chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with tingling in the tongue, felt like it was crawling through her arm to her lungs, then exploding out from there.  Blanched, then at 7 minutes, felt like would pass out. Felt like chest was tight, making it difficult to breathe. but was moving air.  When she got home, then had 100 Benedryl, and then 5 hrs of rigors and chills.  The next day, was exhausted.  Chest burned until Saturday, but no difficulty with breathing.
Information has been received from a consumer concerning her 12 year old daughter with allergic reaction to AUGMENTIN who on 220DEC-2009 was vaccinated with the first dose of GARDASIL (lot # not reported). On 23-FEB-2010 the patient was vaccinated with the second dose GARDASIL (lot# not reported). It was reported the patient experienced swelling, stiffness and stinging at the injection site after each of the two doses of GARDASIL. No medical attention was sought. Vaccination with GARDASIL was continued. At the time of this report, the patient had recovered after being on therapy. Additional information has been requested.
Client's mother describes the daughters arm as achy at times with a indentation approximately 3" long by 1" deep.  She states her daughter is too busy with sports for her to come to the Health Dept. for the nurse to look at her arm.  This nurse did refer the daughter to see doctor.  Mother thinks her daughter started seeing adverse reaction in May of 2005.
This spontaneous report as received from a other health professional refers to unspecified patients of unknown demographics. No information about medical history, drug reactions and allergies was specified. Medical assistant reported that since April 2014, RECOMBIVAX HB (lot#, dose, route, strength not reported) was improperly stored and on an unknown date in approximately 2014 the patient was vaccinated with RECOMBIVAX HB. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. The outcome of is unknown. This is one of the three reports received from the same reporter (MARRS # 1409USA013208 and 1410USA004355). Additional information has been requested.
tested positive for COVID virus; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported for a patient that a patient of unspecified age and gender received first dose of BNT162B2, via an unspecified route of administration in Jan2021 at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The pharmacist reported that last week the patient was given COVID vaccine to Health Care Worker, this week (in Jan2021) the patient had tested positive for COVID virus. Wondering if and when person can get 2nd dose of vaccine. The event outcome was unknown.  Information on the lot/batch number has been requested.
Documented on 8/8- Recent SHINGRIX vaccine (left arm 8/2/18 at Pharmacy). That evening noticed arm was exceptionally sore. Next day began having generalized body aches, chills, HA, fatigue, feverish. Husband also got the vaccine but was fine. Symptoms continued x 3 days after vaccine. Still does not feel 100%. Within past 24 hours started having fever blisters on upper lip. H/oOfever blister, flare up with stress, illness, etc. Progressing more rapidly than normal.
As injection was made, blood squirted out and streamed down my arm; This case was reported by a consumer via sales rep and described the occurrence of injection site hemorrhage in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 10 years before reporting date).   On 21st February 2020, the patient received the 1st dose of Shingrix .5 ml. On 21st February 2020, immediately after receiving Shingrix, the patient experienced injection site hemorrhage. On an unknown date, the outcome of the injection site hemorrhage was unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient for self. The age at vaccination was not reported. The patient stated that received the vaccine and blood squirted out and streamed down the arm. The pharmacist quickly blotted it and patient had concerned that part of the vaccine was lost with the blood. The patient was concerned that might have lost part or all of the vaccine because of the blood squirt and hence do not get the full protection as the dosage of the vaccine is only 0.5 ml.
5/7/10 patient received Tdap vaccine at school at 14:00 noticed swelling at injection site and redness. 5/8/10 increased redness, swelling & warmth at injection site starting at deltoid and extending down to elbow. Parent took to ER-gave Rx for Keflex 500 mg tid x 10d. 5/10/10 sore but improved- (+) itchy, red eyes. Advise ice & BENADRYL, finish KEFLEX.
Information has been received from a health professional concerning a patient who was vaccinated with a 2 ml oral dose of Rotateq. Subsequently the patient was diagnosed with intussusception. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Upon internal review, the patient's intussusception was considered to be an other important medical event. Additional information is not expected.
Severe pain with movement 10/10 radiating from injection site up left side of neck & down to left thumb & wrist. Hardness/swollen at injection site & down, but not to elbow (Left shoulder/deltoid). Blotchy red discoloration injection site to elbow.
Incorrect dose administered to patient. Patient was administered entire contents from a 5 dose multi-use vial.
Wondered if she may have had a herpes outbreak / would then affect her glaucoma; Pain above her eyebrow / Sore to the touch; sore to the touch; Rash; Itch; This case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax. Concurrent medical conditions included herpes virus infection and glaucoma. Concomitant products included acyclovir.   On 24th January 2020, the patient received the 1st dose of Shingrix. In March 2020, between 1 and 3 months after receiving Shingrix and acyclovir and an unknown time after starting Alcohol, the patient experienced herpes virus infection, facial pain, pain, rash and pruritus. The patient was treated with ethanol (Alcohol). On an unknown date, the outcome of the herpes virus infection, facial pain, pain, rash and pruritus were unknown.   It was unknown if the reporter considered the herpes virus infection, facial pain, pain, rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient takes Acyclovir to keep her herpes suppressed and it has been years since she had a breakout.   The patient received Shingrix and started to have pain above her eyebrow and was sore to the touch.  The patient eye doctor asked if she had shingles and said no then a little later wondered if she may have had a herpes outbreak.  The patient remembers an area around her waist that had no bumps but did itch to which she applied alcohol.   The patient did had outbreaks when she was stressed.   The patient was concerned if the Shingrix could triggered a herpes outbreak which would then affect her glaucoma.  The patient was trying to determine whether she should get the second dose of Shingrix.
According to grandma pt became pale, lethargic for  approx 30-45min p/shot; No fever did not bring to MD til 9JUL91; MD unclear whether pt was truly ill;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K004281, expire date 22-MAR-2015; dose and route unknown). The total cumulative excursion time was 1128 hours with the lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
minor allergic reaction; Redness and swelling at the injection site; Redness at the injection site; Swelling at the injection site; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from a physician via other health care professional.  This case involves a patient (demographics unknown) who had minor allergic reaction (hypersensitivity) and redness and swelling at the injection site (vaccination site inflammation) (with symptoms: vaccination site erythema and vaccination site swelling) after receiving DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 24-Jan-2012, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot C418AA, form: suspension for injection, expiry: 14-Nov-2014) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious minor allergic reaction (hypersensitivity) and redness and swelling at the injection site (vaccination site inflammation) (with symptoms: vaccination site erythema and vaccination site swelling) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  It was reported, "She reported that on 24-Jan-2012 a patient received a dose of Sanofi DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) vaccine and had a minor allergic reaction consisting of redness and swelling at the injection site. She reported that the reaction did not require medical intervention"  She did not have further adverse event (AE) details. No Product Quality Control (PQC). No additional AEs reported. No additional information provided. The caller was unable to provide the brand name of the TDAP vaccine but did confirm that it was manufactured by Sanofi  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  At time of reporting, the outcome of the events was unknown.
Pt received the vaccine on May 9th 2019.  on May 13th pt presented to the facility complaining of back pain. Per note she developed right sided back pain on May 10th approximately on dermatome T9-T10. Pt rated it a 3/10 pain that is burning and aching. A rash started to develop on May 12th and spread overnight. She complained of itching and burning. There was one vesicle noted at her visit among the red rash.  Pt has never had shingles before. An order for Valacyclovir HCL 1g take one tablet 3 times  daily  for 7 days.  Pt has completed  the course of medication.
syncope s/p vaccine.   Also s/p chemo for pancreatic and liver CA.  + fatigue, nausea, dry heaves.  Vitals stable. PT taken by eMS to ER for possible hydration secondary to chemo.
The dose given was inadvertently pulled from a primary series vial rather than from a bivalent vial. No symptoms or signs reported so far.
small swelling  at site and 4cm by 6cm redness  with constant itchiness began 5 days later. On Jan 24 took a Benadryl and sprayed site with Benadryl spray (topical) plus applied.
Right deltoid where Tdap administered on 6/6/09 became indurated, erythematous, swollen, warm, painful. On Monday 6/8 patient seen in office and induration = 7 x 7 cm. On 6/9 induration was 18 x 11 cm and very painful. Induration site of Tdap. Pt received GSK flu vaccine lower on deltoid but rxn was at site of Tdap.
This spontaneous report was received from a registered nurse refers to an unknown number of patients pf unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were inadvertently vaccinated with RECOMBIVX HB (dose, route and lot# were not reported) that had been improperly stored. No adverse effects reported, No Product Quality Complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information is not expected as the reporter did not wish further contact.
Within 5 minutes, started feeling very tired and dizzy, leaned head back trying to relax.  Approximately 15 minutes after vaccine had seizure lasting up to 15 seconds possibly.  Brought to floor carefully.  Then had small second seizure (about 5 seconds in duration).  Difficulty Breathing immediately.  Then extreme trouble breathing/stopped breathing , given 0.3 mg EpiPen in right thigh, gasped and began breathing again.  Checked pulse (80 b/pm) then waited about 3 minutes and EMTs arrived.  BP was 140/90 ish.  Both higher but not terribly high.
Subsequently in July 2000, the pt developed wide-based unsteady gait and his trunk deviated from side to side when he sat. These experiences were considered other medical events. He was taken to the ER.
Sore throat; Sniffles; She got sick the next day; This is a spontaneous report from a contactable consumer(reporter's sister).  A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The caller states she has another sister with health conditions. Her sister with health issues got the vaccine and her arm wasn't even sore. She got sick the next day. Caller clarifies her sister was sick for a couple days with a sore throat and sniffles and that, but her arm wasn't sore at all because she laughed at the caller.  Information about Lot/batch number has been requested.
Pt recvd vax & exp problems w/eye; pt was seen by MD who dx optic nerve swelling; pt was prescribed meds; pt indicated that MD judged sx to be a react to Engerix-B;
It was reported that a 30 year old female received a Rabies Imovax ID vaccination on 03/29/2000. Reportedly that same day the pt experienced nausea, vomiting, a headache and swelling at the site of injection.
admitted to hospital on 3/25/21 for Cholelithiasis and during the workups had an Ultrasound - VL Lower Ext Veenous Duplex Bilateral study on 3/26/21.
My eye started swelling 48 hours after event. Continues to swell until closed. Saw an NP on 3.09.21 - suggested Benedryl and cold compresses.
Redness Swelling itching warm to touch > Onset later that right mom gave BENADRYL & ice over the weekend
patient stated that she had not had a pneumonia vaccines prior; vaccine was given due to the chronic condition of diabetes upon further investigation she had a pneumonvax 23 in September so the prevnar was given early. no adverse effects reported at this time
Within an hour of getting the vaccine, I started to feel nauseous and fatigued. Then my body started to tingle so I laid down. 2 hours later I awoke when the phone rang. Still drowsy, I was worried because my throat was swollen inside. Now 5 days later, I still feel poorly.
SHAKING CHILLS SEVERE FRONAL H/A N/V PAIN AT INJECTION SITE
Approx 3 weeks after getting 1st set of Gardasil, patient complained that she was weak and was having a hard time speaking. On 11/29/08 patient had 2 seizures. She was was taken to the ER. Since the first few days of her illness, she stopped being able to talk, walk and has been completely unresponsive. She is on a ventilator & has a feeding tube. She has neurological movements. All of the testing done shows that patient has encephalitis. The cause of the Encephalitis is a reaction to the Gardasil Vaccine.  2/18/09 Received hospital medical records of 12/1-12/4/2008. FINAL DX: meningoencephalitis w/significant mental changes & seizures Records reveal patient experienced seizure that progressed to loss of speech, sustained focal seizures, oral intake reduced, drowsiness, floppy.  Developed fever in hospital.  Neuro & ID consult done.  Tx w/antiseizure meds, antivirals, antibiotics.  Transferred to higher level of care peds neuro ICU.  3/9/09 Received ER records of 12/5/08. FINAL DX: Encephalitis/encephalopathy; seizure disorder; history of depression w/suicidal attempts Records reveal patient had been transferred from outlying hospital. Exam revealed drowsiness, not able to follow commands, PERRL, hypertonicity of all limbs, DTRs increased.  No PICU bed available & held in ER.  Neuro consult done.  Tx w/antivirals & continued on antiseizure meds.   3/9/09 Received hospital medical records of 2/10-currently inpatient FINAL DX: recent viral encephalitis(presumed HSV) & subsequent neurologic devastation presented w/MSSA septic shock, DIC, acute on chronic respiratory failure, acute renal failure, s/p tracheostomy Records reveal patient had been d/c from PICU w/HSV encephalitis 10/2008 w/resulting severe neurological damage.  Now w/fever, hypotension & decreased mental status.  Transferred from outlying ER w/platelets of 17.  Tx w/IV antibiotics, plts/FFP/PRBC transfusions, pressors.  Patient trach to vent w/large amount yellow sputum.
The patient developed a 10cm red patch on his left thigh at the injection site with a 1.2 cm hard knot. Given 2 days before PCV vaccine.
Woke up Wednesday morning the day after the shot with horrible pain in my left thigh and calf. I couldnt get out of bed. The pain also made my left foot numb. The pain was constant throbbing. After some ibuprofen it was a little bit better but still painful. I did call the Tele Nurse who gave me some suggestions. One was to call my doctor. I had an virtual appt that afternoon to discuss the pain. They said the muscle pain was my bodies reaction to the shot since it was a weak area for me. I do have previous back issues. I was having back pain the day before the shot.
Patient arrived to clinic with grandmother (guardian) for the flu vaccine. Patient was administered VFC flulaval guadrivalent due to eligibility that has expired. Dr. provider on duty  made aware of the situation and advised that no harm was done; however, patient would need to return in a week to get vaccinated with this year?s flu vaccine for better protection from this year?s virus. Grandmother notified and was made aware of the med error and recommendation by the Dr.  Grandmother verbalized understanding and made an appointment to bring the patient back for vaccination. Grandmother decline seeing a provider when offered for further medical advise and education when writer offered the option and stated that patient is not experiences any side effects. VAERS notified. The Dr. patient?s pediatrician notified and made aware. LVN
dementia; This is a spontaneous report from a Pfizer Sponsored program. A contactable consumer reported that a female patient (wife) of unspecified age was received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Calling on behalf of her wife that has dementia, she already received the 1st dose of the vaccine and was prescribed a new drug Nuplazid. Husband wanted to know the drug interaction between the two. outcome of the event was unknown.   Information on batch/lot number was requested.
Bump on left arm at injection site, redness, warmth, and soreness.  Improves with icing.
Rash, wide spread. Macupapular rash even at the site of the injection.
Lightheadedness, shortness of breath, and I passed out and had to go to the ER.
The patient received FLUMIST on 12/20/2005 and 2 days later, on 12/22/2005, developed a rash on her trunk and arms.  The rash was treated with diphenhydramine as needed, but failed to resolve.  Prior to receiving FLUMIST she had eye surgery on 12/16/2005 and took VALIUM and saline eye drops following surgery.
PFIZER COVID VACCINE #3 GIVEN 12/3/21, LOT #FK5127; 6/6/22 pt had a positive COVID test from Clinic; 6/12/22 pt to ED with increasing SOB; hypoxia; hypercapnea; intubated and on ventilator; sedated; CXR showed moderate right lower lobe infiltrates with small right pleural effusion; able to be weaned from ventilator after several days; extubated; on O2 via NC; encephalopathic; worsening respiratory acidosis; placed on BiPAP; DNI; family refuses PEG and tracheostomy for pt; on  multiple ABX; transitioned to comfort care and inpatient hospice; pt passed away in the hospital.
pt recv vax & had a local rxn rash & itching around site of inj was advised to use ice & DPH;no breathing diff;
Myositis and severe swelling LUE (site of injection) with associated rhabdomyolysis left arm pain for 2 weeks - started after a flu shot which was very painful for a few days. Had achiness when arm was resting but then noticed weakness in left hand 2 days ago. No numbness in hand but does have a nerve like sensation in arm (not hand). Plus swelling left forearm/arm. No neck pain. Some weakness left hand particularly left index finger. Right handed. Did have an IV left dorsal hand. No left arm trauma.
Child Given vaccine that may have had temperature excursion (Data Logger Failure) with stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination Child Had No ill Effects thus FAR
Information has been received from a physician concerning an 18 year old female who was vaccinated with Gardasil. After receiving her second dose of vaccine, the patient from turned "ghost white." The patient sought unspecified medical attention. On an unspecified date, the patient recovered with turning "ghost white." This is one of several reports received from the same source. Additional information is not expected.
Left arm redness, swelling surrounding site of injection. Treating for cellulitis with antibiotics.
About 1:35 am I was experiencing acid reflux, I prepared some alka-seltzer. As I was beginning to drink it I started to feel faint, My legs started to give out, my glass dropped into the sink, and a was flat on my back on the floor. I got up and went to bed. As I lay there uncovered I began  to perspire, but that soon stopped. After 10 minutes I pulled the sheet over me and 30 minutes later I pulled the blanket over me. At about 2:30 am I was feeling normal except for the reflux. I took a full dose of alka-seltzer and have had no more problems since then. I believe the acid reflux was from eating and drinking wine that evening. I don't know of the fainting was from the vaccine or a touch of flu for one hour.
This spontaneous report as received from a medical assistant refers to a 12 year old male patient. The patient had no pertinent medical history, concurrent condition and concomitant medication. He had no previous drug reactions/allergies. Approximately on 20-JUL-2016, the patient was vaccinated with the third dose of GARDASIL 9 (Lot # 1045700 and expiration date 22-FEB-2018) intramuscularly (strength, dosing details and anatomical location were unknown). On the same day night (also reported as on 20-JUL-2016) the patient experienced leg cramping and nausea. On 21-JUL-2016, the patient went for golfing and "passed out". The patient did not sought medical attention and no treatment was given for the adverse event. No lab diagnostic tests were performed. The outcome of leg cramping, nausea and syncope was reported as recovering. Causality assessment was not provided. No product quality complaint was involved. Additional information is not expected as no reporter contact details were provided.