chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The location was warm and I had a light red rash. I felt hot but I did not have a temperature, I had flu like symptoms for two days. The swelling of my joints continued and my hands and knees where red. I was nausea and fatigued for weeks. I had diarrhea for 3 weeks.
hives around injection site, malaise/feverish, still fatigued on day 18, on day 16 after injection woke up with right eye red itching and burning with blurry vision
Approximately 1 hr after receiving the J&J COVID 19 vaccine SEVERE pruritus began over my entire body. It lasted for 1 1/2 days.  I took 75mg of diphenhydramine every 4 hrs during that time.
shingles; This spontaneous report as received from a lawyer and the patient (pt) refers to a female patient of unknown age. Medical history, concurrent conditions and concomitant medication were not reported.  On or about 04-AUG-2014, the pt was vaccinated by a health care professional with a dose of zoster vaccine live(ZOSTAVAX), (Dose, route, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by physician for shingles resulting from the use of zoster vaccine live(ZOSTAVAX). The outcome of herpes zoster was unknown.
pt recv vax 10JUL96 & 22SEP97 pt devel varicella w/no more than 25 vesicles;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 31-JAN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 with lot number L024129 and expiration date of 21-JAN-2017, intramuscularly (strength, dose and anatomical location were unknown) for prophylaxis. The patient had not experienced an adverse effect. No product quality complaint was involved. Additional information has been requested.
About 5 hours after injection, tenderness in arm appeared and then worsened. Kept me up in the night and would be very painful even with a light touch. Then the next morning I felt fatigued, slight headache, ears ringing and very light headed.
muscle pain; she did not feel good; tiredness; joint pain (thigh/hip/went down to her both legs)/all over body; pain in her back/pain right side of her back; injection site pain; chills; This is a spontaneous report from a contactable consumer (Patient herself) via medical information team. A 82-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: EL322/9, Expiration date: Not provided, NDC number: Not provided), via unspecified routed of administration (Anatomical location: Arm Right) on 27Jan2021 12.10 as single dose for Covid-19 immunisation. The patient medical history included on May2020 she had emergency gallbladder surgery and she had a severe low sodium level. Adds she is still taking gatorade for the sodium level (still low sodium level; doesn't even come to the bottom range) and her doctor told her not to take free water, on 9Mar2020 she had a total knee replacement, she had a hysterectomy 10 years ago She had ongoing Urinary incontinence, ongoing urinary tract infection in Jun2020 or Jul2020, patient family history includes husband passes and she is alone. The patient had no Prior Vaccinations within 4 weeks. The patient concomitant medications included vitamin d3 at 50 mcg orally once a day, oxybutynin orally 5mg twice a day, diphenhydramine hydrochloride orally 25mg once a day for allergy, cephalexin orally 250mg once a day, amitriptyline 10 mg thrice a day orally for urinary incontinence all concomitant medications are ongoing. It was reported that on 27Jan2021 2 hours later patient experienced pain in her back, injection site pain, tiredness, chills, muscle pain, and joint pain ("upper joint of both legs, 1st one leg, then 2nd leg, then both"), also stated that almost two hours to the date she felt pain 7 inches by 9 inches on the right side of her back. Eventually it went away, she also had injection site pain, tiredness; muscle pain really really bad chills; joint pain; but she had no fever; Adds she did not feel good and these effects just came one after the other. Adds she was so cold besides four sweaters and her heating blankets she was still so cold, she does get chilled a lot but this was so obvious, States she had the joint pain all over her body but especially in the joint of her thigh/hip and it went down to her legs. She is not sure when went away because she took two extra strength tylenol and it got better. Adds she lives alone because her husband passes, and she had to use a cane and it was really difficult. The outcome of the event back pain recovered on 31Jan2021, injection site pain recovered on 28Jan2021, chills recovered on 30Jan2021, Fatigue, muscle pain, Arthralgia, she did not feel good recovered on 01Feb2021.
Patient called and stated that he has been lethargic and febrile. He has had a fever from 98 to 101 over the past few days. The fever remains high even with taking Tylenol. He also had injection site reaction.
injection area became sore; skin around injection has slugged off; burning sensation; This is a spontaneous report from a contactable consumer or other non hcp. A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 00:30 (at the age of 52-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included covid-19. The patient concomitant medications included pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported, esomeprazole sodium (NEXIUM) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient experienced injection area became sore, skin around injection has slugged off and burning sensation on 05Feb2021 12:00. No treatment received for events. Patient was not tested positive after vaccination. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient reported feeling dizzy, anxious, fatigued and chest tightness Patient provided with water and seen by medical team Patient refused medical transport and signed AMA form Patient stated symptoms improved and will be driven home by mother
Morning of 1/16/21, patient woke up early because the arm itched. She had swelling in hands, feet and rash on both arms and her torso. Also had tingling in hands and feet. Had these reactions for a couple days. Also had chills and nausea on Sun, Mon, and Tuesday but those symptoms have subsided. Still has some rash, but is taking Benadryl; has generalized itching.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 included: "Obesity" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cephalosporin, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Streptococcus test: Negative. Reporter is the patient.  Patient was tested positive for Covid-19. Patient notified doctor and was prescribed paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever of 102.5 w/chills & sweats, severe joint swelling & discomfort, immense low back pain & neck pain;ER MD suspected serum sickness from vax & placed on APAP w/codeine;
Hives on face, swelling of face, pain around right eye, body weakness, headaches.
Extremely Achy, So Painful I could barely move, Developed a large lump in my left arm pit and neck, torso, under arms and groin area were covered in a red, hot rash.  Took benadryl and advil to help with pain and  rash.  When rash went away after three days I was then itchy to the point of wanting to rip my skin off.   Achiness lasted about 24 hours, the rash lasted two days with Benadryl and I still have the lump.
fever 102; muscle and joint soreness, injection site reaction resembling bee sting Extra strength tylenol; Benedryl ;triamcinolone acetoneide cream
Headache, Myalgia, Fatigue ,myalgias, headache Narrative:  Sude Effects:Fatigue 12/9, awoke 12/9 with HA,myalgias,and fatigue.. Side Effects with #2vaccine
diagnosed with Kidney cancer; This spontaneous case was reported by a consumer and describes the occurrence of RENAL CANCER (diagnosed with Kidney cancer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 010M(or N)20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced RENAL CANCER (diagnosed with Kidney cancer) (seriousness criterion medically significant). At the time of the report, RENAL CANCER (diagnosed with Kidney cancer) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Angiogram: result not reported she had an MRA on her back.         Concomitant medication use was not provided. Treatment information was not provided.  It was reported that the cancer might be an slow-grown  and she is under more documentation to get a fully diagnose. She was told that she might have had the cancer for almost 10 years. She stated at the end of the call that she had an MRA on her back in October 2020, and believes that from that study she was diagnosed with Kidney cancer after eight months.  Company Comment: This case concerns a 74-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected event of Renal cancer. The event was diagnosed 4 months after the second dose of COVID-19 Vaccine Moderna (mRNA-1273). It was reported that the patient was told that she might have had the cancer for almost 10 years. She stated that she had an MRA on her back in October 2020, and believes that from that study she was diagnosed with Kidney cancer after eight months. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) and on 04-Mar-2021, received second dose of mRNA-1273. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected event of Renal cancer. The event was diagnosed 4 months after the second dose of COVID-19 Vaccine Moderna (mRNA-1273). It was reported that the patient was told that she might have had the cancer for almost 10 years. She stated that she had an MRA on her back in October 2020, and believes that from that study she was diagnosed with Kidney cancer after eight months. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) and on 04-Mar-2021, received second dose of mRNA-1273. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Case number PHHY2011CA84213 is an initial literature report received on 16 Sep 2011. Authors described about novel influenza (H1N1) infection in pediatric renal transplant recipients who were vaccinated with influenza H1N1 vaccine. This report refers to a pediatric patient (age less than 18 years) of unknown gender. The patient's medical history included renal transplant. The patient received induction therapy consisting of five doses of daclizumab (1mg/kg) at two weeks intervals starting the day of transplant. Concomitant medications also included prednisone 0.06 mg/kg/day, tacrolimus 0.06 mg/kg/day and mycophenolate mofetil 757.6 mg/BSA/day. The patient was vaccinated with influenza H1N1 vaccine (manufacturer and batch number: unknown) on an unspecified date. On day 4 after vaccination, the patient developed H1N1 influenza infection which got confirmed. The patient received either oseltamivir or antibiotic medications and supportive treatment for the same. The length of H1N1 course was in range between 3 to 14 days. Authors stated that the clinical course of influenza (H1N1) infection in pediatric renal transplant recipients was generally mild and posed neither significant morbidity nor mortality when supportive treatment and oseltamivir were administered. Authors also mentioned that is unlikely that H1N1 vaccine administration played a significant protective role as longest interval between vaccine administration and presentation with illness observed was only 10 days.
This spontaneous report as received from a medical assistant refers to 4 unspecified patients. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiration date not reported) that were improperly stored, exposed to six temperature excursions over two months for a maximum of 17F for a total of 19 hours. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
BLOOD CLOT; This spontaneous report was received from a female patient of an unspecified age.   The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine Ad26.COV2.S (suspension for injection, route of administration, and batch number were not reported) dose, vaccination site, and start therapy date were not provided, for prophylactic vaccination; and was treated with XARELTO (rivaroxaban; film-coated tablet, oral, batch number was not reported) dose, frequency, and therapy dates were not provided, for an unknown indication. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced a blood clot. The patient reported she got a blood clot after receiving her vaccine, and that she had just started taking rivaroxaban.  Action taken with Covid-19 vaccine Ad26.COV2.S was not applicable, and action taken with rivaroxaban was not reported. The patient outcome for the event of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: v0 This report involves a female patient of unspecified age who experienced a blood clot on an unspecified date after receiving the Janssen COVID-19 Vaccine Ad26.COV2. Concomitant medications included rivaroxaban (recently started). The patient's past medical history and details of the event were not reported. The recent starting of rivaroxaban infers a recent clot or a condition that would predispose the patient to develop a clot, however this case has insufficient information to make a meaningful medical assessment.
While receiving 2nd dose of HPV (gardasil-9) patient started feeling dizzy, faint and pale. This all happened while sitting down receiving vaccine. Able to finish administering vaccine, and laid patient down.  Took vitals right after lying down: 1146: 127/69 Pulse:71 100% pulse ox. Lasted about 10-20 seconds of dizziness and unresponsive. When patient responsive again she verbalized she felt dizzy and sleepy when receiving vaccine.  vitals taken again 10 mins after 1152: 123/66 pulse: 69 pulse ox:99. Last set of vitals taken before leaving clinic 15 mins after symptoms:112/65 pulse:77 99% pulse ox.
Seizure at time of shot. Shaking and jerking, eyes rolled back in head, hot and sweaty.
Patient recieved Influenza (left arm) and Tdap (right arm) injection 1 day postpartum, reports left arm felt heavy ane day after injection with injection site redness and swelling. Seventh day redness, swelling, and warmth speading from left shoulder to elbow. Patient complains of pain when lifting arm over head. Currently breastfeeding, patient started on Keflex 500mg qid for 10 days. Ice packs x 15min intervals when needed.
Arm is swollen; Arm is red; Injection site arm began to hurt and it became progressively more painful/ Arm is very painful; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), VACCINATION SITE ERYTHEMA (Arm is red), VACCINATION SITE PAIN (Injection site arm began to hurt and it became progressively more painful/ Arm is very painful) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced VACCINATION SITE PAIN (Injection site arm began to hurt and it became progressively more painful/ Arm is very painful) and HEADACHE (Headache). On 02-Sep-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen) and VACCINATION SITE ERYTHEMA (Arm is red). At the time of the report, PERIPHERAL SWELLING (Arm is swollen), VACCINATION SITE ERYTHEMA (Arm is red), VACCINATION SITE PAIN (Injection site arm began to hurt and it became progressively more painful/ Arm is very painful) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not  provided.  On 02-Sep-2021, the patient's arm was very painful. The patient was unable to take pain medications.
1/1 vaccination 1/2 Extremely nauseous, vomiting, diarrhea. It felt as though severe pain where kidneys were but it ended up being debilitating back pain; had to miss work. Symptoms lasted for 3 days. My back pain lasted for about a week. Vomiting was for 3 days. I did seek medical attention; zofran and flexeril.  *urgent care **not taking 2nd vaccination. Personal preference. 'Not worth it to go thru that again'.
Severe reaction to the vaccine; Lips swollen completely; Lips and eyes are swollen completely; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction to the vaccine), LIP SWELLING (Lips swollen completely) and EYE SWELLING (Lips and eyes are swollen completely) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lip cosmetic procedure (Had lip filler about a year ago.) in 2020.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Severe reaction to the vaccine), LIP SWELLING (Lips swollen completely) and EYE SWELLING (Lips and eyes are swollen completely). At the time of the report, VACCINATION COMPLICATION (Severe reaction to the vaccine), LIP SWELLING (Lips swollen completely) and EYE SWELLING (Lips and eyes are swollen completely) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided  Patient received first dose of Moderna COVID-19 Vaccine on a Saturday.  This is a spontaneous report received by phone call of a patient with antecedent of lip dermal filler who presented Lip/Eyes swelling of severe intensity after an unknown period of receiving an unknown dose of the product.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This is a spontaneous report received by phone call of a patient with antecedent of lip dermal filler who presented Lip/Eyes swelling of severe intensity after an unknown period of receiving an unknown dose of the product.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  Further information will not be available as per patient did not consent follow up.
no additional AEs; MMR II was reconstituted with 0.4NS instead of MRK STERILE DILUENT on 1/23/23; This spontaneous report was received from a physician and refers to a 12-month-old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported.  On 23-JAN-2023, the patient was vaccinated with with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, once, lot #W023075, expiration date: 05-APR-2024 (anatomical location and route of administration were not provided)administered for prophylaxis, that was reconstituted with 0.4 normal saline (NS) instead of sterile diluent (Product preparation error). There were no additional adverse events reported (No adverse event).
This spontaneous report as received from a nurse via PDC (drug poisoning center) (Manufacturer number: US16-040514) nurse found information on internet refers to 354 out of 359 patients of unknown genders and ages, but 50 years of age and older. These patients' relevant medical histories and past drug histories were unknown. The patients were administered ZOSTAVAX, (dose, frequency, indication, and start dates unknown), via "M (intramuscular)" route in the deltoid region of the upper arm (inappropriate route of drug administration). The lot numbers and expiration dates of the ZOSTAVAX vaccines used are unknown. Concomitant therapy was were not reported. The nurse reported that the patients in this study was reading about received ZOSTAVAX off-label (off label use) via "M" injection. She said that according to the information, it was not uncommon for ZOSTAVAX to be given "IM " and that "IM" administration resulted in fewer injection site reactions. It was unknown if there is relevant lab work. As of 26-AUG-2016, it was unknown if these patients continue on the ZOSTAVAX. The outcome of the events receiving it via "IM" injection, off label use and the injection site reactions was unknown. The causality of the events was unknown. Additional information has been requested.
Heart Inflammation, Shortness of Breath, decrease in physical fitness for about 3 months starting shortly after 2nd dose of Pfizer (I may have gotten Myocarditis)
At one week after the injection, the injection site became hard, red, swollen and hot.  It has lasted three days but appears to be getting better.