chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INJECTION SIGHT ON RIGHT LEG RED AND SWOLLEN, PT FUSSY ON THE 6TH.  10TH FEVER OF 102.2 STILL RED AND SWOLLEN PT IN PAIN AND FUSSY CONTINUED.  13TH DR VISIT FOR URI AND CONTINUED FEVER, SPIKES AT NIGHT, VERY FUSSY AT NIGHT CEPHALEXIN MONOHYDRATE PERSCRIBED, VOMITING.  14 EMERGENCY ROOM 102 WHEEZING SEAL LIKE COUGH, RSV, DIAPER RASH, MILD BREATHING PROBLEMS, RED LUMP STILL IN LEG.  TOUNGE CLIPPED BACK AGO AND EAR TUBES PLACED AND STILL NOT TALKING,  LOSS OF LANG AFTER MMR.....XED WITH BRONCHITIS.  DAY AFTER ER VISIT DECREASED APPETITE, AND ACTIVITY DXED WITH CROUP, QUESTION OF ASTHMA DETERIORATED.  AFTER NOT GETTING BETTER AND HEARING CONTINUING TO NOT IMPROVE AND LANG COMPLETELY GONE, MOTER SKILLS DETERIORATING.  REFERED TO FIRST STEPS EARLY CHILDHOOD INTERVENTION PROGRAM FOR THERAPY HELPS.  EAR INFECTION NOT GOING AWAY OR IMPROVING AFTER MONTHS OF ANTIBOTICS, BRINGING ON HEAD BANGING LANDING HIM IN THE ER FOR SCAN AND UNCONTROLABLE WEEPING,  CONTINUING FRUSTRATION IN COMMUNICATION DIFFICULTIES.
I (unknowingly at the time) was pregnant at the time of my vaccine administration. I didn?t find out until a week or 2 later. My estimate due date was 12/26/2021. I did end up miscarrying this pregnancy on 4/22/2021.
Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (5mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Woke up at night feeling nauseous , went to restroom, came out and fell due to blacking out. Came to and was sweating  profusely. Weakness the whole of next day and then was ok after that. Happened  approx 3 weeks after first dose. Also was already suffering from severe pinched nerve in neck (this came on suddenly a week or so after the vaccination.. no accident or injury,  not sure if anything to do with vaccine) and was taking pain killers.
VACCINE LEAKED OUT DURING ADMINISTRATION; PARTIAL DOSE ADMINISTERED; This spontaneous report received from a patient concerned a male 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine leaked out during administration, and partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine leaked out during administration and partial dose administered was not reported. This report was non-serious.
Approximately 3 minutes after Gardasil injection, patient began slumping forward in her chair, and then began slight jerking movements.  Patient exhibited these movements for only 5-10 seconds.  After sitting for about 15 minutes, patient began feeling better.  Patient denies losing consciousness; however, reports "feeling dizzy".  Patient has not eaten anything today, but has had a soda.  (it is 1:42 p.m. now)  DepoProvera was administered immediately after Gardasil in the opposite arm.
Patient received vaccine on 5/4/18 and started itching the night of 5/5/18. On Sunday morning 5/6/18, patient woke up and throat was closing. The patient went to the ER and contacted us 5/7/18 about the incident.
Pt with rash onset 5/10/15 and temp 100.0 range last night. Pt. had varicella vaccine 5/1/15. No recent travel. Water filled vesicles on red base of face, trunk, genitals, and extremities noted on 5/11/2015 office visit. Dx: Varicella s/p vaccine.
This spontaneous report as received from a physician via a field representative refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (unknown route, dose and strength) for vaccination. The patient had received other two unspecified vaccinations on the same day of vaccination with ZOSTAVAX. On an unknown date, after being vaccinated, developed a rash on her arm, arm not specified. The patient was referred to dermatologist. The outcome of the event was resolved on an unknown date. The reporting physician and the dermatologist stated that the rash was not from the ZOSTAVAX vaccination. Additional information is not expected as the reporter did not provide consent for further contact.
Atopic Dermatitis.  A small patch started 4 days after 2nd Shingles shot.  Progressed, spread  and now impacts most areas of the body.  moisturizing skin.
Developed hives and swelling 5 hours after receiving vaccines. Hives were only on the face, nowhere else.
urticaria secondary to anthrax vax;rash persistent on & under arms & in groin area;
erection lasting more than 3 hours ( it's ok now but just thought i should report it ).
7 1/2hr p/vax given noted pain, black & blue bruise;muscle ache stinging, burning sensation;9OCT97 bruise measures 2 3/4 x 1 1/2 & client went to work today;hard knot is felt when area pressed;
Case number PHEH2012US023031 is an initial spontaneous report received from a nurse on 20 Nov 2012: This report  refers to a patient whose identifiers were not reported. It was reported that the patient received only the MenCYW-135 liquid component of MENVEO vaccine (batch number: not reported) intramuscularly without being reconstituted with MenA lyophilized conjugate on 16 Nov 2012. No other adverse reaction was reported following this administration error.
C/O swelling and redness at injection sites Tdap. (L) arm induration 4 1/2 in long x 5 1/2 in wide. MENACTRA (R) arm induration 6 in long x 7 1/2 in wide pulse strong good cap refill.
Swelling, redness, warmth to touch (R) arm 5" x 5" upper arm.
Immediate bleeding. Immediate swelling and purple hematoma at injection site-about 3/4 inch wide. Immediately administered cold pack.
Information has been received from a nurse concerning an approximately 74 year old male consumer with no known allergies, high cholesterol and a history of "arterial flutter corrected with ablation" who on 09-APR-2008 was vaccinated SQ with a first dose of zoster vaccine live (Oka/Merck) (lot # 659762/1874U). Concomitant therapy included CARDIZEM CD, ezetimibe (MSD), FLOMAX, saw palmetto, aspirin, niacin, SYNTHROID, simvastatin (MSD), PAXIL, folic acid and RISPERDAL. Subsequently, the patient developed a tender area on his scalp. On 22-APR-2008 or 23-APR-2008 the patient was seen by a dermatologist and a culture of the area was performed. The results can back as shingles. At the time of the report this patient was recovering. There was no product quality complaint involved. Follow-up information indicated no new information. Follow-up information from the registered nurse indicated no new information. Additional information is not expected.
This spontaneous report as received from a nurse and refers to a 15-month-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-JAN-2019, the patient was inadvertently vaccinated with less than recommended dose of M-M-R II (dose, strength, frequency, lot# and expiration date were not reported) subcutaneously for prophylaxis. No adverse effects were reported.
Guillain-Barre, currently in the Hospital receiving treatment.  Started with severe abdominal pain then transitioned into the loss of feeling in both legs within 24 hours.
from the day after the injection, a 3 by 1 inch bruise formed around the injection site on left arm. it is hot to the touch, the tissue under the bruise feels hard/callous, and is painful when touched. bruise and other symptoms persist until 7 days (today) after the vaccination
Therapy non-responder. This case was reported by a healthcare professional and described an adult female subject who did not respond to immunization to hepatititis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis. On an unspecified date before 03 October 2006, the subject received 3rd dose of Engerix-B. On 03 October 2006, at an unspecified time after vaccination with Engerix-B, a hepatitis B surface antibody titer was negative.  Relevant test results included [laboratory results/hospital investigations].  At the time of reporting the outcome of the event was was unspecified.
This spontaneous case reported by a nurse, describes the occurrence of inappropriate schedule of product administration (received their second dose of Moderna 7 days early) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced inappropriate schedule of product administration (received their second dose of Moderna 7 days early). At the time of the report, inappropriate schedule of product administration (received their second dose of Moderna 7 days early) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Feels like Nerve pain all over my body---my back, legs, arms, etc. And absolutely no energy and nausea.
36 HOURS OF FEVER , WENT UP T0 104.2, SEVERE CHILLS,  SWEATING, BODY ACHES
That evening I had tiredness (was exhausted) slept through the evening and night. I was very cold. Then next morning, I had a terrible migraine and I felt nauseated and like my muscles and skin ached (flu- like symptoms). That evening , I had a the migraine still but all the symptoms were gone but the migraine lasted a couple of weeks and it was much stronger than it normally is. I do have a migraine every day but this was much stronger. I took a few Flovatriptin - acute treatment for migraines and then just stayed in bed for about the whole two weeks - and used a lot of ice and tried to sleep.  After speaking with my doctor, I tried a new medication for me -  URBRELVY - doctor prescribed (Televisit with doctor). And that took the migraine away.
Case number PHEH2016US031086 is initial spontaneous case received from other health care professional on 25 Nov 2016. This report refers to male patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1620301, expiry date not reported) at a dose of 0.5 ml intramuscular on 24 Oct 2016. On the same day, the patient experienced localized tenderness and painful range of motion. The patient received large doses of NSAIDS (unspecified) and ice to improve. The patient could not use arm for 2 to 3 days. The outcome of the events was reported as complete recovery on 28 Oct 2016. The seriousness of the events was reported as disability. The causality of the events was not reported.
pt devel fever 27AUG97 in AM;t100;by that eve T103.6 pt treated w/Motrin;28AUG97 AM t102.6;pt recv motrin p/ 1/2hr t102.6;pt put in bath tub t101.4;pt c/o sore rt arm & dec appetite;no local redness or swelling @ inj site;
7 days p/vax mom noted swelling in deltoid area rt arm; pt has t100 orally, heat & swelling @ site;
Information has been received from a registered nurse concerning an 8 year old patient who was vaccinated with a dose of VARIVAX (Merck) (dose unspecified) and had a chickenpox breakthrough. At the time of report, it was unknown if the patient recovered or not.
Arm is still sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 17th February 2022, the patient received Shingles vaccine. In February 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced arm soreness. Consent to follow up was not possible as no contact details were available.
Shivering  Muscle pain Tiredness Lethargic Pain in arm Fever
Pt recvd vax 29JUL91 on 1AUG91 generalized aches, lightheadedness syncope; 4AUG91 - 10AUG91 weakness, fatigue, h/a, elbow knee pain, local rxn lt arm, redness, induration;
Pt fully vaccinated as of 2/24/21, COVID+ on 7/3/21 seen in ED
Dizziness, flushing, chills, blurred vision, and weakness. Symptoms began within 10 minutes of vaccination. Lasted for 15-20 minutes before subsiding.
Fever/shaking chills (severe)/nausea/palpitations. Fatigue/malaise/dyspnea (moderate), disequilibrium.
Patient presented to the Hospital Emergency Department complaining of redness and warmth in Left arm. Physician administered SOLU-MEDROL 125 mg IM x1 and prescribed oral prednisone.
Pt c/o chills, nausea and low grade fever x 2 days after receiving vaccine. Also c/o redness and swelling of the injection site. Redness and swelling have improved by time of reporting, but still mild.
1) red rash on left thoracic region where lymes rash was this past summer, Lyme was treated X 3 weeks, no further S & S. 2) redness, warmth and swelling at site of vaccine 3) fever of 101/4.
Rash on upper L body chest over shoulders & back. Red, raised, bumpy, no blisters Fading more every day. The rash is itchy. Gave her Zyrtec 10mg qd & Hydrocortisone 1% Cr prn
Narrative:  74 yo M with a PMH of colon cancer who received second COVID-19 vaccination and subsequently experienced TIA 48 hours later. Patient was seen at OSH where MRI revealed chronic right cerebellar infart. No additional details known.
She has a distinct abnormality in her left foot; she lifts her foot up as if she's had a stroke. She had hemorrhaging in the left thigh. After receiving her vaccine, she had "COVID-19 arm" and pain for a couple of days. I took her to the hospital and she saw a cornea eye specialist due to constant tearing in her eye and pain. She had 2 CAT scans to rule out possibility of suffering a stroke. She also had a Doppler and x-rays to rule out other conditions. She's been seen by neurologist and other specialists to try to determine a diagnosis of the pain and adverse event she's suffering from. No one from the clinic associated any of her symptoms to the vaccine she received, but she has follow-up appointments for further diagnosis and investigation.
My upper back became flushed and a mild rash developed and disappeared about 30 minutes later. I had small mild  rashes on my stomach and back that that lasted until Saturday. My skin felt a bit itchy and prickly in some places.
Initial unsolicited report received from nurse on 01 Feb 2017. This case involves a 39-year-old male patient who was vaccinated with first dose of ADACEL (batch number: U5458DB, expiry date: 28 Sep 2018 ) in left deltoid; tested with a first dose of TUBERCULIN PPD(M) 5 TU (TUBERSOL) (batch number: C5022BA, expiry date: 14 Oct 2018) in left forearm; with a first dose of HEPATITIS B VACCINE (HEP B) (manufacturer: Merck ) in right deltoid on 27 Jan 2017. The patient had no Illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. The patient did not received any concomitant medications. On 28 Jan 2017, one day following the vaccination, the patient had developed arm soreness at the injection site (which was noticed on 30 Jan 2016, when patient came for PPD reading). On an unknown date, following the vaccination the patient had pain in the axilla and he can't palpate any lymph nodes (at the time of this report). It was reported that, he will be seen by the physician depending on the am evaluation. Lab investigations were not performed. The patient was treated with anti-inflammatories. The patient was not recovered from both the events. List of documents held by sender: none.
This spontaneous report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified patients were vaccinated with improperly stored doses of MMR II (dose, route, Lot No. and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter.
6/9 scratchy throat. Rapid test positive.  6/10 second Rapid test in clinic, positive.  No additional symptoms, 6/11 got cough medicine from local pharmacy.  Experienced slight congestion and occasional cough.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 16-DEC-2014 the patient was vaccinated with an improperly stored GARDASIL (lot # K004204, expiry date 12-JAN-2017) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from reporter. Additional information has been requested.
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a pharmacist concerned a 69 year old female. 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, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-AUG-2021, SARS-CoV-2 test was done to detect spike protein and result came as negative antibody test on 17-AUG -2021 (Confirmed immunological vaccination failure). On unspecified date in AUG-2021, again covid-19 antibody test was done which came negative on 23-AUG-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000190644.; Sender's Comments: V0. 20210846353-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Rash to face started 2/9/21 evening incontinence of urine,  2/9/21 overnight nausea, stomach pain  2/8/21 daytime/afternoon
Sore arm, fatigue,chills ,nauseousness ,vomiting  on 12/292020 . Chills ,nausea, vomiting started around 6 pm
Received shingles shot on 9/9/15. Patient presented to the pharmacy on afternoon of 9/12 saying that she had been having headaches on 9/11 (not present 9/12) and showed pharmacy her arm, didn't report exact time she noticed it.  There was a red rash/nodule consistent with a local allergic reaction at the injection site.  Explained to patient that she was likely having an allergic reaction to vaccine, advised Benadryl and a hydrocortisone cream.  Patient stated she didn't want to purchase these items and might feel better if she went to an urgent care clinic.  Told patient it did appear to be allergic but understood if she wanted to get it looked at to ease her mind.  Went to urgent care clinic.  MD told her it could be allergic reaction, gave her Medrol dose pack along with antibiotic in case of any infection at the site.
Resident c/o L arm pain on 4/7/2021 approx 2300. Resident transferred to ED for evaluation, CT abnormalities, transfer to higher level of care, clot manually removed on 4/8/2021, resident returned to nursing facility on 4/12/2021 without complications
Treatment of COVID-19; Treatment of 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 patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. 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) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Anti-viral details: Product: COVID 19 Treatment, brand: Pfizer, Treatment start date: 15Jul2022, Treatment stop date: 19Jul2022, Indication: Treatment of COVID-19. Reported Event: Rebound symptoms 3 days after completion. Positive test again. Symptoms worse than original.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right thigh with moderate erythema to majority of thigh, warm to touch and puncture site in middle or the erythema. Erythema is Blanchable, with some blotching noted. There is no pain, no tenderness with palpation. Follow-up in 2 days unless worsens, will be seen sooner.
This spontaneous report was received from a Nurse Practitioner and refers to an 18 year old female patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisiting allergies, birth defects or medical conditions. At 11:15 AM on 04-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). At 11:00 AM on 04-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the right arm (dose not reported). Both doses of the vaccine administered to the patient were improperly stored as they underwent a temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
This case was reported by a healthcare professional and described the occurrence of inappropriate dose of vaccine administered in a 2-month-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent vaccinations included unspecified vaccine(s); given on 29 February 2008.  On 29 February 2008 at 13:00, the infant subject inadvertently received an adult dose of Engerix B (20 mcg, unknown) as his 2nd dose of the vaccine.  The reporting healthcare professional considered the event to be clinically significant (or requiring intervention).
I received a booster of the Pfizer Vaccine and now have Bells Palsy . My symptoms started 3 days after receiving the booster. Still have Bells Palsy.
Severe chills/fever/body aches/nausea/headache/fatigue/closed eye hallucinations/sweating/mediciney aftertaste/sweat smelled like medicine/dizzy.  All were severe and lasted for 3 days and I was unable to even function for 2.5 days.  Dizziness has lasted longer.