chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching at her head, face and shoulders and the back; This is a spontaneous report from a contactable consumer (patient).  An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot#: EL9261), via an unspecified route of administration on the right arm on 26Jan2021 10:30 at SINGLE DOSE as COVID-19 immunization at the hospital.  Medical history heart attack, ongoing bone disorder (reported as bone), ongoing blood pressure abnormal (reported as blood pressure), ongoing  pain in leg, ongoing blood cholesterol abnormal (reported as cholesterol), ongoing allergy, and ongoing blood clots in leg. The patient was also allergic to sulfa. Ongoing concomitant medications included hydrochlorothiazide, triamterene (MAXZIDE) since 2011 (taking for 10 years) and for blood pressure, cetirizine hydrochloride (ZYRTEC) from unknown date (taking for long time) for allergy, losartan (LOSARTAN) since 2016 (taking for 5 years) for cholesterol, potassium (POTASSIUM) from unknown date (taking for long time) for pain in leg, metoprolol tartrate (LOPRESSOR) since 2011 (taking for 3 years) for blood pressure, omeprazole (PROTONIX) since 2011 (taking for 3 years) for blood clots in leg, fish oil (FISH OIL) from unknown date and indication, acetylsalicylic acid (ASPIRIN) since 2001 (taking for 20 years) for heart attack, colecalciferol (D3) since 2016 (taking for 5 year) for calcium supplementation reported as (calcium and body build up), and calcium (CALCIUM) from unknown date for bones. The patient first dose of the Pfizer COVID 19 vaccine on 26Jan2021 at 10:30AM in the right arm. She noticed about 9PM last night, she started itching at her head, face, shoulders and back. The itching only lasted for a little over an hour (26Jan2021 10:00 PM). She took some diphenhydramine (BENADRYL) and it helped, gave her some relief. She was fully recovered today 27Jan2021. She was scheduled for the next dose 16Feb2021.
GOT CHILL; UNABLE TO SLEEP; SORE HEAD; RIGHT EAR ACHE; SHAKING; HOT FLASHES; COLD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: paracetamol ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for head sore, right ear ache, and shaking. No concomitant medications were reported. On 2021, the subject experienced got chill. On 2021, the subject experienced unable to sleep. On 2021, the subject experienced sore head. On 2021, the subject experienced right ear ache. On 2021, the subject experienced shaking. On 2021, the subject experienced hot flashes. On 2021, the subject experienced cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from got chill, and cold on 2021, had not recovered from sore head, and hot flashes, and the outcome of unable to sleep, right ear ache and shaking was not reported. This report was non-serious.
After giving the vaccine patient began to fall back, so I thought she was just fainting so I leaned her o back to lay her down and when I did she began shaking all over uncontrollably for 20 seconds, eyes wide open. When patient came back to herself she was confused on what had happened.
Pt positive with COVID on 11/12/2021.  Fully vaccinated. ED visit on 11/15/2021. 79-year-old female who was recently diagnosed with COVID 19 presents complaining of progressively worsening symptoms including fatigue, decreased appetite, nausea, myalgias, cough over the past 3 days. Positve for fever 102.1.. Patient states she has a history of asthma and is felt chest tightness with some wheezing intermittently as well. She reports her home inhalers have been helping with the symptoms. She states she checks her pulse ox at home and has not been below 93% on room air. She denies any abdominal pain, black/bloody stools, chest pain, headache, numbness, weakness, trouble walking. She denies any recent travel, leg pain, history of malignancy, history of PE/DVT.She states she has an appointment scheduled at the monoclonal antibody clinic scheduled in the coming days. She was instructed to keep this appointment and to return to the emergency department if she begins having shortness of breath, low oxygen saturation, high fevers or for any other new or worsening symptoms. Pt stable and discharged.
Bruising noted from shoulder to 3 inches above elbow on right arm following injection of Hep A #2. Denies pain or swelling. No problems following 1st injection.
Wheezing,  Decrease in O2 saturation, Increase in RR, SOB, Temp of 99.3.Hospitalized.
Arm soreness and slight fatigue; Arm soreness and slight fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 14:00 (Lot number: EL3247) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, lot number=EL3247, administration time=10:00 AM, vaccine location=Left arm, dose number=1), administration date: 22Feb2021, when the patient was 58 years old, for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset 15Mar2021 16:00, outcome "recovered" (2021) and all described as "Arm soreness and slight fatigue". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional Information: It was stated that the patient experienced adverse events several hours after receiving the second dose of the covid-19 vaccine. The patient did not receive any other vaccine in the four weeks. The patient did not receive other medications in two weeks. The patient never had Covid prior vaccination and was not tested for Covid post vaccination.   No follow-up attempts are possible. No further information is expected.
pentacel was administered instead of kinrix with no reported adverse event; only the DTaP-IPV component of Pentacel was given without the Hib component no reported adverse event; Initial information received on 24-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] instead of kinrix with no reported adverse event and the dtap-ipv component of pentacel was given without the hib component, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Jan-2023, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (Suspension for injection) (lot number; strength; expiry date not reported) via unknown route in unknown administration site for immunization.  On 24-Jan-2023 the patient was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] instead of kinrix with no reported adverse event (wrong product administered) and the dtap-ipv component of pentacle was given without the hib component, with no reported adverse event (single component of a two-component product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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.
Left arm pain for 3 weeks after influenza vaccination.  Describes pain on 7/10 scale, sharp and "shooting up the arm".
This case was reported by a nurse via call center representative and described the occurrence of fever in a 35-year-old male patient who received ENGERIX B Adult (batch number Z25GH, expiry date 5th March 2019). On 20th February 2017 15:00, the patient received ENGERIX B Adult. On 21st February 2017, 1 days after receiving ENGERIX B Adult, the patient experienced fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to ENGERIX B Adult. Additional details were provided as follows: The patient received ENGERIX B Adult in left deltoid. On next day at night, the patient developed a fever. On 21st February 2017, the patient treated with TYLENOL. On 22nd February 2017, the reporter reported that the patient's body temperature was 101.3 degree C and it was remained on-gong while taking TYLENOL. The reported lot number (225GH) for ENGERIX B Adult did not exist and was updated to (Z25GH) as per the sales database.
Extensive Measles-like rash 20 days after MMR and Tdap vaccine with prodromal symptoms of runny nose, fever, sore throat. Reported from patient's health care provider in doctor's office.
shortness of breathe; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSPNOEA (shortness of breathe) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breathe). At the time of the report, DYSPNOEA (shortness of breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs are not given. Treatment information not provided.
Two days post vax pt noted extreme redness and warmth to site of injection. Four days post vax pt developed a 10 cm circular area of redness to right deltoid. Pt was treated with warm compresses and Advil for pain.
This spontaneous report has been received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ROTATEQ (lot#, dose unknown) orally The ROTATEQ was exposed to 33F for 20 days. The outcome and causality were not reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a nurse practitioner and a consumer with no drug allergies and no pertinent medical history for GARDASIL, a Pregnancy Registry product. The baby's 24 year old mother did not have any previous pregnancies, pre-term deliveries, spontaneous abortions, elective terminations or fetal deaths. On 06-NOV-2008 the baby's mother was vaccinated with the first dose of GARDASIL (lot number unknown). On 23-JAN-2009 the baby's mother was vaccinated with the second dose of GARDASIL (lot number 661703/0651X). On 12-JUN-2009 the baby's mother was vaccinated with the third dose of GARDASIL (lot number 661703/0651X). On 16-FEB-2010, the baby's mother delivered the normal female baby with no congenital anomalies weighing 8 pounds, 7 ounces, length 20 inches. It was reported that the baby was stuck, so the patient had to have a C-section. The baby's mother had no concurrent medical conditions. On an unspecified date, the baby experienced heart murmur. At the time of the report, the patient's outcome was unknown. Follow-up information has been received via a medical record concerning the female baby with no known drug allergies who on 20-APR-2010 was vaccinated with the first dose of RECOMBIVAX HB (lot# 665622/1023Y) in her right thigh. Other concomitant vaccines administered on the same day included the first dose of DAPTACEL (manufacturer: Sanofi Pasteur) (lot# C3191AA) in the left thigh, the first dose of ACTHIB (manufacturer: Sanofi Pasteur) (lot# UF596AB) in the right thigh, the first dose of IPOL (manufacturer: Sanofi Pasteur) (lot#D0123) in the left thigh and the first dose of pneumococcal conj vaccine (unspecified) (manufacturer: Lederle) (lot#D93212) in the right thigh. On 24-FEB-2010, the 8 day old patient visited the office. her vital signs were within normal limits. She eats 2 to 4 ounces every four hours. She has bowel movements 1 to 2 times a day. At this visit the patient's patent ductus arteriosus was not audible. The patient was to follow up with cardiology as scheduled. On 05-MAR-2010, the 18 day old patient visited the office. She was fed with bottle. The PDA was again inaudible. She was instructed to follow up with cardiology as scheduled. On 20-APR-2010, the 9 week old patient had a development check appointment in the office. The patient had frequent nasal congestion and occasional cough. She had no fever. She had been experiencing eval scattered rash on chest, shoulders and back for 1 month. It was reported that she had saw pediatric cardiologist on 19-APR-2010 and the patient's murmur was reported to be "gone". The patient was instructed to follow up with cardiology as scheduled. At the time of the report, the patient's outcome was unknown. Upon internal review, patent ductus arteriosus and patent foramen ovale were considered congenital anomalies. The mother's experience was captured in WAES # 0907USA01322. Additional information has been requested.
The patient had severe pain at the time of the injection. The pain persisted for a significant period of time. Slowly, the pain has improved but it has never gone away. The patient has had an ultrasound which showed some inflammation possibly around the bursa. An MRI was recommended if the pain persisted. MRI was performed yesterday but the results are pending.
The vaccinator vaccinated the patient in the left anterolateral thigh using a 5/8" needle.
pt recv vax 2NOV98 2PM & pt started having severe h/a, abd cramps, sl nausea & according to mom feels very warm;mom instructed pt to take APAP;feel better p/APAP but still has h/a & abd cramps;
I broke out with shingle eruptions thats followed my nerves upon my upper chest region.  No other effects from shingles aside from itching.
I had my first bout of shingles. I have had 5 bouts since,; This case was reported by a consumer via media and described the occurrence of shingles in a 82-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/ herself. The patient took first dose of Shingrix and experienced shingles first bout and had 5 bouts since then. The patient was currently 84 years old. The reporter did not consent to follow up.
Menveo reconstituted with sterile water; inappropriate dose of vaccine administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA655A, expiry date 31st January 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-Aug-2022 Reporter's comments: The pharmacist reported that patient was administered with Menveo reconstituted with sterile water. The reporter consent to follow-up. Additional Supportive Information: Menveo reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Moderna Booster was administered to patient that was not 18 years of age. Patient was 17 years old.
MUMPS!!! right jaw, under jaw, large indurated, extremely tender swelling, burning pain in jaw and cheek, earache, low grade fever. starting to resolve one week later. if this isn't real mumps, it sure looks and feels like it. had this as a child, which is why i recognized it in the mirror.
Exactly 2 weeks after my booster shot, my skin became extremely itchy with hives that covered my entire body. The hives continued for an entire month. I visited urgent care who assured me It was something I was eating or putting on my skin that I was allergic to. I was prescribed steroids for a week. By day 3 of my steroid treatment, the hives returned. I was then told to visit an allergist. The allergist tested me for food allergens and environmental allergens -- which came back negative for all. She mentioned she had several patients come in with the same issue from the Moderna booster. She administered a steroid injection and prescribed me a higher dose of steroids for 22 days. It is now a week and 3 days since my steroid injection and the hives are back.
COVID-19 Vaccine EUA fever 102 for two days then 100, headache, fatigue and entire body aches for three days
This is a spontaneous report from a contactable consumer. A 47-years-old male patient (reporter's husband) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. A Consumer calls for information on behalf of her husband about severe muscle pain and inflammation and required hospitalization studies and observation due to severe inflammation and pain in the legs as a consequence of after the administration of the second dose of the Pfizer's COVID-19 vaccine. Outcome of the event was unknown. Information about the Lot/batch number has been requested.
A female pt developed lightening flashes in her eyes following a RabAvert booster vaccination. The pt received a booster vaccination on 30Mar04. On 01Apr04, the pt experienced lightning flashes, increased disturbances from overhead lights, television watching and computer screens. Followed up received 15Apr04: Pt/Reporter provided additional information regarding the numbers of booster injections and the dates. The pt had received three sets (two each booster injections) within the prior six months. The first set of booster injections started on 03Nov03, the second set on 04Feb04 and the final set begin on 30Mar04. The reporter did not know the lot numbers. The pt's relevant medical history included breath cancer, now in remission for greater than eighteen years. The flash vision continued with rare frequency.
joint pain; severe vomiting (5 times); headache; chills; SIck; fatigue; Initial information received on 25-Nov-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 42 years old female patient who experienced joint pain (arthralgia), severe vomiting (vomiting), headache (headache), chills (chills), sick (malaise) and fatigue (fatigue), while she received vaccines INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] or INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included flu vaccine (reported as Years ago she had a reaction to a flu vaccine that included hives). The patient's past medical history, medical treatment(s) and family history were not provided.   On 16-Nov-2019, the patient received a dose  of suspect INFLUENZA QUADRIVAL A-B VACCINE or INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: K3593 and expiry date not reported) via unknown route in the right deltoid.  On an unknown date, the patient woke up with pretty severe vomiting (vomiting) (5 times), she also had headache (headache) and later had chills (chills) and significant joint pain (arthralgia) in her legs, and had fatigue (fatigue). She was slowly improving, but had to call out of work sick (malaise) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE or INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.   Lab data was not reported.  Final diagnosis was fatigue, malaise, chills, headache, vomiting and arthralgia.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for all the events.  Information on the batch number was requested.
Symptoms of a peripheral left seventh nerve palsy (Bell's palsy): Unilateral left facial weakness with drooling and excessive tearing from the left eye.  12/04/09 MR received for DOS 12/02/09. Impression: L peripheral seventh nerve palsy likely secondary to Bell's palsy.  Pt c/o L face weakness, drooling, L eye tearing. On neurological exam: L side muscle tone change, but sensitivity intact. Physician considered L peripheral seventh nerve palsy likely secondary to Bell's palsy. Tx: famciclovir, prednisone, and eye drops.  Pt to follow up with a neurologist.
Transfer from Facility for AMS.  History was obtained from patient's nephew and Facility.  Patient was recently discharged from Facility on 04/20/2022 status post ORIF of right femur.  Per Facility, patient was sent to Facility ED due to AMS, saying she was incoherent, not speaking, slumped over in bed, and not following commands. They thought she may have been having a stroke.  Per patient's nephew, patient likely has had dementia for several years, but has no formal diagnosis.  He states that her baseline mentation is alert and oriented to self, waxes and wanes, and can only carry simple conversations at times.  Nephew states she was at her baseline mentation upon discharge, and was indeed somewhat altered upon arrival to the hospital. Discharge Diagnosis: 1:Altered mental status; 2:Left upper lobe pneumonia; 3:UTI (urinary tract infection), bacterial;;; (HFpEF) heart failure with preserved ejection fraction; Compression fracture of L4 vertebra; Hyperlipidemia; Hypertension; Hypothyroidism in adult; Metabolic encephalopathy; Osteoarthritis of knee; Rheumatoid arthritis.  Discharged on 5/1/22.
I have been having diarehea daily and nausea. I don't eat and I have lost 45 pounds. I don't know if this is connected but I have been sick as a dog for the last four months. I take Zofran and prescription Imodium. My doctors have done a lot of blood tests, colonoscopy, and endoscopy. They are trying to figure out what's going on. They don't know why I can't eat and why I'm nauseous all the time. There hasn't been any definite diagnosis as of yet. I also had a cough that has been going on for the same four months as well.
Vaccine did not absorb fast enough into the arm muscle and a portion spilled out of her arm.