chrisvoncsefalvay/vaers-outcomes huggingface dataset:
21 yr old male without a history of a primary, secondary immunodeficiency, or eczema presents to A/I clinic with concern for a possible adverse reaction to his recent smallpox vaccination - administered in an atypical location 15 days ago. He reports that he has been compliant with keeping the lesion clean and dry despite its location on his upper left back. Patient has not had systemic symptoms. He has not had distant lesions. The patients concern was the size and the slower healing time than expected. He was seen in clinic today by Allergist, Immunizations nurse and the Dermatologist. There is no reason at this time to suspect that he has a 2ndary bacterial infection. Although progressive vaccinia is on the Ddx there doesn't appear to be necrosis at this time, he has what appears to be a ring of granulation tissue (new skin), his WBC is within normal limits, he has demonstrated positive titers to other vaccines (indicating that at least he has humoral immunity). The likely explanation: Poor wound healing due to the location of vaccine. Pictures were obtained with the patients consent. Plan at time of visit - Have patient monitor the lesions - Return to clinic or come to the ER this weekend and contact Allergist who is on call always,  if the skin or center of ulceration becomes discolored, fevers occur, new lesions occur elsewhere. Additionally, he will return on Monday for a re-check, to measure the size and monitor for changes (ideally it will be smaller, show more signs of healing). Should there be signs that this is progressive vaccinia we will inquire about obtaining  Vaccinia IG and begin immunodeficiency w/u. Case d/w (who agrees with above): MSN FNP-BC, Immunization Healthcare Branch.
Extreme and debilitating muscle craps for several hours Ibuprofen and acetaminophen were alternately taken
104 FULL FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported.  On 08-APR-2021, the patient experienced 104 full fever. Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 104 full fever. This report was non-serious.
until the vein opened up and was squirting out blood; until the vein opened up and was squirting out blood; a severe itching rash; This is a spontaneous report from a contactable consumer. An 80-year-old male patient (reporter husband) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 29Jan2021 12:00 at SINGLE DOSE in left arm for COVID-19 immunisation. Medical history included ongoing asthma Onset Date: Probably about 20 years ago, ongoing chronic obstructive pulmonary disease Onset Date: Probably about 20 years ago, ongoing overweight Illness/AE: Little overweight. There was none family medical history relevant to AEs. There were no concomitant medications. The patient received first dose of bnt162b2 (Lot number: EC3246) on 08Jan2021 in Left arm for COVID-19 immunization. The patient experienced a severe itching rash on 01Feb2021 with the outcome not recovered. Area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood on 24Feb2021 with unknown outcome. The rash hasn't gotten worse, and it is staying the same. The AEs require a visit to: Emergency Room and Physician Office. The patient underwent lab tests and procedures which included biopsy: unknown results on 25Feb2021, Bloodwork: Nothing showed up on this test. This is a non-serious report. The outcome of event a severe itching rash was not recovered, outcome of the other events was unknown.  This consumer reported she and her husband were administered second dose of Pfizer COVID-19 Vaccine on 29Jan2021. Her husband apparently has had a reaction of very itchy rash to the Pfizer COVID-19 Vaccine. She reported that the patient saw the Dermatologist and the Dermatologist thinks the Reaction of very itchy rash is a reaction to the Pfizer COVID-19 Vaccine. Regarding testing/investigations related to this report caller provided that the primary care physician ordered bloodwork and nothing showed up in that. Biopsy was taken 25Feb2021 to see if reaction of very itchy rash is related to the Pfizer COVID-19 Vaccine When queried if any adverse event required Emergency room visit, physician's office visit or hospitalization caller reported that the patient was seen in the emergency room, but not admitted to the hospital on 24Feb2021 related to patient's event of area where a vein is very close under the skin itching that he scratched until the vein opened up and was squirting out blood event-they got that situated in the emergency room. Emergency room staff were the ones that recommended that the patient start Claritin. Dermatologist office visit was regarding the reaction of very itchy rash. The patient is taking Claritin and using Calamine lotion or Calamine spray for these events. Reaction assessed: Reaction of very itchy rash, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related.
Severe Headache, Dizziness, itchy, achy, felt like pins and needle were on her skin. Denies fever.
Information has been received from a consumer concerning her 22 year old niece who on approximately 24-FEB-2009 was vaccinated with a dose of GARDASIL (Lot # not reported) 0.5ml, intramuscularly. The patient took an at home pregnancy test a week after she got the vaccine and it was positive. In approximately February 2009, since the patient got the shot, she experienced swelling, tiredness, bloating and tenderness. At the time on the report the patient was not recovered. The patient did not seek medial attention. Additional information is not expected.
On 12/07/2022 in the middle of me working out my heart rate went up to the 200s. I went to the doctor and they did a EKG and I was diagnosed with Orthostatic Hypotension. In February I was also diagnosed with vertigo. I am scheduled to go to a neurologist now.
Administration Error: Patient received first dose of Sputnik out of country, second dose of AstraZenica. According to CDC guidelines, since Sputnik is not EUA approved by CDC or WHO, patient should have received monovalent mRNA dose. Instead, a bivalent dose was administered
Burning  and tingling in my mouth, tongue,throat, chest. Rash on chest and back, dizziness
2 diluent of Arexvy  was mixed together  and was administered to a patient. lot# and expiration same for both diluent.; 2 diluent of Arexvy  was mixed together  and was administered to a patient. lot# and expiration same for both diluent.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 79-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7539N, expiry date 24-APR-2026) for prophylaxis.   On 31-OCT-2023, the patient received Arexvy. On 31-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: 2 diluent of Arexvy  was mixed together  and was administered to a patient. lot# and expiration same for both diluent.) and inappropriate dose of vaccine administered (Verbatim: 2 diluent of Arexvy  was mixed together  and was administered to a patient. lot# and expiration same for both diluent.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 31 Oct 2023: The pharmacist reported 2 diluent of Arexvy  was mixed together  and was administered to a patient. lot and expiration same for both diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
I have had Urticaria Delayed Pressure Reaction disorder (DPR) for over 10 years. I get welts and swelling on my lips, nose and cheeks periodically (3-6 times per month). I have been able to control the DPR well and consistently for years, with Xyzal. It reduces and eliminates the swelling effectively within about 30 minutes - 2 hours.    The average size of the DPR welts are between the size of a dime to a quarter. My skin is raised about 1/8th of an inch. The length is generally 1/2 an inch by 1/2 an inch.   Indicative of this aliment is that once you get a welt, it will be at least 48 hours before you get another one. I never have never had more than one onset of a welt in less than 48 hours, for over 10 years. The last several years the welts have been gradually and consistently getting smaller and less often and they have been easier to control.   However, on June 30, 2021 at 4:00 p.m., I received my second Shingrix shot. On July 3rd, 2.5 days after receiving the Shingrix shot, I started getting a DPR lump on my upper left lip. I did my normal routine with my allergy medication on the onset of it. But, this time the swelling came on so fast and it was extremely larger than I have ever had.  Within an hour, it was huge. The swelling was 4 times larger than any other episode I have ever had (over 10 years). It was about 3.5 inches long and 2.5 inches tall and it was raised at least 3/4 of an inch. It remained swollen for 6 hours.  It spread to the middle of my left check, and almost my entire upper lip was swollen to the point it looked and felt like it would pop. My cheek looked like I had a golf ball in it.   The swelling began to go down and by evening, while my upper lip and face were still swollen, but not as much. Then I started feeling another lump on the other side of my upper lip develop. This was very surprising because I have never had two episodes in less than 48 hours. It started swelling very fast like the last one. I took double the normal dosage of allergy medicine, but it kept swelling. It was still swollen in the morning, as well as my other side of my face.  The now has mostly subsided.   Given that Urticaria DPR is an allergy-based ailment, it is believed to be an autoimmune related disorder.  After the Shingrix shot, my body?s reaction was alarmingly more severe than ever before (4 times larger). It really seemed evident that my body was overreacting unusually severely, due to the Shingrix.   If I had known that that this vaccine had a chance of negatively affecting people with autoimmune challenges, I would NOT have taken it. I hope this does not keep affecting me this way, going forward, because it would be debilitating.  I would like to know if others with DPR or autoimmunity, had a severe reaction after their first or second Shingrix.
8 x 10 cm pink, round rash x 2 days. Motrin and warm compresses.
She got her vaccine, her arm was the most painful of all the other vaccines.  She ended up having later in the day like food poisoning symptoms, intense bowel movements several times a day.  She was literally house bound due to the episodes and intenseness of it.  This has lasted up until Friday, 6/10/2022.  This was the main symptom.  The other symptoms were that her knee caps like they have "rug burns", but was not crawling on concrete or anything.  They look they have been scraped.  She has never had a problem with her knees, and her left knee kept going out from under her to the point that she had to hold onto the railing to go down the steps, this also kept going until this past Friday, 6/10/22.  She was telling her sister this information who also got the Moderna vaccine at a different location and has the exact same symptom, but the right knee and the look of the same scraping area, and they both have the same lot# as well.  The bowel movements were 4-5 times a day daily up until Friday 6/10/22, and her sister was the same way and felt on Thursday 6/09/22 that she was finally coming to be normal again.   She did not take anything for the symptoms.    Where the vaccine site was it was burning hot and juts below where the injection was it was raised skin (welted), but not at the injection itself.  This went away first but took about a week to do so.   Her sister who is her twin also had this reaction as well.
Fever 103 x 2 with papulo-vesicular generalized body rash - self treating.
Covid Arm. Large 3x3cm rash on bicept area, Smaller 2x2 cm rash lateral arm, Welt at injection site.
1/3/22 Patient present to ED via squad after falling at home. Pt reportedly had cold symptoms since 12/25/21. He developed progressive weakness leading to fall. In ED, was found to be positive for SARS CoV 2 and head CT showed acute sinusitis. He was admitted on Augmentin. He was discharged after 5 days. Acute metabolic encephalopathy Generalized weakness -Presented with worsening weakness, wife was unable to transfer patient into his wheelchair due to patient having no strength.  Also seemed very confused. -Per patient's wife, patient nonambulatory at baseline and wheelchair bound however usually able to transfer out of bed and into wheelchair with only 1 person assist.  Due to previous stroke has left-sided hemiparesis at baseline. -CT head on presentation negative for acute intracranial process.  Extensive disease noted in paranasal sinuses. -Mental status appears to fluctuate.  More somnolent yesterday, still drowsy today but awakens more easily. ABG yesterday unremarkable. -No new focal neuro deficits on exam -Repeat UA without evidence of UTI -Weakness and confusion likely secondary to acute viral illness and sinusitis.   -Evaluated by PT/OT, plan for discharge home with home health, hospital bed ordered.   COVID-19 infection - Presented with: Acute encephalopathy, cold-like symptoms - Symptom onset: 12/25/2021 - Positive COVID-19: 1/3/22  - Vaccination status: Vaccinated with J&J with last dose 3/2021 - CXR on admission showed No acute disease in the chest.  - Oxygen status: 95% on RA  - Decadron: Does not qualify due to SpO2>94% on RA. - Remdesivir: Does not qualify due to SpO2>94% on RA and >10 days since symptom onset. - DVT prophylaxis:Currently on full anticoagulation
Pt had intractible screaming and fever to 103 degrees F., starting 10 hours after 3rd DTaP.  Screaming continued more than two hours.  Pt was seen by me the next morning, and was fussy, but with a normal exam.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The nurse reported that on 22-OCT-2014, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J008529, expiration date 12-OCT-2014) (dose number and route not reported). Nurse stated that ZOSTAVAX did not have any previous temperature excursions. ZOSTAVAX was supported with port-expiry data. No adverse symptoms reported. No further information provided. Additional information has been requested.
fever to 103.6 evening of vax & w days subsequent; 3 sz about 3min 24hr post vax;
Couldn't eat or stay awake, high fever couldn't lift arm, throwing up, sore throat, headache severe. 09/27/2004, arm still cant lift, and nauseous.
I am still having muscle and joint pain.; I am still having muscle and joint pain.; Hips shoulder Achilles arms; This is a spontaneous report from a contactable consumer, the patient. A 61-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 on an unknown date in Feb2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had previously taken Phenergan, and experienced drug allergy. Any other medication taken within two weeks of vaccination was not reported. 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 vaccination. On an unknown date in Feb2021 the patient was still having muscle and joint pain, hips shoulder Achilles arms. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the events still having muscle and joint pain, hips shoulder Achilles arms was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Within 5 minutes of vaccination he was in the waiting room and became very dizzy, sweating  and was having trouble breathing.  I reported to the closest worker and she called in another person, assuming one was a nurse and one was not.  She had him look into her eyes, which was difficult, then she had him out his head between his knees for a minute and he was then able to come out of it.  Still a bit dizzy, they moved him to a room with a bed where he could lie down and they put a cold, wet paper towel in his forehead.  He rested there for an additional 10 minutes.  They had him get up and walk before they allowed him to leave.  He had not eaten anything since the night before and he has severe ?needle anxiety ? which both could have contributed to the reaction.  He has not had any issues since, except for a sore arm.
I had the common nausea fever and aches. But more notably, I had a heavier period for a long time than usual.
Anaphylactic reaction; itching/generalized  pruritus/ some prickly the itching; shortness a breath; hives; skin rash; body flushed; Iv infection; This is a spontaneous report from a contactable other healthcare professional (patient). A 74-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EL1284), via an unspecified route of administration, in Arm Left on 12Jan2021 at 17:00 as 0.3ml, single for covid-19 immunization. Medical history included asthma. The patient concomitant medications were not reported. On 19Jan2021, the patient had anaphylactic reaction. The anaphylactic reaction started within minute lasted upto 6 hours with shortness a breadth and was on prednisolone for six days (40mg). The sign and symptoms of the anaphylactic reaction included: vital sign was normal; itching began with in minute and IV infection and body flushed; began to get treated with antihistamines for her hives and precaution. The patient had hives and its thing (unbelievable); then difficulty breathing without wheeze. She had generalized itching and some prickly; the itching was at times like if her body was of hive (generalized pruritus with skin rash). The patient received treatment with Benadryl 6 mg above and pro air - prednisone for 6 days and then with a prescribed. No 2nd dose. The patient did not require any medical intervention; all prescribed her allergy for fused me to go to hospital too much condition. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of reported events Anaphylaxis, rash, urticaria, dyspnea  and pruritis and flushing cannot be excluded. But also consider medical history of  asthma  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.
For the last 4 months since the influenza vaccination, she's suffered from pain in her left deltoid muscle interfering  with elevation or abduction over 90 degrees.
Patient experienced swelling around the right side of neck and chest and vasospasms and swelling  near the right ankle.  Patient was concerned she may have experienced a blood clot
pt recv vax;devel rash on underside of arm which lasted for 1.5 wk;rash reappeared on both lower legs which resolved in 4 days;
Vaccinated with Janssen on 3/31/21.  Symptom onset 7/11/21 with shortness of breath, nausia, sore throat and fatigue.  Tested positive for Covid-19 on 7/11/2021
sore left injection site arm after fist dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm after fist dose of Moderna Covid-19 vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031821A) for COVID-19 vaccination.  No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore left injection site arm after fist dose of Moderna Covid-19 vaccine). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm after fist dose of Moderna Covid-19 vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.Treatment medication was not provided.Concomitant medication was not provided. This case was linked to MOD-2021-386043 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant follow up appended-HCP details added, patient contact info added
Dizziness, warmth, flushing - full body, chest discomfort within 2 min of administration lasting at least 2 hours. No - angioedema, bronchospasm, shock.
(L) arm where MENACTRA was given was warm to touch red itchy and painful area about the size of grapefruit.
cough; sinus pressure; fever between 99 and 101; loss of smell; headaches; drowsiness; This is a spontaneous report from a contactable consumer (patient). A 28-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 08Aug2021 at 14:00 (at the age of 28-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 13Aug2021 at 16:00, the patient experienced 5 days after shot started having cough and sinus pressure. On day 6 and 7 unspecified date of Aug2021 fever between 99 and 101, loss of smell, major sinus pressure and headaches, drowsiness. Patient visited to doctor or other healthcare professional office/clinic visit. Patient received treatment for events. The patient underwent lab tests and procedures which included fever between 99 and 101 on unspecified date of Aug2021 and nasal swab with unknown results on 14Aug2021. The outcome of the events was not resolved.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.