chrisvoncsefalvay/vaers-outcomes huggingface dataset:
An adult female patient received by error Engerix-B pediatric; An adult female patient received by error Engerix-B pediatric; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 26-year-old female patient who received HBV (Engerix B pediatric) (batch number F5L5E, expiry date 11-APR-2025) for prophylaxis.   On 25-JUL-2023, the patient received the 1st dose of Engerix B pediatric. On 25-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: An adult female patient received by error Engerix-B pediatric) and underdose (Verbatim: An adult female patient received by error Engerix-B pediatric).  The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 18-SEP-2023 The medical assistant supervisor reported that an adult female patient received Engerix-B pediatric by error, which led to adult use of a child product and underdose. The reporter consented to follow up via email.
Parents report that after shots on 2-19-09, pt cried non stop greater than 3 hrs.
shaky, jittery. Waited 15 mins extra. Evaluated by EMS-Cleared
Headache, Myalgia, Fever, pain at site Narrative:  Other Relevant History:
Pt felt diaphoretic, pale and nauseated 10 mins after receiving the shot.
1st inj left me fatiqued with brain fog for 3 days.  2nd inj left me with a fever of 101 degrees and aches the next day and night.  Very tired today but fever is very low to almost none.
This spontaneous report was received from the patient's mother and refers to her 13 year old daughter. The patient's concurrent conditions included seasonal allergy and drug hypersensitivity to AUGMENTIN when she was little. Approximately in September 2016 (reported as "about two months ago"), the patient was vaccinated with her first dose of GARDASIL 9 one dose of a three dose series (concentration, route, anatomical place of vaccination, lot # and expiration date were not provided). Concomitant therapies included an unspecified allergy medicine. Approximately in 2016, the patient experienced injection site pain. Despite the patient did not seek for medical attention she received treatment for the adverse event. Approximately in 2016 (reported as "lasted about one month", the patient recovered from injection site pain. Additionally the reporter stated that the patient seemed to be better and she was due to get her next shot on "Friday". The mother was not sure what to do about the next shot since the pain lasted for so long. Nevertheless, the reporter did not provide a causality assessment between the injection site pain and GARDASIL 9. Additional information has been requested.
Burning sensation in throat within 5minutes of Vaccine. PT takes  within 1 hour
From initial information received on 05Jan04 from the pt parent, who is also a physician, regarding an adverse event occurring, it was reported that the pt (gender, age and date of birth not reported) received a Fluzone SV 2003-2004 vaccination, lot number U1291AA, administered IM in the thigh on 08Dec03. Three days post vaccination, on 11Dec03, the pt developed a temp of 104 degrees F, tonsillitis, cough and decreased activity. According to the physician 'supportive care' was given. Reportedly the pt recovered from this experience. 10/Aug/2004: No additional information has been obtained from the reporter. Case is closed. The reporter of this case is the same reporter of case numbers 2004-00024, 2004-00027 and 2004-00028.
SENSATION OF COLD AND HOT AT THE SAME TIME; SHAKING BREASTS; BODY HURTS FROM MUSCLE TENSION; SHIVERING IN LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 19-JUN-2021 17:30 for prophylactic vaccination. No concomitant medications were reported.  On 19-JUN-2021, the subject experienced sensation of cold and hot at the same time. On 19-JUN-2021, the subject experienced shaking breasts. On 19-JUN-2021, the subject experienced body hurts from muscle tension. On 19-JUN-2021, the subject experienced shivering in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shivering in legs, and the outcome of sensation of cold and hot at the same time, shaking breasts and body hurts from muscle tension was not reported. This report was non-serious.
Five minutes after gardasil shot administration client c/o weakness, fatigue, light headedness, nausea.  Approximately 45 minutes after administration client contacted office stating she now has hives on back, b/l arms, waist line and bra line.
Inappropriate age at vaccine administration; Infanrix administered to a 16 y/o; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-year-old female patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th March 2022, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd March 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 2nd March 2022, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 25th March 2022, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: Reporter stated that patient received 2 doses of Infanrix 1st dose on 2nd March 2022 and 2nd dose 25th March 2022. However, dose taken at the age of 16. The reporter consented to follow up. Additional supportive information: As patient received dose at inappropriate age which led to inappropriate age at vaccine administration
I was not having any side-effects today so decided to drive to town.  A few minutes into driving I found myself very disoriented, unable to determine how fast I was going or differentiate between right and left and couldn't understand why other cars were signaling/honking to me.  I kept finding myself in the wrong turn lanes and generally confused. I came home as quickly and safely as I could. I didn't see any warnings or adverse effects about  disorientation or difficulty operating a motor vehicle so thought I should report this.
Difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DYSPNOEA (Difficulty breathing). The patient was treated with EPINEPHRINE for Difficulty breathing, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ONE) at an unspecified dose and frequency. On 19-Mar-2021, DYSPNOEA (Difficulty breathing) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she has been receiving Prolia Injections every 6 months for the past 4 years. Her next Prolia injection is due on Thursday 18-NOV-2021 and Pulmonologist gave her an antihistamine Benadryl prior to vaccination and watched her after vaccination.
Diagnosis of pericarditis and myocarditis requiring emergency care and  ICU admission.  Cardiac symptoms began Sunday, 7/17/22 (2 days after vaccination).  The patient is currently under  cardiology care for at least the next 3 months.
Very sore arm and tired for two days.  7 days later, red, hard, itchy at injection site Have not done treatment yet but will take Benadryl tonight (8th day from vaccine, arm is hot, red, itchy)
Onset of symptoms occurred 11-24-04, approximately 22 hours after administration. Pt. described hive-like rash starting at both axilla and spreading across the chest, neck and shoulders- discreet raised areas, itching with erythema surrounding them then coalescing to one large area. Pt denied dyspnea or shortness of breath. He took OTC Benadryl for three days and rash subsided. He presented to the immunization clinic on 12-2-04. No visible signs of rash remained. Pt denied new foods or other exposure to new products.
5/12/08 phone call from patient complaining of tenderness and swelling to left axillary - (no temperature) swelling approximately 7.5cm, referred to MD.
Received vaccination on 10/28/06.  On 10/29/06, noticed area around injection was very red, warm to touch, swollen (hard lump), and sore.  Noticed red area around injection site was spreading.  Returned to doctor on 10/31.  Took prescribed antibiotics (ceflix 250 BID 3 days).  Returned to doctor for follow-up on 11/7/06...injection site was healed.
Patient was given a 5mL flu shot, instead of 0.5mL. I was drawing it up, and read on the bottle 5mL, not how much should be administered. XXXXXXXX XXXXX was the one that discovered I had made the error. Make sure to make closer attention to what the dosage of the medicine is.
Information has been received from a nurse practitioner concerning a patient who on an unknown date, was vaccinated with the first dose of GARDASIL. On an unknown date, after receiving the vaccine, the patient fainted. Additional information has been requested.
LIGHTHEADEDNESS; PAINFUL INJECTION; DRAGGING HIS BUTT AROUND; NEEDLE HURT ON INJECTION; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 at10:30 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced lightheadedness, painful injection, dragging his butt around, and needle hurt on injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lightheadedness, painful injection, dragging his butt around and needle hurt on injection was not reported. This report was non-serious.
Information has been received from a health professional concerning a 60 year old white female who 02-JUL-2007, was vaccinated intramuscularly on the left side with a first dose of pneumococcal 23v polysaccharide vaccine (lot 655592/1175F). Subsequently, the patient developed a bad rash at injection site. The outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
per mom pt's thigh large red area very hot & pt crying D/T pain; pt limped alot; 25JUL95 per mom black & blue today & painful; pt seen by MD given ATB
persistent severe headaches/severe migraine like headaches; photophobia/sensitivity to light; body aches; fatigue; This is a spontaneous report from a contactable Physician reported for a male patient. A 37-year-old male patient received first dose of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 12Apr2021, as single dose for covid-19 immunisation. Medical history and concomitant medications were not provided. On an unspecified date in 2021, patient started to experience severe migraine like headaches/ persistent severe headaches accompanied with sensitivity to light/ photophobia, body aches and fatigue. The reporter (physician) has tested the patient for multiple issues including COVID-19 and done blood work and all came back negative. The patient has had an MRI which was also negative for any abnormalities. Patient was treated with Aleve, Advil, and steroids but none of which resolved headaches. The patient was still suffering with headaches and photophobia and described them as intermittent with pain ranging from a 2 to a 9 on the pain scale. The patient was evaluated by a neurologist who stated that headaches could be associated side effects from the vaccine and has prescribed medications for migraines to aid in symptom management. The Physician was concerned due to the length of time his patient has been experiencing these symptoms since it was outside of the normal range of time for systemic type symptoms to resolve. He stated that patient was another wise very healthy with no other issues. Outcome for the events persistent severe headaches/severe migraine like headaches and photophobia/sensitivity to light was not recovered and for body aches and fatigue was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Child felt nauseous, dizzy, was sweaty and pale for 5 minutes and then recovered.
Headache; Chills; Sore in both arms; Received two doses at once; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 14-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose number unknown (booster), single (Lot number: GH9693) at the age of 14 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: coviD-19 vaccine (States that her daughter had a booster, 21Jan2022. This was the first of the Bivalent Booster.), administration date: 21Jan2022, when the patient was 13-year-old, for Covid-19 Immunization; Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: EXTRA DOSE ADMINISTERED (non-serious) with onset 22Oct2022, outcome "unknown", described as "Received two doses at once"; HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Sore in both arms".  Additional information: It was reported that the patient received two doses of the Pfizer BioNTech Covid 19 Bivalent Vaccine instead of one dose. The patient's physician said to just watch for tachycardia or other symptoms. The patient had a headache and some chills, she was better on 24Oct2022, just sore in both arms.  Follow-up attempts are completed. No further information is expected.
Within a few minutes of receiving the shot, I developed a headache, elevated blood pressure and numbness and pain in my left arm. My ears felt very hot, as well as the glands immediately below my ears in my neck. I was monitored for approximately 30 minutes where they had me lay down. My temperature was normal. Once my blood pressure was starting to normalize, I was told I was that all of my symptoms were normal and that I was ok to drive home and that I should return if I "had any paralysis." Approximately 2 hours after receiving the shot, I had difficulty swallowing/sore throat, was nauseated and lightheaded. I still had the headache and numbness/pain in my arm, and the pain had radiated up through my shoulder/neck and down through my left shoulder blade. I called my primary care doctor's office and told them what I was experiencing; they told me to either take some Benadryl or to go the closest ER if it became any worse. About an hour after taking the Benadryl it was easier to swallow so I chose to not go to the ER.
Pt developed multiple fluid filled blisters surrounding injection site 1 day after injection. She denied fever, redness, swelling. She did report general malaise. She was advised to take CLARITIN and use BENADRYL or OTC cortisone cream.
In my 63 yrs I had never been allergic to an antibiotic. Within th past 3 months I have had an allergic reaction to 2 different ones. The most recent being reaction to Amoxicillan. Red, itchy, burning rash all over my body requiring 2 trips to urgent care facility.
Fever shaking muscle spasms  twitching leg pains. My arm still has raised area
My arm is still red and hot and it's beginning to itch. Immediately after the vaccine my face got hot and bright red as it does when I have an allergic reaction.  My heart rate raced and chest felt weird, but immediately I had tingling in my left arm from the vaccine. I was winded when speaking for about 24 hours. When I got home, I began taking Benedryl. My arm still has a hard knot and is still red and hot. I'm trying to find out what to do about the red, fever at injection site and the redness. It's starting to itch. This has been 10 days ago that I had the vaccine. I'm not an antivaxxer and look forward to my second vaccine on February 8, but I'm a little apprehensive.
At hour 8, spiked fever to 103 degrees fareinheit; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite.; Approximately 6 hours after injection felt body aches and chills.; Approximately 6 hours after injection felt body aches and chills.; This is Spontaneous report from a Non-contactable Nurse. A 28-years-old female (no pregnant) patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular on 08Jan2021 09:00 at the second single dose at Arm Right for covid-19 immunisation.  Medical history included birth control.  Concomitant medication included vitamin d3 (VITAMIN D3), ethinylestradiol, norethisterone (NORTREL) for birth control, and multivitamin.  The patient previously took phenergan and experienced drug hypersensitivity, the first bnt162b2 on 18Dec2020 and experienced very mildly sore arm at injection site.  On 08Jan2021 received dose #2. Approximately 6 hours after injection felt body aches and chills. On 08Jan2021 17:30, spiked fever to 103 degrees Fahrenheit. Fever stayed greater then 100 degrees with spikes to 103 for over 48 hours despite usage of antipyretics and cold compresses. Also have had intense chills, aches, headache, dizziness and mild nausea with loss of appetite. No local reaction at site noted. The patient did not received treatment for other events, except for Fever. Outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
pt states woke up 3AM 19OCT96 & notice a numbness & tingling sensation in lt foot;states noticed the sensation moving into ankle, knee hip, arm & lt side of neck x 3 days;has residual pain w/soreness & tenderness in lt hip;diff getting up
never came for his 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th October 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never came for his 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Sept-2023 The pharmacist reported that the patient never came for his second dose. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt was very fatigued the day after she received the pneumo shot. On Sunday, 2 days after receiving the shot she woke up with severe hives, fatigue, very sore arm and believed shortness of breath. Md advised and steroid shot was given after no success with Benadryl.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 80-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2018 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805500 was crossed linked to original case 201804863 due to same reporter.
Shaking and being severely cold - June 15,2021 around 10 pm (took 2 Advil to try and relieve symptoms) Feeling very lightheaded and feeling close to passing out - June 16,2021 (took 2 Advil to help with symptoms)  Left underarm lymph node beginning to swell up - June 17,2021
Very swollen arm with redness and vesicles clusters around injection site. Pt went to ED and was treated with antibiotics for cellulitis, antihistamines here.
Swelling and pain, especially around injection site, site warm to touch 1 hour after injection, swelling , pain and warmth for 48 hours+, swelling and soreness into lower arm 6 hours after injection. Soreness over entire arm still present 96 hours after injection.
Pt reported vomiting, but having excessive salivation. Reported to work. Suggestion was to go to local ER due to the excessive salivation was a new & unknown symptom of anthrax.
The patient was inadvertently given 0.2 cc of the regular Pfizer  instead of the Peds Pfizer). The patient has not experienced any adverse side effects and the patient's father was notified of the error and stated understanding. The father was instructed to bring child back for 2nd dose of Peds Pfizer in 21 days, as scheduled.
2 Hep B doses were given on the same day, there was no adverse effect to the child.