chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aug 22nd body started to itch --> rash. Tried hydrogen peroxide baths & BENADRYL at home. 8/27/office visit, prednisone, loratadine & hydrocortisone prescribed - rash went away. As soon as prednisone complete, rash returned. Prednisone ordered. Try swimming in Chlorinated pool. Itching & rash continue to plaque pt. On August 15, 2012, I went to my medical doctor for a routine physical. I am a 55 year old male. I try to eat healthy foods and exercise on a regular basis. It recommended that I have a tetanus shot. I agreed. It was a triple shot- T-dap. On the next Wednesday, my body started to itch, then the next day I got a rash. The rash was on my abdomen and gradually spread to my arms. I tried a hot bath with a little Hydrogen Peroxide in it. It was somewhat soothing. Then I look some BENDARYL. Over the weekend I continued to do my work as the pastor of two churches. By Monday I was feeling pretty bad. I had chills and was very week, to the point that I had my wife call to make an appointment with my doctor. The appointment was with the nurse practitioner. She was convinced that my wife may have changed laundry detergents, that I had come in contact with something that was giving me an allergic reaction. The NP gave me a Rx for steroids (prednisone) and Lidocaine to help me get over the allergic reaction. In a couple of days the itching and rash were gone. I did not event think about the possibility of a reaction to the vaccine until a few days later. Then when I looked at the possible reactions to the T-dap vaccine on the sheet given to me by my Md it became clear to me that the symptoms that I was experiencing were all on the list (itching, hives, chills and weakness). After the Prednisone was gone, the itching came back and the rash was also starting again. I contacted my MD and another Rx for Prednisone (Methprednisone) was ordered. That Rx was completed in 6 days and September 10 the itching started again. I used the hydrocortisone cream (1%) before going to be to decreased the itching. It helped. For the past few days I have gone swimming at the YMCA as the cooler chlorine water seems to help with the itching. This has been a pretty miserable experience for me. September 12, in the evening I applied some of the 1% Hydrocortisone at around 11pm. Soon after, the itching around my waistline and abdomen became pretty intense. September 13, 12-3pm itching is moderate. September 17, 2012 in the evenings the itching continues to be moderate. The itching is around the abdomen and a rash continues to occur. The rash is in the front and on my back. September 21, 2012 the itching and the rash are not getting better. My abdomen is covered with the rash. I am requesting that a report be filled with the VAERS listed on the T-dap "Vaccine Information Statement."
CHILLS, INJECTION SITE REDNESS, AND PAIN; ARM STIFFNESS; SHORTNESS OF BREATH; SWOLLEN LIPS; OTC BENADRYL, PREDNISONE; TYLENOL; IBUPROFEN; 2 HR MONITORING.
Pt recd Pneumovax at appt 5/11/2011. On 5/12/2011 in am called w/ redness sl pain and swelling 50 cent size area on posterior left arm at injection site I told her to apply cold compress and take antihistamine c/b if worse.  5/13 ealy afternoon called c/o more redness swelling and now febrile- I called in Keflex for presumed cellulitis.  I sent a sample of the vaccine to the local lab for culture. Notified pt., our clinic director and the VAERS.
PT RETURNED TO FACILITY ON 2/23/2021 TO REPORT SYMPTOMS OF REDNESS, WARM TO TOUCH, AND SWELLING AT INJECTION SITE - LEFT DELTOID NOTIFIED PTS PRIMARY PHYSICIAN, SET UP APPOINTMENT FOR 1130 TODAY TO BE SEEN
Left axillary swelling developed on day 2 after vaccination. Measuring approximately 6 cm x 6 cm. Site is visibly mildly swollen. Feels firm. Tender to palpation.
Body temperature at 101; Chills; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 28Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. The patient did not receive any concomitant medications. The patient previously received 'coconut' for an unknown indication from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 07Apr2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 around 22:30, the patient experienced chills. On 28Apr2021 at 23:30, the patient experienced body temperature at 101 (unspecified units). The patient reported that he drank water had a thick robe and blanket on. The clinical outcome of the events chills and body temperature at 101(unspecified units) was not resolved at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
On 9/8/19 to 9/9/19  Exhaustion. 9/10 to 9/12  seemed to have recovered.  9/12 taken to ER with severe joint pain, pain in left shoulder, back, stomach, legs, behind the knees and finger joints (both hands).  Diagnosed by ER as serum sickness. Around 9/14 admitted to ICU with severe chest pain. As of 9/21 patient is still in the ICU
swelling in the arm; This case was reported by a physician via call center representative and described the occurrence of swelling arm in a adult 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 swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received the 1st dose of Shingrix a while ago and experienced swelling in the arm. The reporter did not consent to follow up. The Doctor said he could not clarify if the dose was administered IM or SQ because he did not administer it and did not know date of vaccination or when the symptoms started and did not agree to follow up and said that a pharmacist had already reported this. This case linked with US2020196165, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020196165:same reporter
Administration of MMR and VARIVAX intramuscularly; This spontaneous report was received from a physician's assistant concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-MAR-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot # U029496,  expiration date: 21-SEP-2023, administered intramuscularly (unapproved route) as prophylaxis (strength, was not provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #U006486, expiration date: 26-FEB-2023, administered intramuscularly (unapproved route) as prophylaxis (strength was not provided).
Narrative: Pt is a 68y.o. male who died on 05/132021 w/ h/o HTN. CAD, GERD, COPD, AFib, Diabetes, and Schizophrenia. Pt received Moderna Covid-19 Vaccination 2/2 on 05/05/2021. On 05/13/2021 CM arrived to patients home today at 9:30am for a scheduled transport and escort to surgery. Patient did not answer the phone or his door which is not usual for patient. CM consulted with Supervisor and contacted patient next of kin for a recommended wellness check. Patient was found deceased in his home by his brother. Unlikely Moderna Covid-19 vaccine caused/contribute to pt death.
swelling in the joints, specifically in the hands, fingers, wrists and one knee; her head and back hurt, she hurt all over.; she took aspirin last night to help with the back pain so she could sleep but she still couldn't; a slight fever; continuous headache for the last 3 days/her head and back hurt, she hurt all over; swelling everywhere; she had an allergic reaction; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry Date: Unknown), via an unspecified route of administration on 31Jan2021 as single dose for covid-19 immunisation. The patient's medical history and Concomitant medications were not reported. The patient reported that on an unspecified date, she had been experiencing swelling in the joints, specifically in the hands, fingers, wrists and one knee. She also had a slight fever and continuous headache for the last 3 days. Patient wanted to know the information like, if her side effects are caused for the administration of the Pfizer's COVId-19 vaccine and if the use of Extra strong Tylenol containing Caffeins and Aspirin could help with her side effects caused for the administration of the Pfizer's COVId-19 vaccine. It was reported that, she got her first Pfizer covid vaccine on 31Jan2021 and three days later (03Feb2021) she had an allergic reaction but not severe, she had swelling everywhere and the last 2.5 weeks. Her head and back hurt, she hurt all over on an unspecified date. Advil and Tylenol didn't do anything for her, she took aspirin. She took aspirin last night (on unknown date) to help with the back pain so she could sleep but she still couldn't. She had spoken to her doctor. She had heard other people have worse reactions after the second shot, she was hoping she is the reverse. She was asking if she can take aspirin or something before her next vaccine to prevent the pain. Outcome of all the events were unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Moderate Left Arm for 3-4 days Pain Clear runny nose on day 4 post vaccine. Last 2 hours. disappear spontaneously
My arm on the night of my vaccine administration became very hot and tight feeling, and a red swollen spot appeared on my skin. It was very hot to the touch and made my arm throb. The spot grew larger and larger until it encompassed and wrapped around most of my arm. It stayed this way for 48 hours. Today, there is still a swollen rash, but the swelling has gone down, and the redness has as well. It is no longer hot to the touch, but is very uncomfortable when touched.
rash on left thigh; This is a spontaneous report from a contactable consumer (patient).   A 69-year-old male patient received bnt162b2, via an unspecified route of administration on 05Mar2021, at the age of 69-years-old, (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  On 09Mar2021, the patient developed rash on left thigh on an unspecified date with outcome of unknown.    No follow-up attempt is needed. Information about lot/ batch number has be requested.
This spontaneous report was received from a pharmacist via company representative refers to unspecified number of patients (maybe 17 or 18) of unknown age and gender. Medical history and concurrent conditions were not provided. On an unspecified date, between February and March 2015, all these patients received ZOSTAVAX, 0.65 ml once, subcutaneous. No concomitant medications were reported. Some of the patients got a bump at site, not described as blister (Injection site mass). Reporting pharmacist stated that the symptoms dissipated over time and there were no details on any treatment. On 17-APR-2015, another pharmacist during a phone call confirmed the lot number and expiration date for the ZOSTAVAX: K020186 and expiry date: 27-JAN-2016. The pharmacist provided that patient identification information was not readily available at the time of the call and that there were no additional adverse events reported. The outcome of the injection site mass was recovering at the time of the report. Causality assessment was not provided. this is one of two reports received from the same reporter. Additional information has been requested.
Narrative:  1-2 WEEKS (EXACT DATE OF INITIAL ADVERSE EVENT UNKNOWN)AFTER TAKING JANSSEN VACCINE PT STARTED HAVING DIFFICULTY USING RIGHT ARM AND HAND. THE WEAKNESS PROGRESSED TO BILATERAL LEGS. PT HAS DIFFICULTY RISING FROM CHAIR AND IMBALANCE WITH WALKING, SPEECH IS SLURRED. DECREASED STRENGTH IN RIGHT HAND (GRIPS, WRIST EXTENSION, AND FLEXION), RIGHT BICEP, BILATERAL KNEE EXTENSION, AND RIGHT FOOT DORSIFLEXION.
Patient received vaccines on Monday. Swelling started on Wednesday. Mom says it was the size of baseball. This was reported on Wednesday. Tried to follow up Friday, no answer.
Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (dose, lot# unknown) orally. There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore, swollen arm, sore swollen arm pit left arm - where shot was given, fever of 102 deg for 2 days, fever of 100 deg for 1 day, achiness - Flu like symptoms for 3 days, Took Advil 600mg every 6-8 hours.
Pain left upper arm 8/10 and body aches onset night vaccine given 7/12/18. Seen office 7/19/18 given VICODIN for pain. 8 days localized pain lasted.
Shortness of breath, soreness, nausea, diarrhea, night sweats, couldn't breathe, fever
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: The patient received vaccine. Other medication in 2weeks were Unknown. The patient had anti-viral Paxlovid for COVID 19 Treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted due to anxiety relatd to the vaccination.  Patient fainted approximately 10 minutes after it was given when trying to stand up. Was given water after the vaccination as well as laid down post fainting spell.
Body aches, sore throat, fever and cough noted 3 days after vaccination. Took Ibuprofen 800 mg oral TID as needed. Got better after 3 days.
Pt has 8x4cm bruising with faint redness and warmth to left upper arm vaccine injection site.  He first noticed it afternoon of 4/11; had vaccine on 4/8.  MD diagnosed pt with cellulitis left upper arm and ordered Amoxicillin 875mg po BID for 14 doses
Shingles (that are scabbed over); developed shingles (that were scabbed over); This case was reported by a nurse via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation.   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced shingles and scab. On an unknown date, the outcome of the shingles and scab were unknown.   It was unknown if the reporter considered the shingles and scab to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 74 or 75 years. The patient was unable to receive the 2nd dose at the recommended time frame due to surgery with complications.  The patient had since developed shingles (that were scabbed over) and reporter was inquiring when he should receive the 2nd dose or if he should restart the series. The patient had knee surgery, which she states was unrelated to him receiving Shingrix.  The reporter consented to follow up.
ADMINISTERED SECOND DOSE OF COVID 19 PFIZER VACCINE FROM A BATCH 6 DAYS OUT OF DATE. NO ADVERSE EVENT.
Afebrile seizures (2) within 48 hours of receiving immunizations. Seizures were brief, generalized with loss of consciousness.
1hr after flu shot and pneumonia shot had aching joints, itching, hives, sweating and chills, pain over all body, loss appetite, neurological symptoms joints.
25yo M with no sig PMHx or FMHx for ACS presents with 4 days of viral symptoms: f/s/c/myalgia/fatigue/HA that progressed to include CP for last 3 days. Classic positional CP, dull pressure, worse lying flat, better leaning forward, feels every heart contraction.  Work up consistent with Acute Pericarditis and treated outpatient with Ibuprofen and Colchicine.  symptoms worsened and he was evaluated and admitted overnight hospital for observation due to elevated troponin and STE on EKG.  Pt stable and discharged next day.
***PATIENT STATED THAT HER VACCINATION CARD IS FADED AND SHE CAN NOT SEE LOT NUMBER FOR VACCINE!!*** 3 days after getting vaccination, I felt tired and weak. I also had a cough. I laid around for 2 days, I was aching, after those 2 days I was okay. But everything started happening again in April. I have medications for my cough. My body is stiff, and it's a little hard for me to walk. I have headaches, and I can barely eat. I have problems sleeping now. I also have a pain in my leg, and numbness in my right hand. Irritated eyes, and chest pains/ tightness, and these symptoms have been coming and going since April. I've tried to take tylenol for my pains. Patient stated that has not seen a doctor for reaction.
horrendous headache. lasted the night of injection and 1/2 the following day. no treatment.
CANKER SORE UNDER THE LEFT SIDE OF THE TONGUE; SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy to coating in canned food. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total first dose administered on unspecified date for covid-19 prophylaxis. Concomitant medications included lisinopril, and pantoprazole. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received 2 doses with non-company suspect vaccine moderna (elasomeran) (Dose number in series 2) second dose (form of admin, route of admin, and were not reported, batch number: 027H21B, expiry: UNKNOWN) dose was not reported, and third dose (form of admin, route of admin, and were not reported, batch number: 065H22A, expiry: UNKNOWN) dose was not reported, administered on unspecified date for covid-19 prophylaxis (dose number in series 2).  It was unknown whether the patient had any adverse events following two doses of moderna (elasomeran) (dose number in series 2). The patient received fourth dose of non-company suspect vaccine moderna (elasomeran) (Dose number in series 3) (form of admin, route of admin were not reported, batch number: CUS17394, expiry: UNKNOWN) dose was not reported, fourth dose administered on right arm on 09-APR-2021 date for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 3).  On unspecified date in 2023, the patient experienced suspected covid-19 infection (dose number in series 3) and received non-company suspect drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: GD8819, expiry: UNKNOWN) from 03-SEP-2023 to 07-SEP-2023 for covid-19 treatment.  On 03-SEP-2023, the patient experienced canker sore under the left side of the tongue and inside of the lower mouth cavity, also experienced bitter mouth during the entire time (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (dose number in series 2), and elasomeran (dose number in series 3) was not applicable, and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from canker sore under the left side of the tongue, and suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Reports had "flu like symptoms" following first dose of MMR given on 2/5/2020.  1/2 hour after administration of 2nd doses given on 3/6/2020 developed redness to face, neck, upper chest and back.  Went to ED for eval.  Reports she developed rash/hives to face, neck, torso, scalp, upper arms.  Hives have spread to upper thigh and peri area.  Describes rash as "itchy" and painful.  Provider also noted swollen glands at paricervical region, described rash as macular, papular, with some pustules.  Painful to swallow.  Throat slightly injected.  Slight swelling of submanibular glands.  Has been using OTC Benardryl gel caps every 4 hours since Friday without relief of symptoms and hydrocortisone cream to hives.Denied SOB. or trouble breathing.  Employee is afebrile.  on 3/9/2020 was given scripts for Medrol dose pack and Atarax for itching.  Was given another VIS sheet for MMR and highlighted area on page 2 stating that hives, rash and swollen glands can develop following vaccine administration.  Advised by CNP not to have the MMR vaccine in future.  Will recheck with provider on 3/7/2020 to ensure hives are improving.
General malaise, chills, fever, loss of appetite, slight nausea.  Temp 100.7 F at 0045 am on 2/18/21. 500mg acetaminophen taken at 0045 am. Temp of 99.4 F at 0630 am 2/18/21.  Temp of 99.6 F at 1050 2/18/21.  500mg acetaminophen taken at 1050 and repeated at 1420 and 2030 for a total of four doses during this episode. By the morning of 2/19/21 I was feeling almost normal with some residual tiredness and lack of energy.  During this period I did experience some pain at the injection site but do not consider it out of the ordinary.
Abdominal cramps and diarrhea 8 to 14 times a day since April 27; June average 8.4 times/day though now stool is all pencil-like
Persistent, severe, high-pitched, inconsolable crying, decreased appetite (>4 hours) (72 hours total). Evaluated in ER. No treatment.
24-36 hours after Dtap (L thigh) Pt developed red knot and spreading out. No fever, no pain. Pt able to walk and jump, no warmth noted.