chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician via a field representative, referring to a 16 years and 5 months old male patient. The patient had no medical history. Information about concurrent condition and concomitant therapy was unknown. On 22-OCT-2018, the patient was vaccinated with the first dose of GARDASIL 9 (1 dosage form, lot # R008165, expiration date: 11-NOV-2020; strength, route and frequency were unknown) for prophylaxis (reported as human papillomavirus (HPV) prevention). On 23-OCT-2018 (reported as the following day), the patient experienced headache that he described as a pain in the back of his head that lasted for days. Then on 31-OCT-2018, the patient developed a rash that appeared on the back of his neck, a little bit on his back, and an unspecified arm. Then on 02-NOV-2018, at an office visit with the physician, the physician stated that patient had shingles. There was no lab diagnostics or studies performed. The patient received the treatment for the events. The outcome of the events was reported as not recovered. The causality assessment was not provided by the reporter.
Received vaccine 12/5/2011 - stiff neck & unable to bend noted last night - was seen in ER - given oral Ibuprofen - sent to ER today 12/7/2011.
On 8/7 afternoon:  Pt walks in to clinic today complaining of being able to move her left arm without significant pain after receiving her PNEUMOVAX 23 vaccine this am. Pt is sitting quietly with arm by her side. The pain starts in her neck and radiates to her finger. Pt states that the pain has been progressively worse this afternoon, so she walked into clinic for help. Pt states that if she is still her arm pain level is 3-4/10, and if she tries to move her arm it goes to a 9/10. On 8/8 AM, patient reports she was able to move her L arm a little more than she had been able to do the day before.
Pt returned 15-20 minutes after DTaP/IPV/MMR with diffuse erythema and urticaria, EPI and Benadryl given.
Patient is a 73 y.o. male 72 y.o. male with a past medical history significant for atypical AVN RT, atypical atrial flutter, HFpEF, pituitary adenoma s/p resection, CVA, secondary adrenal insufficiency, prostate cancer and Alzheimer's dementia . Presented to hospital 01/26/2023 with COVID pneumonia. Initially required BiPAP but aggressively improved to room air at time of discharge   Comments/Problems to be Addressed After Discharge General follow up with PCP   Discharge Diagnosis and Associated Hospital Course   Acute Hypoxemic Respiratory Failure, improved - in the setting of COVID infection, less likely superimposed bacterial infection - on room air at time of discharge   Covid-19 Pneumonia - Symptoms 01/24, diagnosis 01/26, vaccinated x 5 - CXR without acute abnormality, mild leukocytosis, CRP 87.2 - discontinued Decadron and Remdesivir 3 days total   Atypical Atrial Flutter - Failed previous ablation, home regimen Eliquis, Toprol XL 50 mg daily   Secondary Adrenal Insufficiency - Etiology due to previous pituitary tumor. Home regimen Cortef 10 mg in am, Cortef 5 mg in evening.  -continue home regimen   Hypothyroidism - home regimen Synthroid 137 mcg x 6 days a week, Synthroid 205.5 mcg 1x per week.   Alzheimer's Dementia  - home regimen Namenda 10 mg BID   Hx of CVA
Patient received his flu shot on 12/21/2017. At the time he had a clear runny nose and cough, no fever. He had received this vaccination last season with no problems. On 12/22/2017 he was running a mild fever (100.5). Dad gave TYLENOL and gave him a nap. He then informed mom that patient was getting worse with his cold symptoms and request that mom take him in to get the flu test. Mom arrived home and got patient up from his nap. He was warm but decided to not dispense TYLENOL because the fever was a low grade temp. Pediatrician looked him over and he had a temp of 100.6 and flu and strep tests were both negative. She decided patient had a virus and sent us home. Upon arriving home, mom opened the passenger side door to take patient out of his car seat. When she opened the door she noticed patient's eyes were rolled back and his body was stiff and convulsing. She screamed for dad to call 911 and removed him from the car seat, took him inside and held him close to her on his side. He proceeded to seize until the ambulance arrived (about 3-4 minutes). Paramedics temped him and his fever was 101. They went to Hospital where the parents were told it was a febrile seizure. Chest X-Rays, blood work and urine tests were ran and everything came back good. It took patient 36 hours to start walking without falling several times and as of today, 12/26/2016, he is still barely eating or drinking.
Pt rec'd vaccines at 11a.m. and returned to clinic at 1p.m. w/ twin sibling.  Upon examination pt was found to have temp of 104.3 (rectally), content, immun sites benign, normal MD exam.
This spontaneous report was received from a female patient of an unknown age who is also a registered nurse reporting on herself. The patient did not have medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 01-APR-2017, the patient was vaccinated ZOSTAVAX (lot #, expiration date, strength, dose, frequency, route of administration and anatomical location were not provided). On 02-APR-2017, she had a red, tender spot at the injection site of the size of a silver dollar. It was stated that the patient would seek treatment if it would not get better. No laboratory diagnostics studies were performed. No further information was provided. At the reporting time, the patient had not recovered from the injection site erythema. The causal relationship between the ZOSTAVAX and the event was not provided. Additional information has been requested.
7 days after vaccine, a red, swollen, warm, hard rash appeared on right arm. It quickly spread to cover upper arm. Went to urgent care facility Received Rocephin shot and steroid shot Sent home on Prednisone 4mg dose pack (21 total) and 7 days of Amoxicillin 500 mg twice a day
Pt recvd a series of 3 Engerix-B vax 30NOV90, 29JAN91 & 3JUN91 for Hep B vax & was a poss non-responder;
Information has been received from a Nurse practitioner via a Company representative concerning to a 13 year old female patient. On 06-DEC-2016, the patient was vaccinated with dose 1 of GARDASIL 9 (site, route and lot number not reported) for prophylaxis. In December 2016 (reported as "shortly after the GARDASIL injection, (unspecified date)"), the patient developed an hematoma. On 28-DEC-2016, the patient sought medical attention and was referred to a surgeon. On an unknown date, the surgeon removed from the hematoma, "15 cc's" of fluid. The patient did not die, had no Cancer, no disability, no hospitalization, no life threatening nor overdose. At the time of the report the outcome of hematoma was unknown. No product quality complaint was involved. The reporter stated that the patient's Pediatrician considered that the hematoma was not related to GARDASIL 9. Additional information has been requested.
About 30 hours after administration of vaccine (2/26), patient complained of pain at the site of injection. Pain worsened over the next 24 hours.  Patient slept almost the entire day, lost his appetite, seemed dazed and somewhat confused. By 9 P.M. it was difficult to rouse patient.  Called 911.  Patient admitted to hospital with cellulitis of the left upper arm and possible pneumonia.  Pneumonia ruled out after 48 hours.  Augmentin therapy started 2/29,  P.M.  Patient released from hospital 3/2.  Still on augmentin therapy.  Still experiencing mild pain.  03/12/2008 MR received for DOS 2/27 to 3/2/08. Pt presented with onset of increased somnolence and lethargy, SOB, sweats, fever, chills, purulent sputum and chest pain. Redness at site of recent Pneumovax. Cellulitis of the L arm and R leg noted on PE, as well as thyromegaly and decreased breath sounds and egophony.   4/17/2008 D/C summary recd with D/C Dx:  Cellulitis of the R leg and Left arm, asthmatic bronchitis, hyperlipidemia, atherosclerotic heart disease s/p bypass, well controlled essential hypertension, hypothyroidism, BPH, use of anti-coagulants, atrial fibrillation and DM Type II-diet controlled
bad pain in the leg, near the calf/ confirmed the patient had blood clot in the leg; hurting in the arm; chills; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 15Apr2021 (batch/lot number and expiration date were unknown) as a single dose for COVID-19 immunization. The patient had no medical history. The patient was taking other unspecified medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Mar2021 at the age of 54 years old for COVID-19 immunization. The patient reported having the normal side effect like the hurting in the arm, chills, and stuff on an unspecified date, but after that the patient got a really bad pain in the leg, near the calf and left it go for a week maybe, thinking it would go away, but didn't go away, so the patient went in to the emergency room and the emergency room work on it. That's what they did something to come up wrong with one of the blood test, so then they did an ultrasound and they confirmed the patient had blood clot in the leg, for which the patient was currently on a blood thinner. The patient didn't know if this was going to fix the problem or this was not going to fix the problem. The patient knew that some of the other vaccine caused blood clots, but the patient's doctor won't give any kind of pain medicine, and all they do was to give paracetamol (TYLENOL). They did start the patient on a pill called apixaban (ELIQUIS) taken at 25 mg tablet in the morning and 25 mg in the evening, and this was the thing the patient had never had; anything like this had never happened with the patient before, since the patient had been healthy in all his/her life, so the patient called to ask if there would be any relief as the patient didn't want this. Before the patient went into the emergency room, the patient had taken TYLENOL as treatment for all the events. The patient underwent lab tests and procedures on an unspecified date, which included blood test and chest x-ray with unknown results and an ultrasound, which revealed blood clot in the leg. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore). At the time of the report, VACCINATION SITE PAIN (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever, lightheaded, abnormal breathing, arthalgias, tingling of hands/feet, malaise, loss of feeling in legs. Acute onset. ER visit.
pt recv vax 5AUG97 & 14AUG97 pt devel the pox described as tiny bumps all over stomach, chest, neck & back & a fever of 101.6;
There was a thumping and tightness in my chest centered around my heart, as well as pain in my left arm that traveled, fulfilling the textbook definition of a heart attack. I went to the ER, got an EKG and it looked normal. The tightness lasted for the next few days, and occasionally persists to today (March 27th). After two blood tests, X ray, and blood pressure they determined my troponin levels were not only measurable, they were increasing, so I was admitted to the hospital. I was given aspirin for 30 days, and told to leave caffeine alone for that time, but I was cleared of the daily aspirin doses and allowed to consume caffeine again after approximately two weeks. Furthermore, I was prescribed nitroglycerin pills incase it should happen again. Doctors concluded that one of my heart valves had a spasm, triggering the event.
Got vaccine and broke out with shingles / Suspected vaccination failure; shingles for the 14th time; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got vaccine and broke out with shingles for the 14th time. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
I heard a loud pop in both of my ears walking to my car and lost hearing in both of my ears.  The left one returned to normal after a few minutes but the right one did not.  I lost all hearing in the right ear on 11/18/21 at approximately 7:55 am.  I went to the Emergency Room and then saw an ENT on 11/26/21 and was started on oral steroids for two weeks.  I had 5 steroid injections into my right ear 12/15/21 and 12/31/21 in an attempt to regain some hearing back.  I was diagnosed with SSHNL and have severe Tinnitus as well.
Within 12 hours, normal vaccine symptoms including fever of 101.5, chills and fatigue. Those symptoms all went away within 24 hours. Three days later, new more severe symptoms appeared including heart palpitations, high blood pressure, severe fatigue and shortness of breath. These symptoms happened in episodes every 3-4 days for two weeks and then at least once per week for two more weeks. I went to the hospital, my endocrinologist, my GP and a cardiologist. A whole battery of tests were done, but no cause was found beyond the explanation that it could have been from the vaccine. Six weeks out from the vaccine, all symptoms subsided and have not returned, at least for now.
Tingling and numbness started in both feet the day after my 2nd dose. It spread to my calves then started in both hands and later my forearms. I also experienced flu-like symptoms for 24 hours.  When the tingling spread to my forearms, I went to the emergency room and was referred to a neurologist. Over the next couple of days, the symptoms decreased (but persisted) in severity everywhere but my feet. It is now 4 months later and I still have constant tingling in my lower legs and arms with decreased sensitivity. Blood tests have not revealed anything that would cause this.
This is a 62 yo male who presented to the ED with c/o of worsening SOB.  He has a PMHx as listed including an atypical PNA a couple years ago w/u by clinic per patient no clear explanation regarding condition a couple of years ago.  Since then he has been fairly stable, follows with doctor as an OP.  He was seen as OP 5/13 d/t progressive SOB, extreme fatigue over the last several weeks. Additionally, he admits to generalized weakness, unable to do activities he was previously able to perform without breaks.  He denies any nausea, vomiting, diarrhea, constipation, fever, recent illness, medication changes, sick family members, chest pain, heart palpitations, peripheral edema, bird/bat exposures, TB hx/exp He had a CTA chest 5/13 which was negative for pulmonary embolism but has evidence of diffuse bilateral ground glass opacities with some nodular infiltrates.  He was sent home on home oxygen 2LNC to wear continuously and told to come to the ER for persistent hypoxia or worsening symptoms. Today he comes to the ER with worsening hypoxia, SpO2 74% on RA, placed on 6L for SpO2 91%.  Lab work fairly unremarkable.  Pulmonology consulted in the ER, recommended admission for further work up.  He was placed on Augmentin and doxycycline.  Will be NPO after midnight for possible BAL in the AM.  Hospital medicine asked for admission.  . PT IS INPATIENT AT THIS TIME.
cold symptoms; nasal drip; congestion; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (051529).  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "recovered", described as "cold symptoms"; RHINORRHOEA (non-serious), outcome "recovered", described as "nasal drip"; NASAL CONGESTION (non-serious), outcome "recovered", described as "congestion".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
cellulitis at site with edema, erythema and violaccous hue which resolved in 7 days.
Developed hives and swelling around eyes at 8PM on 8/18/06 which was 53 hrs after vaccine. As of 8/23 pt continues to have hives but seem to be improving. Being treated with Claritin daily.
Chills, aches, headache, and fever of 101 degree started around 10:00-11:00 PM. Vomited twice at 1 and 2 AM. Fever of 101 temperature lasted until 7 AM. At 7 AM, I took 2 tylenol to make fever go down. I took 2 more at 3 PM. Fatigue, body aches, and headache lasted until 4 PM that day.
Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose).    No concomitant medication were reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; FENOFIBRATE; LISINOPRIL; ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 after BNT162B2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Intermittent dizziness; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 16Feb2021 at 14:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient did not had any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received an unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 26Jan2021 at 14:00 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient previously received levofloxacin (LEVAQUIN) and experienced drug allergy. On 16Feb2021 at 18:00, the patient experienced intermittent dizziness which began 4 hours after second pfizer vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event intermittent dizziness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information had been received from a healthcare worker referring to a patient of unknown age and gender. Information of pertinent medical history and drug reactions/allergies of the patient were not reported. On 06-JUL-2015 the patient was vaccinated with expired M-M-R II (dose, strength and route unknown), lot # H016132 with expiration date of 31-AUG-2014. Concomitant medication was not reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.