chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This required heart catheterization; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID:.  A 36-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (hospitalization), outcome "unknown", described as "This required heart catheterization". Therapeutic measures were taken as a result of cardiac disorder. Reporter said that:" I can provide all hospital documentation needed to prove this was in conjunction with the shot to receive this help."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient had felt sweaty and nauseated and light headed. patient called ambulance not transported to er
five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the first of five reports.   A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Covid-19 virus test positive and  suspected LOE  due to temporal relationship.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021021909 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021021910 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021021911 Same reporter/ drug/ event for different patients.;US-PFIZER INC-2021021912 Same reporter/ drug/ event for different patients.
The pt experienced a blotchy raised rash on chest only, with itchiness. It was irritated by clothing. No respiratory symptoms. The rash faded but did not disappear. It reoccurred on 11/26/00. The pt took Benadryl for some relief. On 12/11 the rash faded.
After the first dose, a Lipoma appeared on the left side collarbone. After the second dose, on May 3, a Low grade fever began about 24 hours after the vaccine. Reaction was consistent with the reports for headache, fever, fatigue for first couple of days. The severity improved, but the fatigue and fever remained. Fatigue also became sweats, and continuing fever. Low-grade fever has not let up since the reaction started and is ongoing, with exhaustion much worse 4 weeks later, and chest & neck pressure and discomfort
Reports that she noticed a red mark developing at the injection site approx 2 days later that began to increase in size.  States also began to experience pain and discomfort to the site (8/10 in severity).  Was seen in Urgent Care and started on cephalexin on 12/20/22.  States that the MD reported that the redness/pain to her upper right arm could be a reaction to the vaccine but the MD felt it was likely cellulitis.  MD reports that her symptoms were completely resolved by the time she completed the antibiotic treatment.  Has complete use of  her right arm.
p/vax pt felt dizzy, exp h/a, general weakness & malaise;sx improved however pt cont to have intermittent h/a is very tired & is sleeping several hr a day (more than usual);
The Pharmacy made a mistake. When I arrived on Saturday for what I thought would be the second doze.  The Pharmacist told me they made a mistake. They never gave me the covid first doze. They gave me a buster.   I do not even know what they gave me. The card states Pfizer GH9697 but not sure if that is accurate.   This is the first time that I have the vaccine because my liver was not in good condition. I waited until my liver was healthier. Now I do not know what to do. I am not sure if Ok to take the second doze of covid vac.  I need to have the correct vaccines to leave the country on the 23rd. Please help me!!
had two seizures on the same day; epilepsy; This is a spontaneous report received from a non-contactable consumer reported for a 20-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient had epilepsy. He had two seizures this week on the same day and he had not had a seizure in 1.5 years. The outcome of the events was unknown.  Information on the lot/batch has been requested.
15 days post vaccinations- has quarter-sized-50 cent sized area. Red sharp borders, small blisters in center. Treat w/heat & TYLENOL or ibuprofen - monitor.
Change in vision, on exam noted to have swollen right optic disc, MRI normal, likely a secondary non-artertitic ischemic optic neuropathy and further workup is pending.
A pruritic area of erythema present for about 7-10 days after the injection with a mildly tender mass underlying it.  After this resolved, there was a pea-sized mass of residual induration and some residual postinflammatory hyperpigmentation overlying that site.
after the 3rd injection the customer stated that she felt lightheaded and dizzy, then she passed out. Pharmacist kept her from falling to the floor and hitting her head, checked a pulse and she had a pulse. She came to momentarily and started talking saying she felt like she had taken a nap. After a few minutes she stood up and was able to walk out of the store. She let pharmacist know she has a history of seizures and that she has passed out with vaccines before and was really nervous for these ones.
Reported high fever approximately 24 hours after receiving vaccine "101.9 F", aching.  Took medication to reduce fever.  Approximately 36 hours after vaccine, temperature 98.8 F on 2/7/08 AM.
Right arm soreness where injection was given. Woke up next morning with a slight fever. Site of injection swelled up to the size of a golf ball, redness and warm to touch. Onset of reaction was later that evening.
Almost had soreness at injection site that lasted 24 hours.  Four hours after injection, felt fatigued.  Twelve hours after injection, had continual low-grade fever alternating with chills, and strong headache.  The chills and fever lasted for 10 hours.  The headache lasted for 12 hours and was relieved by taking  Ibprofin.
Patient reports persistent pain at the site of injection and later, development of generalized right shoulder pain, worse with raising his right arm. Also notes numbness and tingling of the 5th, 4th and 3rd digit in the weeks following the vaccine administration
Pt recvd 3 Engerix-B vax on 0,1,6 mo schedule;09JAN90 titer indicated little response.
Dizziness, nausea and vomiting on first and second day after vaccine. Nausea and vomiting stopped on third day, dizziness persists.
Per pt was having hot & cold chills thru out the night. Site of injection is tender and warm, elevated BP & HR. Sweating reported.
I had Influenza (quadrivalent) & Pneumococcal Polysaccharide vaccines together - High Fever, Malaise, Wheezing, Chills, Coughing, Nausea, Dry Heaving, Dizzy, Head felt weird, headache, swollen lymph nodes under arm on side where flu shot was given, sore throat, could not sit up or stand. Got very ill and almost called an ambulance. I also took BENADRYL at the onset in case some was allergy related. It did nothing. This was not a mild response but severe.
Fever 100.7; muscle aches; headache; swelling at injection site; This is a spontaneous report from a contactable other health professional. A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via Intramuscular route of administration on Right arm on 06Feb2021 12:30 at single dose for covid-19 immunisation administered at Public Health facility. Medical history was none. Known allergies include Tetracyclines. Concomitant medications include advil [ibuprofen] (IBUPROFEN); dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), bromazepam (NIQUIL); paracetamol (TYLENOL) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). On 06Feb2021 13:30, patient experienced Fever 100.7, muscle aches, headache, swelling at injection site. The patient did not receive any treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Covid has not been tested post vaccination. The seriousness was reported as non-serious. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Night sweats, abdominal pain, right sided lower back pain, mild shortness of air, 5 cm complex ovarian mass was found via transvaginal ultrasound on the date listed, right sided. Was started on birth control tablets. ROMA score done, all levels within normal limits. Currently still following, will have repeat ultrasound 2 weeks from now to reevaluate progression. Pain was present for several weeks, had to wait 2 months for an appointment to get in to see MD for evaluation.
Information has been received from a physician's assistant concerning a 59 year old female with a history of coronary artery disease, hypercholesterolaemia, hypothyroidism, vitamin B12 deficiency, vitiligo, and allergic reaction to erythromycin and LIPITOR who on 13-JUL-2007 was vaccinated subcutaneously with a 0.5 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included PREMARIN, levothyroxine Na, niacin and simvastatin (manufacturer unknown).  On 29-JUL-2007 the patient developed a rash on her cheeks that looked like zoster.  The rash was bilateral and did not cause pain.  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved. Follow up information indicated that the patient did experience pain of a level 3 on a 0-10 scale (0 least 10 most). The patient had no other syatemic symptoms. There was no recent exposures to chicken pox or herpes zoster. A specimen was not collected for PCR. On 29-AUG-2007 the patient recovered. Additional information is not expected.
Developed hives immediately after receiving vaccine at site and on trunk.  Benadryl given.  Mother requested to have child monitored - Vital signs and O2 stable for 45 minutes.  Parent requested patient to be monitored longer - transported to ED via ambulance.  Referred to allergist also.
Child left clinic room felt fine. Walked down hall with Dad to exit. Dad turned around and caught him as he fainted. Felt nauseous. Juice given had not eaten since 8:30 AM. Cool compress applied to neck. Assisted to chair. Color returning to face. Dad pulled vehicle up to back door. 100 degree day. Left with Dad feeling back to normal. Counseled to get food and rest today.
fever 101,2 to 100.4-100.1 after Tylenol, body and joints aches , fatigue, headache, chills and diarrhea
The pt complained of throat tightness, swelling of hands and feet, rash and developed difficulty breathing. There was burning at the injection site with a hot feeling. She complained of itching at hands and mouth and dryness of throat. Fever of 100F.
24 hours after vaccination the patient developed reddness, swelling and itching at the vaccine site.
Expired 12/22/22 Hep B given to patient on 1/12/23
Patient had started peritoneal dialysis at home with me, his wife, 8 days before the second shot. All was going well. We got his second shot on the morig of March 18.  His only reaction seemed to be soreness at injection site. At 11 pm we started dialysis as usual, with the cycler.  At 12 pm he was having trouble breathing after just having been filled with 1500 ml of dialysate. This was the first time this happened. I gave hi nitro glycerine and had the cycler take out the 1500 ml of dialysate, and stopped the therapy for the night. He then felt better, and apologized for waking me up. In the morning he was dead.  I believe it is possible that the vaccine tipped the balance of patients already taxed system. As I know that people who have serious diseases and are older are encouraged to take the vaccine, this outcome should be known to the CDC.
50 days after the 2nd dose of the Moderna Vaccination, I started having panic attacks.  With the panic attacks, I also experience extreme dizziness, tingling throughout my body and significant spikes in blood pressure.  It is now 71 days after my 2nd dose of the Moderna vaccination and I am still experiencing panic attacks, dizziness, rapid heart rate, and body tingling.  The episodes are intermittent.  Some days I am completely incapacitated and can't leave my bed which means I am out of work on those days.  Some days, I am completely fine and can make it through the day.  I am being treated by my doctor with Celexa which is an anxiety medication.  So far, the medication isn't working.  I had no indication of anxiety or panic attacks prior to getting the vaccination.
Pt recv vax on 4/12/99; 4 hr post vax pt exp fever & malaise
Intracerebral hematoma  SAH (subarachnoid hemorrhage)  Cerebrovascular accident, unspecified mechanism Seizures
Swollen, reddened left preauicular lymph node. Continued swelling without pain. Swelling duration continued including today. Has not fully resolved, however swelling has diminished, although not fully resolved - can both see and feel swelling still.
I had severe hip pain and lower right back pain. I also experienced chills , fever, exhaustion , shortness of breath and  pain in upper rt thigh with nausea.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-MAR-2013, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 21-SEP-2015, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Tachycardia-Medium, Additional Details: having a dessert and then passed out
On 4/6/01, received vaccine and 10 minutes later, developed fullness in ears, felt crackling in back of head. (Wife has had 2 week episode of upper respiratory infection). Pt presented on 4/9/01 for evaluation and treatment. He was given Z-pack of Zithromax for sinusitis and otitis media. Required a refill on 4/19/01. Recovered on 4/24/01.
Starting in the morning of 09/14/2022, I went to the doctor and got tested for COVID-19 which was positive. I had a telehealth visit with my doctor afterwards and I was prescribed pills. I stayed in the house for 2 weeks. I had a cough and my head was stuffed up. My sinuses were a little congested and I lost my sense of taste and smell for a few days but otherwise it wasn't to bad. The cough lasted the longest of all symptoms (a few weeks) while all the other symptoms resolved by about a week. however, I feel that was more related to sinus drainage than COVID-19 itself.
24 hours: Acute Myopericarditis, Difficulty breathing, Heavy chest  Within hours: Fever, Severe Chills, extreme fatigue
reddened, sl edematous area approx size of twenty five cent piece on rt arm;advised to put cold cloth on area;take APAP if necessary;call MD if worse;
Rash/redness occurred 2 days ago on (R) deltoid. Rash was red, swollen and warm to the touch. Redness was the width of his arm. Sensitivity to touch and itching were noted. No other symptoms noted. Swelling noted today (3/15/13).
Vaccine given too high in the arm and was given in the joint, employee was unable to raise arm and has extreme pain to the right arm.  Was treated with steroids and physical therapy at a clinic.
This case was reported by a physician and described the occurrence of transverse myelitis in a 55 year old male subject who was vaccinated with Engerix B. The reporter is the subject. The subject's medical history included asthma, back disc problems, benign prostatic hyperplasia, elevated blood pressure, elevated cholesterol, and meningioma which was removed in 2004. Concurrent medications included Lipitor that the subject has taken for 10 years, Levoxyl, Norvasc, Flomax, Altace, Singulair, Avodart, Advil. On an unspecified date 15 to 20 years prior to the date of reporting, 20 December 2006, the subject received the 3rd dose of Hepatitis B vaccine (unknown manufacturer( with no problems. On an unspecified date in 2005, a Hepatitis B surface antibody titer was negative. On 15 December 2005, the subject received the 4th dose of Engerix B. On an unspecified date in May 2006, approximately 4 months after the 4th dose of Engerix B, a hepatitis B surface antibody titer was again negative. On 07 June 2006, the subject received the 5th dose of Engerix B. On 07 July 2006 and the subject received 6th dose of Engerix B. On an unspecified date in late July 2006, less than one month after the 6th dose of Engerix, the subject experienced weight loss which ultimately resulted in a loss of 15 pounds, fatigue, muscle pain, and muscle wasting. The subject also experienced a loss of sense of well being, and was unable to perform surgery. The subject was seen by a rheumatologist, infectious disease physician, neurologist, and endocrinologist. On an unspecified date after July 2006, the subject had an extensive work up including a computed tomography scan, magnetic resonance imaging, myelogram, bone marrow biopsy, and blood work, which ruled out cancer, Amyotrophic lateral sclerosis, adrenal insufficiency, pituitary insufficiency, and Lyme disease. The blood work was notable for low testosterone. The subject was diagnosed with transverse myelitis. The physician considered the events were disabling and clinically significant (or requiring intervention) (OMIC). The subject was treated with testosterone, the subject subsequently experienced anemia and was treated with epcetin alfa (Procrit). The weight loss resolved on an unspecified date in November 2006. At the time of initial reporting 28 December 2006, the other events were improved and the subject "feels 80 percent better." On an unspecified date in 2006, after July 2006, a hepatitis B surface antibody titer was "300." The physician reported that, the timing and onset of the symptoms is consistent with receiving the vaccine. The subject discontinued therapy with Lipitor in October 2006. The physician feels the issues may not be related to Lipitor because there were no creatine phosphokinase elevations.
At the proximal site of the lt bicep there was a very large erythemic area approx 6-7 cm in size with irregular borders which encompassed the injection site, raised and warm to the touch.
seizure, lips pale, cold, clammy, dizzy. called 911 and they assessed her and took her to hospital.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 30-JUN-2015 the patient was vaccinated the patient was vaccinated with an improperly stored dose of ROTATEQ, oral; dose, route, Lot number and frequency unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
4/10/03 vaccine given Thurs. approx 5:30pm-soreness noted Friday am-swollen from injection site to elbow-also red and hot to touch.
Inflammation and swelling on 5 inch diameter surrounding injection site. Mild fever, chest tightness.
Pt developed a fine red rash over most of body except face and a fever. Pt was also diagnosed with URI and bilateral otitis media on the same day.  Pt was treated with Amoxicillin.
Patient complained of pain in lower back and spasms, as well as headache. Initially complained of chest pain but says that improved over time.
I had a headache instantly after receiving the vaccine. At 03:00AM, on 04/04, I woke up and started vomiting for the next 3 hours. I was able to stop enough to get my children up and then I started to vomit again. I took some anti-nausea medication (promethazine and Ondansetron) it helped a little, but I kept throwing it back up. My children called 911 and they sent an ambulance for me. They gave me another ondansetron, but I had used a suppository. They took me to a ER. While at the ER they performed a lot of tests. There was an abdominal CT, transvaginal ultrasound because of the stomach pain, I had an EKG and a lot of blood work. They gave me medication for my migraine and I was given an IV. I also received something for the pain in my stomach, but I don't recall what it was. I was given enough medication to where I could finally get a little rest. The results that they came back with was that there was free fluid in my belly, there were spots on the scans around my ovaries and uterus and there was a lot of swelling in my intestines and stomach. I was referred to a couple other different doctors. Six months prior to receiving the vaccine, I went into septic shock and my heart briefly stopped. There was a lot of damage to different systems of my body after that happened. The doctors were not sure what kind of reaction I had. They weren't sure if it was a coincidence with what I already had going on, or if it was the vaccine. I also had a false positive pregnancy test and if I test, it still shows positive. They drew blood to verify that I was not pregnant. I went to an OBGYN and now I need to go to an gastroenterologist. I also followed up with my PCP.
Two days post vax pt was found in his bed very lethargic and withdrawn. Pt developed a bright red flush covering entire body. Within one hour he experienced sever itching and agitation. Pt was seen in the ER and treated with Benadryl.
Felt cold; Took temp 94.0F (R) hypothermia, child is fine now as of 30NOV90 11AM.
Swelling of injection site next day, redness and swelling the size of a quarter. Seen by physician.