chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling of the left upper arm where received the vaccine Narrative:  I received the vaccine on 3/10/21 at 10am, by 5pm, noticed a half of tennis ball sized swelling in the injection site, and by next morning 3/11/2021, swelling has been extended to whole upper arm. I have a tendency to sleep with my both arm raised over my head, and by next morning 3/12/21, the swelling travelled to axillary area. I had difficulty put my arm down for next 3 days because the left armpit was swollen, and also left side chest and shoulder and next skin was pulling every time i tried to put my arm down. the swelling was completely gone by 3/19/21.  Other Relevant History:
Onset of dizziness within moments of receiving the vaccine which has persisted for hours and has not let up  but is mostly mild. Mild nausea at the moment.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: CIPROFLOXACIN, on 10May2023. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Patient received vaccine. Patient took other medication in 2weeks. Immediately after 1st dose, had a strong bitter taste in back of throat that didn't go away until patient stopped the medicine. Patient had severe diarrhea starting a few hours after taking first dose. Patient had stomach pain in the upper part of her stomach that was still happening today.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Per federal vaccinator, client complained of pain at injection site after 1st dose of Moderna COVID vaccine. Client reported she went to her doctor and had to get a cortisone shot.
during the 24 hrs following vax pt had several episodes lasting 1 1/2-3 hrs of unconsolable crying;
Pneumonia; COVID-19; COVID-19; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer, the patient's sibling.   A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198; Expiration Date: 30Jun2021), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation.  Medical history included ongoing cancer. The patient's concomitant medications included unspecified cancer treatment, which he stopped as it was not helping him.  On 03Feb2021, the patient experienced COVID-19.  On an unknown date, he developed pneumonia. The events did not require hospitalization. The patient received unspecified treatment for the COVID-19. There was no treatment given for the pneumonia. The clinical outcome of the COVID-19 was not recovered, while that of the pneumonia was recovered on an unknown date.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by medical providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Diagnosis of Shingles. Treated with oral Valacyclovir HCL 1 gm, 3x/day for 7 days.
Patient states that three weeks ago he received dose number 2 of Pfizer covid 19 vaccination. Within the next few days he developed joint pain and swelling both hands and right knee
Was given first dose of Moderna Covid vaccine and within 10 minutes started c/o tingling lips, numbness in tongue and back of throat and tingling in cheeks.  Refused to take benadryl and watched for 30 minutes. O2 sat 96%.
started having tachycardia on 2/4/21 while watching TV, HR from 110-150. Went to ER in am on 2/5/21 and admitted with A-Fib RVR.
Flublok injected to a 15 month old male patient / no AE; Initial information received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Office Staff).  This case involves a 15 months old male patient who received 0.5 ml once dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date unknown) via intramuscular route in the left thigh for Prophylactic vaccination on an unknown date. (PT: Product administered to patient of inappropriate age)  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.   At a time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Pt. received Hepatitis A, yellow fever and MENACTRA vaccines on 3-16-15 at clinic visit. Given oral typhoid pills to take at home. Pt. took first pill 3-17-15 am and noticed fine bumps over face and neck by 7 pm 3-17-15. Very itchy. BENADRYL helped decrease itching. Typhoid dc'd. Symptoms resolved.
Initial report received from a consumer on 24 MAY 2013. A female patient, whose age, medical history was not reported and concomitant medications included DURICEF, had received an intramuscular dose of TD vaccine from unknown manufacturer (batch number and dose number were not reported) in left arm on an unspecified date in 1995. On an unspecified date in 1995 after vaccination, the patient's left arm was sore. The patient could not move her left arm for 2 weeks, movement was painful. Corrective treatment and laboratory investigations were not reported. On an unspecified date, the patient had recovered from the events. Documents held by the sender: none
Bell's palsy (unilateral). 9/2/09 Consultant record received DOS 8/31/09. Assessment: Bell's Palsy. Patient presents with sudden onset (L) facial palsy / weakness. Feeling of weakness on (R) side.  9/17/09 Hospital records received DOS 8/31/09 to 9/1/09. Assessment: Bell's Palsy. Patient visiting from Mexico, presents with 2 day history of right facial numbness. Could not close left eye, drooling from left side of mouth. Facial numbness. Peripheral facial nerve palsy, asymmetry of forehead wrinkles, mouth asymmetry. White exudates left peritonsillar recess. Patient immproved.
Headaches, dizziness, shortness of breath, foggy mind, weight loss, withing six months vomiting every day around 4 am for few months, weight loss continued, severe thirst, brittle nails and some would crack in the middle and fall out completely, hair loss was noticed which continued to fall out in patches throughout the following 3 years. Hair loss throughout the body: arms and legs and recently in the last 3 months pubic hair is falling off in patches as it started on the head.
4/16/14 - 1 wk of cough, intermittent fever - dxd with bronchiolitis/Rt infrahilar pneumonia - txt with ZITHROMAX - albuterol - ORAPRED better 4/17/14. 4/21/2014 - refused to walk - poor balance. 4/22 - refusal to crawl seen in ER. 4/23/14 - Adm to hospital - vaccine cerebellitis.
passed away; This is a spontaneous report received from a non-contactable consumer from a Pfizer-sponsored program. The consumer reported same events for two patients (two friends). This is one of the two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single; dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took both doses and passed away on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101123341 Same reporter/drug/event, different patient; Reported Cause(s) of Death: passed away
Information has been received from a licensed practical nurse (L.P.N.) concerning a 3-year-old female who on 20-AUG2004 was vaccinated intramuscularly with a 0.5 ml dose of Varivax. On approximately 07-OCT-2006 the patient developed breakthrough chickenpox and was seen by a physician on 09-OCT-2006. It was reported that on 11-OCT-2006 the patient was better. At the time of this report she was recovering. No product quality complaint was involved. Additional information has been requested.
Headache for 3 and a half weeks - ongoing. Tingling/ cramping in calf muscles. Vertigo.
My mother had blistering on her scalp. She went to her primary care providers office and was diagnosed with shingles. My mother was prescibed an anti-viral medication which caused severe diarrhea. My mother finished the course of treatment.  Since it is still early in the course of this illness it is not clear yet all of the negative outcomes.
A non-serious spontaneous report of "14-year-old patient at the clinic received two doses of FLUMIST by mistake" was received from a medical assistant concerning a 14-year-old female. No relevant medical history or concomitant medications have been reported for this patient. On 27-Oct-2009, the patient inadvertently received two doses of FLUMIST from two different nurses at the clinic on the same day. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Loss of Appetite, Lethargy, Listlessness, Repeated Vomiting, High Fever (104)
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patient's pertinent medical history or concurrent condition was not reported. On unspecified dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (lot # L031603, expiration date 18-FEB-2017, lot # L034932, expiration date 03-MAR-2017, lot # L045678, expiration date 09-MAY-2017, lot # reported as L046509, expiration date 17-MAY-2017, lot # L030586, expiration date 10-FEB-2017, lot # K019102, expiration date 15-APR-2016, lot # L023112, expiration date 24-DEC-2016 dose, strength, route, frequency and indication were unknown). No adverse effects were reported. Temperature: 27F Time frame: 2 hours and 40 minutes Data logger: Yes Was it administered (AE)? Yes Was it previous temperature excursion? No This is one of several reports received from the same source. Additional information has been requested.
Onset of pain (R) shoulder followed by weakness. Pain for one month followed by lessening pain for two months with accompanied weakness in (R) arm and shoulder. Diagnosis as Parsonage-Turner Syndrome March 2014.
Mom states the day after injection arm was red and sore.States this morning has "golf ball sizes lump" and redness on back of right arm where injection was given.
Severe pain on left arm. Patient was crying uncontrollably that mother had to call 911 and take her by EMS. However, records from the hospital ER where she was treated did not reflect the magnitute of symptoms mother was describing. She was discharged on Motrin for pain only.
hot sweats  passing out  dry mouth gasping for breath extreme energy loss (couldn't stand up)
Pt recvd 3 doses of Engerix-B vax 4NOV90, 1DEC90, & 5MAY91 & 9OCT91 it was determined that pts titer was neg p/3 doses of Engerix-B;
This spontaneous report was received from a medical assistant referring to multiple patients of unknown demographics. The pertinent medical history, concurrent conditions and concomitant therapies of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot# M034187, expiration date: 17-MAY-2019) (dose, route of administration and anatomical location were not provided), for prophylaxis. The vaccines underwent the temperature excursion of more than 32 Fahrenheit degrees (F) but less than 35 F for 3 hours and 20 minutes, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was filed. Follow up information has been received from the medical assistant on 10-MAY-2017, reported that the temperature excursion occurred in the middle of the night when no one was present and the cause was unknown. Follow up information has been received from the medical assistant on 07-JUN-2017. The patients' identifiers, age and gender were provided. The patient was a female infant (reported as 2 & 4 months old) patient vaccinated with LIQUID PEDVAXHIB in a clinic by a clinic nurse. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA006513: US-009507513-1704USA010745: US-009507513-1705USA013407: US-009507513-1705USA013406: US-009507513-1705USA013408: US-009507513-1706USA009003: US-009507513-1706USA009002: US-009507513-1706USA009001: US-009507513-1706USA009004: US-009507513-1706USA009007: US-009507513-1706USA009006: US-009507513-1706USA009005:
pt recvd vax 9AUG92 & about 1 hr p/receiving vax devel myalgias; that evening developed t103, h/a, diaphoresis; sc persisted for approx 2 to 3 wks;
The pt's wife/caregiver came to the pharmacy to inform the pharmacist that the pt had to go to the ED because of likely bursitis reaction (vaccine administered too high). The ED nurse had mentioned to the pt/wife that it could be how his arm is shaped (ie: not much deltoid muscle there) but to inform the pharmacy of the incident to make sure vaccines are being administered with proper technique. Wife was very calm and understanding of the situation and was informed by pharmacist that we will pass along the message to entire staff/report as necessary.
Pt seen in office 07/02/02 with papules some vesicular. Had c/o itchy rash x 24 hours. Diagnosed post evaluated by doctor with varicella.
12/3/04: 9:15 flu "shot" given: has had these for many years. 11:30 awakened with itching, welts '"all over" , eyes swollen shut, SOB "like asthma". No medication allergies. History of bee sting allergy: 12/4/04 0030 to ER given IM Benadryl and Cortisone, then oral Benadryl later . 1 eye still swollen.
Information has been received from a nurse practitioner concerning a 7 month old female who on 2/23/05 was vaccinated with a dose of varicella virus vaccine live due to varicella outbreak at day care. It was noted that the child had pneumonia at the time of vaccination. Concomitant therapy included amoxicillin/clavulanate potassium and azithromycin. Post vaccination, on approximately 2/27/05, the child developed a fever of 105 and constant crying. She was taken to the emergency room on 2/27/05 and was admitted with diagnoses of pneumonia, thrush and dehydration. A chest x-ray was normal. She was treated with nystatin and was released on 3/1/05. She is recovering. The reporter felt the patient's experience was an other important medical event (OMIC). Additional information has been requested.
During administration the syringe broke and vaccine leaked out. An unknown amount of vaccine was administered to patient resulting in a sub-therapeutic dose.
Patient hospitalized for seizure disorder and intentional drug overdose within 6 weeks of receiving COVID vaccination.
on 5/14/21 - developed small rash on chest.  On 5/17, developed large red rash (no bumps...all under skin)  on both legs on front calf area.  On 5/20, the rash on my chest has completely disappeared and the rash on both legs is starting to turn brown and fade.   NOTE:  On 3/19, I had my second Shingrix shot (Herpes Zoster). In between the Shingrix shot on 3/19, I had two allergy shots for environmental allergies between then and the 5/11 vaccine shot.  The last allergy shot was on 4/26 (two weeks prior to the 5/11 vaccine shot).
This case was reported by a consumer via sales rep and described the occurrence of itchy rash in a female patient who received SHINGRIX for prophylaxis. On 21st May 2018, the patient received SHINGRIX. On 3rd July 2018, 43 days after receiving SHINGRIX, the patient experienced itchy rash and erythromacular rash. On an unknown date, the outcome of the itchy rash and erythromacular rash were unknown. It was unknown if the reporter considered the itchy rash and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vial shot at pharmacy. Suddenly before the day before reporting, she developed several red, itchy spots on various parts of body (outside of left leg, near groin, and midsection). The patient asked if this could be related to that shot.
Initial report from a non-healthcare professional on 19 NOVEMBER 2012. A 69-year-old female patient, who had no known allergies and had no illness at the time of vaccination and medical history, had received a dose of FLUZONE HD intramuscularly (lot number: unknown, anatomical site of administration was not reported) on 16 NOVEMBER 2012. On 16 November 2012, after 4  hours of vaccination, the patient had vomiting, nausea, diarrhea, chills and upset stomach. The symptoms lasted for 4 hours and then the patient felt better. Corrective treatments and laboratory investigations were not reported. The patient had recovered on an unspecified date. Follow up information received from the non-healthcare professional on 10 MAY 2013. The patient's date of birth was reported as 22 OCTOBER 1943. The patient had received FLUZONE HIGH DOSE No Preservative 2012-2013 (batch number U4524AA, expiry date: 21 APRIL 2013) in the left deltoid.
Mom, contacted me and said she noticed a red hard lump at injection site the next morning. Painful to touch.  About the size of a dime.  Infant Tylenol and ibuprofen were used for pain/discomfort, along with cold compress.  Mom also massaged area.  Area of concern did grow to a quarter size lump and then slowly dissipated.  Patient fully recovered.
pt recv vax 20JUL95 & 30MAR96 pt presented to a MD w/50 pindot lesions on abd only;10 of the lesions were typical-appearing chickenpox lesions, while the others appeared atypical & lasted longer than typical chickenpox;cold-like sx & fever;
Received vaccines on 6/28/07 soon thereafter developed redness and swelling over entire upper arm which lasted 3-4 days.
Patient received second dose in 2017, third dose was Infanrix on 13-aug-2021.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 6-year-old male patient who received DTPa (Infanrix) (batch number 23YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa (DTaP vaccine) and DTPa (DTaP vaccine).   On 13th August 2021, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 13th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving DTaP vaccine and DTaP vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient was on the DTaP catch up schedule. The patient received DTaP 1st and 2nd dose in 2017. The patient received the 3rd dose as Infanrix on 13th August 2021, which led to lengthening of vaccination schedule. The reporter stated that the Lot number was from agency.  The reporter did not know for sure if the first two doses were Infanrix (but that was what they had in stock).
Hives, trunk area, ZYRTEC 10 mg QD and to force fluids.
This spontaneous report ws received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. The pharmacist informed that on 19-AUG-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 injection, 10 vials of 1, 0.5 ml, intramuscular, lot # J009827, expiration date 10-AUG-2014. No adverse effects were reported. Additional information has been requested.
On 03/20/01 PM, the patient had chills, shakes, afebrile, and bilateral numbness of hands. On 03/21/01, the patient had severe abdominal, chest pain, and nausea. On 03/22/01, the patient had a loss of consciousness, hypotension, swelling of her lips, and face. On 03/22/01, prescription of Prednisone given by Family MD.
Itchy rash on upper frontal body. Arms, chest, stomach. Putting on Triamcinolone Acetone have also tried Benadryl cream and oral Benadryl.  Has been 4 days now with rash.