chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On October 22, 2021 Pt experienced flashes of light in both eyes and nausea around noon. these lasted a few minutes. By 3pm he was experiencing sudden migraine like pain. Was told to take him to the emergency room. When arriving he has ct scan, cta, chest xray and MRi done. It was found that he had blood clots. he was admitted to the stroke floor of local Hospital for further observation. Cardiologist was also called in to review his charts. They changed out two of his medication and put him on Brilinta and Eliquis. also followed up with a echogram with contrast the following week.
Just after vaccination patient experienced difficulty swallowing, tingling all over body, possible throat tightening, and increased blood pressure. Pt reported to ER and was given Benadryl. Symptoms resolved.
Patient with onset of sharp chest pain 1 day after second vaccination. Patient diagnosed with myopericarditis and admitted to the hospital for further evaluation and management. Patient with improved symptoms, but placed on several medications for continued management of inflammation.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Blood cholesterol abnormal" (unspecified if ongoing); "thyroid cancer" (unspecified if ongoing), notes: 13 years ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300200096 same  patient/reporter, different drug/AE;
Initial information was received on 03 November 2008 from another manufacturer, document number 45208254, whose initial reporter was a consumer. This report was not medically confirmed. A female patient received the influenza vaccine, reported as the flu vaccine (manufacturer, lot number and date not reported). She developed Bells Palsy four days after receiving the influenza vaccine. Recovery date was not reported. No further information was provided. Documents held by sender: None.
Received the first dose of Shingrix and then a few weeks later developed a case of shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult 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, couple of weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age vaccination was not reported but was selected as adult as per vaccine indication. The healthcare professional (HCP) reported that a patient had an outbreak of Shingles after receiving the 1st dose. The reporter did not consent to follow-up. The reporter asked that If i had patient who received the first dose of Shingrix and then a few weeks later developed a case of shingles, do I need to restart the entire vaccination series for her or can I just proceed with the second dose after confirming the appropriate amount of time has elapsed and the acute episode has resolved. The reporter disconnected without giving contact or patient information.
Pt began feeling bad with chest pain and fatigue, SOB after the vaccine.  Per spouse woke up in the middle of the night and tried to get out of bed but fainted and possibly had a seizure, had foam coming out of her mouth.  Was transported to the ER and released.
10/15/2019 pt presented to Clinic with temp of 100.0 and rash to cheeks. Provider noted faint slightly erthyematous papular rash to cheeks and forehead without pruritis.
pt recvd vax approx 30mins p/vax c/o hot flashes states felt sl nausea which subsided p/ate a cookie; face, neck, upper trunk & arms flushed-bright pink in color;color remained 1-2 hrs p/but pt states feels OK
Pt recvd vax 24JUL92 & w/in 5 to 10 mins following vax pt devel a red rash & swelling 5-10 cm @ the inject site; pt was treated w/ice & DPH & recovered; No further details were provided;
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided. On unknown dates, these patients were vaccinated with improperly stored doses of PROQUAD (Merck) (therapy type: RHA, lot # L046509, expiry date: 17-MAY-2017; lot # L045676, expiry date: 09-MAY-2017; lot # L051099, expiry date: 17-JUN-2017). The vaccine underwent a temperature excursion of 21.4 degrees Fahrenheit within the time frame of 24 hours. M-M-R II appeared on the product list, however no doses of the vaccine were administered to the patients. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
cramping on the stomach; a fever over 101; wiped out; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (cramping on the stomach), PYREXIA (a fever over 101) and FATIGUE (wiped out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (cramping on the stomach), PYREXIA (a fever over 101) and FATIGUE (wiped out). At the time of the report, ABDOMINAL PAIN UPPER (cramping on the stomach), PYREXIA (a fever over 101) and FATIGUE (wiped out) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-089723 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089723:
difficulty breathing, tightness in chest, rapid and skipped heart beats, paleness, excessive urination,feeling of choking,dizziness
broke out in hives / got hives all over; This case was reported by a other health professional and described the occurrence of hives in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 weeks after receiving Shingrix and 1 week after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   The reporter considered the hives to be possibly related to Shingrix. It was unknown if the reporter considered the hives to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. A year or so ago her husband got Shingrix shot and then a week later he got the flu shot. Then a week later he got hives all over. The reporter reported there was polysorbate in Shingrix. He had gotten the flu shot since with no problem. They thought it was the Shingrix shot. The COVID vaccine had polyethylene glycol in it. Caller stated she had previously reported it to Glaxo Smith Kline.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. on 09-JUN-2015, the patient was inadvertently vaccinated with ZOSTAVAX vial of 19,400 PFU (plaque forming units) (strength, dose, route and lot number or batch number unspecified). No concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
Mother reported child had hives and 101 temp after 1st set of immunizations when she returned for 2nd set in May. Child referred to MD for follow up immunizations. Vaccine transferred to MD and at that time has received DTaP. No problem other than slight fever.
chill/can't get warm; headache; stomach ache; 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, solution for injection in pre-filled syringe, lot number and expiry date unknown), via an unspecified route of administration, on 29Sep2020, at single dose, for immunization and; influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration, on 29Sep2020, at unknown dosage, for immunization. The patient's medical history and concomitant medications were not reported. The patient had a flu shot and Prevnar 13 shot yesterday and from an unspecified date in 2020 the patient was having the chill, headache and stomach ache, therefore the patient was going home and further stated that he/she can't get warm. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected; information about the lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist concerning a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 26-OCT-2016, the patient was vaccinated with ZOSTAVAX, 19400 plaque forming units (PFU), Lot # L040445, expiration date: 15-JAN-2017, on the same day he received a second dose of ZOSTAVAX lot # and expiration date were not reported (The vaccines strength, dose, and route were not provided). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Vaccine given at approximately 10 AM 11/3/05. BY evening, client reports fever 102, edema from armpit to elbow, diaphoresis, pain and redness at left injection site. Next day, client extremely lethargic and tired - slept all day. Continued with intermittent fever for 4 days. 11/7/05 Symptoms subsiding.
body rash, raised temp, consistent diarrhea needing Pedialyte to stay hydrated causing diaper rash as well
Patient reports symptoms of injection site pain, tiredness, headache, muscle pain, chills, joint pain, coughing, congestion, runny nose, sore throat, and temp of 100.6 after taking acetaminophen.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 71 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUPROPION, start date: Jan2004, stop date: Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) positive, notes: But after 8 days, I developed symptoms again and tested positive; (Jul2022) negative, notes: After 5 days of taking Paxlovid, I tested negative for COVID (antibody test), and again after 7 days; (unspecified date) Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment of COVID-19 included Paxlovid from 27Jun2022 to 02Jul2022.  Clinical course: No known allergies were reported. Patient received Bupropion in two weeks. After 5 days of taking Paxlovid, patient tested negative for COVID (antibody test), and again after 7 days. But after 8 days on 05Jul2022, patient developed symptoms again at 10:00 pm and tested positive.
The pt experienced emesis, teeth grinding, clenching fists, flushing of cheeks, loss of attention. Symptoms resolved spontaneously. The pt had a febrile seizure.
This spontaneous report as received from a medical assistant (also reported as administrator) refers to a patient of unknown age and gender. On 07-JUN-2016, unspecified dose of improperly stored PROQUAD (lot #L050907, expiry date: 14-JUN-2017/M004895, expiry date: 26-JUN-2017) was administered to the patient. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Tested positive for Covid virus/cough/Low grade fever; Tested positive for Covid virus/cough/Low grade fever; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266), via an unspecified route of administration on 16Feb2021 (at the age of 72-year-old) as single dose and second dose via an unspecified route of administration on 09Mar2021 (at the age of 72-year-old) (Lot Number: EN6208) as single dose both for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient tested positive for covid virus on 11May2021. Patient reported that she and her husband were fully vaccinated with the Covid vaccine and then recently they both tested positive for Covid virus. Mentions there were also 2 children and 2 adults who were positive. She received her first Covid vaccine on 16Feb2021 and the second dose on 09Mar2021 and then tested positive for Covid virus on 11May2021. She thinks she had a rapid test and another testing that was sent to Lab. Stated she had one shot in the right and one in the left, but unsure which dose was in which arm. No other vaccines given the same day and no problems with vaccines in past. she would like to know which variant they had. She stated after she tested positive for Covid she experienced cough and low grade fever. Stated she and her husband were given monoclonal antibodies at Hospital on Wednesday, 12May2021 she believes. At end of call, patient clarifies that they were all at a dinner party together with 4 adults vaccinated and 2 unvaccinated children, one being her daughter and niece they both also tested positive for Covid virus, which she finds profound. Mentions she just read that the CDC is only interested in post vaccination serious cases. She declines to complete reports for her daughter and niece stating she will have her call herself. No history of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines administered on same date of the Pfizer Suspect. The events required a visit to Physician Office. Adverse events following prior vaccinations was none. The patient underwent lab tests and procedures which included Covid virus testing: positive on 11May2021, had both rapid and other testing that was sent to Lab. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Nausea, cold, blurred vision, shortness of breath, pain between shoulder blades.  Blood pressure 160/108 @ 1137, blood glucose 95 @ 1140 (patient states she hasn?t eaten today), BP 206/138, sp02 99% room air, heart rate 99 @ 1155.  EKG unremarkable @ 1147.  Ambulance called at 1150. Patient transferred to hospital and off property at 1217.
Large localized reaction to ULD extending to forearm, shoulder and upper chest 12/5/17 in clinic. Warm to touch, sig. swelling. No streaking. Worsening 12/06/17. Low grade fever 100.3 F and at home x 2 days.
Patient was initially presented on 11/23/2021 with a chief complaint of generalized fatigue and body aches for the last few days.  Past medical history significant for diabetes mellitus type 2 insulin dependent, hypertension, dyslipidemia, depression with anxiety, diabetic polyneuropathy, history of peptic ulcer disease with previous GI bleed, history of seizure disorder, history of chronic kidney disease stage 3, and history of colon cancer status post partial colectomy with colostomy. Patient lives with the son and unable to obtain significant amount of information initially as patient had significant confusion.  Vitals were stable in the ED and lab work abnormal for elevated creatinine of 2.2 significant elevation from baseline of 1.4.  COVID-19 was positive and chest x-ray did not show any significant evidence for bilateral infiltrates suggestive of COVID-19 pneumonia.  Patient completed Remdesivir.  She was started on Decadron.  Home dose of gabapentin was held due to significant confusion.  Patient was evaluated by Neurology on 11/27 and recommended that patient appeared to have confusion and unable to make any diagnosis.  He recommended to continue to follow with Dr. as outpatient. Patient was subsequently admitted for further evaluation and treatment under Hospital with COVID-19 infection and dehydration.  Patient was given IV fluid and improved with the acute kidney injury and hyperkalemia.  Patient initially had significant confusion due to COVID-19 infection.  Psychiatry was consulted to evaluate for capacity evaluation and Dr. suggested patient have confusion due to acute medical condition and it is appeared to be temporary.  Patient subsequently improved significantly with mental status and able to participate with review of system questions.  Therefore, Psychiatry was requested to evaluate, and Dr. suggested patient have capacity to make medical decisions for herself.  Patient was evaluated by Physical and Occupational therapy and was recommended for post-acute therapy.  Patient continued to refuse post-acute therapy and states that she has a walker and wheelchair at home, and she also refused home health care arrangement.  Apparently previous provider and the social worker were unable to contact the son and however the RN today was able to talk to son and plan of care was updated.  Patient was provided transportation via cap.
Enlargement of goiter noted starting one week after 1st dose and continued for the next two months. Thyroidectomy was done 10/4/21.
Patient was vaccinated at 1300 and presented about 1.5 hrs after vaccination (1430) stating that their tongue felt a little swollen and throat felt 'funny' ongoing but not worsening for about 45 minutes. No itching or hives. No difficulty breathing. Pulse ox 99%, HR 94%. Patient had already taken one Benadryl tab about 30 mins prior to presenting to RNs. RN offered ambulance, patient declined. Explained that patient could take another Benadryl tab based on dosing if they choose. Provided guidance on s/s of anaphylaxis and importance of calling 911 immediately if they starting noticing any SOB. Rechecked all vitals at 1500, WNL. Patient states feeling about the same, not worsening. Completed one more vitals check at 1530, BP: 111/70, Pulse ox: 99%, HR: 77. Patient feels the same. Educated again on s/s of anaphylaxis.   This patient has previously received a Jynneos vaccine w/out complications in 9/2022.
Around 11am, child started with "heavy breathing."  Child's pediatrician was contacted.  Advised to bring child to ER - enroute child's respiratory distressed increased.  Generalized body rash and temp 100.6 R upon arrival at ER.  Family reports child given "injection" in ER - unsure of medication given.
Seen one week after vaccines at community clinic for irritability and poor swallowing and spitting up of citrus foods.  No fever, no diarrhea, no rash.  No other symptoms.  On exam he was a bit tender on the neck and had pharyngitis and otitis media.  He was treated with antibiotics.  Symptoms improved within a few days.
Covid-19 breakthrough. 1st Vaccine received on 01/22/2021. 69 y/o with PMHx of AFib with pacemaker, IBS and renal insufficiency presents to ER with c/o increasing weakness, cough, fall and diarrhea over past week. O2sat on room air 96%, CXR with mild bilateral PNA. Started on IV ABX.
Beginning on or about January 16, 2021, about two weeks after my first dose of the Pfizer/BioNTech vaccine, I developed an itchy, dry red spot on my left forearm. It appeared similar to ringworm, so I began treating it with an OTC antifungal. There were no improvements after 4 weeks of treatment, and around February 12, I began to develop smaller but similar red spots on my right forearm. Over the following two weeks more patches began to appear. Today I was diagnosed by a dermatologist with Pityriasis rosea. The spots are now scattered across my arms, torso, and upper legs, and have continued to get worse since the first spot appeared. I am reporting this event as I know that often pityriasis rosea appears following a viral respiratory illness. I have had no symptoms of a respiratory illness in over a year, but I wondered if perhaps the event was triggered by the vaccine, as it mimics a viral infection for the immune system.
On 11/13/2021- 7:00 pm that evening, I had pain in my back and sides, primarily on the right. I tried using heating pads, that did not work. I used 500 mg Tylenol, that did not help. I started having stabbing pain on my lower mid back, intermittently, like every 5 minutes from 7:00pm to 2:00am the next morning. Along with the stabbing pains,  on Sunday I felt something was walking on my back and that was off and on, at random times through out the day. I had an itching sensation. it was like a wave sensation along my spine. It was intermittent. Sometimes once a day,  sometimes 2 times a day. It was presenting like shingles. I had shingles before. I went to the urgent care. They indicated when they looked at my back they did not note any abnormalities of my sensation. The sensation, ever since November, I may have it 2 days ago, there is itching at the center of my back. There is no treatment provided for it because no one saw it as shingles. They didn't see it as a rash. So they did not know how to diagnose it. I still have intermittent neuralgia. The rash has gone away.
01/31/22 presents to ED for "Fatigue". PMHx of "hypertension, ESRD on dialysis"
About 4 hours after getting the first shot, I experienced itching on my lower back and continued to get rashes all over my body for the next few days and still am now. Very small part of my lip swelled and watery eyes.
Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 210/103, dizziness, and shaky. Epinephrine given with relief of swelling within 20 min. Two hours later reports vomiting and diarrhea.