chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 15:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 years, 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: "hyperlipidemia" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing). There were no concomitant medications. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Nov2022) Positive, notes: Positive rapid test 6 days after trearment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment of COVID-19 with Paxlovid from 06Nov2022 to 10Nov2022.; Sender's Comments: Based on the information given in narrative, the causal relationship between the events and the suspect drug BNT162B2 cannot be excluded.
Patient received her 3rd Gardasil vaccine in her left arm and then immediately following, her Hep A vaccine in her right arm.  Within seconds following the vaccinations patient became lightheaded and dizzy, and said she could not see.  She stated she thought she was blacking out.  She did not lose consciousness.  She had been standing up and was immediately assisted to the exam table to sit down.  Upon sitting down her dizziness and blindness subsided. She was instructed to lie down.  But, patient insisted she had to go to the bathroom right away.  As she was escorted to the BR, she became dizzy again and was unable to see.  She became incontinent of stool as well.  She was assisted to the bathroom and after sitting on the toilet she said she felt better.  She was cleaned up and sat in the bathroom for approx. 10 minutes.  Upon trying to stand, she again became dizzy, so she sat back down.  We stayed in the bathroom approx. 45 minutes until patient felt able to walk with assistance to the car.  During the walk to the car, she continued to feel lightheaded and dizzy, but did not lose consciousness or vision.  Upon arriving home she layed on the sofa for 2-4 hours.  There were no more adverse symptoms.
pt felt hot and clammy after injection, stated felt like she might pass out. pt sat in chair and slowly became unresponsive but never had any breathing issues. EMS was called and an ammonia inhalent was used. Pt responded to ammonia and was alert when EMS arrived. Pt was alert and coherent and vitals were stable. Pt refused transport to hospital.
Information has been received from a physician concerning a female (age unknown) with thyroid nodule and hypertension who on 24-MAY-2007 was vaccinated with a first dose of Zostavax (lot#652966/0623F) and on 25-May-2007 was vaccinated with another dose of Zostavax (lot#656861/0329U). Concomitant therapy included LIPITOR and ALTACE. The patient was seen by the physician on 24-May-2007 and was given the first injection of Zostavax. The physician wrote in the chart that the patient had received the injection, but the computerized office system was not updated. The patient then was told by a medical assistant to fill the prescription for Zostavax and returned to the office for injection. The patient completed this on 25-May-2007 and received a second injection on 25-May-2007. On approximately 25-MAY-2007 the patient experienced a headache described as "a burning in the head". The nurse mentioned that the patient was seen in the office on 29-May-2007 for a complaint of headache and "a burning in the head" that resolved in 24 hours. The date the headache began was unknown, but it resolved by the time the patient saw the physician on 29-May-2007. The physicians exam was unremarkable and no abnormal findings were noted. Additional information has been requested.
Large hive like reaction at injection site appeared suddenly after one week. Red, warm, hard. I am going to ice it and apply topical steroid cream
Dose 1 side effect: fever of 102 °F at 4:30pm, muscle ache, chills at 3am Treatment with Tylenol, felt fine by Monday 3/30  Dose 2: fever 101°F at 4pm, treatment: Tylenol and Vicks -NyQuil Acetaminophen, felt fine by Monday  4/19
Patient is a 99 y.o. female with history of CAD, HTN, HLD, spinal stenosis, breast ca, who presents from ALF with 1-2 weeks malaise, found to have UTI and admitted for UTI treatment and PT consult.   HPI Patient is a 99 y.o. female with history of CAD, HTN, HLD, spinal stenosis, breast ca, who presents with BIBA from ALF with c/o multiple days of feeling unwell, being in bed 8-9 days.   Patient has felt very fatigued, and weak over the last 1-2 weeks. The only other specific symptoms she is experiencing is pain from her hemorrhoids. Otherwise, she denies fevers or chills, rhinorrhea, sore throat, chest pain, dyspnea, cough, abdominal pain, nausea/vomiting, change in bowel habits, urinary symptoms. Given persistence of symptoms presented to ED   Resides in an assisted living, and is quite active.   On arrival to ED vitals were unremarkable. Physical exam only notable for one small mildly inflamed external hemorrhoid. Labs demonstrated potassium 2.9, troponin 23-- > 26, WBC 11, Hb 10, UA >100, 20-50 hyaline casts, 3-5 granular casts. CXR without acute process. She was treated with 500 cc NS, 250 cc NS with 40 M EQ of potassium, and 40 mEq of oral potassium, ceftriaxone.she was a 2 person assist to the commode, and thus was admitted to medicine for further management.
Fever; Headache; body pain; This is a spontaneous report from a contactable consumer (Patients husband) reported for his wife. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 06May2021 as DOSE 1, SINGLE for COVID-19 immunization in a local county vaccination center. The patient medical and concomitant medication history were reported. On May2021 the patient experienced fever, headache and body pain. Caller would like to know would it be okay for her to take over the counter Ibuprofen or Tylenol more preferred? Consent for follow up: Declined. The outcome of events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
chest tightness, pain, inflammation in torso and ribcage starting 12/31/2021 and continuing to this day. no known positive COVID test result.  treating with diet, herbs, and resources in long-covid community groups. not healed yet.
Narrative: Patient received second Moderna 4/26/2021 vaccination. He had no prior LEFT shoulder pain or complaints. He was hospitalized following a UTI and thought to have had a cerebellar stroke due to ataxia; however, MRI was negative. Patient had EMGs done, multiple confounding factors that can be found in his outside medical records from the hospital in system from 7/21/2021 including lumbar radiculopathy, neuropathy, h/o of severe ETOH dependence. However, recent MRI dated 12/13/2021 for worsening LEFT shoulder pain concerning for rare disorder, Parsonage Turner Syndrome, affecting that joint. Patient states the LEFT shoulder pain significantly worsened from a 4/10 to 8-9/10 pain in about 14-21 days after the 11/10/2021 for Moderna 3rd dose, requesting an MRI for the shoulder as well as seeing an orthopedic surgeon who recommended the MRI (but whose specialty was not shoulders). The MRI findings and the time frame are why an ADE is suspected. Furthermore, MRI of the brain confirmed no cause for the ataxia (i.e., no cerebellar stroke) from his June/July 2021 MRI to eval for his ataxia. A consult for neurology f/u is pending. EMGs of UE and LE were done in June/July 2021. Also significant is that patient's rehab has improved faster than expected by KT/PT. This lends to a possible vaccine reaction; although, a constellation of other contributing factors remain. Also potentially related is that patient had obstructive uropathy during this period. It is uncertain whether this may also be part of this, but he had been urinating better prior to his hospitalization on or about June 11,2021, and while he was treated for prostatitis, one would have expected him to have been at baseline more rapidly with treatment. This is resolving finally in these last two month.
Patient received 2nd dose of Pfizer and as he is seated waiting for his 15 minutes patient became lethargic and started fainting.  Patient also experienced sweating, perspiration,  shaking and vomiting.  Ambulance was called and was taken to the hospital .
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with ROTATEQ (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
itching continued; thought she had psoriasis; "itching in my hairline, back of neck, and hives"; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS ("itching in my hairline, back of neck, and hives"), PRURITUS (itching continued) and PSORIASIS (thought she had psoriasis) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and METOPROLOL for Blood pressure, PRAVASTATIN for High cholesterol, FAMOTIDINE, CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Feb-2021, the patient experienced PRURITUS ("itching in my hairline, back of neck, and hives"). On 04-Mar-2021, the patient experienced PRURITUS (itching continued) and PSORIASIS (thought she had psoriasis). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, PRURITUS ("itching in my hairline, back of neck, and hives") had resolved and PRURITUS (itching continued) and PSORIASIS (thought she had psoriasis) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 04 Mar 2021, the patient was seen by a physician for her rash.   This case was linked to MOD-2021-176888 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received, updated event outcome for itching  was recovered
It was reported that a patient (2 of 2) received a Tripedia  vaccination )Lot #U0536AA), administration date not specified. Reportedly. sometimes after the vaccination, the patient developed a severe local reaction with 5-6 cm swelling and erythema. Linked case: U2001-01022.
Had a seizure that lasted for 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had a seizure that lasted for 30 minutes) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     The patient's past medical history included Seizures (He does have a history of seizures but had not had one in a while.). Previously administered products included for COVID-19 vaccination: Johnson and Johnson (J&J) COVID-19 vaccine (first vaccination was the Johnson and Johnson (J&J) COVID-19 vaccine and batch number 203A21A) on 19-May-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson (J&J) COVID-19 vaccine. Concurrent medical conditions included Autism spectrum disorder (under the care of a physician for autism spectrum disorder). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE), GUANFACINE and SERTRALINE for an unknown indication.    On 21-Dec-2021 at 6:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021 at 11:30 PM, the patient experienced SEIZURE (Had a seizure that lasted for 30 minutes) (seriousness criterion medically significant). On 22-Dec-2021, SEIZURE (Had a seizure that lasted for 30 minutes) had resolved.            No treatment information was provided by the reporter.  Mother who was a caretaker for her son reported that patient received the Moderna COVID-19 booster vaccine and had a seizure that lasted for 30 minutes. No temperature. It was tremors with his eyes rolling. Patient does have a history of seizures but had not had one in a while. Patient was under the care of a physician for autism spectrum disorder.  Company comment: This is a  spontaneous case concerning a  19-year-old male  patient with concurrent medical condition of Autism spectrum disorder and medical history of seizures; who experienced unexpected event of seizure. The event occurred approximately 5 hours after the third dose of mRNA-1273 vaccine. It was reported that seizure lasted for 30 minutes. No temperature. It was tremors with his eyes rolling. Treatment details were not provided. Concurrent medical condition of Autism spectrum disorder and medical history of seizures remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a  spontaneous case concerning a  19-year-old male  patient with concurrent medical condition of Autism spectrum disorder and medical history of seizures; who experienced unexpected event of seizure. The event occurred approximately 5 hours after the third dose of mRNA-1273 vaccine. It was reported that seizure lasted for 30 minutes. No temperature. It was tremors with his eyes rolling. Treatment details were not provided. Concurrent medical condition of Autism spectrum disorder and medical history of seizures remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
rash; Could be poison ivy; This case was reported by a consumer and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 hours after receiving Shingles vaccine, the patient experienced rash and poison ivy rash. On an unknown date, the outcome of the rash and poison ivy rash were not recovered/not resolved.   It was unknown if the reporter considered the rash and poison ivy rash to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received the shingles shot 3 years ago from reporting date and now had the rash. the patient would be going to the doctor and hoped it was not shingles. The patient stated that it could be poison ivy. The follow-up would not possible as no contact details were available.
Patient received second COVID-19 vaccine. While waiting in observation, he developed chest heaviness. Described it as a 4 year old sitting on his chest. B/P up slightly at 148/102 (highest) and 143/84 (lowest). HR in the 90's. Denies chest pain and shortness of breath. Patient taken to the emergency department for observation and diagnostic testing   Patient is a recent liver transplant recipient (2020). In ED, patient's EKG was normal. Troponin less than 4. Monitored for several hours and symptoms resolved. Discharged home.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient took Paxlovid for COVID 19 treatment from 03Aug2022 to 07Aug2022 via oral route. Recurrence of COVID symptoms on 11Aug2022. No treatment received for the recurrence.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The reported "COVID 19 treatment " after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
The COVID  vaccine (Lot number FK5618) was given after it's beyond use date of 1/27/2022. Outcomes of giving the vaccine after the BUD unknown.
pt began screaming in pain, drawing up knees & vomiting; seen at clinic; dx w/intussusception; had surgery to correct obstruction;
Pt begn vomiting, mom states T rising to 103; Seen in ER given suppositories for vomiting & fever; Later broke out in rash & began antibiotics fever to 105;Mom says seen by MD, recovery took 3 days;
Pt received booster dose of Pfizer covid vaccine on 10/23/2021. She presented to the ED on 11/1/2021 with shortness of breath. Found to have extensive pulmonary emboli. Symptoms of SOB started on 10/29/2021, within 6 days of vaccination. Only other risk factor for PE is chronic tamoxifen. H/o breast cancer 2 years ago, treated. Unknown if the PE is related to the vaccine, but felt it was important to report.
Headache, Myalgia, Fever, Diarrhea & NauseaVomiting Narrative:  Patient received vaccine on 3/5/2021 and began experiencing symptoms on 3/6/21. Reported symptoms include injection site pain/discomfort, fever (101.2 F), chills, headaches x 2 days, body aches, fatigue, nausea, and diarrhea. Patient reports "medium risk exposure to COVID + individual on 2/22/21. Test performed this date. Results unknown. Reports use ibuprofen 800mg x 2 doses.  Other Relevant History:
pt pvt MD examined pt 15AUG in office w/nl clinical exam but pt has subjective c/o arm soreness, lightheadedness & gen myalgias;afeb;MD gave pt rx for pred;poss systemic rxn to DT vax;
Patient has continued pain and weakness in the right arm after receiving the vaccine several months ago (01/21/2019)
Right thigh, 5 inch by 4 inch red inflamed reaction hot to the touch.
Patient presented to the ED on 5/18/2021 for arterial occlusion. She was subsequently hospitalized. Per doctor's notes: 5/18/21 was admitted with ischemic leg pain and w/ urgent need for a planned complex revascularization procedure of the RLE w/ Dr. of vascular surgery which was completed later 5/18/21. This is within 6 weeks of receiving COVID vaccination.
Pt experienced vertigo which he stated he experienced off-site after his first vaccination as well. He remained on site for 1 hour and 5 minutes and the symptoms dissipated and he was able to leave on his own.
about 6 days after injection my arm became hot/red and itchy around the injection site, then a large lump appeared - this did not dissipate until day 13 post injection after using cool compresses, antihistimines and vigorous rubbing of the arm - I did not have a "rash" but definitely a defined area that grew larger as it dissipated
Father of client visited SCHD on Thursday, March 4th 2010 and c/o that his entire family including the above client has had chest congestion, runny nose, aches, on and off fever since receiving the H1N1 vaccine. Client has not been seen by a physician for the signs and symptoms.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for four patients. This is for the 4th of the four reports. A patient of an unspecified age, gender, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced body ache and chills. Clinical outcome of the events was unknown at time of this report. The information on the lot number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018186943 same reporter/drug/event, different patient.
sick for 5 days on 7th day i had multiple seizures the hospital misdiagnosed it saying it was a tumor. They attempted brain surgery at hospital. It was blood hemorrhage. Two weeks after the second shot i was admitted t a hospital with multiple blood clots.
Left arm and arm pit swelled up to almost twice their normal size about two hours after injection.  It was very sore. Lymph nodes were swollen on that side too, on my neck and in arm pit region. I had two kids in my care and I was alone so I just waited to see if the swelling would go down. It did, two days later.   This was my second dose. My first dose I just had localized pain near the injection site.
I got the second shot  on apr 17th. Symptoms of shingles started May 13. I got a shingles outbreak under my right breast. Have never had it before. I am immunocompromised with Crohn?s disease
Reported by mom on subsequent visit 2 wks p/inject lt upper arm swollen & red from elbow to shoulder for several days; high fever; hi pitched cry some puffiness of face;
26MAY92 mild fever gave APAP 27MAY92 fever 103 fussy, wouldn't eat, seen by MD; 28MAY92 t106.2 taken to hosp ER; tx Pediaprofin; no improvement devel diarrhea 30MAY92, became mildly dehydrated adm to hosp 31MAY92; pt has flu;
Vaccine Received 05/07/2021 1735 - within 2 hours - fatigue/tired, mild aches,  Did not resolve  started with frontal Bitemple Headache and nasal congestion that did not go away with rest, fluids, zyrtec.  984 106/62 96% 84 R=16 seen on clinic 5/10/2021
This case was reported by a pharmacist via a call center representative and described the occurrence of feeling cold in a 79-year-old male patient who received BOOSTRIX (batch number H5299, expiry date unknown). On 2nd October, the patient received OOSTRIX .5 ml. On 2nd October 2015, 6 hrs after receiving BOOSTRIX, the patient experienced feeling cold, chills, feeling hot, nausea and headache. On an unknown date, the outcome of the feeling cold, chills, feeling hot, nausea and headache were recovered/resolved. It was unknown if the reporter considered the feeling cold, chills, feeling hot, nausea and headache to be related to BOOSTRIX. Additional details were received as follows: The patient and his wife both were vaccinated with BOOSTRIX. The patient experienced feeling of extremity cold to the bone, shaking and nauseous, and then he became very hot, took of clothing. There events were lasted for few hours. On 2nd October 2015, 6 hrs after receiving BOOSTRIX, the patient experienced feeling cold, chills, feeling hot and nausea. On 2nd October 2015, less than a day after receiving BOOSTRIX, the patient experienced headache. This lasted for 3 to 4 hours. The patient did not have a fever or signs of allergic reaction. The patient has a normal pulse and heart rate.