chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the vaccine, 2 doses, and still got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 28-APR-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The case was reported by the patient's sibling. The patient received two doses of shingles vaccine and still got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
High fever, delirium. Body aches, joint pain in every joint of body, headache, nausea, sore throat, cough. I am now suffering with kidney stones, water retention and gained 15 lbs since I had the injection. Puffiness, bloating. Puffiness in hands, ankles, stomach. I have shortness of breath with sever anxiety that wakes me up. My heart races over 120 beats per minute during these anxiety attacks.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 4-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with an unspecified dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014), on 04-FEB-2014. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient never called back and were going to consult with physician. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Patient received the wrong age Pfizer for ages 12 years and older  no side effects reported
cold; suck for a couple of days/ achey; chill; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of chills in a 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, unknown after receiving Shingles vaccine, the patient experienced chills, cold and pain. On an unknown date, the outcome of the chills, cold and pain were recovered/resolved.   It was unknown if the reporter considered the chills, cold and pain to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient reported that, the shots are good but also suck for a couple of days when first get them. The patient received 1st shot of Shingles vaccine and was achy and had a cold chills for about 3 days. The patient reported that before 1st shot the pharmacist asked that if he/she had anything important to do for the next 3 days. The case was linked with case US2021AMR156032 (2nd dose) reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156032:Same reporter
Achy left arm and she noted a silver dollar sized bruise around shot. Saw doctor and he advised her to apply cold compress. On 9/27/12-patient reports symptoms are gone now.
Patient experienced itching, shortness of breath, and tachycardia shortly after vaccination despite pre-medications (diphenhydramine, methylprednisolone, and famotidine) due to reaction (shortness of breath) associated with first dose of vaccination. Patient transported to the emergency department where vital signs were within normal ranges, observed, and administered intravenous fluids and albuterol-ipratropium via nebulizer. Symptoms resolved and discharged to home medically stable.
Worsening pain to L deltoid region where vaccine was administered. Limited range of motion, mainly abduction of left arm due to pain.
Presented because of brief (seconds long) episode of difficulty breathing (sounded congested and maybe SOB), self-resolved, no peri-oral cyanosis, was breathing the entire time. Brought to ED via EMS.  No decreased PO, no fevers, no emesis, no increased spit-ups.  Upon arrival to the ED, patient was noted to be hypothermic (on repeat) on 35.3 C.  Sepsis work up was initiated including blood culture, urine culture, urinalysis, BMP, CBC and LP was unsuccessful x3.  CBC was reassuring.  COVID screen sent and negative  Temps up to 36.3 prior to transfer to NICU with bundling and hat.  Admission Date: 11/19/2020 Discharge Date:  12/4/2020  Patient was admitted for rule out sepsis workup given episode of hypothermia following a transient brief respiratory distress episode at home which was concerning for BRUE   FEN: Continued on home regimen of 24 kcal FBM/Enfamil PO ad lib. Given persistent reflux , trial of Similac total comfort 24 kcal  Formula on 11/27 with no improvement. Trial on chilled  22 kcal FBM/ Enfacare on 11/30 and continued until discharge.    Resp: Remained stable on room air.   CV: Remained hemodynamically stable.   ID: Admitted for rule out sepsis workup given hypothermia in ED. She received at 48 hour course of  Vancomycin and ceftriaxone (11/19-11/21).. Blood , CSF and urine cultures negative .US guided LP obtained on unit and CSF analysis not consistent with infectious etiology.    Neuro: Baby had an event on day of admission - 45 second episode of desaturation and bradycardia with color change along with posturing/stiffening of body and eye deviation requiring stimulation and CPAP. Due to concern for seizure, obtained neurology consult and started on VEEG which showed background consistent with prematurity but  no seizures and  HUS which was unremarkable. Neurology signed off.   GI: An apnea study with pH monitoring  performed given concern for reflux with Sandifer syndrome , results as follows:"very mild desaturation events are associated with brief central apnea. I doubt that these are clinically relevant. Reflux index is higher than expected for age. There are no associated vital sign changes, except for occasional mild desaturations as described above. The combination of the description of the BRUE and the increased reflux index makes it plausible that the infant had a reflux associated event and appropriately protected her airway. Please keep in mind that none of the events that are charted by nursing were captured on this study "   Given likelihood of reflux being etiology of events  , patient started on omeprazole on 11/23 and continued until discharge . Continued to have apnea/bradycardia/desaturation events on omeprazole sporadically , with one significant event requiring PPV. Plan to discharge after remaining event free for 7 days and with home apnea monitor . Last event was on 11/27 and patient discharged on 12/4, event free with home monitor. Parents received bedside teaching and spent 12 hours at bedside for practice with usage of monitor. Home nursing visits to asses for comfort level/concerns with monitor use to be scheduled for parents ( representative will reach out after discharge)
Tightness in left chest. Tingling in left arm, hand, and left side of body. Pale, felt like fainting and throwing up, cold. Paramedics called, blood pressure elevated, pulse elevated. Oxygen administered and she started to feel a little better. Chest pain and numbness persisted. Recommended medical evaluation.
Pt developed an injection site reaction characterized by an area of redness, swelling and purple discoloration 2 inches in diameter.
Moderna x 3. Tested positive for Covid on 03/9/2022. Admitted to hospital on 03/09/2022. Expired on 03/13/2022 while still hospitalized.
Pt recvd a 1st series of 3 Engerix-B vax given 23MAY90, 21JUN90, 13DEC90; 8wks post vax there was no antibody response-negative HBSAB;
Approximately 3 days post vaccine I began to have severe tinnitus. On the same day, I began to have difficulty with my vision , especially in the left eye, a headache and all my joints began to ache. I was also very tired. The symptoms progressively got worse  over the following two weeks and included a couple of episodes of heart rhythm irregularities . During the third week, the headache, eye issues and joint pain began to resolve but the tinnitus is debilitating and prevents me from mentally focusing or sleeping.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning an eight-year-old male. Neither relevant medical history nor concomitant medication have been reported for this patient. On 10-Dec-2011, the patient inadvertently received expired FLUMIST. The product expired on 05-Dec-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 30-Mar-2012 and incorporated into narrative: No late occurring adverse event.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 03-Nov-2021 at 1:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 73.19 years. No concomitant medications were reported. Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with temperature 35 degrees Fahrenheit at 10:00 AM .The vial was initially moved to the fridge on 05-Oct-2021 and proposed beyond use date was 05-Nov-2021. Product moved to clinic on 03-Nov-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vial was only punctured right before administration. Vaccine was not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Pt developed marked L perio-intal edema within 1 hr of vaccinations. He complained also of chills but highest temperature 37.1. Improving at this time.
she received her shipment of Flublok out of range and it was administered to patient, no AE; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case is linked to case 2019SA281974 (same reporter).  This case involves a 69 years old patient who received 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA1941, Exp. Date 30-Jun-2020) via intramuscular route in the left arm on 07-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Patient had redness and tenderness in arm of vaccination. "Hardness" at injection site. Visited health department and told to take ALEVE. No hives, rash, difficulty breathing reported. Still "hard" on day of reporting but not red.
ADMINISTRATION ERROR:  She got the vaccine (HEp A) and it was an adult dose not a child's dose.  She has not had any initial reaction.  They are going to FU with the family.  The doctor talked to the mom.
Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild, Additional Details: right after i gave the patient the vaccine, the patient fainted and blacked out. The patient then proceeded to seize
One week after vaccination (10/15/21), patient started developing new swelling at the site of injection. Through 10/16 and 10/17 swelling turned red and painful and grew down arm and under arm. It is a continuous redness, and is not a rash.  Patient had no reaction at all up until 10/15/21.
cont severe pain & throbbing in lt arm between elbow & shoulder;had full body bone scan, complete neuro test;motor sensory, reflex each nerve, paraspinous;5 sessions of physical therapy;still in pain;cannot find anything wrong;
Pain in left shoulder/arm difficult to move or touch. Spreading redness and swelling from injection site to elbow - painful and hot to touch. Fever, chills, joint pain, aches. Ongoing from 12/15 to present... (Similar symptoms in majority of people who got shots).
MODERNA Covid-19 Vaccine EUA    1/8 Pain and tightness  on right side from neck to flank.   1/9 Patient went to get a Covid -19 test. She could hear "bubbles" when she breathed. She was sent to the ER and diagnosed with a right pneumothorax.
Developed hepatitis about 90 days after the 5th dose and I am still sick and recovering from it. Referred to  Gastroenterology.
Patient received vaccine and left - returned to clinic within 5 minutes with complaints of itching in right and left arm.  Patient described that after first dose she had itching reaction about 3 days after the dose.  That episode was resolved with one dose of benadryl po.   Today - patient was given a benadryl tablet to take at home since patient requested to be able to drive before sedative effects of tablet set in.
No additional adverse effect reported; On 11-FEB-2020 patient received a dose of improperly stored ROTATEQ.; This spontaneous report was received from a Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 11-FEB-2020, the patient received one dose of an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength and frequency not reported) (lot # 1660112 had been verified to be valid lot numbers; expiration date: 18-OCT-2020). The temperature excursion was at below 2 degrees Celsius (C) (1.28 C), for a time frame of 2 hours and 30 hours, and no had previous temperature excursion. It was reported that the call was due to data logger. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005842:
Expired vaccine was accidentally administered (expiration: 8/18/23; administration: 11/4/23) to patient, pt did not experience any adverse event. Consulted manufacturer regarding vaccine administration beyond expiration date, advised to repeat vaccination as soon as possible.
This spontaneous report as received from a nurse refers to a 18 year old male patient. The patient was vaccinated with an adult dose of VAQTA (route, dose and lot # were unknown) on 20-JUN-2013. No adverse effects. Additional information has been requested.
Left lower leg and calf: severe nerve pain; skin sensitive to touch; sharp stabbing pain with slightest touch.
Arm soreness, chills x 1 day.  Supraclavicular lymphadenopathy 3 days after injection
I woke up today, 1/22/2021, with an extremely itchy left arm. I also woke up 1 hour after the alarm went off, and was still lethargic. The source of the itch is a 1.5" rash just below the vaccination site on my left arm.  The rash appears over a hard or swollen bump that is the same size as the rash.   I may also have a rash on my left neck because it itches, but I can't see or feel it.
Bilateral leg swelling from hips to knees. Bilateral legs warm to touch. Decreased appetite. Crying inconsolably.
Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Rapid heart rate) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced TACHYCARDIA (Rapid heart rate). On 02-Apr-2021, TACHYCARDIA (Rapid heart rate) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Heart rate: rapid (abnormal) Rapid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were reported. No treatment information was provided by the reporter.
pimples on end on end of tongue; big  pimples on right side of cheeks/pimples on end on end of tongue; lump  on side of throat; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 18May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient reported that she received second dose on 18May, 24May she flew out of county for work travel and began to have the following symptoms: big pimples on right side of cheeks, lump on side of throat, pimples on end on end of tongue. The clinical outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Two days following the first dose of the Pfizer vaccine, the patient developed redness around the injection site that was hot to the touch. The redness/inflammation did grow to a larger area than just the injection site. I counseled on icing and treating with tylenol, ibuprofen, or benadryl and reporting back if the inflamed area continued to expand to a larger portion of her arm.
9 days after vaccine, I experienced 2 days of deep muscle and  joint pain.  Then on day #10, I woke up with a nickel size reddened tender lump on the left (vaccine side) arm about 2 inches away from the injection site.  The following day I  awoke with 2 more reddened tender lumps.   This time one of them is the size of a silver dollar.  These are hardened lumps that are tender and mildly itchy.  They are NOT exactly where the injection was administered, but within 2 to 4 inches away.  Never had a headache or a fever.
pt recv vax 27MAR96 & 31MAR96 pt devel 4 hives;
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 19-APR-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA injection (strength, dose and frequency were not reported) (lot # N012324, expiration date: 05-APR-2018) for prophylaxis (expired product administered). No adverse effects were reported. No further information was provided. There was no product quality complaint (PQC) reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1804USA010908:
2/16/203 Vaccine given: 2/17/2023 The patient says she had a fever, Bones hurt, unable to get out of Bed. Symptoms continued. 2/19/2023 fatigue, Brain fog (hard to describe) until 3/4/2023. 3/7/2023 - stiff fatigue but starting to ease up with symptoms.
I have been getting intermittent migraines (I have tracking data of dates, severity, and possible triggers) for over a year. During this specific incident, the pain was in a different location, and didn't respond to any of my usual tricks to get it to clear. I tried to resolve on my own at home for about 4 days before seeking medical care. It took me an additional week to actually be able to get medical care. With help from a pharmacist I was able to get it manageable and saw my doctor for a new migraine prescription on August 26th. I have had intermittent headaches since then.
The patient has extreme pain, weakness and pain up into his neck and shoulder on the side he received his vaccination.  States he feels weak and awful, unable to get up and do things for himself the morning after receiving the vaccine.
Fever, NauseaVomiting, chills, fatigue, sweats Narrative:
Pt reports headaches, lasting for hours at a time within 1 wk, rashes shin of right leg, stomach, L side underarm, neck, back of scalp with internal itching. Received hydroxyzine 25mg cetirizine 10mg. triamcinolone 60gm, rash on neck still present 1 month later. Hot flashes, nose bleed. The follow up states nose bleeds, sores in scalp, elevated hari loss, internal itching, headaches, bodyaches, stiffness and soreness in both knees, cracking, brittle finger nails and toenails.
Had really bad neck pain following shot. Was awoken in middle of the night with ?brain on fire? feeling that lasted about 10 minutes and then went away.