chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt with acute febrile illness consistent with tick borne infection - fever, malaise, myalgia with abn labs began afternoon after vaccination (shortly thereafter), req hosp 7/12 to 7/14/2015. Peds I.D. (Dept Head) and ward (Gen Peds) attendings in agreement that sx are consistent with tick related disease and not vaccine reaction after tx with doxycycline. (Resolved after tx antibx.)
Feverish, muscles achy. Took Advil. Today I have 3 large red bumps on injection arm that are extremely painful to touch.
For three days, fatigue and aching in neck and across shoulders. The aching went away, but I am still fatigued and I feel groggy/sedated. I can't focus well, mentally, and my memory is affected.
Scratchy throat, restricted breathing, itchy inner ear - 1 hr 15 min after immunization. BENADRYL shot administered - observed two hours - symptoms went away. Released 3 hrs 35 min after vaccine administered.
Intense pain and heaviness on right deltoid the injection site starting on 1/24/17 7pm, noted large patch of redness around injection site as well as a erythematous streak radiated from right deltoid to right axilla.
This case was reported by a nurse and described the occurrence of an injection site reaction in an 18 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed for prophylaxis. On 14AUG2003 the patient received the 4th dose of Infanrix. On 15AUG2003, one day post -immunization, the patient developed an injection site reaction characterized by swelling and redness. The patient was seen in the emergency room and treated with diphenhydramine hydrochloride and paracetamol. On 19AUG2003, the events resolved. The physician considered the events were related to Infanrix lot 610A2.
Patient stated, "She got pain immediately during injection." Next day she stated it was swollen at the site." Went and saw her doctor who confirmed it was red and hot to the touch. Patient stated, "I tried advil and it helped a little bit. I did not try Benadryl." Staff stated, Patient's arm was fairly/pretty large (swollen).
Localized reaction to deltoid: discoloration/redness around injection site with swelling. Skin feels taut/tight and patient has tenderness to touch.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (Lot # L017142, expiry date 13-MAY-2017). No adverse events reported. This is one of the two reports received from same reporter. Additional information has been requested.
A non-serious spontaneous report of "we gave H1N1 to a 14-month-old male infant" was received from a physician. No concomitant medications have been reported for this patient. The medical history of the patient included Sturge-Weber disease since childbirth and the patient was treated with oral salbutamol last winter for an unspecified illness. The child was healthy after two weeks of vaccination. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 30-Nov-2009 and incorporated into the narrative: medical history, concomitant medications and address of the reporter.
One week after receiving the Td injection in right deltoid the patient developed a red, swollen area around the injection site with radiation of redness to the right elbow.  Hardness palpated under the skin.  No pain.  She reports itching.  Saw MD on 10/20/05 and was given Kenalog IM, and started on benadryl and cortisone cream.
Headache, low grade fever (100.5 F), chills, flushed face, sensitivity to light, muscle aches. Sudden ataxia with involuntary leg muscle movements; when attempted to walk feet lifted by themselves in a prancing or marching step. Legs were giving out and difficulty to walk and weakness in both legs as if unable to support weight. This occurred 3 times between 11:00 AM and 3:00 PM. Lost voluntary motor function in both legs.
Patient was only 17 at the time the vaccine was administered. This was not realized until patient presented for 2nd dose on 8/4/2021. No adverse reaction. Underage only.
upon awakening, lt deltoid area sore, hard, hot, & markedly edematous; pain w/omvement; area measures 2.4cm long x 20 cm wide; pt denies numbness in fingers;
Sore arm day after the vaccine, 3.25.2021-3.26.2021. Icthing on injection site 4.1.2021 at 4:00-5:00 pm,  At 9:00 pm noticed slight swelling around injection site, raised red bump, sort of like a hive. Warm to touch, slightly painful. 4.2.2021- 8:44 am ....... Still a red patch over injection site, still warm to the touch, only slightly painful if pressed, Feels somewhat icthy when passing over it with hand.  Will report anything new.
Blood pressure elevation variating 135/90 up to 155/105, headache/pressure, watery eyes
left arm getting hot and numbing sensation; left arm getting hot and numbing sensation; tenderness where the  injection was; Tingling; This is a spontaneous report received from a contactable consumer. This 48-year-old female consumer (patient) reported for herself that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8734) on 07Apr2021 on her left arm for COVID-19 immunization. Medical history and concomitant drugs were not provided. The patient began to feel the following while walking to her car afterward: left arm getting hot and numbing sensation.  It is not as severe as of 08Apr2021.  She can feel numbness in her fingertips and tenderness where the injection was. The patient was wondering if she should get the second dose of it based off of her symptoms from the first dose. The patient stated her numbness, tingling, and tenderness in the injection was not preventing her from typing or working. She stated it was just something she felt. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Throwing up; Fever of 99 deg F; severe back pain; feet were swollen up to the knees; feet were swollen up to the knees; arm was sore but not too bad; A spontaneous report was received from a caregiver concerning a female patient of 82 years of age ,who was administered with Moderna's covid-19 vaccine and experienced Throwing up,fever of 99 degree F,severe back pain,feet were swollen upto the knees,arm was sore but not too bad.  Patient's medical was not mentioned.Concomitant medications include Methotrexate for arthritis.  On 29-JAN-2021,prior to the onset of events,patient received the second of two planned doses of mRNA-1273(Lot number:unknown) for prophylaxis of covid-19 infection.  On 30-JAN-2021,the patient's son called to report what there mother was experiencing after receiving her second dose of moderna covid-19 vaccine yesterday 29-JAN-2021.He said that they went to check on their mother and they saw her throwing up and have a fever of 99 degree F.She also had severe back pain and feet were swollen up to the knees and arm of the injection site was sore but not too bad.  The outcome of the events were unknown.
This case was reported by a other health professional via call center representative and described the occurrence of polyarthritis in a male patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced polyarthritis (serious criteria GSK medically significant), fever and flu symptoms. On an unknown date, the outcome of the polyarthritis, fever and flu symptoms were recovered/resolved. It was unknown if the reporter considered the polyarthritis, fever and flu symptoms to be related to Hepatitis B vaccine. Additional details were reported as follows: This case was reported by the physician's assistant. The age at vaccination was not reported. The reporter thought, the patient previously received Hepatitis B vaccine over 10 years before the time of reporting. The call was transferred to medical information for additional questions. The reporter consented to follow up. This case has been linked with case US2019040212, reported by the same reporter.
This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dosing regimen and lot # unspecified). No concomitant medications were reported. It was reported that on an unknown date patient was vaccinated with ZOSTAVAX and the patient subsequently developed shingles. No further information pertaining to this event was reported. There was no product quality complaint involved. The outcome of herpes zoster was unknown. Causality assessment was not reported. Additional information has been requested.
Tested Positive for COVID-19 using BINAX Home test kit 9AM 12/8/22. Called doctor's office and had a telemedicine call on 12/9/22 at 8AM. I was not able to take any medicine (Paxlovid?) due to my current Rx's and health conditions per CRNP at clinic.  I started feeling bad on 12/6/22 in PM. I had a fever for 4-5 days (98.9 to 101.9). No fever on 12/11/22. I was extremely weak and had major aches and pains. I lost sense of smell for 2-3 days. I also had a runny nose for days with lots of mucous and sinus congestion. I did not have any chest congestion or much of a cough.
Initial report was received 12 November 2012 from a health care professional which involved a cluster of two patients. The other patient has been captured in case number 2012-10632. A 58-year-old female patient who had no current illness, had received a left deltoid intramuscular injection of FLUZONE, lot number UH752AB on 05 November 2012 and three days later, she developed shingles on her left arm, back, and on her left arm at the vaccination site. Laboratory and diagnostic data was reported as "none". The patient received treatment in the office (not specified). Outcome was reported as both recovered and not recovered (therefore, unknown). Documents held by sender: None.
The pt experienced urticaria on face, back, neck and chest. Treated with meds.
10/5/05 In arm right deltoid pneumoccal vaccine site, soreness, warm. Swelling, aching /// /// /// swelling down arm to armpit. Says she took ibuprofen /// also took benadryl last night. Edema progressed /// 4 fingers above her elbow in her right arm /// /// //// //// .
pt had episode of syncpe, following which pt was limp, then described as having stiffening & shaking of extremities x few seconds-occurred 15 mins p/vax; also considering vasovagal etiology
Breakthrough case admission after 2 vaccines pfizer 8/31/21 Lot# FC3182;  Pfizer 9/21/21 Lot# 301358A
Large ITCHY rash about a week after.  Still there 2 weeks out and is now "puffy" as if it has fluid
Patient was very nervous before getting the vaccines. About 2 minutes after receiving the vaccines, the patient worked himself up and was crying and asking for water. He passed out for around 10 seconds but regained consciousness very quickly. He was sitting down so he did not have any injuries.
Currently in Hospital ICU with muscle weakness unable to walk lift legs arm weakness progressively getting worse since 9/16/2022 day of both injections.  9/21/2022 today is first day of treatment IGIV.
late evening on 1OCT97 lt arm began hurting, was swollen, hot & red stayed this way for 2 days;instructed to use cool packs for 10min off & on;go to MD if gets worse;
Patient received tetanus shot on 06/30/2003 @ 08:30am.  At 21:10 down experioneal chest pain with brightness.  Also had nausea and all over body pain.  These symptoms continued until 07/03/2003 when symptoms resolved themselves.  Patient did not seek medical attention.
Pt recv vax & became hypotensive. Pt seen in ER. This is 1 of 2 reports from this site of adverse rxn following vax w/ lot #4978002
Regressive autism following full series of vaccines (immunization record enclosed). Currently chelating for heavy metals/mercury.
Patient entered monitoring area at 9:26 am.  She had been pre-medicated with Benadryl 50 mg 30 minutes before vaccine administration due to hx of anaphylatic reactions to medications in past.  Patient had also taken her routine Allegra 180 mg this morning.  At 9:36 am patient c/o itching in the neck & arm areas, some redness present.  Patient denied SOB, wheezing, lip/tongue swelling or light headedness or  abd. pain.  O2 sats 97%, pulse 72.  Patient given Zyrtec 10 mg at 9:45 am and at 9:55 am itching improved, O2 sat at 98%, B/P=163/99, pulse 72 and patient states feeling much better.  Given famotidine 20 mg and VS 179/76, pulse 68, O2 sat 96% and states feeling betted.  One hour post injection, patient feels safe
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13May2023 as dose 6 (booster), single (Lot number: 066H22A) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID given from 12Aug2023 to 17Aug2023. No follow-up attempts are possible. No further information is expected.
Patient was administered a pediatric dose of Pfizer and then immediately administered an adult dose of Pfizer once administration error was discovered per CDC administration error revaccination guidelines. Patient was made aware of administration error immediately. No adverse symptoms were noted at time of administration.
pt recvd vax 31MAY95 & w/in minutes p/vax exp nausea & vomiting;pt seen by MD & tx w/Donnatal p/vax;sx resolved the same day as the day of onset;
Severe constant headaches and low grade fever. Increasing worse with each day. Seen by the ER twice and regular physician and GI. No one can find any other reason for these symptoms.
Information has been received from a nurse referring to four unspecified patients of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored (Merck) PROQUAD (lot # K008185, expiration date 05-DEC-2015, dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient complained of swollen arm, itchiness, bruising that spread down to elbow and soreness when lifting arm
101.7 fever later same night vaccine was administered, as well as red and warm to the touch at site of injection. Better next am, but then developed a rash/hives and swelling size of a fist at the site of the injection 12/16/19.
Client reports swelling in both hands after receiving the vaccine Fire Rescue evaluated patient.  Patient had her own Benadryl and self administered 25 mg. orally.  Swelling began to decrease and BP lowered as well.   No presence of hives or SOB.  Per Fire Rescue no further evaluation needed.  Client released at 12:00pm.
This RN returned and contacted office to discuss reactions to intramuscular influenza vaccines. She advised first influenza vaccines was given in 1999. Her medical records documents split influenza given 7 Nov 1999 (unknown manuf/lot#). She recalls getting a large red bump to her arm about size of an orange that extended up to her shoulder that lasted about 3-5 days. She recalls same thing occurring in 2000 (no vaccine documented) with addition of hives extending to her face/neck and upper chest region (above bra line), had sniffles, her throat itched, and her right eye was swollen. She recalls self-treating and doesn't recall any ER/medical visits as worked with medical teams. She did not receive another flu vaccine for the next several years. Her medical records list other split influenza with unknown manufacturer and lot number given on 17 March 2004, Oct 2006 (MedImmune 500433P), 25 Nov 2009 (H1N1), and 25 Sep 2010, and she reports progressive site irritation (small erythematous area at site that would progress each year). On 21 Sep 2011 patient requested flu vaccine given due to increased risk of exposure as a health care provider. The MD pretreated her with oral ZYRTEC and ZANTAC given possibility of allergy to vaccine component prior to administration of IM Influenza preservative free (per 21 Sep 2011 note). She recalls "3-4 hours later while napping (got sleepy from "BENADRYL") she heard strange noises only to realize she was wheezing, tachycardic, had increased congestion, hives and eyes swollen". She notified nursing staff in medical. This note documented bilateral bronchial wheezing with no accessory muscle use otherwise normal physical exam (no vital signs found) and treated with Albuterol MDI with resolution of symptoms. She again went to sleep and felt better upon awakening. Since then she has not had IM influenza. She reported a "similar" adverse reaction during a prolonged dental procedure (root canal) on 2 April 2012 (date per medical records). Providers document 30 minutes after injected with lidocaine with epi she began to experience shaking in arms, face and jaw, heart racing and felt lightheaded (no note in dental records on this event). She never lost consciousness, but had to fix her gaze on one spot for senses to return. She reported total of 2 episodes, one on the ship and one in the clinic during a period of 1 week following multiple palatal injections. Records document on 16 April 2012 and 16 May 2012, she was evaluated by allergist for possible allergy to lidocaine with/without preservative. Allergy testing to lidocaine with and without preservatives was tolerated well with no adverse reactions. Providers note documents latex IgG titer sent on 18 April 2012; however no results were found. Vaccine history: Records list FLUMIST was given 22 Nov 2008, 28 Aug 2009, 28 Aug 2012, 09 Oct 2013, 22 Oct 2014, and 01 Oct 2015 (records list both mist and IM given). She concurrently received other vaccines from 2000-2015 to include MEN, MMR, Typhoid, Td/Tdap, YF, and AVA without adverse reactions. Allergist note 18 Apr 2012 lists possible hepatitis B non-responder with negative varicella IgG, and positive MMR titers from 2009.
On 1/30/2007 pt had fever of 99 and a few lesions: 1 spot on her right thigh with some surrounding erythema and induration, but no fluctuance.  There was no head to it and one other excoriated papule on her stomach.
started itching very bad from shoulder to elbow; arm got a little bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (started itching very bad from shoulder to elbow) and VACCINATION SITE SWELLING (arm got a little bit swollen) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0015214) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LYSINE, FLUOROMETHOLONE, LATANOPROST, BROMOCRIPTINE MESILATE (BROMIDINE), LISINOPRIL, COLECALCIFEROL (VITAMIN D), BIOTIN and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (started itching very bad from shoulder to elbow) and VACCINATION SITE SWELLING (arm got a little bit swollen). At the time of the report, VACCINATION SITE PRURITUS (started itching very bad from shoulder to elbow) and VACCINATION SITE SWELLING (arm got a little bit swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  Other Concomitant mediation included: Samciclovir, Timnol, amoidaodine and Water pill.  Treatment: Alcohol.
Patient received FLUZONE HD on 10/9/13 and reported a itchy rash on her legs and arms on 10/14/13. She said it started a day or 2 after she received her flu shot.
My child had an allergic reaction. Her arm swoll up, she was in pain, and the clinic is not sure what they gave her. They think because their clinic had one more of this and one less shot of that, that is what my daughter received.
Pt recvd 3 doses of Hep B vax & did not respond;
Hypotonic, hyporesponsive episode, pallor, emesis, loss of tone ("went limp"). Admitted for observation. 03/13/2008 MR received for DOS 12/18-20/2007 with DX: ALTE.  Mom reports that 2 hrs after immunizations child was crying, became pale and stopped breathing.  Child became dusky a few times, had one episode of diarrhea and vomiting.  PE in ER WNL.
a 20 months old male patient was inadvertently administering ActHib with a wrong diluent, No AE; Initial information received on 25-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 20 months old male patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] (lot number UJ121AAE and expiry date: 05-Dec-2020) via an unknown route in the right thigh for prophylactic vaccination on 19-Aug-2020.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (Product preparation error) (same day latency).  It was reported that the nurse had inadvertently reconstituted ActHib with the wrong diluent. The product was administered to a 20-months-old baby on August 19, 2020.   No adverse reactions 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.
Began getting extremely tired and weak and stomach started to feel sick.  Several hours later threw up food and beverage. Several hours after that, shivers, headache, dizziness, fever highest at 102.5, extreme stomach pains, hurt to touch, vomiting.