chrisvoncsefalvay/vaers-outcomes huggingface dataset:
admitted to inpatient medicine floor on 02Mar2021 for COVID-19 pneumonia; increasing O2 (oxygen) requirements; This is a spontaneous report from a contactable pharmacist reporting for a patient. A 70-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), intramuscular, administered in Arm Left on 24Feb2021 as SINGLE DOSE for covid-19 immunisation at 70 years old on a hospital. Medical history included colitis ulcerative, rosacea, systemic lupus erythematosus from an unknown date. It was unknown if other vaccines were given in four weeks. No COVID prior vaccination. Concomitant medications included hydroxychloroquine taken for systemic lupus erythematosus; sulfasalazine taken for an unspecified indication; mercaptopurine taken for colitis ulcerative; and doxycycline (DOXYCYCLINE) taken for rosacea; all start and stop dates were not reported (other medications in two weeks). The patient was admitted to inpatient medicine floor on 02Mar2021 for COVID-19 Pneumonia (onset date 02Mar2021). The patient was transferred to ICU on 04Mar2021 given increasing O2 (oxygen) requirements (onset date 04Mar2021). Treatment included dexamethasone and tocilizumab. The patient underwent lab tests and procedures which included Nasal Swab (PCR) (Sars-Cov-2 Test): positive on 02Mar2021. Outcome of the events was unknown.; Sender's Comments: The event COVID-19 pneumonia is likely an intercurrent condition and unrelated to suspect drug BNT162B2. Full immunity is expected 7 days after the second dose. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Nurse pinched the skin and injected the vaccine within subcutaneous fat, did not stick needle all the way into muscle. 6 hours later, injection site became red, hot, painful, hard and swollen. 60 hours later and the redness, warmth, hardness and pain has spread further down the arm. Low grade fever day 3 relieved with ibuprofen
Pt admitted to hospital where she died on Feb 7, 2022. No other information available.
Information has been received from a registered nurse concerning a 64 year old female with hypertension and asthma who on 22-AUG-2007 was vaccinated with Zostavax (Lot #658086/0761U) subcutaneously in her left upper arm. Concomitant therapy included hydrochlorothiazide (manufacturer not specified), ACIPHEX, SPIRIVA, TEKTURNA, LEXAPRO, calcium (unspecified) and vitamin D (unspecified). On 23-AUG-2007 the patient developed vesicular lesions in the left anticubital fossa one day after receiving her Zostavax. The patient was first examined in the office on 31-AUG-2007 and was prescribed topical cortisone cream. The patient was examined again on 05-SEP-2007. A culture of the lesions was positive for varicella. The patient was prescribed LYRICA on 05-SEP-2007 due to left upper extremity pain. As of 10-SEP-2007, the patient's vesicular lesions culture positive for varicella persisted. The nurse noted the patient is scheduled for a follow-up appointment on 19-SEP-2007. Additional information has been requested.
Had some blood clot in his urine; This is a spontaneous report received from a contactable consumer. A male patient with age reported as 52 (unknown unit) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via unspecified route of administration on unspecified date in 2021 (reported as Monday or Tuesday) as 1st dose, single for COVID-19 immunisation. The patient's medical history included diabetic. The patient had not had COVID in the past. The patient's concomitant medications were not reported. Reporter stated that she had some questions. Her husband and she got the Pfizer shot and they didn't have anything, everything was fine. They had one family member and he was 52 and diabetic (history) and he worked in an area where he was out of range at the time of this report, so they could not talk to him for about like next half an hour. So, this week, he had the Pfizer shot and he was also put on two new medications (unspecified medications) right after that. He woke and he went to his work today and then he called, and he had some blood clot in his urine. The first thing they thought of was the company which they didn't had (further clarification unknown). So, they just need to know that new medication, also he was diabetic (history) and he had been on the same medication forever and there was no problem but the two new medication that he was put on (sentence incomplete). About lot number reporter stated that she did not have all that. They were just concerned, and reporter was kind of like, reporter asked if he should go to emergency room with the blood clot showed up in the urine or could that just be a urinary tract infection (UTI). It was his first COVID shot and he had not had COVID in the past. Reporter further stated, the two new drugs that he started, they just wanted to know if they need to worry about blood clot like if it could from the shot or it could be from the two drugs that he was taking. Reporter further asked if this was something that he should go to the emergency room. Reporter also asked if blood clot was possible due to Pfizer vaccine or it could be a urinary tract infection. She just wanted to know if Pfizer vaccine did cause blood clot like the Johnson and Johnson did (further clarification unknown). About vaccination date of second shot reporter stated in two weeks or something she did not know. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Itching. feels like something crawling under my skin. for about three weeks. Then after second dose 9/30/2021, severe blurred vision, peripheral vision blocked, front vision blurred. Stubbed toe on 10/2 bc of blurred vision and peripheral obstructed vision.
I have COPD. Caller later stated on the call. I've got COPD I mean it's even hard for me talk to you right now. I'm sorry I'm just upset it's really hard; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "I have COPD. Caller later stated on the call. I've got COPD I mean it's even hard for me talk to you right now. I'm sorry I'm just upset it's really hard".  Additional information: Caller called in seeking assistance with the Abrysvo vaccine.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Received vaccine 3/19/04 in doctors office. Fine all week. I gave her Tylenol periodically until Monday to relieve crankiness, pain at insertion site. Monday night, fever 101. Responded to Tylenol. Seemed fine Tuesday morning. At 1 PM Tuesday 3/23/04, gave her Tylenol elixir for temp of 102 degrees. At 1:15, patient seized (focal seizure, blank stare, gaze off to left side), unresponsive, foaming of mouth. Took rectal temp 102 rectally. (Breathing/color was good.) Gave patient Tylenol suppository. Called 911. Patient appeared questionable post-ictal en route to hospital in ambulance. Arrived at hospital at 1:45 and as placing patient to stretcher, patient seized again. This time, tonic-clonic, some respiratory distress (was on non-rebreathe since ambulance team arrived to the scene). Eyebrows twitching. This 2nd seizure lasted 20 minutes and patient needed Ativan to break the seizure. Patient stabilized and transferred to hospital. In hospital, found no source of fever. CT negative, LP negative, rule out meningitis. No ear infection, no apparent respiratory infection. Blood culture, urine culture negative. RSV negative. No source could be found for seizure except possibly vaccine (Patient received Varicella vaccine 3/19.). Also later for routine follow up for patient (patient discharged from hospital 3/24 late afternoon after all tests negative). In doctor's office Friday 3/26/04, now presents with upper respiratory infection (pretty severe; wheezing, needed several treatments and now beginning of ear infection. This was one week from administration of vaccine. Could this be side effects from vaccine as well?  Medical record on 04/30/04 states: complete. Nurse follow up on 06/10/04 states: Complete.
pt presented to MD w/vomiting not projectile, no fever over 4 days cont vomit devel diarrhea;almost to point of dehydration;resolved w/in 4 days returned to nl state of hlth;
tested positive; tested positive; sick; cough; HA body aches; fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 47 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 14Dec2021 (Lot number: FF2589) at the age of 47 years as dose 3 (booster), single, administration date 25Feb2021 (Lot number: EL3247) as dose 2, single and administration date 03Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jan2022, outcome "unknown" and all described as "tested positive"; ILLNESS (non-serious) with onset 26Jan2022, outcome "unknown", described as "sick"; PYREXIA (non-serious) with onset 26Jan2022, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 26Jan2022, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 26Jan2022, outcome "unknown", described as "HA body aches"; COUGH (non-serious) with onset 26Jan2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Jan2022) positive, notes: Other; (26Jan2022) negative, notes: Other. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, illness, pyrexia, chills, pain, cough.  Clinical course: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was Unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, has the patient been tested for COVID-19 was Yes. covid test type post vaccination was Other.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
DEATH; This spontaneous report received from a consumer via media through a company representative concerned a male of unspecified age, race and ethnicity. 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: unknown, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, reporter stated that " Take a good look at my kids & their grandpa. He lived less than a mile from our house. He was a daily constant in our lives. You took him from us. Your little experiment has caused so much death, pain, and suffering".   On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed or not.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 .20211266689-COVID-19 VACCINE AD26.COV2.S- death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
SICK; FEVER 101; 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. The patient's concurrent conditions included allergies. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sick, and fever 101. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, and fever 101. This report was non-serious.
Patient reports a history of reactions to vaccinations.  She had an abscess post MMR in 1994 that required a surgical procedure.  She also had a significant local reaction to the Pneumovax, date unknown.  She has had allergy testing and is not allergic to eggs.  She cannot wear contacts, because it makes her eyes red and swollen.  She wonders if she may be allergic to thimerosol, but has not been tested for it.  Patient reports a raised, red, warm 10cm area around injection site that lasted 5-6 days before resolving on its own. Symptoms began a day or 2 after the flu vaccination.  Patient did receive a thimerosol free vaccine, as requested.
3 weeks after second shot I have noticed swollen supraclavical lymph node on the left side. Feels about the size of a grape but could be larger/smaller. Will be going to doctor to get it checked out. I have no other symptoms that I have noticed.
first vaccine-started within 3 hrs of injection. Intense muscle and joint pain for 48 hours. second vaccine-started within 30 minutes of injection=dizziness. Followed within 3 hours=shaking, intense pain in muscles and joints, intense headache, chills off and on. This continued for 72 hours. Followed by intense feeling of burning up interspersed with the chills. Culminating at 82 hours with intense chest pains. I then had to take 4 nitroglycerin pills, 0.4mg each ( 1 every 5 minutes) before the chest pains stopped. Then after that, all of the side effects ceased except for tiredness which lasted another 24 hours. Note: I have nitroglycerin on hand since I had a heart attack in 2001. I only occasionally need to take it, not more then 1x/year, sometimes I can go for several years without taking any. If I had not had any on hand, I would have gone to the nearest ER.  Note-I have continued to have shakiness off and on about 3x/week which is still persisting.
Red rash on arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Red rash on arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy.    On 16-Jan-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 RASH (Red rash on arm). At the time of the report, VACCINATION SITE RASH (Red rash on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a medical assistant concerning a 5 year old male patient who on 21-FEB-2001 was vaccinated with a dose of varicella virus vaccine live. On approximately 28-DEC-2005, the patient developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Herpes zoster diagnosis in a herpes zoster vaccine recipient. Treated with Valtrex for 7 days. Lasted about 2 weeks. Pain, but no itching. Not hospitalized.
Hives all over the face and body with severe intensity started 9 days after the booster shot and continued over close to two weeks. After that they have become localized and get triggered randomly to unknown stimuli on a daily basis.
Patient received the COVID-19 vaccine on 1/4/21 and 1/23/21, so was fully vaccinated when testing positive for COVID-19 on 10/12/21.
Initial report received from a health care professional on 21 March 2011. A 17-year-old male patient received on 09 September 2010 a left deltoid injection of MENACTRA, sanofi pasteur lot number U3515AA. The patient had no known allergies and took no concomitant medications. The patient had no illness at the time of vaccination. On 09 September 2010, ten to fifteen minutes after receiving the vaccine, the patient slumped into his parent's arms at the checkout desk. The parent held him upright for a few minutes then lowered him to the floor where he had seizure activity. The patient was taken to the Emergency Room (ER). The outcome was reported as not recovered. Documents held by sender: None.
administered only the liquid portion; administered only the liquid portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 5th January 2022, the patient received Menveo. On 5th January 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that the day before reporting, she administered only the liquid portion of Menveo to the patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not have any patient or vaccine lot, expiration date information at the time of the call as she was not at work. The reporter consented to follow up.
Pfizer-BioTech COVID-19 Vaccine EUA 24 hrs post vaccination I started feeling fatigued, muscle and headaches which seemed to move around my body for about 24 hrs. At one point it seemed to settle into my hand. Knuckles swelled arthritis like. When walking up stairs I had significant muscle weakness in my legs and exertional  dyspnea.  Eyes felt "feverish" but had no fever. The next morning while trying to do a routine workout the same thing happened. It was a significant change to my normal condition. The dyspnea was the most concerning. The body aches settled into my lower back. Fatigue was moderate-moderately severe.  As the day went on things waxed and waned.  By the end of 72 hrs. most symptoms subsided. Friday 01/08/2021 I had a completely normal workout, no exertional  dyspnea, fatigue subsided, no body aches. Back to normal. I would consider the symptoms to have been  Moderate+.
This spontaneous report was received from an office manager and refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot# reported as M056221, expiration date: 15-OCT-2017; lot# reported as M032358, expiration date: 05-JUL-2018; lot# M027347, expiration date: 01-JUN-2018 and lot# M023384, expiration date: 11-MAY-2018). No adverse effects were reported. Temperature excursion details: Temperature: >-10*C but <8*C Time frame: 190.5 hours Previous temperature excursion? No Digital data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007291:
This was my first COVID-19 vaccine.  Second is scheduled for 2 March.  Soreness developed at point of injection that evening, but not unusual.  I felt pressure in head/neck area and had dry cough that evening.  Took Advil PM before going to bed.  About 2am that night I started having severe chills.  I took temp at 5am and it was 101.7.  Took Tylenol and temp went to 99.8 by 7 am.  Temp went back up to 101.5 by noon.   Had called my workplace medical and they want me to stay out for 3 days due to the reaction.
Client received vaccines on 6/22/06. She called our office on 6/28/06. Reports that over the weekend she had she had nausea and vomiting, headache especially behind her eyes, and fever. Her fever in worse at night and spikes to 101. Then about 2 days ago her skin started getting yellow. she also reports that her urine is dark gold. Encouraged client to see her primary physician. Dr sent her to have some blood and urine tests. At 1:30 on 6/28/06 Dr office called the health dept. The clients liver enzymes are elevated. Dr's nurse reports that her levels are: ALT 321, AST 210, Alkaline phosphate 300, Bilirubin 4. DR ordered a Hep panel on her blood. Results should be back 7/3/2006.
Feeling of dizziness, lightheadedness, in a fog, off balance - all started on 3/6/21 at 9:30 am while doing floor exercise at home.  I couldn't get up without listing to the right.  My husband who is a firefighter had me get on all 4's until I was able to get up.  It happened several times over the weekend ie:  lying down watching tv, reading a book on the sofa I was and still am experiencing it every day since then.  Each "episode" lasts for approximately 30 seconds.
terrible headache; chills; fever for 24 hours; Other vaccine on 28Jan2021; Other vaccine on 28Jan2021; This is a spontaneous report received from a contactable consumer (patient herself). A non-pregnant female unspecified aged patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration to the Left arm on 28Jan2021 at 13:00 at a single dose for COVID-19 immunization. Medical history included Allergies: Adhesive tape. Concomitant medication that the patient received within 2 weeks of vaccination included Simvistatin (SIMVASTATIN) and losartan (LOSARTAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the fifth day after received the vaccination at 01Feb2021, the patient experinced that suffered terrible headache, chills, fever for 24 hours. The patient received the Other vaccine of Pfizer on same date 28Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, has the patient not been tested for COVID-19. Patient reported the seriousness as non-Serious. The patient did not receive any treatment received for the adverse event. The outcome of the events are Recovering.  Information on the lot/batch number has been requested.
Influenza symptoms of sore muscles, sore joints, mild fever, fatigue. Duration of awakening 11/01/23 through Morning of 11/02/23. A period of about 24 hours.
pt recvd vax 31AUG95 & pt became pale,limp,eye partially closed,not responding to stimuli,w/shallow resp;this lasted for approx 10mins;pt taken to ER & then transferred to another hosp dx hypotonic episode & cyanosis related to pertussis