chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HPI Rash The problem is new.  The current episode started  3 days.  Since onset, the problem has been gradually worsening (spreading).  Affected locations include left arm.  Symptom characteristics include warmth and redness.  Exposed to: Had herpes zoster vaccine 4 days ago.  Associated symptoms include fatigue (slight).  Negative for non-blanching rash, headache, sore throat, stiff neck, joint pain, anorexia, congestion, malaise, swollen glands, vomiting, myalgias, cough, diarrhea, nail changes, facial edema, painful lesions, fever, shortness of breath and rhinorrhea.  Treatments tried: Ice and motrin.  Tetanus  status is unknown.  PMH includes Negative for diabetes, immunocompromised, MRSA, psoriasis, strep, asthma, allergies, eczema, varicella series (had disease) and mmr series (had mumps). Pt had herpes zoster vaccine administered by a pharmacist 6/4/16 and 6/5/16 developed redness, warmth, itching +  swelling to site on posterior left arm that has been increasing in size. has been applying ice and taking ibuprofen w/ effect.
pt recv vax 2NOV95 & became pregnant (LMP 20NOV95) estimated delivery date 27AUG96;ultrasound (date unspecified) was nl;@ 24wk pt devel bronchitis & tx w/ATB;@ 32wk pt exposed to natural varicella;A male infant born @ 37wk w/hypospadias;
Information has been received from a nurse concerning unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of RECOMBIVAX HB (dose, strength, frequency, route, lot # and expiration date were unknown) were administered to the unspecified patients for prophylaxis. The RECOMBIVAX HB were exposed to following temperatures: from 35 Fahrenheit to 49 Fahrenheit, 32 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit and 35 Fahrenheit for a time frame of 24 hours, respectively. No adverse effects were reported. Data logger was involved, but no previous temperature excursion was reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003951: US-009507513-1612USA003952: US-009507513-1612USA003950.
after recv vax pt devel large red swollen area on rt arm region c/o itchiness on 5/27, no itchiness on 5/28 & temp 97.8 po
Saturday afternoon start to feel fatigue  8:00 pm 102.7 degrees (2 Tylenols)  9:00 pm 103.2 10:00 pm 103.7  11:00pm 2 Tylenols 11:00 102. degrees Frim 8:00 - Monday 7:00 am; pain was immense; legs, arms, abdomen, jaw, neck and a headache to the moon and back. offset every 4 hrs Tylenols' Monday; continue pain on right side, left chest and headache; continue to us Tylenols' every 4 hrs.
pt recv vax 2MAY97 & 12MAY97 pt devel varicella consisting of 10-15 lesions/papules on erythematous base on hands, wrists, & inner thighs;did not exp fever or lethargy;
Developed left lower leg pain the follow day after receiving his second COVID vaccine.  Still persistent to date.
Patient was given vaccine dose outside of the EUA authorized age range (16yo and time of vaccination).  Mild flu like symptoms (headache/achy the day following shot) but no other adverse events reported.
prolonged crying/screaming approx 5 hrs; limp, pallor for few hrs approx 4 hrs p/vax;
Low grade headache all day followed by low grade fever starting around 4pm. Fever reoccurred at night for next three days. I just rested and got extra sleep until the symptoms went away.
red swollen area at site of DTaP non tender, no streaks, no treatment needed.
I received the shot at approximately 9:30-10:00am(which was my second dose). By 8:30pm, I had severe pain in my arm and I had a headache. At approximately 3:00am, I was awakened by a fever of 102.8. I was extremely weak, had a headache, and felt what I can only describe as delirious. I am quite confident these symptoms were a result of the fever. Despite rotating Tylenol and Motrin, I was unable to get the fever under control. This fever lasted for approximately 3-4 days. The severe pain in my arm remained for about a week. I'm no stranger to shots, and I'm certainly not sensitive to them. I have never experience pain from a shot like this before. Since receiving the second dose I am also experiencing hot flashes. Some of these hot flashes are quite severe, and others feel like I have a mild fever. They generally last for an hour or two. They have not gone away, but they do appear to only be occurring once or twice a day now, with a severe one occurring every couple days.
Extreme body chills (4 hours), body aches, headache, temp 102, sick to stomach, huge rash softball size, hard bump surrounding injection site
100.5 fever. Aches, chills, everything hurt, nausea, exhaustion. Lasted 24 hours. Then fatigue and nausea for 2 more days.
Dizzy, racing heart, panic/anxiety in the middle of a college lecture, felt like I was going to pass out, felt like I had been hit by a train starting at 11:30am. By 4:30pm I went to bed feeling so horrible.
Fever of 102, rash, headache, nausea, body ache, tenderness and pain on right arm.
received an expired dose of Menveo, it expired on 31Mar2021 / administered on 14Apr2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA419A, expiry date 31st March 2021) for prophylaxis.   On 14th April 2021, the patient received Menveo. On 14th April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The healthcare provider reported that on 14th April 2021 the patient received Menveo which was alredy expired on 31st March 2021. The reporter consent to follow up. The reported batch number AMXA419A for Menveo did not exist and was updated to AMVA419A as per the sales datasheet.
after 10 min I started a headache, then felt lightheaded getting worse as time pass, then my lips started to tingling, then my cheeks, then my tongue. My cheeks started to get red and a bit swollen, then my breathing was getting weird, my blood pressure rise. At that moment I agreed to go in the rescue.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4358310-00 (RA). A 40-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for Covid-19 immunization; adalimumab (HUMIRA), (Lot number: 1155993) at unknown (citrate free), subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Covid". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for BNT162b2: The reporter's causality for the event(s) of "Covid" with BNT162b2 was related (reported as Possible). Causality for adalimumab (HUMIRA): The reporter's causality for the event(s) of "Covid" with adalimumab (HUMIRA) was a reasonable possibility. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on available information the events of Drug ineffective, Covid-19 are assessed as possibly related to the suspect vaccine BNT162B2 based on temporal association.
Severe diarrhea and some night sweats. It lasted until the evening of March 3rd and I took pill pepto bismol that evening to control and again the following morning but the next night, the night of March 4th I had the night sweats. The diarrhea started with stomach pains on Sunday morning the 21st of February. I also had arm pain, and fatigue and a couple of night sweats Saturday the 20th. The diarrhea seems to be under control with the pepto bismol but I heard some rumbling last night.
Developed maculo-papular discreet lesions over chest and back day 12 after smallpox vax. No other symptoms. Appears like the multiple other cases of white young males with similar lesions, non-pruritic.
administration of Kinrix to a 4 month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Oct-2022 Reporter's comment: Nurse called to ask information about the administration of Kinrix to 4 month old patient. The reporter asked for safety information as well as how to proceed with this patient. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
onset at 4:00 p.m. of body aches, lasting until 5:00 PM following day fatigue lasting approximately one week
Starting ~1 1/2 hrs after 2nd DTaP baby started uncontrollable crying that lasted at least 6 hrs.  He felt hot but temp. not checked.  Would not eat.  Went limp between crying spells.
It began on 01/01/2023 as a rash on my right arm. Over the course of about 7 days, the rash spread from right arm, left arm, both legs, hips, then my upper back. I had intense itch, raised tiny bumps with almost like little blisters on them. Then it progressed from raised tiny bumps to diffused red patches, bruised, and intense itch on my whole body. It is still ongoing. It is beginning to resolve after I saw the doctor yesterday. I saw my primary doctor on January the 11th. At that point in time, I started taking CLARITIN, hydroxyzine, and betamethasone valerate with no improvement so then I went to a dermatologist. He added prednisone, and now my rash is resolving. He told me it was a systemic hypersensitivity reaction to a medication or something I breathed in. Note that I had also had my air ducts cleaned in my home and a lot of the dust came back into my house that may or may not have caused this.
VOMITING; PAINFUL HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 23 year old male. 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: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced vomiting. On 11-MAY-2021, the subject experienced painful headache. On 11-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 11-MAY-2021, was recovering from fever, and had not recovered from painful headache. This report was non-serious.
1st dose 05Jan2020, 2nd not yet; Unknown allergic reaction; This case was reported by a physician via sales rep and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2020, the patient did not receive the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 5th January 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the allergic reaction and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Feb-2023: The patient received first dose of Shingrix. The patient experienced an unknown allergic reaction.  The patient had not received second dose.  The healthcare professional inquired about giving second dose now.  The adverse event contains all information reported information.  The patient saw email to safety team regarding sales representative contact information.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Vaccine was expired at time of administration, it was past the 10 weeks in fridge.  Vaccine expired on 3/30/22.  Left voicemail for patient to call back to let her know cdc advices re-vaccination.
Entire left arm tingling, weak, pain in injection site area and forearm.  Pain continues up left side of neck and head, headache pain on left side of head and front left forehead.  General fatigue.
(L) arm swelling, redness, hot to touch x 2 days, no fever. Relieved by BENADRYL and ice.
After Dose #1, I had fatigue but a day later had knee pain which progressively got worse until I could not walk.  After Dose #2 on March 12, 2021, sharp pains continued involving the knee, the shin, the ankles and feet.  The lower half of my body ached so bad I could not sleep.  The pain was always worse at night while laying down.
Within about a day I developed itchy skin on my back which migrate to my sides, stomach and back of my neck and shoulders. The itching was accompanied by red and lightly blistered skin rash. This lasted about a week. I had a similar kind of allergic reaction to the drug DEPLIN years ago. In addition to the redness and itching my skin seemed to have small raised bumps like goose bumps. My skull also seemed to dry out and my only treatment was some moisturizer cream and it seemed to clear up in about a week.
Information from the review of scientific literature was received on 19MAR2018. A 22 year-old male experienced autoinoculation, post-vaccination nonviral pustulosis, fever, myalgia, headache and fatigue following immunization with ACAM2000. Nine days after receiving ACAM2000, the male presented with complaints of a pruritic rash on back, shoulders and right thigh; subjective fevers, generalized muscle aches, severe headache and fatigue. The patient reported a recent history of severe sunburn with blistering on back and shoulders just before vaccination; otherwise no significant medical history. Upon exam, his vital signs were within normal limits. He appeared uncomfortable with several 2-3 cm umbilicated pustules and surrounding erythema on his back and shoulders. He had several erythematous non-umbilicated 1 mm perifollicular papules on his right thigh. His inoculation site had become a 1.5 cm circular pustule with a central fissure weeping purulent material and a large area of surrounding erythema and induration. Real-time polymerase chain reaction (PCR) assays from two vesicular lesions detected orthopox DNA. Further analysis confirmed vaccinia in both specimens. Generalized vaccinia was considered due to the presence of systemic symptoms which suggested viremia. However the systemic symptoms could also be explained by post-vaccination immune response or the hematogenous spread of vaccinia. The author suggested that a strong argument could be made for autoinoculation versus generalized vaccinia due to the recent history of sunburn upon immunization which may have created the tendency to scratch pruritic areas with contaminated fingers causing the transfer of vaccinia to skin with poor epithelial barriers due to the sun damage. The case met criteria for confirmed inadvertent autoinoculation per CDC case definitions, but did not meet criteria for generalized vaccinia. Separately, the outbreak of small perifollicular papules and pustules on his thigh were most consistent with non-viral pustulosis. The patient was closely monitored and treated with symptomatic medications over the next 10 days; his fatigue, muscle aches, and headache resolved and his rash scabbed over and dissipated. Sender's Comments: This report was retrieved from a literature article describing a 22 year old male who experienced autoinoculation and pustulosis following sunburn and vaccination with ACAM2000.
Anaphylactoid rxn reported; pt had 1st flu shot in NOV91 & had an immediate rxn characterized by coughing, rhinorrhea & tightness in throat (was in mild distress); pt was fine in 2 hrs w/o rx; no egg allergy;
Red bump on my forehead; it feels like kind of sore when I touch it; Red bump on my forehead; it feels like kind of sore when I touch it; She is getting red bumps today on the part where she got injected; Sore arm; I get this pain in my pointer finger in my right hand; A little weakness in my right leg; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 75-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 75-years-old) as a single dose for covid-19 immunisation. Medical history included high blood pressure, osteoporosis and overactive bladder. The patient concomitant medications were not reported. The previously had first dose (first shot) of BNT162B2 for covid-19 immunisation and had sore arm. It was reported that she is getting red bumps today (on 07Feb2021) on the part where she got injected. The consumer stated after second shot also, I had no symptoms except for sore arm on an unspecified date in Feb2021. The only thing that I noticed which was from second shot and which was really crazy is, once in a while I get this pain in my pointer finger in my right hand and that was it, it comes and it goes. But today, and in the last couple of days I noticed a little weakness in my right leg, but today when I went to work somebody said what is that big red bump on your forehead and I looked and there was a big red circle, there was a bump, like a real bump on my forehead. I didn't hide it, I didn't even think if it was allergic as I only had a banana before I went to work and a cup of coffee which I have lot of time. I am wondering if this bump that I have on my forehead which looks ridiculous and it is a big red bump, like a tumor bump, it feels like kind of sore when I touch it, is from the vaccine because I haven't had anything but the vaccine." Consumer stated, "Main thing I am concerned about is the big red bump on my forehead." Treatment: Consumer stated, "I never had that before, it is very slight. The main thing was the bump on my head that came today and I didn't have it when I left the house. I didn't hit my head or anything. I just took two Tylenol and an allergy pill in case if it was some kind of allergy." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fevers, Generalized weakness, Paresthesias and Pain in extremities, joint pain, swelling, shortness of breath, balance and dizziness and multiple falls, ataxia, peripheral neuropathy, autoimmune triggered chronic inflammatory demyelinating polyneuopathy along with arthralgias and vertigo, tinnitus, amnesia, fibromyalgia, fatigue
Information has been received on 05-FEB-2019 from a lawyer and a female patient regarding a case in litigation. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) in 2015 at a physician office, by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On an unknown date, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the vaccine ZOSTAVAX and/or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Severe body aches, felt "like I was paralyzed" headache, fever, chills, SOB wheezing 3 hours after receiving flu vaccination.
Pt grandmother states around dinner time pt became very sleepy hard to keep awake, after going to sleep awoke after about 30 minutes. Vomiting and vomited several times from then until midnight. No elevated temp or other s/s next morning. Pt was well and has had no symptoms since.