chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adverse experience; revaccinated; Temperature excursion involving, PEDVAX HIB, RECOMBIVAX HB, VAQTA, GARDASIL 9, and ROTATEQ; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 4-month-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On 20-DEC-2021, the patient was vaccinated with an improperly stored doses haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U003873, expiration date: 15-APR-2023, which have been verified to be valid lot numbers for haemophilus b conjugate vaccine (meningococcal protein conjugate) administered in left thigh and with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (lot # 1821803, expiration date: 26-JUL-2022 (also reported as 25-JUL-2022), which have been verified to be valid lot numbers for rotavirus vaccine, live, oral, pentavalent (strengths, doses # and exact doses were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion of below 36°F (30.4°F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination (inappropriate schedule of vaccine administered). The outcome of the event of ill-defined disorder was reported as resolved on an unknown date.   The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown.  The reporter considered the event of ill-defined disorder to be important medical event (medically significant).  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2201USA000582:
Booster; I'm having issues with my balance right now; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "I'm having issues with my balance right now". Therapeutic measures were taken as a result of balance disorder.  Additional information: Patient called in to place a refill for the medication Premarin. During the call patient stated that the patient was having issues with balance right now. Patient later stated on the call. The patient got the Pfizer Vaccine, got three of them knew. Patient was going to physical therapy they said they were looking into that being related to the vaccine, cause patient having some really bad ones.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Severe hypertension. Following the second dose I was having severe headaches. I checked my blood pressure on 2/17/21 and it was 212/116. I was having palpitations and parathesia in my right foot. I immediately contacted my provider and he confirmed my hypertension and I was prescribed two separate anti hypertensive medications. I began these medications however they have been ineffective at treating the high blood pressure. I began to have chest pains, headaches continued, and due to the hypertensive crisis I presented to the ER on 3/3/21 which required IVP BP medications, EKG,  cardiac labs, etc. Prior to the COVID vaccination I have always had a normal blood pressure at all of my physical appointments.
At time of flu vaccine visit, child vomited right after admin in clinic room. Mom stated child had more vomiting. Temp up to 103F, complained of fatigue-went to Emergency Room. Two days later younger sister developed fever, no appetite and the next week the other sister developed fever. Took comment from mother she was not getting second doses of flu vaccine because of these illnesses-that flu vaccine "caused" them to be terribly ill with nausea, vomiting, fatigue, fever.
Mild sore arm; muscle ache into shoulder blade and neck for 36 hours; muscle ache into shoulder blade and neck for 36 hours; muscle ache into shoulder blade and neck for 36 hours; mild fatigue for 72 hours at minimum; low grade headache for 48 hours; This is a spontaneous report from a non-contactable consumer (patient). A 33-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E132495121, expiry date not reported), via an unspecified route of administration on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included food allergy (garlic, oatmeal, turkey, chickpeas/garbanzo beans). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included vitamin d nos (VITAMIN D). On 27Jan2021 17:00, the patient experienced mild sore arm and muscle ache into shoulder blade and neck for 36 hours, mild fatigue for 72 hours at minimum, low grade headache for 48 hours. The patient underwent lab tests and procedures which included SARS-COV-2 test with pending result since 29Jan2021. No treatment was received for the adverse events. Clinical outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
A report was received from a health care professional on 10/15/02, concerning a vaccinee who experienced a red, hot swollen arm after receiving Fluvirin on 10/5/02. On 10/15/02, the vaccine received 0.5ml Fluvirin to the left arm and within minutes developed swelling of the entire arm which was also red and hot. Ice packs were applied with no relief. The vaccinee had not recovered at the time of the report. The reporter has assessed the relationship of the vaccine to the event as probable.
Swollen and sore at injection site, chills, body aches, headache and tired
Patient received the flu vaccine and came back few hours later with redness and rash on the upper arm around the site of injection.  He did not report any shortness of breath but was concerned. We advised patient to take a benadryl and to also let PCP know about the reaction. Also asked him to go to ER if symptoms get worse
This past spring I started getting frequent headaches and migrianes. Currently I get headaches most days, I started tracking in May after realizing in April they were getting worse. May: 21 headaches days of which 5 were migraine days June: 24 headache days of which 9 were  migraine days July: 27 headache days of which 5 were migraine days (this was after I actively started trying to de-stress and limit my triggers)
No adverse reaction. Patient was given Moderna Monovalent Booster dose instead of the Moderna Bivalent Booster. Patient notified.
Area of erythema, and induration, approx 3 in diameter, non tender but warm to touch over  deltoid area.
Patient has pain in the right arm, started two days after vaccine was given. Patient has right arm tenderness of the upper 1/3 of (R) lateral right arm. Has pain on pressure and arm elevation. ALEVE twice daily for 1 week, to call office it gets worse.
Patient presented with blood in stool and several weeks of green, watery stools. Advised to eliminate all dairy from mom's diet for 2 weeks, ordered FOBT and stool sample testing on 11/05/2018. Administered Hemocult lab during the visit and the result was positive. Mom dropped off a stool sample on 11/06/2018 and the sample was sent to Lab for GI Pathogen Panel.
A  female patient experienced sharp pain under her breast and back, headache and fever after treatment with RabAvert. RabAvert was given for pre exposure prophylaxis on 07/01/04 and 07/08/04 (dosage and route unspecified). On 07/14/04, she developed a sudden sharp pain under her breast and radiating to the back. She became clammy, feverish and experienced a headache. To ease the pain, she laid on the floor. Her temperature that evening was 99.2 F (37.3C) and the pain had subsided. The following morning, the fever and headache continued.
A couple hours after rec. shot arm started to ache. It worsened over a couple days - could not use arm - could not extend arm in any direction w/o sudden sharp long lasting pain. Saw Dr. The pain gradually improved and now (2 months later) arm is much better - but not pain free.
pt recv vax & several days later pt devel a case of generalized vesicles;reporter did not think pt was vaccinated;
evening feeding, fussy w/temp (felt warm to touch given APAP) started jerking & eyes rolled back in head; taken to ER: t103 @ home; temp 100.3 @ hosp;
Developed headache on 1/12/08.  Then developed "flu-like" symptoms, fever, runny nose and sore throat.
stiff back neck, painful, waking up at night from 2/23/2021 to 2/26/2021. applied 'Tiger Balm' and took aspirin. Getting better by 2/26/2021
RANDOM NOSE BLEED AND HUGE BLOOD CLOT CAME OUT, HEADACHES, FATIGUE AND TIREDNESS.
3/17/21: Patient presented and was admitted through ED for N/V. Patient is status post colonoscopy.  Colonoscopy was uncomplicated with polypectomy.  She reports persistent vomiting after an hour since then.   Per the EUA, hospitalizations to be reported irrespective of attribution to vaccine.
Developed varicella despite receiving VARIVAX on 11/20/2003 and MMRV on 10/2/07.
a 33/F s/p NSVD viable male neonate at 28w4d after spontaneous onset of preterm labor. Pregnancy history of TAB in 2015. GYN history of ?LEEP for HPV+ many years ago, 09/24/19 pap NIL, HPV-. Current pregnancy course complicated by fetal macrosomia at 97th %ile on 20w3d US, first trimester A1c was WNL and BMI was 24. Otherwise uncomplicated pregnancy with routine prenatal care, negative Progenity NIPT and AFP screening. Patient did receive Moderna COVID19 immunization at 28w0d on 05/18/21 per personal wishes after informed consent of risks and benefits. On 05/20/21 and 05/21/21 she played some gentle softball, which she normally does once weekly. During these games she does not run. On the second day she went home early to rest because she wasn't feeling well, starting having pelvic cramping and back pain around 2100 that evening. Symptoms progressed overnight, by 0400 on 05/22/21 she was still having cramping with some bleeding (unclear if vaginal or hematuria) and nausea/vomiting. She called the on-call physician and was advised to present to L&D immediately for evaluation. By the time she arrived on L&D, her contractions were very strong. As she was giving her admission urine sample she felt a fetal presenting part and called for help. Liveborn male neonate 1540 grams was delivered at 0741 on 05/22/21 with APGARs of 8 at one minute and 9 at five minutes. Had a small hemostatic periclitoral laceration that did not require repair and EBL 50mL. Placenta was delivered intact spontaneously with 3VC.  Urine toxicology screening negative. Cord blood pH 7.33 arterial, 7.39 venous. Urine culture negative. Initial leukocytosis to 20.82 on 05/22/21 has completely resolved to 10.59.  Patient's postpartum course was uncomplicated, and she was discharged home within a couple days. She did receive her second Moderna dose on 06/15/21.  Patient's son was cared for in the NICU with brief intubation on first day of life (received surfactant), then progressed to CPAP and subsequently nasal cannula oxygen. Diagnosed with respiratory distress syndrome, apnea-bradycardia of prematurity, and a grade 1 R germinal matrix hemorrhage. Received a short course of phototherapy for hyperbilirubinemia. Passed car seat challenge and hearing screen. Circumcision performed 07/16/21. Received all routine immunizations through 2 months of age while in the NICU. He was discharged home on nasal cannula oxygen on 07/21/21 at postmenstrual age of 37w1d at 3268 grams. He has been breastfeeding, growing, and developing normally and was able to discontinue oxygen supplementation on 08/31/21.
4 days after patient received her second COVID 19 vaccine, she developed midsternal chest tightness radiating to bilateral jaw and left arm while driving that persisted therefore, she came to  hospital for further treatment and evaluation. She was found to have elevated Troponin T 5th Gen and a cardiac MRI was done showing acute myopericarditis. She also subsequently developed EKG changes as well.
Patient presented with hypotenstion, antibiotics given, pt was also treated for aspiration pneumonia. pt discharged back to group home.
Very intense and terrifying nightmares; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Jul2021 at 17:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC)  for unknown indication and ethinylestradiol, norgestimate (SPRINTEC) for birth control on an unknown date. On 20Jul2021 at 22:30, first night after receiving the first shot, the patient experienced very intense and terrifying nightmares. Therapeutic measures were not taken as a result of the event.  Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event very intense and terrifying nightmares was unknown at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
an expired FLUZONE QIV PFS administered to a pregnant patient, with no adverse event; an expired FLUZONE QIV PFS administered to a pregnant patient, with no adverse event; Initial information received on 22-Sep-2021 regarding an unsolicited valid non-serious case from nurse, consumer/non-healthcare professional and physician via Agency (under reference 00780606).  This case involves a 31 years old female pregnant (30 week) patient who received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) [expired product administered and exposure during pregnancy].  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported event occurred during 30 weeks of gestation period.  The date of last menstrual period was not reported.  The estimated due date was 22-Nov-2021.  The information on patient's previous pregnancy/ies were not reported.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 15-Sep-2021, the patient received a 0.5mL dose of suspect FLUZONE QIV (Total, lot UT7002DA and expiration date: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day latency).  It was also a case of vaccine exposure during pregnancy (same day latency).  It was reported "Would like to know if the dose is considered valid?"  At time of reporting, the outcome was unknown for the reported events.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  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.
Not received second dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Not received second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-JUL-2023 The reporter was the spouse of the patient who stated that patient received first dose of Shingrix 5 years ago and never got the second dose to complete the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 24May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years 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: "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: NORVASC, start date: 01Feb2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; positive, notes: 4 days after testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Positive test result for COVID 4 days after testing positive. Patient had a home rapid test. Patient had a runny nose, sneezing, fatigue. Treatment included Amlodipine tab 2.5 mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had issue with inject side pain, muscle pain, joint pain, redness, going on 3 days at time of call (12/27/2020)
Redness, swelling, warmth, itching around injection site 10cm x 11cm.
Rheumatoid arthritis flare up; Trigger finger on left hand; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), TRIGGER FINGER (Trigger finger on left hand) and FATIGUE (Fatigue). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and TRIGGER FINGER (Trigger finger on left hand) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was reported. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis (reported as rheumatoid arthritis flare up), which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Upadacitinib for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning an adult female patient, with relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) AESI of Rheumatoid arthritis (reported as rheumatoid arthritis flare up), which occurred related to the first dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Upadacitinib for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
shingles about 2 weeks post vaccine. And still have been on a heavy and painful period since the shot.
Complained of pain, arm redness, swelling and warmth to right upper arm at injection site the morning after prevnar vaccine injection. Subjective fever two nights.
Information has been received concerning her daughter who on 07/03/00 was vaccinated intramuscularly with one dose of varicella vaccine. This does not comply with the recommended route of administration. In July 2000 the pt developed a headache, a low grade fever of 100.5 and vomiting. The pt sought unspecified medical attention.
COVID-19 POSITIVE; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, peanuts allergy, and non-alcohol user, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, the patient experienced covid-19 positive. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of covid-19 positive was not reported. This report was non-serious.
A few minutes after adminstration of Hepatitis B vaccine, employee became flushed, c/o tingling and a feeling of being "jittery". B/P 160/100. 25 mg Benadryl po given without much improvement. 911 called. D/C later from ER to home.
This started exactly 14 days after i received the Janssen vaccine. I received it from pharmacy. I have a rash that started on my left shoulder within a few hours it spread to my entire back and stomach.  It is now on the back of my neck and has lightened a bit on my stomach. I have been taking benedryl and using cortisone cream. it does not itch at all.
The child was at school. During naptime the teacher noticed redness on the child's right thigh.