chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First was that I had a similar reaction to my second shot: fever, chills, exhaustion, fuzzy brain for a day. That passed after a day or two.  But then I had two things that came up that were not normal for me - and at my age I have been through a lot medically but I know what is normal.... 1. In early October I was practicing yoga like I do 2-3 times a week for years, and suddenly my right Achilles tendon tore. I didnt fall or do anything stupid with it, just my normal like I have done for years, and somehow that caused the injury. It didn't snap apart but it did tear and that required treatment. It didnt heal the way it was supposed to either, and I wound up being off my feet for two whole months, and not able to drive either, had to take a monthlong medical leave from work because it was so debilitating. Now, in early April, six months later, I am just finishing PT for it and I am still just barely getting back to yoga. This was a major injury.  I want to say: I do not know that the Covid vaccine caused this injury, but there was some correlation. AND this injury was so weird and unusual for me, being so fit and regular and careful in the exercise I do, that I think it should be considered.   2. In December, I got a bad case of eczema for the first time in my life. It covered my entire torso back and front and was seriously inflamed. It is under better control now with doctor care, medicine and a lot of home care, but still there and I still have to do a lot of home care to make sure I am okay.  This was also something I have never had before ever in my life, or anything like it - and therefore worth my reporting, in my opinion. One other piece worth adding here: I read news reports that some people who got Covid had skin rashes with Omicron, so it is also possible during that December/January timeframe that I got Covid. From March on I was testing once a week for work, but not during the time period that I got the eczema. Once I realized there was a connection, it was too late to test.
Excruciating panic in muscles on right side of body unable to walk sit lay down sleep with out pain 2 days after shot Urgent care and X-ray treatment and bulging muscles in back muscles which moved into my wrist Hips legs ankles shoulders and body pain meds have helped and at home therapy and care for it still ongoing pain and inflammation in my muscles/ joints
Patient received a shingles vaccination and flu shot on 9/25/20. On 11/27/20 she returned for her second dose. She informed me that her entire arm swole up and turned slightly red. Today she informed me that she also had a bruise in the are of the shot that was still present., I confirmed that the bruise was in fact still there 2 months later.
Info has been received from a physician concerning a 5 year old female, with "moderate to severe" asthma and no drug reactions/allergies reported, who in 1999 was vaccinated with a dose of varicella virus vaccine. Concomitant therapy included montelukast sodium and fluticasone propionate (Flovent) (also reported an "Slovent"). On 4/19/05, the pt experienced mild case of varicella with 25 lesions. No known lab diagnostic studies were performed. Unspecified medical attention was sought. No product quality complaint was involved. The reporter also noted that the pt took montelukast sodium and experienced an adverse event. Additional info has been requested.
fever, shakiness, red eyes that are sensitive to light,  partial facial numbness above eye and nose, pt has high tolerance to pain and had severe pain in left arm, some slight tightness in chest  pt used proair and tightness stopped, fever recordings 99.4,100.7,101.4,101.8 @ 8pm ,101.5 @830pm pt took 2 extra strength Tylenols at 7pm. also added cold wash rag at 8pm.101.0
Swelling noted under left axillary, tenderness developed, still swollen and tender 2 days later, low grade fever.
1:00pmTinglingInFace,Headache,Chills,JointPain,ElevatedBloodPressure
2hr p/vax had shaking chill w/nausea & malaise, t102 oral, one episode vomiting, gen musculoskeletal aches & pain, t102 till MN then temp 101 until 4MAR97 next day;
Increased tinnitus/ringing in ears; This is a spontaneous report from a contactable consumer. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: UNKNOWN, Dose: UNKNOWN), via an unspecified route of administration on left arm on 23Feb2021 at 1.00 pm as Covid-19 immunization. No medical history and concomitant medications were reported by the patient. The patient is allergic to sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received omeprazole (UNKNOWN MANUFACTURER), Allopurinol (UNKNOWN MANUFACTURER), Tadalafil (UNKNOWN MANUFACTURER), Vitamins (UNKNOWN MANUFACTURER) within 2 weeks of vaccination. Prior to the vaccination the patient was not diagnosed with Covid-19. Since vaccination patient was not tested for covid-19. The patient past medication history was not reported. The patient experienced an increase in tinnitus on 01Mar2021.the patient also reported that he had some tinnitus before but it was more noticeable and bothersome. The patient did not receive any treatments for the events. The clinical outcome of the event was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
I had a migraine from heck, complete with the worst pain imaginable, vomiting, and light sensitivity.  I woke up with a "regular" migraine the morning after the shot that progressively got worse.  In the evening, I went to an urgent care facility where I received IV fluids and IV medication for pain and vomiting.  I started feeling better shortly afterward, but it took the next 2 days before I felt completely normal again.  As a side note, about a month to 6 weeks after the shot, I started randomly started breaking out in hives over various body parts.  There's no rhyme or reason as to where I get the hives and nothing in my life has otherwise changed.  Given the gap, I don't know if this is related to the vaccination but wanted to mention it.
I was fatigue, hard to swallow, headaches, sweaty palms, chest pressure pain.
Pt started rash on leg of injection site the all over body 6-7 days after date of vaccine. Pt started fever after that for 4 days 101-102.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: tingling on feet and fingers-Medium, Additional Details: diagnosis at urgent care states pt had a vasovagal attack
developed swelling and pain left arm within 1 week of administration Janssen Covid -19 vaccine IM left arm on 3/27/2021, on 4/16/21 left upper extremity venous sonogram  demonstrated left axillary vein thrombosis
Little rashes, bumps like little bumps all over my arms, my body and they itch; Little rashes, bumps like little bumps all over my arms, my body and they itch; Little rashes, bumps like little bumps all over my arms, my body and they itch; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received bnt162b2 (BNT162B2, solution for injection, (Batch/Lot number: not reported) via an unspecified route of administration on 17Aug2021 as dose number unknown, single for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced little rashes, bumps like little bumps all over my arms, my body and they itch. The patient stated that couple of days after the vaccination started getting in little rashes, bumps like little bumps all over arms, body and they itch and patient was trying to get to know like what can I put on to stop the itching and how long does these usually last. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.
On 2/13/17, Pt. received QUADRACEL (DTaP and IPV) in upper (L) deltoid and Influenza (multi dose vial) in lower (L) deltoid on 2/13/17. Developed redness, swelling at site noted in am of 2/14/17. Pt. seen 2/15/17. Has cellulitis 10 cm x 13 cm noted from Influenza site extending down to elbow. Given PO cephalexin (250/5 ml) 10 ml BID x 10 days and BENADRYL PO PRN, cool compresses PRN.
On day #9 post injection (12/31/20) of Moderna Vaccine I developed a red itchy rash (no raised bumps), about the size of goose egg around injection site.  I have been taking 50 mg  Benedryl PO at bedtime.  Today is day #12 post injection and the rash has spread slightly, but the redness and itching are significantly reduced.
SLIGHT SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced slight soreness at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight soreness at the injection site was not reported. This report was non-serious.
Vaccines that were administrated beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administrated beyond use date after the thaw process) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if patient had chronic or long lasting health conditions.     On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administrated beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administrated beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient age was reported as 51 years 10 months. It was unknown if patient had acute illness at the time of vaccination and up to one month before. It was unknown if patient had been diagnosed with or tested positive for COVID-19. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Treatment medications were not reported.
Rash on (L) thigh with mild severity & gradual onset x 2 days.
Body aches began about 11-12 hours after dose and continued for about 40 hours after dose.  Severe chills began about 4:00 am, 19 hours after dose and lasted several hours.  Chills returned two to three times over the next 20 hours.  Low-grade fever began about 8:00 am, 23 hours after dose.  Fever peaked to 101.2 F about 36 hours after dose.  All symptoms resolved within 48 hours after dose.  Fever and pain were reduced with use of acetaminophen.  Two doses of 1000mg taken.  One around 9:00 am on 1/6/21 and another around 9:00 pm on 1/6/21.
Information has been received from a pharmacist concerning a male pt, with a history of Meniere's disease, who was vaccinated with a dose of hep A virus vaccine inactivated. Concomitant vaccine included a dose of pneumococcal vaccine, polyval. Subsequently, the pt experienced a flare up of his Meniere's disease. The pt had been prescribed Prednisone at an immunosuppressant dose. At the time of the report the pt had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Meniere's disease was considered to be an other important medical event (OMIC) by the reporter. Additional information has been requested.
Golf ball sized, circular, red rash at sight of injection.  Slightly warm & slightly hard upon palpation.
This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A female patient of unspecified age received first dose of TRUMENBA, via an unspecified route of administration in the arm, on an unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced injection site very sore, on an unspecified date, with outcome of unknown. Follow-up (15OCT2015): Follow-up attempts are completed. No further information is expected.
Cardiac arrest; This is a solicited report via a contactable consumer based on information received by Pfizer from a company (manufacturer control number: 21K-163-4137210-00).   A 47-year-old male patient received bnt162b2 (BNT162B2), intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for psoriasis.  The patient medical history was not reported.     The patient's concomitant medications were not reported. On 29Sep2021, the patient experienced cardiac arrest with outcome of recovered on an unspecified date in 2021.  The action taken in response to the event for risankizumab rzaa was dose not changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. The reporter's causality for the event of cardiac arrest was not provided. Company's opinion is that the event of cardiac arrest is not assessable.; Sender's Comments: Based on the limited information available, a causal association between the suspect drug and the event cannot be completely 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 was received from a 52 year old female patient, reporting on herself. The patient's medical history or concurrent conditions were not reported. On 11-NOV-2014, the patient was vaccinated with ZOSTAVAX (strength, dose, lot number and expiration date were not provided). Other suspect therapy included prednisone (manufacturer unknown) tablet, (strength, dose, route, indication, lot number and expiration date were not provided) started on 04-MAY-2016. Concomitant medication included FLONASE and CLARITIN. On 30-APR-2016, the patient developed a painful rash, which progressively got worse. On 03-MAY-2016, the patient went to her provider and was diagnosed with shingles. Therefore, the patient was given an unspecified antiviral for 7 days, the patient did not state how her treatment was working as she just started it. It was also reported that, there was not intervention to prevent serious criteria. There were not significant disability, incapacity, life threatening, hospitalization or prolonged. And there was not product quality complaint involved. At the time of reporting, the outcome of shingles was reported as recovering. The action taken with prednisone (manufacturer unknown) was unknown. Additionally, the patient stated that she did not know if prednisone (manufacturer unknown) contributed to her symptoms. Additional information has been requested.
Pt reported that she developed dark urine 2 days post vaccine. Pt states that the same thing happened when she received second dose of CV-19 vaccine.
Pt received Booster dose on 12/3. Patient asked his cardiologist if he should even get this dose, because he had Ventricular tachycardia after each previous dose. Cardiologist encouraged him to get it. 12/5 patient had Ventricular Tachycardia 2 days post vaccination.
Patient reports severe fatigue.  Reports unable to walk across room without feeling like his body was giving out.
Elevated heart rate in 110-130s approximately 12 minutes after injection given.  Pt states feeling ?jittery and racing heart..?Denies shortness of breath, chest pain/tightness. Denies any tingling in throat. SpO2 99% on room air. Bp 120/72. No other symptoms. During period of monitoring heart rate decreases to 80s for few minutes then elevated to >110s.  After 30 minutes pt returns home. For next 4 hours following occasional periods of elevated heart rate 110-130s. Only 3 episodes the next day. Mild headache during this day but no other symptoms.
Initial unsolicited report received from the literature on 02 October 2015. The following is verbatim from the article: We describe a case of immune thrombocytopenic purpura (ITP) occurring 15 days after the first dose of a 4-dose rabies vaccination series. ITP is thought to be an immune-mediated process triggered by an infection or toxin. There is little evidence in the literature beyond case reports of an association of ITP with vaccines other than with the measles, mumps, and rubella vaccine. This is the third reported case of ITP associated with rabies vaccination. Because of the rare occurrence of this adverse event relative to the severity of rabies infection, the benefits of rabies vaccination, when indicated, outweigh the low and possible risk of ITP. This case involves a patient (age and gender not reported) who was vaccinated with four-dose series of Rabies vaccine (batch number, expiration date, dose, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medication were not reported. On an unspecified date, 15 days after the first dose of vaccination, the patient experienced immune thrombocytopenic purpura. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. Upon internal review, company assessed the event of Immune thrombocytopenic purpura after first dose of rabies vaccination as serious and important medical event. List of documents held by sender: none.
VIAL OF VACCINE WAS DILUTED WITH 1.5ML OF DILUENT INSTEAD OF 1.8ML.  Called patient on June 12 to explain what had happened and her only symptom was a sore arm for a day.
the red spot has grown; injection site swelling; injection site redness; injection site itching; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 29Apr2021 at 12:45 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on unknown dates. Concomitant medications included esomeprazole magnesium (NEXIUM), omeprazole (PRILOSEC) and loratadine (CLARITIN); all taken for unspecified indications from unknown dates. The patient previously took codeine and other pain medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 08Apr2021 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 COVID vaccine. On 29Apr2021 at 17:30, the patient experienced pain in the left arm at the injection site . On 30Apr2021 at 11:45, the patient noticed some swelling, redness as well as itching. Patient had been icing it. On 30Apr2021 at 15:00 patient took a picture to send to someone and on 01May2021 at 19:00, patient took another picture to compare and noticed that red spot had grown. At 20:00 and 23:00, patient took benadryl to see if it helps and at 23:00, patient took another picture to see if the benadryl was helping and patient was not sure it was. The clinical outcome of the events pain in the left arm at the injection site, swelling, redness as well as itching and red spot had grown was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient reported having palpitations about 2 hours after receiving the first dose of Moderna. He continued to have palpitations and chest pain off and on for about 3 weeks. He went to see his doctor and the patient said the doctor said all tests were negative. The patient has not received any treatment for the adverse reaction and we are holding the second dose for now until confirmation from his doctor.
Moderate pain at injection site for 24+ hours, but beginning to resolve. Fever and chills overnight, and both mostly resolved after 6-8 hours with Naproxen).
This spontaneous report was received from a healthcare worker refers to multiple patients of unknown age and gender. The patients concurrent conditions, pertinent medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PEDVAXHIB (digital data logger) (lot # K007258, expiration date 04-MAR-2017). The vaccine was exposed to the temperature: 48.9F with the time frame of 1 hour 10 minutes. There was no previous exposure. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient tested positive for SARS-CoV-2 after full vaccination. He had no symptoms and was discovered through response testing during an outbreak
Dizziness, Headache, Fever, CoughWheeze, Fatigue, Injection site pain, Swelling at injection site Narrative:  Other Relevant History:
Red and warm for several days post shot about 3 inches in diameter.  This disappeared  leaving a 1 inch dark circle.  Approximately 9 days later a red solid 1 inch in diameter resurfaced that was red and itchy,  This was outlined by a perfect red circle approximately 3 inches in diameter.   A picture was sent to my physician.  No treatment and this dissipated in approximately 3-5 days.
fatigue and a lot of fatigue / still has the fatigue today; This case was reported by a consumer and described the occurrence of fatigue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 29th May 2021, the patient received the 1st dose of Shingrix. On 29th May 2021, less than a day after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details was reported as follows: The age at vaccination was not reported. The patient received Shingrix 3 days ago and experienced fatigue the first night and a lot fatigue the second and third night . The reporter stated that she had received Covid 19 shot 2months ago. The patient still had the fatigue today. The reporter did not consented to follow up. The case is linked with US2021117068, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021117068:same reporter