chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 knees replacements; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EN5318), in arm and on 01Mar2021 as dose 2, single (Lot number: EN6202) at the age of 75 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "parathyroidectomy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: KNEE ARTHROPLASTY (medically significant), outcome "unknown", described as "2 knees replacements".  Clinical course: Only other thing different with caller's health was that in Jan2022, after getting all of these vaccines caller had a parathyroidectomy and during the previous year, after the first and second doses of the vaccine, caller had 2 knees replacements. No additional vaccines administered on same date of the Pfizer suspect. No events required a visit to emergency room and physician office. Prior vaccinations (within 4 weeks) no other vaccinations were done. Events following prior vaccinations were not provided. Family medical history relevant to events were not provided. No relevant tests done. There were no predisposing factors and culture was not performed. Information on culture positive, serotyping, culture source and antipyretic use were not provided.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Knee arthroplasty which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes 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.
Client started oral Typhoid on 1/27/06 and she noticed facial rash-little red bumps not itching in week of 1/30/06. No more rash by the week of 2/6/06. Follow-up Information 31-MAR-2006: Client did not know when this rash started, she noticed the rash on the week of 1/30/06. No date or time provided by client.
On 06/05/2000 the patient developed shingles on the left side of her face and an infection. On 06/16/2000 the patient experienced folliculitis. On 06/16/2000 the patient recovered.
Right arm deltoid spreading to bicep redness, slight induration, itchiness (pruritus) erythema.
About 3 weeks after the vaccine my legs were shaky. I noticed it was hard to walk up stairs and down. By Christmas it was worse. I called my doctor to get an appointment and while waiting for that appointment I had to use a cane to walk, my speech got slurred and I became dizzy all the time. I am now using a Walker and wheelchair. They have tested me for everything such as MS, Parkinson?s and ALS and my scans were good and blood works looked fine other than SED rate was high. Seen a neurologist and he  said he has no idea what?s going on. I?ve told them over and over I started having this issue after the shot.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/29/2023 HEMIPLEGIA & HEMIPARESIS, RIGHT DOMINANT SIDE, LATE EFFECT OF ISCHEMIC STROKE
"shaking" w/t40.1 a/being brought to ER; was fully alert & oriented in ER;
I had huge lump in my armpit pit swell up/It is just like a swollen ball probably a lymph node; Pain; This is a spontaneous report from a contactable consumer reported for self. A patient of unspecified age and gender received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: unknown), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced huge lump in armpit pit swell up. It is just like a swollen ball probably a lymph node patient was assuming anyways it was really sore. Patient was wondering how long this thing is going to last. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
the next day worsen itchy redder cream; condition worsened; arms have rxns; Initial information was received on 21-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 49 years old female patient who experienced arms have rxns and the next day worsen itchy redder cream  after being vaccinated with yellow fever vaccine [YF-vax].  The patient's past medical history, medical treatment(s), concomitants, vaccination(s) and family history were not provided.  On 14-Apr-2023, the patient received a dose of 0.5 ml total suspect yellow fever vaccine Solution for injection (strength: standard) (lot number: UJ782AA, expiration date: 17-Feb-2024) via subcutaneous route in unknown administration site for Immunization (immunization).  On 14-Apr-2023 the patient developed a non-serious event of "arms have rxns" (limb discomfort) same day following the administration of yellow fever vaccine.  On 15-Apr-2023 the patient developed a non-serious the next day "worsen itchy redder cream" (pruritus) and condition worsened (condition aggravated) 1 day following the administration of yellow fever vaccine.  No lab data reported.  Action taken: not applicable.  A redder cream as corrective treatment was received for the events (condition worsened, the next day worsen itchy redder cream). It was not reported if the patient received a corrective treatment for the event (arms have rxns).  Outcome: Recovered / Resolved on an unknown date for the event arms have rxns and was Recovering / Resolving for the event the next day worsen itchy redder cream.
Patient states that the evening after receiving the vaccine, his entire upper arm became inflamed and painful. The next day the redness grew in size around the injection site. It was also very painful. He presented to pharmacy on 02/20/19 and said that by the second day, the pain had subsided mostly, but he still felt the adverse event needed to be reported. His wife received vaccine at same time with no issue.
pt slept for about 2 hrs p/being vaxed; pt then cried continuously for about 5 hrs;
Woke up at 3am feverish, nauseous, muscle pain and cramps (twisty feeling), body shaking, heart racing, arm pain at injection site, headache, top of scalp inflamed to the touch, slight chest pain, tired, itching in weird places I've never itched before (underneath my fingernail beds, tops of feet, for instance).  Took 5mg Norco,  2.5mg Valium, 325mg aspirin, and half benedryl.
Since 9/8/2021, she has been having some problems  with cough, shortness of breath, and headache.  She thought she had a sinus  infection.  She went to see her primary care physician and was tested positive  for COVID-19.  She was sent over to ER for  Regeneron transfusion on 9/16/21.   However, the patient was found to be quite hypoxemic with ABG showing a pO2 of  only 54.8 on room air.  The patient was then started on Decadron and since  the CTA of the chest showed bilateral consolidation, she was started on  Rocephin and Zithromax and then the Hospitalist Service was called for  admission.  When I saw the patient, she was saturating 93% to 94% on 2 L nasal  cannula.  Her main complaint is her cough right now.  She does not feel short  of breath at this point of time.  No chest pain.  Mild nausea, but no  vomiting.  No diarrhea.  No loss of taste or smell.  Says she lives alone. Admitted on 9/16/21 as an inpatient.  Continued Decadron  on her.  Started her on remdesivir as well.  Put her on oxygen.   Started her on vitamin C and vitamin D as well. For the Bilateral pneumonia, gave her Rocephin and Zithromax.  Patient says occasionally she is able to bring up a  sputum, mostly it is clear, but sometimes slightly yellow ting as well, but no  epistaxis, no hemoptysis. On 9/21/21 patient's symptoms resolved. REquires 1L NC with exertion. Discharged on 9/22/21 with 5 more days of azithromycin and cephalexin.
Moderna COVID-19 vial  was punctured more than 12 hours prior to being drawn up and administered to patient on 4/26/22. Vial punctured for more than 12 hours.  Vial not expired per manufacturers date.    Patient and provider notified.  No adverse reaction noted, patient will self monitor at home.   Will call provider's office if any issues.
I immediately had soreness and raised bump at the site of injection. I got a an itchy throat and cough within a couple hours and the pain in the arm has yet to subside.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000892.
Extreme swelling of arm injected, loss of mobility in the arm and intense pain that is still unresolved.
Patient described general itching around the mouth a few minutes after the vaccine.  Symptoms progressed while in observation, and spread all over body with generalized itching.  Consulted nurse triage and administered 50mg diphenhydramine IM with slight improvement right after.  Had patient under observation for half an hour, with symptoms improving over time.  Patient described no itching when she left the clinic.  Instructions were given to observe for symptoms and to call 911 if they return.  Med Administered under the Business and Professions Code as adopted by the Board of Pharmacy for the treatment of severe allergic reaction NDC: 0462-0218-02 lot#010091 exp: 01/2022
The pt experienced fever, cough, purulent rhinitis, persistent high fever, lethargy, dehydration, viral exanthema. Diagnosed with OM and neutropenia.
after the vaccine arm got swollen was administered Fever and nausea  Doctor- follow up with neurologist and at the moment she wasn't expressing any symptoms and if she started experiencing any symptoms call PCP  The symptoms began at 5p.m. and hasn't gotten the doctor but will call him tomorrow
It was reported in a published article, title as stated above and presented at the 2005 annual meeting of the American college of allergy, asthma and immunology, Nov 3-9 2005 concerning a 23 year old female with chronic mucocutaneous candidiasis who began to suffer from persistent thrush, failure to thrive, recurrent otitis media (staph aureus) and pneumonia (staph aureus and pseudomonas aeruginosa) since 6 weeks of age, who was vaccinated with PNEUMOVAX 23 vaccine (manufacturer unknown), (dose, duration and indication not reported). At age 4, she was noted to have poor antibody response to pneumococcal polysaccharide antigen, but normal to diphtheria and tetanus. Pneumonia episodes decreased with intravenous immunoglobulin IVIG at age 6. At 11 years of age, she developed persistent times capitis and severe Coombs positive hemolytic anemia. Four months later, she was noted to be very fatigued, slightly jaundiced and chest x ray showed pleural pericardial effusions. At 12 years of age, she developed severe Candida esophagitis and ulcerations. She had 2 times PBMN stem cell transplantation from HLA identical brother at 17 years of age without any reconstitution. At age 17 years she had depressed chemotactic response to FMLP low IgA, IgG2, and C4 levels. Low T cell (CD3+560 /ul, CD4+310/ul, CD8+170/ul,) and NK cell CD 16+56+:30/ul) counts were found at age 18. Candida albicans was isolated several times in KOH preparations and cultures from skin, mouth tongue in addition to her severe Candida esophagitis. At 18 years of age, she was diagnosed to have systemic lupus erythematous SLE on the basis of Coombs + hemolytic anemia, double stranded, deoxyribonucleic acid analysis (dsDNA) (1:20) serum antinuclear antibodies test ANA positivity (1:320) serositis (pericardial) and prolonged activated partial thromboplastin time PPT with positive anticardiolipin antibodies besides clinical findings. At age 23, she was admitted to the hospital due to Coombs + hemolytic anemia second time and died due to multiple organ failure. The authors state that chronic mucocutaneous candidiasis CMC is a heterogeneous group of diseases characterized by persistent yeast infection usually with Candida albicans and described for the first time, a patient with CMC that was diagnosed with SLE, with clinical as well as lab findings. Additional information is not expected. A copy of the published article is attached as further documentation of the patients experience.
Approximately 10 minutes after immunization fine red rash, raised rash noted on trunk an two red bumps (L) face. Temp taken - 97 degrees cutaneous - no respiratory difficulty, edema of face, lips, tongue; playful in no distress. Mom advised to give BENADRYL age/wt and  go to ER if worsens.
On 6/4/2021 patient received her third dose of the COVID 19 vaccine. Per phone conversation with the patient, patient arrived to vaccine clinic with a written letter by physician requesting to receive an additional dose. Patient received first dose 3/20/2021 and second dose 4/10/2021. Vaccine is currently only approved for a two dose series. Patient denied any unexpected or prolonged side effects.
Sore arm, general fatigue and in the middle of the night I felt chills and feverish but was able to go back to sleep.
Dizziness Narrative:  Patient in recovery area slumped in chair, and was sent to ER for eval.
30 minutes after receiving the first Covid-19 vaccine I was driving home when I felt a shortness of breath and my thinking became very fuzzy. No one was on the street I was driving and I panicked and dialed 911 because I thought I was about to blackout and I wanted someone  to come help in case I did. The operator talked me through whatever was happening. It was decided I had had a panic attack and no ambulance was called. Nothing like this had ever happened to me before. I had a headache the rest of the day but no more panic attacks.
On 5/17/99, the pt experienced a fever, anxiety, back ache, dry mouth, nausea, and heartburn. The pt sought unspecified medical attention. Subsequently she recovered from her experiences. No further information is available.
a 22-year-old woman with no past medical history who had 2nd moderna vaccine about 3 days ago.  She presents to ER with typical post vaccination syndrome including fever, muscle aches and neck pain, headache and in this case chest discomfort 2 days after the 2nd dose of vaccine. Cardiology is  concerned with myopericarditis.
2days p/vax pt devel rash, 12 red raised vesicular lesions, low grade temp.
cough, difficulty breathing, productive cough, 02 requirement, weakness resulting in hospitalization and death. received treatment : Azithromycin and Decadron  02/09/2021-02/19/2020
Pt complained of severe pain at the site of injection, 2 days, post vax. Pt complained of swelling of the area. Exam on 11/1/00, pt had a temperature of 98F; right deltoid had a 3cm X 3cm mass raised 2cm above the normal level. It was warm and tender. No fluctuation but did have discoloration of the skin over the mass. Pt was given Motrin 400mg and compresses. Symptoms resolved except for mild pain on palpitation. Exam on 11/15/00 showed ecchymosis 2cm X 2cm with indentation 1cm.
Information has been received from a physician, via a company representative, concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL (Lot # not provided). Following the vaccination, the patient fainted, and then recovered (duration not specified). No further details were provided. The patient sought unspecified medical attention. The physician reported that two other female patients also fainted after vaccination with GARDASIL (Lot # not provided) (WAES #0707USA04932, 0708USA00117). Additional information has been requested. This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a physician and a healthcare professional, concerning a 13 year old female student who on 04-JUN-2007, was vaccinated with the first dose of GARDASIL (Lot # 655165/1425F). There was no illness at the time of vaccination. Following the vaccination (duration and date not specified), the patient fainted, and then recovered (duration not specified). No further details were provided. The patient sought unspecified medical attention. The physician reported that two other female patients also fainted after vaccination with GARDASIL (Lot # not provided) (WAES #0707USA04932, 0708USA00117). Additional information is not expected.
Measles like rash primarily on torso, persistent cough, runny nose, lethargy, fever.  Still symptomatic on 6/22/2007. Tested for Strep (negative). Treated with antihistamine (benadryl), antipruritic, and childrens advil.
Patient reported body shaking/tremors, and nausea/vomiting until approximately 1am. Pt received shot about noon and said symptoms started about 5 hours later.
More than three weeks of moderately severe diarrhea (occult blood pos) after 2 month vaccines.
dizziness; "it makes me feel unbalanced."; egg-size rash around the site of the injection; body aches; arm soreness; face flushing; heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), FLUSHING ( face flushing), PALPITATIONS (heart palpitations), DIZZINESS (dizziness) and BALANCE DISORDER ("it makes me feel unbalanced.") in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), FLUSHING ( face flushing), PALPITATIONS (heart palpitations) and PAIN (body aches). On 02-Feb-2021, the patient experienced DIZZINESS (dizziness), BALANCE DISORDER ("it makes me feel unbalanced.") and VACCINATION SITE RASH (egg-size rash around the site of the injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm soreness), FLUSHING ( face flushing), PALPITATIONS (heart palpitations), DIZZINESS (dizziness), BALANCE DISORDER ("it makes me feel unbalanced."), PAIN (body aches) and VACCINATION SITE RASH (egg-size rash around the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. Patient has used Benadryl gel for her rash.
Died after taking short of Moderna experimental vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died after taking short of Moderna experimental vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who died (unexpected, fatal event) an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, pre-existing conditions, diagnostic tests, and treatment provided has not been disclosed. Cause of death was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no medical history reported, who died (unexpected, fatal event) an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, pre-existing conditions, diagnostic tests, and treatment provided has not been disclosed. Cause of death was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
11:17am Tightness around chest, as if bra band was suddenly two sizes too small, but no problem breathing. Lasted five minutes. 11:20am Slight tightness in throat. Lasted five minutes. 5:00pm Injection site pain, intermittent for two weeks.
Information has been received from a woman at a physician's office concerning a 12 month old female with no allergies and no medical history who on 11JUL2003 at 13:15 was vaccinated subcutaneously with a first dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. On 18JUL2003, while on vacation one week after vaccination, the physician's office received a call from the mother of the patient. She reported that the patient had "broke out with varicella and went through the stages" on the left arm, left hand, left leg and the face. She also reported that a rash had developed around the injection site on the left arm, left hand, the left side of the face and the left leg. The patient was not seen in the medical facility. Unspecified medical attention was sought. No diagnostic tests were performed. The patient's mother treated her with calamine lotion and colloidal oatmeal baths (AVEENO) as needed. Subsequently, the patient's symptoms resolved and the patient recovered. No product quality complaint was involved. Additional information has been requested.
Slight headache the evening after the  vaccination. Day after vaccination fever, chills, aches, unsteady on my feet. I had a similar reaction to the first dose of this vaccine but the onset was later. The worst day was the second day after the vaccination.
Moderna COVID-19 Vaccine EUA. Nausea, diarrhea, fatigue, headache, muscle aches, chills, chest pain/pressure.
approx 10min p/vax pt fainted had lung pain & diff to orient;reporter states looked like just a faint, but pt sent to clinic because didn't come out of it real fast;
4-29-08 - 1:00 AM - Fever/chills. 4-29-08 - 8:00 AM - Nausea/chills, stomach cramping. Dry heaves - done at 10:00 AM. Fever gone at 8:00 PM on 4-29-08.
Initial misuse report received from a healthcare professional  on 02 July 2013. An 11-year-old male patient had received DAPTACEL vaccine instead of ADACEL. No adverse event was reported. List of documents held by sender: none.
Swollen armpit and lymph nodes on same side as vaccine. Still remain swollen 3 wks post vaccine (2 wks and 3 days post appearing).  Notified MD via message system. She reassured this can be normal and to give it approximately 6 wks. If no better at that time will evaluate.
Information has been received from a health professional concerning a 20 year old female who on 06-OCT-2007 was vaccinated with Gardasil IM. On 06-OCT-2007 the patient experienced itching from the injection site down to her fingers that lasted for about 48 hours post vaccination. Subsequently, the patient recovered from itching from the injection site. The patient sought medical attention with a doctors office visit. Additional information has been requested.