chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of psychotic episode in a patient who received BEXSERO for prophylaxis. Concurrent medical conditions included celiac disease. On an unknown date, the patient received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced psychotic episode. On an unknown date, the outcome of the psychotic episode was unknown. It was unknown if the reporter considered the psychotic episode to be related to BEXSERO. Additional information was reported as follows: The age at vaccination was not reported. The nurse notified the reporter, that the patient after vaccination with BEXSERO experienced psychotic events. No further patient or event details were reported. This was 1 of the 2 cases reported by the same reporter, for the patient belonging to the same family.
12/21/2021-MOderna 0.25 booster dose was given to a 5 year old.  no reaction noted. 12/22/21-Dr spoke to parent today and parent reported no reaction.  Child has been fine. no side effects.
Product COVID 19 Treatment; Product COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Aug2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "Product COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) positive, notes: antigen test was still positive; (23Sep2023) Negative, notes: First negative antigen tests were on 23Sep & 24Sep; (24Sep2023) Negative, notes: First negative antigen tests were on 23Sep & 24Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid symptoms mostly resolved following Paxlovid treatment, but antigen test was still positive. Covid symptoms returned on 12Sep. First negative antigen tests were on 23Sep & 24Sep.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
silver dollar size lightened area w/sl red border & quarter size red center;sl induration, sensation of heat & tenderness over site;sl pain w/palpation up to shoulder;tx zithromax, warm moist pack/ice every 4hr;
Pt came in for his 3rd covid booster, instead of getting the bivalent covid immunization, he received a 3rd monovalent
This spontaneous report as received from a registered nurse refers to unspecified number of patients. On an unknown date, the patients were vaccinated with some improperly stored doses of ROTATEQ (doses, route and lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
15 min following administraiton of vaccines, felt dizzy was returned to exam room, cool compress was used, small about , was clammy and sweaty. BP 88/68, 66 pulse, drank cranberry juice and pretzels. 2:25 - 90/72; 2:30 98/67 pulse 76. States feels fine and able to drive self home. 2:35 BP 98/67 69 was 100/67 prior to immunization. Was released at 2:45 PM.
Soreness in the upper right arm at injection site starting approximately 3 weeks following vaccination date. There was some immediate discomfort at the time of vaccination followed by soreness at the injection site. I felt sluggish and warm during the evening hours; I did not take my temperature at the time. Initial soreness and sluggish behavior resolved within 1-2 days following injection.
Pericarditis iinflammation of the outer lining of the heart x2. Lack of energy and tiredness.
Systemic: Anaphylaxis-Severe, Systemic: Vomiting; symptoms lasted 2 days
Information has been received from a nurse concerning a 26 year old female who on 01-JUL-2008 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot # 660391/0063X). Concomitant therapy included hormonal contraceptives (unspecified). The patient developed a swollen, 2 cm, right, axillary lymph node, on the same side that she was vaccinated with her first dose of GARDASIL. She was referred to have an ultra sound of the area. At time of reporting, patient was not recovered. Unspecified medical attention was sought through a call to the office. Additional information has been requested. 9/23/08-records received for DOS 7/8/08-C/O lump under arm status post Gardasil. Right axilla small nodule questionable cyst. This is in follow-up to report(s) previously submitted on 8/14/2008, 1/7/2009.  Follow-up information has been received from a health professional who reported that the patient without a pertinent medical history on 11-SEP-2008, the patient received the second dose of GARDASIL (lot n. 660618/0572X) and on 20-JAN-2009, the patient received the third dose of GARDASIL (lot n. 661766/0652X), 0.5 mL intramuscularly.  Concomitant therapy included YASMIN (previously reported as hormonal contraceptives (unspecified).  The healthcare worker reported that the patient experienced a rash on her left leg, from her hip to her knee, after receiving the second dose of GARDASIL on 12-SEP-2008.  The patient was seen by the practice.  No labs were performed.  At time of reporting the patient recovered on an unspecified date.  Additional information has been requested.
Tuesday 10/16/2018 DIB, swelling around eyes, puffy face. Achy bones, nausea, severe headache, fever chills with night sweat into 10/17/18 continuing with diarrhea. Treatment with rest and detoxing, 10/18/18 to walk-in clinic reporting, the reaction no outcome treatment.
Finger tips and palms turned pink.  Gave patient 25 mg liquid diphenhydramine and observed for 30 minutes.  Pinkness in hands went away and patient was sent to follow up with physician, although patient later called back to say they did not wait at physician's office and went home.
Pt felt flushed, had a HA and was dizzy. Was taken to first aid and medic reported pt BP 200/99 several times. Pt transported to ER for high BP and dizziness
Hospital Course:    Patient is a 77 y.o. male patient with a history of pAfib Eliquis, CAD, CKD, OSA, HTN, HLD, GERD, hiatal hernia BPH, SSS s/p PPM, Parkinson's disease, and hx of Roux-en-Y gastric bypass. He presented from Hospital on 10/21/2022 with encephalopathy and increased, productive cough. He was found to be COVID positive at the outside hospital and required intubation due to hypoxia. He attempted OG insertion but had hematemesis. GI was consulted and he underwent EGD. He was found to have bleeding esophageal ulcer that was injected and clipped. Course further complicated by pneumomediastinum with concern for esophageal perforation. He briefly required TPN and bowel rest. He was initially extubated. However, course further complicated by klebsiella pneumonia, then aspiration pneumonia requiring reintubation on 11/11. Extubated 11/5 code status updated to DNRCCA-DNI at that time. However he continues to require heated high flow oxygen. Ongoing dysphagia with concern that patient will need J-tube placed for continued feeding.    After discussion with family and hospice, patient has elected for DNRCC with plans for ongoing oxygen wean at inpt hospice.
Duplicate vaccination. Patient requested and received vaccine on 9/15/21 and came in again on 9/25/21 for a 2nd dose. On 9/25/21, patient did not remember if he had gotten the vaccine already and his profile was not reviewed for duplications and no DUR rejections displayed at time of processing. RPh on duty was made away of the duplication by our Clinical Services team. RPh attempted to reach out to patient to collect more information. Unable to reach patient at this time, will continue to reach out.
after taking both doses of the Pfizer COVID-19 vaccine did he get COVID; after taking both doses of the Pfizer COVID-19 vaccine did he get COVID; This is a spontaneous report from a contactable consumer(patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), DOSE 2 via an unspecified route of administration on 14Apr2021 (at the age of 59-year-old) (Batch/Lot Number: EN6204) as dose2, single and DOSE 1 via an unspecified route of administration on 24Mar2021 (at the age of 59-year-old) (Batch/Lot number: Confirmed to be either EN4200 or EN4600) as dose1,single for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. Patient wants to know why after taking both doses of the Pfizer COVID-19 vaccine did he get COVID. He states that his boss also tested positive for COVID. He states he did reach out to his doctor at the hospital, but he is out sick, and they are supposed to give information to the nurse. He stated he thought he signed up for V Safe and he wants to report that he got the virus after getting the vaccine. Patient reported that he took both doses of the Pfizer COVID vaccine and he has tested positive for the COVID virus on 01SEP2021 via a nasal swab. This case assessed as non-serious by the reporter. Event resulted to visit Physician Office. The patient underwent lab tests and procedures which included COVID nasal swab: positive on 01Sep2021. The outcome of the event COVID-19 was reported as unknown.
Redness and tenderness 4x6 inch area of left Deltoid 24hrs after shot.
11/2/02 @ 7p.m. patient's ears started to get red, itchy and swollen.  By 1 a.m. she had broken out in large red welts all over her body.  By 8 a.m. on 11/3/02, she felt as if her throat was swelling and was then taken in to the ER.  She made subsequent trips into clinic on 11/4/02 and ER visit on 11/6/02.
Patient developed upper extremity weakness starting two days after first dose of pfizer vaccine progressing to the point of being unable to lift arms.  Was hospitalized  and apparently treated with Prednisone and then re-hospitalized on 4-22-21.  He has absent reflexes in upper extremities with 1/5 shoulder strength bilaterally, normal strength and reflexes in lower extremities.  Seen by neurology who feels presentation consistent with an atypical form of Guillen Barre or Acute Inflammatory Demyelninating Polyneuropathy.
Extreme uterine pain so severe it caused nausea, rapid pulse, dizziness, and shortness of breath. Total time was about 15 minutes. Pain went away gradually. Unable to move due to severity of the pain so I could not contact a doctor, travel to a hospital, or call for help.  Pain was immobilizing.
difficulty swallowing; lightheaded; anaphylaxis; obstructed airway; stridor; inability to talk; This is a spontaneous report from a contactable Nurse (patient). A 52-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 10:00 (Batch/Lot Number: EL0140) (at the age of 52-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included hypertension from an unknown date, Known allergies: Flu Shot, Raw egg. The patient did not receive other vaccine in four weeks. The patient did not get covid prior vaccination. Concomitant medications in two weeks included metoprolol; losartan; minocycline; bupropion hydrochloride (WELLBUTRIN) and colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported.  On 20Jan2021 13:00, approximately 4 hours post vaccine the patient developed difficulty swallowing, lightheaded, she went home but ended up in ER with anaphylaxis treated with Epinephrine, solumedrol and benadryl. She was discharged that evening from the ER, symptoms resolved. The same symptoms started the next day on 21Jan2021 around 11am, this time symptoms were much quicker onset, she left work for ER and had totally obstructed airway and stridor, inability to talk. She was hospitalized after ER treatment and was discharged the next day on 22Jan2021, early afternoon. She was advised not to get the 2nd vaccine, which she had not. The patient was hospitalized for the events from 21Jan2021 to 22Jan2021. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of all the events included Epinephrine, Solumedrol, Diphenhydramine, zofran. The patient did not get covid tested post vaccination. The outcome of the events was resolved in 2021.; Sender's Comments: Based on the available information in the case, the causal association between the events, dysphagia, dizziness, anaphylactic reaction, obstructive airway disorder, stridor, speech disorder and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Right arm became swollen, indurated, erythematous, and tender following immunization on 4/2/13. Area of swelling, induration, erythema and tenderness was 4 inches in size (approx) at time of follow up visit for adverse event on 4/3/13.
High-grade fever (106F) and irritability 7 days, post vax. which lasted for 4 full days; associated with very poor PO intake and a diffuse morbilliform rash that started during his 2nd day of the high fever. Physical exam revealed no source for the fever.
lt thigh cellulitis started on po Keflex 14JAN99, adm to hosp 19JAN99 for IV Clindamycin & Nafcillin;discharged 23JAN99;
Not able to concentrate as sharply on his work; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and DISTURBANCE IN ATTENTION (Not able to concentrate as sharply on his work) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity (during the pandemic gained additional weight due to inactivity).    On 16-Apr-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (Not able to concentrate as sharply on his work). On 17-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, DISTURBANCE IN ATTENTION (Not able to concentrate as sharply on his work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.      This case was linked to MOD-2021-219479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received and contains patient information, product information and events
This spontaneous report was received from a registered pharmacist refers to a 58 year old female patient. Current conditions included allergy to cephalosporins, quinolones (reaction: swelling) and penicillins (reaction: rash) and fibromyalgia. On 14-OCT-2013 the patient was vaccinated with a dose of 0.65 milliliter (ml) ZOSTAVAX (lot # and expiration date was unknown), subcutaneously in the left arm. On 15-OCT-2013, patient developed redness and rash at injection site. On 18-OCT-2013, rash had spread from deltoid region to elbow and was warm to touch. Physician diagnosed patient with cellulitis and infection. Treatment was given for the events: doxycycline and prednisone were initiated. Medical attention was sought for the events. The events did not resolve at the time of this report. Causality was not reported. Additional information has been requested.
Information has been received from a registered nurse (RN) concerning a 12 year old female with no pertinent medical history or allergies who "2 months ago", in approximately June 2008, was vaccinated intramuscularly with 0.5 ml first dose of GARDASIL vaccine (yeast). There was no concomitant medication. In approximately June 2008, after the vaccination, the patient experienced a "stomach ache, fatigue, and a headache". Unspecified Medical attention was sought. No laboratory diagnostics studies were performed. Subsequently, the patient recovered. On 01-AUG-2008 the patient was vaccinated intramuscularly with 0.5 ml second dose of GARDASIL vaccine (yeast) at the office. The patient was instructed to sit and wait 15 minutes post-vaccination and the patient did not have symptoms again. No additional adverse event information was reported. Additional information has been requested.
migraine; swollen throat; swollen mouth; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 21Mar2021, the patient experienced migraine, swollen throat and swollen mouth. The clinical outcome for all events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot been obtained.
Low grade fever (24 hours) , body aches (24 hours), joint pain (24 hours) , headache (3 days), nausea (only last about 1-2 hours) Took Advil with little relief.
the morning following the vax pt broke out in a total body rash w/itching & burning; itching, burning recurs q 4 hrs; seen by MD @ clinic; rx DPH, Pred, tapering dose starting dose;
CHILLS, FEVER, DIARRHEA, SEIZURES (3 TIMES LASTING 10-15 MINUTES)
Flu shot given (L) arm shortly afterwards, Pt c/o pain radiating down her (L) arm into hand. After she made a fist pain was better. Instructed to use ice pack and use ibuprofen.
began to notice pain @ site eve of inj was awaken in noc by arm pain called hlth dept & described approx 1 1/2" diameter redness, swelling & pain 1 1/4" below site;used APAP for pain;11APR97 inc discomfort, inc redness, swelling;
swollen lymph nodes on left side of neck; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: en6208) via an unspecified route of administration in the left arm on 17Mar2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patients medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient has not tested for COVID-19. On 21Mar2021 at 00:00, the patient experienced swollen lymph node on left side of neck. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the event swollen lymph nodes. The clinical outcome of the event swollen lymph node was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Site: Itching at Injection Site-Mild, Systemic: pt has had laryngitis since 24 hours after first dose given-Mild, Systemic: Weakness-Mild, Additional Details: the patient did not report weakness, however to submit this report, it is requiring me to select at least one option besides other
-Initially I had moderate side effects to my 2nd shot, shortness of breath/increase of asthma symptoms, severe joint pain, flu-like symptoms (slight fever, chills, loss of appetite, inability to sleep) lasting for a total of 4 days. I have anaphylaxis to Walnuts (2x needed epipen and hospitalization) and asthma, many seasonal allergies, and am highly biologically sensitive (have broken out in hives several times),  -8 days later I traveled to a high altitude location (Aspen, CO), and had 4 glasses of wine over a 8 hour period. For the next two days I skiied for 5 hours, going up to 12,500 ft in altitude. On the first morning after arrival I started feeling badly, with symptoms including dizziness, asthma symptoms (unusual for me as it is only exercise-induced), a headache in the front of my head, and a slight redness in my left eye. As the days increase my symptoms increased to the point of inability to leave the house. After 3 days I received an IV, oxygen, that did not help. On day 4 I went to the hospital after a virtual appointment with a clinician and had chest xrays taken as Hospital (never received the results) and was put on Diamox 250MG 2x/day, this helped slightly. Day 6 I left and traveled back to CT at low altitude, my symptoms did not improve immediately and got worse (eyes became significantly more red by this point), asthma and dizziness increased). Two days after arriving home I went to two doctors who misdiagnosed me with a sinus infection, water in my middle left year and left lung, and conjunctivitis. I was given antibiotic eyedrops that had no improvement for 36 hours. Upon receiving a 1mg cortisone shot these symptoms improved, I was also given 500MG of a Z-pack type antibiotic 1x day/4 days. I went to my PCP, doctor who was able to accurately diagnose my symptoms as an immune response to being unable to acclimatize due to my moderate immune response to the 2nd shot. My body went through significant inflammation. He treated me with Prednisone and continued my antibiotic.
Pneumovax given in Left Deltoid on 10-17-08.  Pt's husband states that patient developed redness swelling tenderness and low grade fever 48 hours after the vaccination in the left arm.  States that a prescription was called in for Keflex by him (husband is a physician) and the patient made a full recovery.
I never had tinnitus (ringing in ear) before in my life and there's never been any issue with my ears neither.  1 day post dose 1, I started to hear intermittent sounds like ringing and cricket in my right ear. about 2 weeks after that, the ringing started full force 24/7... Still am hearing the ringing as of now, it's been almost three weeks...