chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; Joint aches (specifically my hands/fingers); body aches; headache the first half of the morning; minor pain at the injection site; fever of 100.5F. This was its highest later in the day at 101.5F.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 12:30 as dose number unknown (booster), single (Lot number: GJ6742, Expiration Date: 31Jul2023) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed. Unknown manufacturer), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 26Oct2022, outcome "recovering", described as "fever of 100.5F. This was its highest later in the day at 101.5F."; CHILLS (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint aches (specifically my hands/fingers)"; PAIN (non-serious), outcome "unknown", described as "body aches"; HEADACHE (non-serious), outcome "unknown", described as "headache the first half of the morning"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "minor pain at the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The fever was accompanied by chills, joint aches (specifically my hands/fingers), and body aches. Patient had a headache the first half of the morning. Patient also had minor pain at the injection site. For the fever patient took Tylenol every 5-6 hours. The fever seemed to subside by late evening around 10-11pm.
Headache, Arthralgia, Fatigue, chills, injection site pain and swelling Narrative:
Notable swelling, soreness, tenderness, and mild redness at injection site lasting three days (so far)
Severe shaking chills and tremors starting 12 hours after injection, and lasting 90 min. No fever
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that a patient received an expired dose of VARIVAX (Merck) (Lot# G008367, expiry date: 22-AUG-2013), (dose, route and location unspecified) on 20-OCT-2013. No adverse effect reported. Additional information has been requested.
Dyspnea, wheezing 15 minutes after vaccine dose. Epinephrine administered. Paramedics on scene. Patient refused transportation to ER. Dyspnea resolved 3 minutes post epi.
Patient has been experiencing constant tiredness, dizziness, difficult and blur speech , face numbness, and blurred vision a day after getting the vaccine. Patient also experienced hot and cold episodes that went away after taking Tylenol, but they came back when the medicine wore off.
The next day between 10:00 and 11:00am noticed body aches and felt feverish. By noon time had fever of 100.1 F and body aches worsened. By 1:00/2:00pm body aches were severe, pain to touch skin, had fever of 104.5, chills were severe, had vomiting, and unable to keep liquids down, diaphoretic, and severe headache. Around 3:00pm, last recorded fever was 104.9 F.  Next day, around noon, noticed increase in sweating and a decrease in all other symptoms. The vomiting had stopped. Fever broke and was down to 99.9 F. Had decrease in body aches and headache, which were minimal around 7:00/9:00pm. The rest of the symptoms were gone. Had minimal body aches, but no appetite and lethargy for 3 to 4 more days.
Chills for 3 hours and nausea (dry Heaves) 100.4 fever
Pt received DTaP and IPV vaccines left deltoid 10/03/2005. 10/05/2005 during PPD reading it was noted arm was swollen, red, and hot to touch. Pt was given Keflex 250/50 9ml. Q 6 hours for 2 weeks. No fever noted 10/05/2005 T 97.1.
This case was reported by a healthcare professional (Certified Medical Assistant) and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Historic vaccination included diphtheria and tetanus toxoids and acellular pertussive vaccine ;GlaxoSmithKline;unknown;unknown given on 7 September 2010 and 1 August 2011. Concurrent vaccination included MMR vaccine (non-gsk) ;non-GSK manufacturer;unknown; left thigh given on 26 July 2012. The subject had no reactions to his two prior INFANRIX vaccinations. On 26 July 2012 the subject received 3rd dose of INFANRIX (intramuscular, right thigh). On 26, 27 or 28 July 2012, less than one week after vaccination with INFANRIX, the subject experienced extensive swelling of vaccinated limb and sick in stomach. The subject was experiencing swelling in the leg above the knee to the groin and the swelling was worse in the middle of the thigh (not at injection site). The subject was also sick to stomach. At the time of reporting the events were unresolved. This case was associated with pharmaceutical product complaint. The Certified Medical Assistant (CMA) reported that the office received a new box of INFANRIX with lot AC14B157CA on Thursday, 26 July 2012. Four children received doses from the new box and all were given intramuscular shots. Three different individuals administered the shots. The CMA reported that three of the four subjects were having a "sizeable local reaction". According to the CMA, two subjects received the vaccine on Thursday, 26 July 2012 and two received the vaccine on Friday, 27 July 2012. The CMA explained that the subjects who received the vaccine on Thursday were having a "stronger reaction". This case is one of the subject's who received the vaccine on Thursday. See cases A0989417A, A0989438A and A0989439A for details on the other subjects. Follow up received from the healthcare professional (Certified Medical Assistant) on 15 August 2012. The CMA reported that the physician was concerned that something was wrong with the reported lot (AC14B157CA) of INFANRIX since four patients experienced reactions after receiving the vaccination. The office requested replacement for the 3 boxes of vaccines with the reported lot. According to product complaint investigation results reported by GSK Biologicals quality assurance on 21 September 2012, the product complaint was assessed to be unsubstantiated.
Right arm sore and swollen for 3 days Headache/migraine for 3 days  Feeling crummy
This spontaneous report was received on 09-DEC-2016 from the grandmother of an 11 year old female who experienced adverse events after receiving GARDASIL (see case # 1612USA005619).  The reporter stated that in November 2016 (reported as three and a half weeks ago), a friend of her grandaughter's died.  It was unclear from the statement whether this girl received GARDASIL before her death.  Cause of death was not reported. Upon internal review, died was considered medically significant. Additional information is not expected as the reporter did not provide contact information. Sender's Comments: US-009507513-1612USA005619: Reported Cause(s) of Death: died.
pt recv vax & devel redness, swelling & a bruise @ the site of vax;pt cried for 45min;tx w/cool compresses & APAP;
lost his taste and smell; lost his taste and smell; sore throat; sore body; This is a spontaneous report from a contactable consumer or other non-health care professional (Patients Son). A 67-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown Expiration date: Unknown) via an unspecified route of administration (at the age of 66-year-old), administered in Left Arm (left upper arm by the shoulder) on 12Mar2021 between 0900 and 1000 in the morning as dose 1, single for COVID-19 immunization. Patient medical history included ongoing diabetes mellitus (Diagnosed about 10-20 years ago) and ongoing hypertension (Diagnosed about 10-20 years ago). There were no concomitant medications. On 30Mar2021 patient experienced lost his taste and smell. On an unspecified date in Mar2021 patient experienced sore throat, sore body. The reporter was calling about his father who received his first dose of the Covid vaccine 3 weeks ago. Stated his father is experiencing soreness of his body, sore throat, loss of taste, and loss of smell. Soreness of the body and throat: Started about a week ago, has improved but is still there. Loss of Taste and Smell: Started yesterday. Persisting the same. Caller wonders if this is something that is a normal side effect of the vaccine. States that his next dose is due next week. The reporter denied medications, labs, testing, or treatments relevant to this event. Reporter wonders if this is something that is a normal side effect of the vaccine. No Prior Vaccinations within 4 weeks of vaccination. The patient did not take any treatment for the events. States that his next dose is due next week. The outcome of event lost his taste and smell was not recovered and outcome of events sore throat, sore body was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Subsequent to receiving first and second doses of varicella virus vaccine live  a serum VZV antibody test revealed a lack of seroconversion.
Second dose at less recommended interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 30th October 2022) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 13th July 2021, the patient received the 2nd dose of Shingrix. On 13th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported but it could be 58 or 59 years. The first dose was administrated to the patient on 22nd June 2021. The patient had received a second dose of the vaccine at a less recommended interval from the first dose, which led to shortening of vaccination schedule. No further events were reported. The reporter agreed to be contacted for follow-up.  Consented to follow up.
A physician reported that a 78 year old male, post vax, on that evening, he developed an injection site reaction characterized by itching, swelling, and redness that extended to the elbow. He was treated with Benadryl and applications of warm compresses and recovered. This is 1 of 4 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23.
Unusual injection site reaction, large red swollen ring approx 4 to 5 inches in diameter around injection site. Not painful or uncomfortable, but some pain in shoulder.
Major drowsiness following vaccine, I treated it with a nap. Drop of blood at injection site. Treated with a band aid.
given Fluzone Quadrivalent MDV instead of the Aplisol; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves male patient of age 28 to 30 years who received 0.1 ml of vaccine Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] (lot UI998AE, expiry date 30-Jun-2019) instead of APLISOL (TUBERCULIN PPD) not produced by Sanofi Pasteur (lot number not reported) via SD (subdermal) route in the left forearm on 21-May-2019 for PPD patch test. The patient later received the PPD skin test at another site with the Aplisol  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong product administered.  It was not reported if the patient had any adverse event.  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.
Headache, Arthralgia, Fatigue, chills, injection site pain and swelling  Narrative:
Vaccination error. When Phase released for K-12 educators, patient was able to make an appointment with our facility when only Moderna vaccine was available at our site.  Patient is 17 years old and received first dose on March 11 2021. Error noticed when patient came for the second dose on April 8th 2021. The error was discussed with mother,  and the mother and patient agreed to get the second dose as scheduled as off-label use. Discussed it will be reported to VAERS as vaccination error. Patient was monitored 15 minutes without any noticeable side effects before leaving the site.  Per patient and mother, no side effect with first dose.
Pt recd Hep B #1 reports cold sxs, body aches, runny nose, cough and phlegm, fever within 24 hours of vaccination, sxs lasting until today (02/15/09) with fever only. Pt reports only spring allergy sxs, never in winter.
Post vax, devel headache, cough, fever, & cold sweaty sensation, lost appetite, feels fatigued.
Information has been received from a healthcare worker referring to 12 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017, dose, dose# and route unknown) which were improperly stored. The vaccines were stored under 48 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Initial injection was recieved with arm extended out and raised in car window. Really painful injection. Several seconds after vaccine injected I felt a wave of chills on my body and immediately started profusely sweating. Seconds after that i then began to get extremely dizzy, blacking out, trying to stay conscious for a personnel to walk by and after a few moments the feeling slowly lightened up minus the excessive sweating and chills. Personnel then told me it was just anxiety and brushed it off. I have never had a reaction like this from a vaccine before so this experience was unsettling.
First day I was fine I was the normal symptoms. The next day my legs paralyze from my hips to all the way down to my feet. I couldn't move them. They were burning and tingly like on fire. It's been 2 years and I am still going through the same thing. My hear sometimes it starts racing really fast making it hard for me to breathe.
Resident given expired flu vaccine Influenza Vaccine Adjuvanted Fluad Quadrivalent 0.5ml  GTIN (01): 00370461121034 SN (21): 3PWARB8CDF EXP (17): June 30, 2022 Lot (10): 312866
I started having SOB on standing and it has not subsided. No PMHx of asthma, COPD.   Menstrual cycle has changed?starts 5 days early and is thick and brown colored at the beginning. I am on ortho tricyclen.  Developed left supraclavicular lymphadenopathy that lasted 10 days. I was very concerned about this, as I have never had one before and have no history of TB and no cancer that I know of.
Anaphylactic reaction 15 minutes after receiving injection.  Throat and tongue swelling, light-headeness, diaphoresis, hypotension. Treated with Epi-Pen and Benadryl injection, followed by observation in Emergency Dept.
Employee developed fever of 101 initially. Was 102 by 12/22/2020 @ 3AM. Alternating Tylenol/Ibuprofen and reports improvement in symptoms.
Patient  stated that 2 days after receiving the vaccine (11/28), she noticed hives starting to form on her front of neck, chest, legs, and arms that have significantly decreased to 2 small hives on her arm.
Patient had a syncope episode along with urinary incomitance shortly after receiving the Janssen vaccine. Pt was sitting in the medical monitor area when the event happened. Pt was unconscious for less than a minute and EMS was called. EMS evaluated pt, he was pale but fully verbal and functioning.  vitals were stable,  BP 110/69, HR 74,  02 97. Pt refused transport but was monitored at the site by Dr,  for an hr before being released. Pt was instructed to go to UC/ER if he had another episode or new s/s and follow up with his primary care provider. The following day, the patient's primary care provider, NP tried multiple times to reach out and follow up with pt. Pt did not respond to his PCP.
pt recvd vax 15JUN93 & 3 hrs p/vax h/a cont & pt exp dizziness, nausea, SOB & devel a red rash on neck; pt went to ER was given DPH; had allerg react;
pt recv 3 doses of hep vax in 1986;following 3rd dose pt exp arm & leg pain lasted 9mo;pt could not lift leg;immune problem; sensitivity to trees, grass;exp itching; MD suspected lupus pt put on numerous meds dx w/lupus;
Information has been received from a health professional concerning a 6 year old male who on 13-AUG-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 28-MAR-2007 the patient experienced fever and varicella rash of less than 50 lesions. The patient was treated with TYLENOL, rest and fluids. Subsequently, the patient recovered from fever and varicella rash. Medical attention was sought. No product complaint was involved. Additional information has been requested.
My symptoms started out mild with a light headache and fatigue. I figured it was just lingering side effects from the vaccine. Each day I felt no progress. Fever and chills eventually started as well as nausea and dizziness. I have a pressure in my head as well.  For the past week now I've been dealing with the dizziness and nausea everyday. I've had to miss several days of work because of it. I have tried allergy medications to relieve any pressure in my head and thinking maybe it will help with any congestion that could be leading to dizziness. I have made no progress.
fever up to 101.8;body aches;diaphoresis, chills;dizziness;
Pt. states she received her vaccination on 04/06/2021. She states she was experience soreness at the vaccination site and fatigue for 2 days. Today she is experiencing chest pain on inspiration and was unsure if this could be related to the vaccine. Advised patient to go to urgent care/ED or contact primary care physician
2 hours after receiving Pfizer COVID vaccine, vision in left eye presented with new floaters, flashes of light, and visual disturbance.  Described as constant by patient, has not resolved 3 days s/p vaccination
Cherry red nickel sized reaction that progressed to palm size starting Wednesday 02/06/2019 to present 02/08/209-Site still progressing. Has spread to back of leg. Advised mother to take him to urgent care.
Child had a fever as high as 103.5, pulse 176 and tremulousness and had to be treated in the E.R.
Started running fever- got to 104 degrees, body ached, swelling, redness, and heat at vaccine site- didn't take Tylenol, but fever would return.
11/09/22 presents to ED for "altered mental status" "high blood sugar". PMHx of "HTN, and DM II"
pt recv vax 8MAY96 & 9MAY96 was noted to have devel what appeared to be cellulitis in the area around the inj site (lt arm);tx 3 days w/zIV ATB;event resolved quickly
Received 1st dose Feb 3 @ 7am.  Felt minor soreness for 2 days.  Felt fine afterwards.  Feb 12 developed flu like symptoms, headache mild fever, tiredness.  Symptoms progressed Sat & Sun.  Monday she was speaking with her brother who said she wasnt making sense.  Called ambulance & brought her to hospital.   Ran CT scan, multiple MRIs and did spinal tap.  Diagnosed with HSE enciphilitis.  Has had multiple seizures.  Very confused, can barely speak, doesnt recognize or understand who people are.  Troubling motor skills.
I'm on day 3 of very congested running noise noise bleeds never remember ever having one ever before fevered hot and cold sweats arm sore red and hot to touch chest congestion light headed dizzy bad sore throat and head aches
Lack of energy. Pain that pops up any place for a minute the leaves. Somewhat sick in stomach , lightly dizzy.  headache all day.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient reports lymph node under armpit feels swollen. He noticed injection site reaction within 1-2 hours of receiving vaccine, but has not experienced any other systemic reactions.
Information has been received from a registered nurse concerning a 72 year old female with asthma, osteoporosis and hypothyroidism and a history of kidney stone and migraine who on 12-FEB-2007 was vaccinated intramuscularly in the left deltoid with Pneumovax 23 (Lot#654977/08888F). Concomitant therapy included SYNTHROID, LIPITOR, aspirin, alendronate sodium, CITRACAL, PIORINAL, cholecalciferol, NOVO-GABAPENTIN and BENADRYL. On 13-FEB-2007 the patient experienced that her upper left arm became extremely red and bright in color, swollen, painful and hot. The nurse reported that the texture of the reaction was smooth. She also reported that the patient had limited use of her left arm because of the reaction. The patient was treated with BENADRYL (dose not specified) and prednisone (dose not specified). Subsequently, it was reported that the reaction had resolved and the patient had recovered within one week. The events were considered to be disabling by the reporter. Additional information has been requested.
Patient developed anaphylaxis 2 hours after receiving  Pfizer shot. She had swollen lips and her throat began to swell. She took a 25mg Benadryl 2.5 hours after the shot and is continuing to monitor to see if she needs to seek medical attention.
suspected vaccination failure; My wife gets them / Then still gets some sort of flu; My wife gets them and.is sick as a dog every year.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu vaccine and was sick as dog every year. After that the patient had some sort of flu. It was reported, It was all about the money follow the money read and look up all the ingredients on the box then decide if want that junk in your body. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation were not provided.
Redness, warmth, swelling at injection site on left arm.  Treatment at home: ice/heat, ibuprofen and outlined redness to watch for spreading.