chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and concomitant medications were not reported. The patient had unspecified allergies. In May 2017 (reported as a week and half ago), the patient was vaccinated with LIQUID PEDVAXHIB for prophylaxis.  On an unknown date in 2017, the patient had a lot of allergies, besides the reporter did not confirm if the patient had an adverse event. The patient sought medical attention but, it was unknown if the patient had laboratory diagnostic tests or if he/she received any treatment. The outcome of multiple allergies was unknown. The causality between the event and LIQUID PEDVAXHIB was not reported. Additional information is not expected because no consent for follow up was provided.
tendon inflammation; red dots all over my legs; I could not just walk; on my left leg down I have a bump and it's painful; on my left leg down I have a bump and it's painful; This is a spontaneous report from a contactable consumer or other non hcp. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14May2021 (at the age of 47 years old) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No relevant medical history. The patient reported that he got first dose of PFIZER-BIONTECH COVID-19 VACCINE on 14May2021 and was scheduled to get his second dose on 04Jun2021. The patient looking for guidance if he should get a second dose today as he experienced adverse reactions after first dose. On 30May2021, when he woke up in the morning he could not just walk, stated never happened before. His right thigh, right leg completely painful, he got crutches and started to walk. On 31May2021, he went to emergency room, where they did an X- ray and blood tests for blood clots but they did not see any blood clots. They gave him some gel and some muscle relaxants and told him that maybe he had tendon inflammation, but he did not run or he did not even exercise. Now after 4-5 days (Jun2021), cannot walk and now he started walking a little bit, but pain was still there. His thigh was swollen, and he had red dots all over his legs and on his left leg down he had a bump, and it was painful. He also had this red and red dots everywhere. The patient underwent lab tests and procedures which included X- ray and blood tests: did not see any blood clots on 31May2021. The outcome of the events red dots all over my leg, tendon inflammation was unknown, i could not just walk was recovering, on my left leg down i have a bump and it's painful was not recovered.
The customer reported a reaction of swelling and pain; The customer reported a reaction of swelling and pain; Patient developed Redness and swelling; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, NDC number: 0005197102, Lot Number: X91013 and Expiry date: Jan2021, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The consumer mentioned that a customer reported a reaction of swelling and pain on unspecified date. The patient developed redness and swelling. Outcome of the events was unknown.
He mentioned feeling lightheaded in the car & severe arm pain at the injection site.  5 minutes later experienced cramping sensation in his facial cheeks on both sides.  Within 10 more min encountered numbness in his face & his arms began to have sensation of, "dead weight" along w/nausea & unable to move rt. hand.  VERY lightheaded all along. We had to travel due to limited supply.  His symptoms mimiced a stroke; however, it was determined that it was a severe nuerological reaction & not a stroke. After arrival at the hospital his face felt fully numb & he was unable to smile, like normal. Lower extremities were fine. 102.5 fever next a.m. w/headaches, fatigure and aches that week.
Patient was given Undiluted Pfizer Pediatric Dose, resulting in higher concentration administration. Per dad, patient experienced fever.
Apart from the expected symptoms (fatigue, shortness of breath, arm pain around the injection site), I began noticing slight lymph edema in the vaccinated arm yesterday evening, and awoke this morning to sharp pain in my right axilla, which is also sore to the touch.
My husband who is 64 years old, was a previously in good health. Only history was mild cardiomyopathy diagnosed 12 years ago. And elevated blood pressure, which was normal with medications. He was very active, maintained a demanding full time job and was a great husband of 2 children. He received his 2nd dose of Pfizer on approximately 4/1/21. He didn?t complain of any side effect. However, on the morning of 4/27/21 he woke me up saying that he could not breath. We started driving to the hospital, however he got worse and we stopped at the fire station. They gave his oxygen and rushed him to the hospital. We came to hospital and when the fire truck was pulling in, I was told that my husband went into pulseless electrical activity. CPR was started and after approximately 5 minutes he regained pulse. He was taken to the ICU and therapeutic hypothetic protocol was completed. Since then, he is still requiring mechanical ventilation. He opens his eyes spontaneously, at times appears to obey small commands and is bedridden.
varicella, cough, nasal secretion - Information has baeen received from a registered nurse concerning  a 4 year old caucasian female patient who on 11 Mar 1997 was vaccinated with a first dose of varicella virus vaccine live.  On 18 Mar 2000 the patient began to develop lesions.  On 20 Mar 2000 the physician's office was notified that the patient has 25 lesions in all stages of chickenpox.  Additionally, the patient has a slight cough and runny nose.  The patient was afebrile and the lesions were reported as non-pruritis.  It was noted that the patient is doing well and that her mother is to monitor her.  Additonal information has been requested.
Patient started experiencing numbness and tingling on her right side and then all over on Sunday evening 5/2/21. It affected her gait and the numbness and tingling in her legs caused her to have to catch herself and hold on to something to keep from falling. She described that her legs felt weak for a few seconds when walking. This sensation gradually decreased in intensity and duration. When I saw her at 5 pm on 5/3, she had normal gait and only felt the numbness and tingling very briefly. Her exam including her neuro exam was normal on 5/3 when I saw her.  The sensation of numbness and tingling completely resolved by 5/4.  She also experienced HA, nausea and fatigue, but did not have syncope, dizziness or fevers.
2nd one to have a heart attack; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at a single dose as Covid vaccine. Medical history and concomitant medications were not reported. After stating Pfizer has submitted a request for Emergency Use Authorization for potential COVID-19 vaccine and it was now in the FDA's hands, the reporter inquired if Pfizer had more information if so then what's the ingredients. It was then reported that the patient's the 2nd one to have a heart attack on an unspecified date. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: The association between the event heart attack with BNT162b2 can not 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.
Patient with history of COPD, diabetes type II, and CKD. He was brought to the ED by EMS on 1/7/23 with shortness of breath, weakness, and chills for the past three days. He additionally reported increased leg swelling, cough, fever, body aches, and decreased appetite. EMS reports the patient initially had O2 sats in the 60s and was placed on 15-20 L via NRB. The patient wears 2L O2 at baseline via nasal canula. A COVID PCR test performed in the ED resulted positive. Patient was admitted 1/7/23 - 1/18/23. Discharge diagnoses include respiratory failure; severe pneumonia, suspected bacterial; sepsis; COVID-19; RSV; acute on chronic combined systolic and diastolic congestive heart failure. During admission, patient was placed on BiPAP but failed and required intubation for dyspnea and hypoxemia. He was intubated 1/8 and extubated 1/14. After extubation, the patient was on low flow oxygen which was weaned off. Patient has received the primary COVID vaccine series.
A report was received from a health professional on 11Oct02, concerning a 58 year old female vaccinee who experienced an injection site reaction approx 30 minutes after receiving Fluvirin on 10Jul02. On 10Jul02, the vaccinee received Fluvirin. Approximately 30 minutes later the vaccinee experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP200200500, PJP200200501, PJP200200502, PJP200200503, and PJP200200497. Update 1 10Dec02, a report was received from a health care professional, the injection site reaction had resolved at the time of the report.
arm erythema; arm pain; axillary pain; possible lymphadenitis; This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities, pain in arm, axillary pain and lymphadenitis. On an unknown date, the outcome of the erythema of extremities, pain in arm, axillary pain and lymphadenitis were unknown.   It was unknown if the reporter considered the erythema of extremities, pain in arm, axillary pain and lymphadenitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm erythema and pain, axillary pain and possible lymphadenitis following dose one of Shingrix. The patient's initials and date of birth were not provided. The patient received the dose at pharmacy, no details for pharmacy provided.
Patient developed red itchy eyes about 3-4 hours after vaccine was given and did not feel well. She left work to go to the emergency room about 3-4 hours later.
muscle pain; joint pain; headache; fever; injection site swelling; nausea; diarrhea; vomiting; arm pain; This is a spontaneous report from a contactable consumer reported for himself.  A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 (at age of 45 years old) 09:00AM (Lot Number: EW0179) as 1st dose, single for covid-19 immunisation.  Medical history included covid-19, No known allergies.  The patient's concomitant medications received within 2 weeks of vaccination were none.  The patient experienced muscle pain, joint pain, headache, fever, injection site swelling, nausea, diarrhea, vomiting and arm pain, all on 19May2021 11:00 PM, no treatment received for events, and patient was not recovered from events. Adverse events result in Congenital anomaly or birth defect and Seriousness criteria reported as Congenital anomaly/birth defect (pending clarification). Prior to vaccination, the patient was diagnosed with COVID-19, Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts possible. No further information expected.
5:15 Mucus in throat, given water and swallowing okay, breathing okay HR 84, R 20 5:30 Swallowing remains okay. Has medicine taste 5:45 BP 120/90, HR 80, R 20  Instructed to call 911 at discharge for any throat or breathing issues
Migraine onset 5/20 and lasting each day until 5/28/2021.  Some days worse than others. Extreme fatigue 5/21/2021 throughout the day and evening (I had three naps and went to bed around 7 PM until 7 AM the next day)! Neck and arm pain lasting 5/20 - 5/24/2021 (tightness, soreness, pain) slight loss of appetite
Unusual delayed dermal event. Erythematous rash several cm in diameter surrounding injection site. The rash is not painful. Rash occurred about 7-8 days post injection but was not visible before. Cocern about mild Arthus type reaction in skin. Has this been reported previously??
Slightly dizzy right after the injection. Chills occured. Wthin 4 hours, pressure in chest which went into an irregular heart beat. I went to sleep woke up no irregular beats but severe chills, loss of appetite for 8 days. Lost 5 lbs. Followed up with medical Dr. She told me to contact you and not to take the second shot.
My daughter was very premature but she had overcome all obstacles. She was breathing on her own with no issues & eating by bottle; since she had the vaccinations, she's been struggling bad with eating & she's been having desats as well as bradys. She had to go back on oxygen today after 3 weeks of breathing on her own!!!
I received my second dose of the COVID vaccine (Pfizer/BioNTech on 2/5/2021.  I had already been experiencing moderate to significant upper right abdominal quadrant (liver) pain a couple days after my first COVID vaccine which was administered on 1/15/2021.  These symptoms were periodically acute and persisted at a moderate to severe level for approximately 6-8 weeks following my second dose of the vaccine.     I had routine labs done on 1/22/2021 (1 week after my first COVID vaccine) and these labs showed elevated ALT.  Prior to this I have never had elevated ALT.     The acuity eventually subsided with mild to moderate pain persisting and moving to periodic through July/August 2021. To date (6/1/2022) I still periodically experience transient episodes of mild to moderate liver area pain.  On 3/23/2021 my follow-up labs showed ALT barely back in range (23 U/L).    On 9/14/2021 some follow-up labs showed ALT back to "my personal normal" (pre-vaccine) range of 17 U/L.
tested positive for covid and symptoms were mild; tested positive for covid and symptoms were mild; This is a spontaneous report received from contactable reporter(Consumer or other non HCP) for a sponsored program. A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Psoriatic arthritis" (ongoing); "Psoriasis" (ongoing); "Rheumatoid arthritis" (ongoing). Concomitant medication included: ENBREL taken for psoriatic arthropathy. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "tested positive for covid and symptoms were mild". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) unknown results; sars-cov-2 test: (2021) positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 17 old male who on 22-JUL-1993 and 08-JUL-1997 was vaccinated with the first and second dose of MMR II. On 11-NOV-2009 the blood work was done and the results indicated IgM<1:10, IgG 5.48, and serum amylase 106, on the same day, the patient was diagnosed. On 04-DEC-2009 the patient experienced mumps. The patient was afebrile and had parotitis on the right side. The outcome of mumps was unknown. Follow-up information has been received from physician concerning a 18 year old male who on 22-JUL-1993 and 08-JUL-1997 was vaccinated with the first and second dose of MMR II. On 27-NOV-2009 the patient experienced mumps on 29-NOV-2009 was diagnosed. The patient was afebrile and had parotitis on the right side. At the time of the report the patient's outcome was unknown. Additional information has been requested.
got first shot of pfizer vaccine on 5/1 at 5pm, felt fine that evening other than tired. Later that night my arm started to hurt. The next day had fatigue, dizziness. The third day my arm was better but eyes felt sensitive to light, burning sensation on both eyes but worse on right eye, then right eyelid got swollen, hurt with blinking. No eye redness. Every time I woke up there was crusting in my eye. Got visine drops that burnt when I applied them, washed eye twice a day with massage. Still had swollen eye for 10 days before it resolved. Also on the 3rd day after I got the vaccine, when my eye symptoms started, I noticed that when I lay down at night it felt like someone was pressing down on her chest and had racing a heart beat. Took tylenol PM to help sleep. Had to skip work those days, was not taking adderall those days or caffeine. Slowly chest symptoms resolved (took at least 2-3 weeks) and feeling  fine now. I usually get spring allergies and this year was worse than other years, but this sort of reaction has never happened to me. On June 26 I visited the emergency room because I developed a rash in my arm (this might be unrelated but I'm still not sure what caused it). It felt like it was burning and a pins and needles sensation. I had EKG and full blood test done and it was determined that my inflammation levels were high. I have had 2 other blood tests showing persistent elevated levels of C-reactive protein, platelets and sedimentation. My primary doctor issue a referral to se a rheumatologist  and currently waiting for an appointment.
5/26/2021 vaccination. 5/27/2021 03:00AM I woke up and felt like I had a fever. My feet felt like they were on fire, burning sensation. I had 101 temperature, chills, nausea, headache. I slept all day. 5/28/2021 I woke up feeling ok. 6/19/2021 I started to notice hair loss. It has been going on until November 15, 2021. I did seek medical attention with a dermatologist and diagnosed with 'telogen effluvium'. I was advised the timing between the serious illness and vaccine; it was a true shock to my body. I lost about 30-40% of my hair over that period of time.
New information was received in patient details, medical history and outcome of events. Information regarding PREVNAR 13 was received from a physician regarding a female patient who experienced soreness in the leg, didn't want to walk or put weight on it. The patient received a dose on an unknown date in 2010. The patient experienced soreness in the leg, didn't want to walk or put weight on it in 2010, after administration of PREVNAR 13. The patient returned to the doctor's office on 16 Sep 2010 due to soreness of leg. Tests, diagnosis and treatments were not reported. The outcome of all events is recovered. No additional information was available at the time of this report. See Related Case: US WYE H17604310, same source (non expedited event).
patient has mitral insufficiency and vasovagal syncope. hit a vein and sight of blood and needle almost caused her to pass out. she was sitting on floor, very nauseous, blacking out, cold sweats, and palpitations.
Initial report was received 17 January 2013 with follow-up information received on 05 June 2013. This report was initially received by a company representative, however was not received by the Global Pharmacovigilance Department until 05 June 2013. A female subject (age and date of birth not reported) had received ACAM2000, Typhoid (manufacturer unknown), Anthrax (other manufacturer), Hepatitis A (other manufacturer) vaccines on 14 November 2012 and 13 days later on 27 November 2012, she developed possible myopericarditis of mild severity. The subject had relevant medical history of elevated troponin (start date 26 November 2012) and chest pressure (start date 14 November 2012). According to the investigator, "otherwise healthy subject with exercise associated mild chest pressure with onset date of vaccine and continuing 14 days." Concomitant therapies consisted of "LEVITRA" as an "oral contraceptive" beginning 20 November 2012. On 26 November 2012, rapid Troponin and preliminary ECG were normal, however, lab troponin was 0.11 ng/mL (mild) and the subject was referred for care. Follow-up troponin on 29 November 2012 was normal (less than 0.10 ng/mL) and ECG report was normal. During this office visit, the subject reported her last episode of chest pressure occurred on 28 November 2012. The subject also experienced a nonserious event of mild itching and burning at the smallpox vaccine site (left arm) beginning 16 November 2012 (listed as ongoing at the time of the report, stop date not reported). Outcome for the event of possible myopericarditis was recovered on 29 November 2012. According to the investigator, the event of possible myopericarditis was probably related to the study product.
Extremely tired for a week after vaccine - forcing me to take a nap almost daily. Muscle pain into neck and down left arm
left facial numbness- possible early Bell's Palsy. started on Prednisone 60mg po qd x 7days. sent to follow up Neurologist
6mins post vaccination, pt reported flushing/sweating and nausea. Vitals: 11:08 102/69, 105, 18, 100% -- > 11:15AM 110/70, 108, 18, 100% Pt stable and released from the vaccination site
Information has been received from a nurse practitioner concerning a female who was vaccinated with MMR II. Subsequently the pt developed enlarged lymph nodes and myalgia without fever. After a few days the pt recovered. The pt sought unspecified medical attention. Additional info has been requested.
Pain at site, swelling, immobility and fever for 2 days reported by patient.
Blood pressure went up and kept escalating. It started at 132/(forgot) right after shot, which is already high for me. I had a doctor's appointment right after the vaccine, so I went to that. By the time they took my BP there, it was 145/80something. Heart was racing. The doctor was concerned and sent me to the ER, where I had a battery of tests. BP peaked at 159/89 in ER. Pulse remained in the 70s.
Headache, Arthralgia, pain in arm and fatigue Narrative:  Other Relevant History:
Patient had swelling of her eyes 1 hour after getting vaccine. Later went to ER due to developing hives, rash, pain, burning of face and heaviness of chest. Treated Kw/ prednisone, PEPCID, and hydroxyzine. She was feeling better and rash going away the next day.
noticed inc hair breakage/loss since DEC93; perms hair every 6 wks; last perm JAN94; dermatology consult: traction or chemical induced hair breakage;
About an hour after I got the injection, I started sneezing, about 10 times in a row.  I had two more such sneezing episodes that day and one again the next morning.  There was no other reason that I could think of -- no odors in my house,  nothing food-related, etc. -- that could account for that.  I thought that maybe I was getting a cold, but that is not the case, and the sneezing fits have stopped.