ACC without delay. ACC notifed of arrival and was taken directly to Triage.  Arrival vitals: 131/85     81        98.5         R- 20 SPO2= 99 RA  At ACC - treated with: - Benadryl 25mg IV - Famotidine 20mg IV - Solumedrol 125mg IV - Albuterol Inhaler  Improved after meds.
This spontaneous report was received from a registered nurse (who was also an immunization official) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (dose, lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced an unspecified temperature excursion. It was not reported whether a data logger was involved or if there were previous temperature excursions. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014586:
Whimpering in crib at 01:00 on 6/21/00. Mom attended to him and she found him semi-conscious, jerking with his arms and legs. The episode lasted 5 minutes. He became flaccid and went back to sleep. Has had no problem since seen by MD and had a normal exam.
Soreness in the muscles at injection site. Unable to raise arm to the side without tightness & pain
muscle aches, chills, fever, headache; all still persisting today (10/25)
Skipped period. Was supposed to start 2 days after vaccine and as of todays date she still has not started.
Pruritis, dizziness, nausea, worsening chronic pain, worsening anxiety that developed immediately after receiving 2nd dose of COVID19 pfizer vaccination. Was seen in ER with unremarkable blood work. Has since had worsening flare of her fibromyalgia and chronic pain which has resulted in significant disability. Diffuse pruritis has improved.
Patient is under the age of 18 and was provided Moderna vaccine.  Per CDC guidance and in consultation with facility medical direction, the patient was provided a second dose of Moderna vaccine off-label. The patient conferenced with our leadership at the site before the second vaccination to discuss the recommendation before proceeding. Patient is doing well post vaccination.
This spontaneous report as received from a other health professional refers to a 2 year old patient. On 29-JUL-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
p/recv vax pt devel hives on face, ``welts''; then had a solid red rash; MD felt it was allergic react, treated w/benadryl
NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was 298 pounds, and height was 68 inches. The patient's past medical history included: numerous back/neck surgeries from accidents, and concurrent conditions included: latex allergy, and drug allergy to ASA (Aspirin), diazepam, and gabapentin. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, 1 total, administered on 21-OCT-2021 for prophylactic vaccination on left arm. The patient reported that, she was fine and had no issues post initial vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855114, and expiry: unknown) dose was not reported, 1 total, administered on 30-DEC-2021 for prophylactic vaccination on left arm (dose number in series 2). No concomitant medications were reported.  On 03-JAN-2022  in the morning the patient had no complaints but experienced nausea with vomiting twice since 17:00. The patient described it as liquid only (no food) (dose number in series 2) and denied any other complaint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea and vomiting was not reported. This report was non-serious.