chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I could not breathe; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Severe amounts of blood clot in both lungs and severe amount of blood clots in my left leg; it turned out to be the blood clots everywhere in my system; Profound dizziness; Confusion among other things; I still have lot of coughing; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809, expiry date not reported, age at the time of vaccination: 82-year-old), via an unspecified route of administration, administered in Arm (don't know right or left arm) on 19Feb2021 as dose 2, single for covid-19 immunisation administered in vaccination center. The patient had no medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EL9261), in Arm (don't know right or left arm) on 28Jan2021 for covid-19 immunization. The patient did not receive any other vaccination prior to the first shot of suspect vaccine. On an unknown date in 2021 (right after the second dose), the patient could not breath and went into hospital for a surgery in emergency and it turned out to be the blood clots everywhere in his system and he never had before. It has been a couple of week ago. He spent two bouts in a hospital, had surgery and was continuing with multiple MRIs and CAT scans to see if he had brain issues and what not. The problem that developed was he have had all kinds of lupus test and CAT scans and everything and he had no sign of this problem before the vaccine. After the vaccine, he have severe amounts of blood clot in both lungs and severe amount of blood clots in his left leg and he was being treated for those and being operated for those and they removed some of the blood clots in the lungs but not in the leg at this moment. Now he is in home and he had to go back into the hospital again in a different hospital for the side effects from the surgery (further not clarified). But he was still scheduled for lot more tests because they don't know because he still have lot of coughing and a lot of things going on yet. He just said he don't have the exact date of the hospitalization. The patient also experienced profound dizziness, confusion among other things. The patient received corrective treatment for the side effects from vaccine, he is taking Eliquis and many other medications which he don't have the list of them and they are in hospital records. The patient underwent lab tests and procedures which included Lupus test, CAT scan (computerised tomogram) and MRI (magnetic resonance imaging) on an unknown date and results were unknown. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Light hives on both forearms approximately 2 hours after Shingrix vaccination. To treat the hives, patient received Solu-medrol 125mg IM at 12:52pm in the left gluteal, and Diphenhydramine 25mg orally at 12:49pm. Patient was contacted at 2:09pm on June 25 after he had been drive home, and patient stated the hives have improved to light pink and barely elevated, and he was instructed to continue diphenhydramine 25mg one every 4-6 hours as needed.
Information has been received from a nurse practitioner concerning a 17 year old female with penicillin allergy who on 12-FEB-2007 was vaccinated with Gardasil 0.5ml intramuscularly (lot number 653736/0014U). There was no concomitant medication. On 12-FEB-2007, 45 to 60 minutes post vaccination, the patient called the physician's office stating that she had hives on her arms and legs. The treatment was Benadryl. On 13-FEB-2007, the patient was seen at the physician's office and still had hives on her arms and legs but no shortness of breath. No other treatment was given. The hives were improving. Hives on arms and legs were considered an other important medical event. Additional information has been requested.
Tinnitus, ringing in ears, specifically left ear, loud, constant, never had before
It was reported that a female patient received a TD Adult vaccination on 21 Feb 2001. Reportedly the patient developed a fever of 102F, general malaise and body aches which persists 2 days after vaccination.
exacerbation adult-onset still's disease; exacerbation adult-onset still's disease; HERO-TOGETHER: A POST-EMERGENCY USE AUTHORIZATION OBSERVATIONAL COHORT STUDY TO EVALUATE THE SAFETY OF THE PFIZER-BIONTECH COVID-19 VACCINE IN HEALTHCARE WORKERS  This is a report from a non-interventional study source and post authorization safety study.   A 28-year-old female subject received first dose of BNT162B2 (reported as COVID-19 vaccine) on 19Dec2020 and the second dose on 16Jan2021, both via an unspecified route of administration as single dose for covid-19 immunization. Medical history included adult onset still's disease (her last flare about 2 years ago). The subject's concomitant medications were not reported. In Dec2020, the subject experienced exacerbation adult-onset still's disease, which was considered as medically significant event (reported as non-serious by the investigator). On 01Feb2021, the subject presented to rheumatology office for follow-up of adult onset stills disease. She was doing very well with her last flare about 2 years ago, until 2 months ago when she had a flare lasting about a week. This flare was followed by a second flare after she received her second dose of her COVID vaccine, again lasting about a week. She was treated both with 20 mg of prednisone. On 26May2021 (Today), she stated that she was doing well, denied any fever, chills, or significant joint pain or stiffness. The only joint where she was experiencing pain is her left knee, which had been a chronic problem for last 2 years. She denied trauma to the knee. Received methylprednisolone 40mg left knee injection for symptom relief. Rheumatologist assessment: "This 28-year-old female with previously stable and very quiet adult onset stills disease. It is likely that her current flares were related to the receipt of Covid vaccine. If she continued to have more frequent flares, she would let me know, and we would discuss treatment with a disease-modifying antirheumatic drug (DMARD)". The action taken in response to the event for BNT162B2 was not applicable.  The outcome of the event was recovering.  There was a reasonable possibility that the event exacerbation adult-onset still's disease was related to COVID-19 vaccine.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded  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.
this spontaneous report as received from a physician refers to a 35 year old female patient. The patient was allergy to penicillin. On 05-JUN-2014 the patient was vaccinated with the first does of (Oka/Merck) VARIVAX (lot#J005294, expiration date: 30-APR-2014, 0.5 ml) subcutaneous. There was no concomitant therapy. The physician stated lab work (titer) was completed after first dose and result was less than 135. On 10-JUL-2014 (last Thursday), the patient experienced an outbreak of varicella. The patient came in office on 15-JUL-2014 (today) for second dose and was still experiencing outbreak of varicella. No second does was administered. The patient had a long standing diminished immune response to B cells and was unclear if this would be a factor in patient's immune function. No treatment was given for the adverse event. The outcome of above adverse events was unknown. Additional information has been requested.
Sleeplessness lasting 3 weeks, could not sleep more than 2-3 hours at a time/ sleeplessness; General feeling of agitation after dose 1, only way to describe it is what I would imagine an athlete on steroids feels. Peaked at about week 2/ agitation; Restlessness; Nursing mother; BNT162b2 was administered to breast feeding mother/ Nursing mother; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Sep2021 14:30 (Lot number: EW0180) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious) with onset 01Sep2021 14:30, outcome "unknown", described as "Nursing mother", PRODUCT USE ISSUE (non-serious) with onset 01Sep2021 14:30, outcome "unknown", described as "BNT162b2 was administered to breast feeding mother/ Nursing mother", INSOMNIA (non-serious) with onset 03Sep2021 10:00, outcome "recovered" (Sep2021), described as "Sleeplessness lasting 3 weeks, could not sleep more than 2-3 hours at a time/ sleeplessness", AGITATION (non-serious) with onset 03Sep2021 10:00, outcome "recovered", described as "General feeling of agitation after dose 1, only way to describe it is what I would imagine an athlete on steroids feels. Peaked at about week 2/ agitation", RESTLESSNESS (non-serious) with onset 03Sep2021 10:00, outcome "recovered", described as "Restlessness". Therapeutic measures were not taken as a result of insomnia, agitation, restlessness.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported of a general feeling of agitation after dose 1, only way to describe it was what she would imagine an athlete on steroids feels. It peaked at about week 2. The patient waited as long as she could before receiving dose 2 but required to receive it before the end of September due to mandate. Nursing mother. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a 75 year old male patient with asthma and high blood pressure and refers to himself. The patient was allergic to unspecified sulfonamides (reported as Sulfa) and unspecified penicillin. On 23-DEC-2015 (reported as "vaccine was given last Wednesday"), the patient was vaccinated with a dose of ZOSTAVAX in the left arm, lot # reported as "RX 0911521-03764", (strength, dose, route of administration and expiration date were not provided). It was unspecified if the patient took any concomitant medications. On approximately 24-DEC-2015 (reported as "a day or two after injection was given"), the patient started feeling itching at the site of injection and when he felt/touched at the site of injection he felt pain. The patient did not receive the treatment for the adverse events. The patient did not have lab diagnostic studies performed. At the time of the report, the patient did not recover from the adverse events (the events did not improve). The patient did not seek medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
This is a spontaneous case, initially received from other health professional on 08-Oct-2018, concerning a 35-year-old, adult, female patient. The patient had no medical history. The patient did not receive any concomitant medications. On 05-Oct-2018 (Friday), the doses were withdrawn from FLUCELVAX multi-dose vial (MDV). On 08-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230 and expiry date: 31-May-2018), which was pre-drawn three days in advance. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious. This case 201804361 was cross-linked to case 201804360 due to the same reporter.
pt recvd vax & then walked 30 mins fainted & hit back of head on rt side; lying on floor nurse helped sit; BP taken 130/90, P64, reckeck BP 120/90, P84; pupils reacted to light x/large; pt states hurt where bumped; h/a, weakness;
My first shot was on May 3rd, I got my period on May 12th, but after my second shot on May 24th, I have missed three menstrual cycles and counting. Please note that I have always been on time like clockwork my entire life, and I have not been sexually active during this timeframe.
Extreme chills and fever in the night.  Woke up with 100-degree fever at 5:30am.  Took Tylenol.  Felt lethargic all day, but was better after about 24-hours later. I did have Covid-19 testing positive on 10/31/20.
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: THE PATIENT RECEIVED THE VACCINE AND WAS SEATED IN THE WAITING AREA . AFTER A FEW MINUTES, THE PATIENT BEGAN TO FAINT. THE PHARMACIST AND TECHNICIAN HELPED HIM TO THE FLOOR. HE STATED THAT THIS HAS HAPPENED TO HIM BEFORE WHEN HE HAD BLOOD DRAWN. HE ALSO CALLED HIS MOTHER AND SHE CONFIRMED THAT HE HAS A HISTORY OF SYNCOPE WHEN RECEIVING SHOTS. THE PATIENT DID NOT GO TO THE HOSPITAL, BUT HAD A FRIEND COME TO GET HIM. HE WAS CALLED LATER THAT NIGHT AND STATED THAT EVERYTHING WAS BACK TO NORMAL.
This spontaneous report was received from a pharmacist concerning a 60 year old female patient with drug reaction/allergies Ibuprofen, iodine, sulfa drugs, gastroesophageal reflux disease (GERD, asthma and depression. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, frequency, strength, lot number, expiration date and route were not reported). Concomitant therapies included SEREVENT, SINGLULAIR, FLONASE, nortriptyline, albuterol, RANITIDINE, BENADRYL, aluminium hydroxide, GAVISCON ANTACID TABLETS, VITAMIN D (UNSPECIFIED) and minerals (Unspecified), CENTRUM. the pharmacist reported that an unspecified date in the past, a patient developed a large, itchy rash and shortness of breath after receiving M-M-R II. The outcome was reported as recovered on an unknown date. Patient seek medical attention. Additional information has been requested. These case is one (1) of two (2) reports from the same source. (MARRS 1407USA006059 and 1407USA006768)
First time recipient of Influenza Vaccine, reported itching and small rash under eyes, patient monitored vital signs and went back to normal
pt recv vax 14AUG98 & rash began w/in 24hr on chest, legs, arms;itching occasionally;no resp difficulties;no exposure to chemicals, detergents change, no hx of exposure to insect bites/ticks/milk;
Patient had pallor, severe dizziness and complaints of change in auditory perception approximately 15 minutes following administration of vaccines. Patient returned with assistance to exam room and placed in supine position with legs raised above head. Assessed HR 72 BPM, BP 88/48 left arm, SpO2 98% room air 13:15 PM. At 13:25 PM returned patient to sitting position and gave hydration via oral route. Assessed HR 88 BPM, BP 92/58 left arm, SpO2 98% room air. Assessed by MD and dismissed in mother's care without further complications.
Full body muscle pain, skin pain but no redness, headache, stomach pain. Injection site pain.  Nausea.  Does not appear to be anaphylaxis.  All pain is significantly worse than flu symptoms except nausea which is manageable. Light headed. Weakness.  2nd shot only. First shot was much better tolerated.
Cough with phlegm, sore throat on 9/23/21 onset, and vomiting diarrhea and abdominal pain up to 9/30/21
Cellulitis - area at injection is 1" & deep skin loss - whole area of approx. 5" is losing skin. Pt prescribed prednisone & AUGMENTIN for treatment.
Chills, achs, weakness. Began about 4pm day of vaccination (2/28/21). Most severe overnight and through next morning. Symptoms abruptly ended about 1pm day following vaccination (3/1/21). No treatment. --I had COVID and related pneumonia late March into May 2020
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic type 2" (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 Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Aug2022) Positive, notes: Tested positive as of 30Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech COVID-19 Vaccine was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled, and packaged by Withheld. The final scope was determined to be lot 30155BA. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or SQRTs/AQRTs were held because of this complaint. The complaint condition of lack of effect was not confirmed, therefore, the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior to any lot being released to the market.  Follow-up attempts are completed. No further information is expected.
Left arm pain at vaccination site with redness, extreme swelling, and warmth from shoulder to elbow.
So, it was like a rash that was itchy, it was on my back, stomach and chest, it was really itchy. I just took Benadryl over the counter, I would wash with cool water. I would take a Benadryl every 12 hours. It would get better and then come back. This lasted for about 30 day. By the first week of December it just completely disappeared. It was just gone. It wasn't bad enough where I would not do this again, it was annoying, but nothing to harsh.
15 minutes s/p injection patient c/o  "numbness" isolated to the "tip of her tongue." Patient was given 25 mg PO of liquid diphenhydramine. There was no swelling of the lips or tongue. No signs of respiratory distress. Respirations even and unlabored. Patient able to speak in full sentences and manage secretions. Patient transferred to "urgent care" to be evaluated by a provider.
Immediately after administration of DTAP, injection site became swollen and red. Ice pack was applied and 1 teaspoon of Benadryl Elixir was given.
This spontaneous report as received from a nurse practitioner refers to a 11 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 06-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Fatigue for 2 days   Rash at injection site started 1 week after the injection and lasted 4 days
rt inner aspect of forearm gave appearance of steamburn; involved area just below elbow to above wrist on 27FEB92 w/inc temp; low grade for 24 hrs then redness faded;
Rash around the injection site after 10 days of receiving the first dose, with itchiness.
I had a seizure hours after my vaccination. I?ve lost my speech and continue to have multiple episodes a day. I can?t work. I can?t drive. I can?t do anything I used to be able to do prior to May 27 when I received my booster.
12 month old patient given proquad with varicella in single presentation. No symptoms or adverse outcomes.
bone aches; chills; headache; is also tired; pain in the arm that started that afternoon.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm that started that afternoon.), BONE PAIN (bone aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (is also tired) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm that started that afternoon.). On 07-Apr-2021, the patient experienced BONE PAIN (bone aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (is also tired). At the time of the report, PAIN IN EXTREMITY (pain in the arm that started that afternoon.), BONE PAIN (bone aches), CHILLS (chills), HEADACHE (headache) and FATIGUE (is also tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    concomitant medications included pill for sugar, fish capsule and pill for cholesterol.
Information has been received from a nurse practitioner concerning a 21 year old female who was vaccinated with the first dose of GARDASIL on an unspecified date. In August 2008, the patient experienced tightening in her back. She continued to have upper back pain which caused difficulty in sleeping and walking. The patient sought unknown medical attention. At the time of report the patient's status was not recovered. Follow up information has been received from a medical assistant indicating that the patient was still experiencing back pain. Pain traveled to the shoulder blades into the neck and traveled into the lower back. Mother of the patient told the medical assistant that the patient had not recovered and it was "hard for her to be active, and she was still uncomfortable when sleeping". Additional information has been requested.