chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Induration wheel of about 70mm with thicken redness around the edges. Painful to touch. Evaluated in office with RN on 10/26/23 @3:30 pm. Provider pulled into room to verify the allergy and assess the area of concern. Patients parents are present and have been advised of the allergy. Mother is advised to give the child and antihistamine to help with the allergy. Mother is asked to report on the childs area of concern tomorrow.
This spontaneous report as received from a nurse via a physician through a company representative refers to an approximately 12 year old male patient. The patient's medical history was not reported. It was unknown if the patient had any drug reactions/allergies. On 25-JUL-2017, the patient was vaccinated with GARDASIL 9 (Strength, frequency and route were not reported) of lot # N012093 with an expiry date of 13-JAN-2020 in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX administered in the right arm and MENVEO administered in the left arm (Vaccine administered at inappropriate site). Approximately, on an unknown date in July 2017, the patient experienced pain. Approximately, on an unknown date in July 2017, after all three injections, the patient experienced a "vagal response". The physician monitored the patient . On an unknown date in July 2017, the patient's blood pressure was checked. The results were not provided. The patient was given water along with "something to eat". There was no product quality complaint involved. The outcome of the events was reported to be recovered, approximately on July 2017 after leaving the physician's office. The causality assessment was not provided. Lot number (N012093) has been verified to be a valid lot number for GARDASIL 9.
Due to availability did not receive second dose; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The repoprter stated that, due to availability and cost, did not receive 2nd dose of Shingrix.
BODY ACHES; CAN BARELY MOVE; BARELY SLEPT; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body aches, can barely move, barely slept, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, fever, headache, can barely move and barely slept was not reported. This report was non-serious.
Rash started on back and torso, extended to limbs.  Some itch and some blisters.  ^ day pack of prednisone and  more antihistamines. rash cleared up in about a week. Still experiencing some skin peeling.
Initial information received from a healthcare provider on 16 August 2013. A 16 year old female patient was vaccinated intramuscularly into the right deltoid with MENACTRA, batch U4418AA on the 14 August 2013. The patient's concomitant medications and medical history were not reported. It was reported that the patient had no illness at the time of vaccination. Within 24 hours on the 15 August 2013, the patient experienced a decreased sensation of the 4th and 5th finger of the right hand, paresthesia down the right medial side of the right arm and right axillary tenderness. The patient was seen by a physician on an unreported date. Treatment details were not reported. No further information was available at the time of this report. The patient outcome is not recovered. Documents held by the sender: None
Reported rash on face, neck and body (3days), Pt cranky. 2/21/ seen by physician and treated.
Patient presented to emergency department on 11/3/2021 with complaints of chest pain. He reported feeling unwell for the past week and tested positive for COVID-19 on 11/1/2021. Patient did not require any symptomatic treatment for his COVID-19 infection during admission. He was discharged home on 11/5/2021. Patient completed his primary COVID-19 vaccine series with Pfizer on 1/26/2021 and 2/16/2021.
pt exp fever for 1 wk following 1st MMR vax; no further details were provided;
Pt. was asked which shoulder to place injection, he is right handed, injection was given in the left deltoid. Pt. verbalizes that the injection hurt. Then voiced it was his bad shoulder maybe that's why it hurt so bad. Pt. became dyaphoric stating that he doesn't feel right blood pressure was taken 71/36 and retaken was 82/52. No signs of a reaction at this time around the sight of injection. Possibly a vagal stimulation. Pt. was taken to emergency department. Per ED note: Patient presents to ED with c/o diaphoresis following injection in PCC. Pt states he was being routinely seen for Hep A/B injection in clinic, injection was given, pt states he became sweaty and felt dizzy. Pt reports when injection was given it felt like a nerve was hit. It was very painful.
HYPOXIA 4/5/2022 BPH W LOWER URINARY TRACT SYMPTOMS
Pfizer-BioNTech COVID-19 Vaccine EUA - About 10 minutes after receiving the first dose of the Pfizer COVID-19 vaccine, pt complained of being dizzy and faint.  Pt broke out in a sweat and complained of tingling down his left arm (site of administration was left deltoid) and into his fingers.  Pt was instructed to lay down on his side and was given an ice pack to apply to his wrist for the sweating.  He was also offered water and to call EMS, which was refused.  At this time his blood pressure was checked reading, 102/63 pulse 62.  Pt continued to be closely monitored for 30 minutes.  During this time he was able verbalize symptoms and continued to complain of dizziness and generalized weakness.  After 30 minutes pt sat up and waited an additional 15 minutes before he decided to stand up and at that time decided he was fit to leave.  Another blood pressure reading was taken 110/64 pulse 67.  He stated that a normal blood pressure reading for him was around 135mmHg systolic.
Low grade fever (99.6), chills, muscle aches. Took Tylenol, helped relieve all symptoms temporarily. Lasted about 24 hours.
Initial unsolicited report received from a consumer (patient) on 20 Oct 2016. This case involves a 76-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose: not reported) by intramuscular route in left deltoid on 17 Oct 2016. Illness at time of vaccination was reported as convalescent stage of GI problems 1 week earlier, pre-existing physician diagnosed allergies, birth defects, medical conditions included recent stomach problems patient was taking CARAFATE 3-4 times daily (concomitant medications). On 17 Oct 2016, same day following the vaccination the patient experienced her whole digestive system was being affected and she felt dizzy and had could not think straight. Patient reported that she was recuperating from having GI problems and claimed that they were reactivated after receiving the flu shot, the patient planned to contact her physician on 20 Oct 2016 regarding her symptoms. The patient's lab tests and corrective treatment was not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Pt was about to graduate from high school. Pt had college form to fill out, re: health status. Hepatitis B vaccine was suggested. Pt received 1st injection 3/16. 2nd-4/17/2000. In May 2000, pt was admitted to the hospital with acute cerebritis that required steroid therapy.The steroid therapy ultimately lead to aseptic necrosis of hips . Pt had had dental surgety and had draining sinuses. 60 DAY FOLLOW UP STATES: Pt has not recovered. Ataxia. Post vaccination cerebellitis started 04/10/2000.
This spontaneous report was received from a healthcare worker refers to an infant female patient of unknown age. The patient's concurrent conditions, pertinent medical history and concomitant medications were not reported. On 18-MAY-2016, the patient was vaccinated with ROTATEQ orally and experienced vomiting "2 minutes later". The outcome of the event was unknown. The reporter did not provide the relatedness of vomiting with ROTATEQ. Additional information has been requested.
difficulty breathing, chest tightness, bright red skin, throat pain. Diagnosed with anaphylaxis.  Treated with IV meds and Epineferine over 3.5 hours. 12/1 and 12/2 Medical records received for DOS 9/14/09. ED visit. Final DX:  Allergic reaction unspecified.  S/P vaccine facial redness and eye edema. Presented w/throat pain and hoarse voice. Redness, swelling. Dyspnea. Rash. Exp wheeze. Breath sounds diminished bil. Abrupt onset.      ICD9 Code:  995.3
Rapid heart rate; flushing in body; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had unspecified allergies to food, medications or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Mar2021 at 12:15, the patient experienced rapid heart rate and flushing in body. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events rapid heart rate and flushing in body was recovered on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
body aches; headaches; fever of 102 to 103; injection site was inflamed and painful; injection site was inflamed and painful; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), HEADACHE (headaches), PYREXIA (fever of 102 to 103), INJECTION SITE SWELLING (injection site was inflamed and painful) and INJECTION SITE PAIN (injection site was inflamed and painful) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches), HEADACHE (headaches), PYREXIA (fever of 102 to 103), INJECTION SITE SWELLING (injection site was inflamed and painful) and INJECTION SITE PAIN (injection site was inflamed and painful). At the time of the report, MYALGIA (body aches), HEADACHE (headaches), PYREXIA (fever of 102 to 103), INJECTION SITE SWELLING (injection site was inflamed and painful) and INJECTION SITE PAIN (injection site was inflamed and painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Tylenol
Polymyalgia rheumatica; This is a report for the following source.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer-biontech (DOSE 1, SINGLE), for covid-19 immunization. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), 7 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Aldolase: normal; Antinuclear antibody: normal; Blood creatine phosphokinase: normal; C-reactive protein: normalized; C-reactive protein: 5.07 mg/dl; Examination: notable for tenderness in the bilateral shoulders, notes: wrists, hips and knees; 2012 ACR criteria; Red blood cell sedimentation rate: 79, notes: Unit: mm/h; normalized; Rheumatoid factor: normal; SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of polymyalgia rheumatica.  Clinical course:A 69-year-old  man presented to BAMC rheumatology with 2 months of bilateral arthralgias and stiffness in the shoulders, hips, wrists, and knees. Symptom onset was 1 week after completing the Pfizer-BioNTech vaccination series. The patient had a primary relative with rheumatoid arthritis, but no personal history of autoimmune disease or COVID infection. The patient never received immunosuppression in the past, and nomedication changes were made at the time of vaccination. Examination was notable for tenderness in the bilateral shoulders, wrists, hips, and knees, which resolved with a 3-week course of prednisone. He had no clinical evidence of temporal arteritis. Laboratory evaluation was remarkable for an elevated ESR (79 mm/h) and CRP (5.07 mg/dL). Rheumatoid factor, ACPA, creatine kinase, and aldolase testing were normal. COVID-19 testing (PCR) was negative. Repeat ESR and CRP normalized in 3 weeks on prednisone. The patient met the 2012 ACR criteria for polymyalgia rheumatica and was treated with a slow steroid taper over a period of 13 months.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of  "POLYMYALGIA RHEUMATICA ". The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Ran fever up to 101 and had night sweats for first 48 hours. Also had stiff and sore joints for about 2 weeks before going away.. Developed ringing in both ears. This has persisted for 3 weeks now and is continuing. Saw a doctor on demand and she diagnosed me with tinnitus and referred me to see an ENT. Saw ENT listed in form and the diagnosed me with the same.  Ringing of the ears are constant and not gone away.
On 10-26-01, came home from school with 104.9 headache, swollen lymph nodes-throat-red dizzy went to pediatrician on 10-29-01 given antibiotic. Fever would not go down even with Tylenol, ibuprofen then temp decreased 95 degrees F. reoccurring problems not able to walk, blurred vision, abdominal pain, joint pain, Seen by rheumatologist and pulmonologist. Has pleural effusion. At present on steroid inhaler. Ruled out Lupus, Possible arthritic baterial infection. related to Hepatitis b vaccine per rheumatologist.
no other AE reported; a patient was administered an expired VARlV AX; This spontaneous report was received from a pharmacist and refers to a 22-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-JAN-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, subcutaneously, lot # R023735, expiration date: 20-AUG-2020 (anatomical location not provided) for prophylaxis. There was no adverse event reported.
This spontaneous report as received from an office manager refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of PEDVAXHIB lot# K008873 with expiration date 06-FEB-2017 (dose and route of administration were not reported). Administered doses of PEDVAXHIB experienced a temperature excursion at 47 Fahrenheit degrees for 1 hour, with a prior excursion at 33 Fahrenheit degrees for 15 hours. No adverse effects were reported. Product quality complaint (PQC) was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008786: US-009507513-1612USA008787.
Shortness of breath; Tightness in the chest; Loss of taste; Elevated blood pressure; Back pain; difficulty sleeping; Extreme fatigue; headaches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ENG6208), via an unspecified route in left arm on 11Mar2021 at 12:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypertension. The patient had past drug allergy with ibuprofen. The patient received other medications (unspecified) within two weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021, the patient experienced extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure. No treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent nasal swab test on 22Mar2021 and test the result was negative. The clinical outcome of extreme fatigue, headaches, chills, shortness of breath, tightness in the chest, back pain, difficulty sleeping, loss of taste and elevated blood pressure was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
I started my period on Friday morning (before the shot) and it was gone within 24 hours. I have had normal 28day cycle, 4-5 day normal/light periods my entire life so this is NOT normal.
fever <12 hours after injection of 103.1, fatigue, tiredness; denies redness, denies swelling, fever persisting >48 hours
Information has been received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On unspecified dates, the patient was vaccinated with a dose of improperly stored ZOSTAVAX lot # N016185 and expiration date of 31-JUL-2018, (route of administration and anatomical location were not reported) for prophylaxis, which were stored in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees for 23 hours. Vaccine was reconstituted with properly stored sterile diluent (MERCK).  No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1712USA001694: US-009507513-1712USA013911.
I woke up this morning with a sore arm and around noon I started feeling very tired and fatigued and around 8:00 p.m. I started feeling feverish with chills nausea tiredness and headache.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The health care professional (HCP) reported that the patient experienced arm soreness. This report came from Inside sales. The Inside Sales representative did not have any patient or vaccine information. The representative only had limited information about the adverse event. This is one of the 7 cases reported by the same reporter.
1/7/22: Pfizer vaccine first dose. 1/12/22: Cerebral ischemic event leading to total paralysis. 1/16/22: Cerebral ischemic event leading to death.
Blurry vision 4/25. (All) joint pain. Dizziness. Numbness and tingling both arms. Muscle cramps (fingers to shoulders - both arms).
1309 injection by rn.   1335 timer went off for patient to leave. pt states her throat is a little tightand she is having trouble breathing. 96% on room air. 160/118. HR 112.  EMS called  1339 84% on room air HR 125. Pt raspy voice and difficult to breathe. Epi 0.3 mg sub q given in left back of arm by rn, bsn. Benadryl 25 mg po given.   1341 HR 113 85% on RA. Pt still symptomatic.  1343 HR 94, 87% on RA. Pt remains symptomatic.  1345 HR 86, 87% on RA. Pt states it is hard to breathe and swallow.  1348 HR 157, 83% on RA. BP 150/90. Pt states her chin is numb and her tounge feels weird and her face is itching. Epi 0.3 mg sub q given in right back of arm by RN.  1349 EMS at clinic. Report given by RN, BSN.
A few hours after receiving the shot my arm and shoulder started to freeze up. I was unable to more any part of my arm without excruciating pain. as time went on the pain go back to where without help I could not move my arm and hand. The next day I called Dr. and was advised to take different medications I already had. I had already tried the medication so I was referred to go to the ER. At the ER they only prescribed pain medication and let me know nothing was found on the X Ray. I was sent home even though the pain still was there. It took several days for the pain to subside a little so that I could move it some. Three weeks latter I still have weakness in the arm and pain in my shoulder.
Dose 1:   Sore arm for 3 days Dose 2:  Shot at 8:00am,  wrist tingling/numb right after, arm felt hot and sore around 11:00am.  4:00pm very tired and sore.  8:00pm cold, uncontrolled trembling,  about 4:00am woke up soaked with sweat.  achy all over.  Weakness, dizziness when I got up, took about 10 steps and needed to sit down and rest, a little nauseous,  headache.   Ate lunch at 11:00am, around 12:00 started to feel a little better.  Went to bed early, still not feeling well.   Symptoms resolved by  morning.  Symptoms in my opinion were moderate to severe.  I cant believe how hard it hit me.....
Vaccination site (L) deltoid edematous erythema, (large area of upper arm, hot to touch, large area of induration, pt reports having fever of 105 degrees F x one night with h/a, joint pain. Onset of symptoms 02/29/16 to present. Fever x one night.
Severe muscle cramps; and Pain and spasms (muscle). Treatment: Aqua Therapy once a week. It is helping with my symptoms.
Pt lost color in her face,became faint & lost consciousness for 2-3 mins.; started within 30 sec. of receiving IPV. Pt was weak & semiconscious for 1 hr.; complained of pain & soreness in rt arm for 16 hrs.
Period started, normal cycle length. Extremely heavy flow. Approx 120 ml in first 24 hours.
pt recvd vax; p/ dose 3, exp a circular, firm,reddish, 1/2 cm,elevated "keloid"; not subsided