chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warmth 3 to 4 inches below injection site (of injected arm); red blotches 3 to 4 inches below injection site (of injected arm); red blotches 3 to 4 inches below injection site (of injected arm); he had a little discomfort at the injection site; Tenderness (pain) 3 to 4 inches below injection site (of injected arm)/left arm hurting; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4ak57, expiry date 23-MAR-2025) for prophylaxis.   Previously administered products included TDAP with an associated reaction of no adverse event (Prior immunizations (with no problem): TDAP) and Pneumonia vaccine with an associated reaction of no adverse event (Prior immunizations (with no problem): Pneumonia). Concurrent medical conditions included type ii diabetes mellitus and blood cholesterol increased.   On 30-OCT-2023, the patient received Arexvy (intramuscular, left deltoid). In OCT-2023, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: Tenderness (pain) 3 to 4 inches below injection site (of injected arm)/left arm hurting). On 31-OCT-2023, the patient experienced injection site discomfort (Verbatim: he had a little discomfort at the injection site). On an unknown date, the patient experienced skin warm (Verbatim: warmth 3 to 4 inches below injection site (of injected arm)), red blotches (Verbatim: red blotches 3 to 4 inches below injection site (of injected arm)) and erythema of extremities (Verbatim: red blotches 3 to 4 inches below injection site (of injected arm)). The outcome of the injection site discomfort, skin warm, pain in arm, red blotches and erythema of extremities were not resolved.   The reporter considered the injection site discomfort, skin warm, pain in arm, red blotches and erythema of extremities to be related to Arexvy.   The company considered the injection site discomfort, skin warm, pain in arm, red blotches and erythema of extremities to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-NOV-2023 The reporter was the patient and received Arexvy in the morning.  The day before reporting, he had a little discomfort (at the injection site). At the time of reporting, he pushed at the injection site and it was tender. While sleeping last night he noticed his left arm was hurting.  This morning he saw pinkish-red blotches three to four inches below the injection site just before his elbow.  Also the blotchy area was warm and the red blotchy area was very tender. This had not yet resolved. The reporter consented to follow up.
varicella type rash, consistent with shingles, on his left upper quadrant; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 28-AUG-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered a varicella type rash, consistent with shingles, on his left upper quadrant. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event to be disability.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to urgent care three days after receiving vaccine hypoxic (room air saturation 86% (96% after administered albuterol during visit) with headache, chills, nausea, fever, cough, sweats, fatigue, malaise, and mild wheezing and shortness of breath. Diagnosed with bronchitis, prescribed albuterol and antimicrobials, and discharged to home. On follow-up visits with primary care provider bronchitis resolved.
Pt was given vaccine around 2:44 pm without any problems. The pt awoke the following morning with his arm noted to be very red and swollen. Pt c/o pain when arm is moved. Area of redness about the size of a grapefruit.
Pt noted mild rash 30 min post vaccine. No resp or OP sx. No other skin involvement.   PE blanching erythema UE only   Probably sunburn -Advised sunscreen -Warned of sx of anaphylaxis (unlikely)
103 temp with nausea and vomiting. 129/72, 123 hr/ 94%
Information has been received from a physician concerning a 9 year old female who on 25-JAN-2001 was vaccinated with the first dose of MMR II, and the second dose (HSA) on 03-MAY-2004. On 05-DEC-2009 the patient developed mumps. She was diagnosed with mumps on 06-DEC-2009. The patient did not have a fever. The patient had swollen glands, sore throat and parotitis and the parotitis count was 121. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
she had red, more like light pink circles all over her face and lower hands. It was the weirdest thing. She thought she was having an acne breakout.; Information has been received from a currently 42 years old registered nurse via Pfizer referring to herself. She had a history of Wolff-Parkinson-White and was ablated twice. The last time was 19 years ago and she had not had any problems since then. The patient was allergic to a lot of antibiotics. She had a titer drawn in May or June 2002 and it was low and they gave her a booster.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (strength, dose, route, lot# and expiration date were not provided).   The patient had reaction to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown). Within 24 hours, she had red, more like light pink circles all over her face and lower hands. It was the weirdest thing. She thought she was having an acne breakout. The outcome of acne was unknown. The reporter considered the acne to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown).
Pt. told his mom his arm felt itchy within an hour or 2 after vaccine. Then arm was red and swollen for 3 days. Nurse followed up and mom of pt. stated arm is back to normal no concerns.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose number unknown, single (Lot number: EN6201) at the age of 19 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing), notes: Other medical history: Autoimmune. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (08Jun2022) Negative, notes: Covid 19 Neg on the 9; (11Jun2022) positive, notes: Covid 19 positive again on day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Start date of treatment for COVID-19 was 31May2022. Stop date of treatment for COVID-19 was 04Jun2022.
Floater in left eye, diagnosed as Central Retina Vein Occlusion.  Blued vision  followed 2 weeks later.
Patient came in for immunization. Noticed he needed a Dose of Dtap and IPV in order to be up to date on shots. Instead of given separately quadracel was given.
3.30.21 Family brought pt to ED because right nephrostomy tube (that had just been replaced 3/26) was not draining. She was admitted to the hospital on 3/30/2021 with fatigue and concern for malfunction of recently exchanged NT which are in place for ureteric dysfunction. Found to be COVID positive on arrival to ED.    Discharge Diagnosis and Associated Hospital Course   Ureteric Dysfunction Bilateral Nephrostomy Tubes in place Possible UTI - H/o bilateral nephrostomy tube placement secondary to ureteric dysfunction secondary to pyelonephritis with stents in place - Last nephrostomy tubes were placed on Saturday, 3/27/21 per in VIR; since that time her right nephrostomy tube was not draining and pt has noted increased fatigue so presented for evaluation - CT Kidney Stone:  Bilateral percutaneous nephrostomy tubes, appear appropriately positioned without obvious complication.  No hydronephrosis or urolithiasis. Nonspecific thickened appearance of the rectosigmoid colon without adjacent stranding - VIR followed for NT tube check however tube started draining urine so no need for check - Urine cx with GNB so treating with keflex on dc   COVID-19 Virus Infection - Date of symptom onset: 3/30/21 (isolation to end 4/8/21) - Symptoms: Fatigue  - Date of positive COVID-19 test: 3/30/21  - Location of positive COVID-19 test: ED  - Oxygen status: None  - PT/OT consults indicated :  yes  - Case Management/Social Services consulted:  yes  - DVT prophylaxis: Lovenox  - Decadron:  NO   - Remdesivir:  NO
Pt had vaccines on 3/27/15 and broke out in a rash on her torso and thighs on 3/30/15.
1st covid vaccine received on 12/31/2020. On 1/2/2001 in the am had her right eye and cheek swollen, headache and chills by afternoon mouth and right eye was drooping.  Was prescribed RX prednisone on 1/15/2021.  Current symptom (1/15/2021) is mouth drooping, other swelling and eye drooping resolved. Reports has occurred twice before. About 7 years ago with unknown etiology, lasted for about 6 months, Occurred again about 5 years ago with unknown etiology and lasted about one month.
I had a sore arm and tired for about a day.  I was exposed to COVID-19 on 01/02/2023. I tested positive for COVID-19 on 01/02/2023. I had low grade fever and I felt like I had a cold.  I contacted my doctor and got a prescription for Paxlovid. I tolerated the medication without any complications. It did leave a funny taste in my mouth. As of today, I do not have any lingering symptoms.
rt leg swelling, redness, heat at injection site; taken to local ed and placed on augmentin; developed diarrhea; seen in clinic on 3/31/11, antibiotic stopped and placed on loratidine, instructed to use warm compresses at site; returned to office 4/1/11 improving
Pt presented with altered mentalt status, dark urine and generalized weakness and electrolyte imbalance and UTI. pt was treated for afib RVR with amiodarone and lopressor. Requireda a left thoracentesis.  Antibiotic used for UTI. Pt discharged.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received two shots of non-company covid-19 vaccine (dose number in series 1, unspecified manufacturer) (form of administration, route of admin, and batch number were not reported) dose not reported, administered on an unspecified date for prophylactic vaccination. No adverse events reported post series 1 vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died of covid-19 infection (suspected covid-19 infection, and suspected clinical vaccination failure, dose number in series 2). The reporter reported as "A friend just died of covid after having both shots and booster". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from suspected covid-19 infection and the outcome of the suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with product quality complaint: 90000209691.; Sender's Comments: V0: 20220100210- covid-19 vaccine ad26.cov2.s-suspected covid-19 infection . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20220100210- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: SUSPECTED COVID-19 INFECTION
Patient vaccines. Patient stated after the injection that he did not feel well. When questioned on symptoms, patient stated he was having heart palpitations and felt dizzy.  Stated patient has anxiety and panic attacks, and has been anxious about receiving the vaccine.  Patient was observed for 15 minutes, and was asked to remain sitting for the full 15 minutes.  Patient's symptoms subsided after approximately 5 minutes, and he continued to sit while waiting for parents to receive their vaccines and their 15 minutes of waiting after their vaccines. Patient did not require any further assistance and was able to leave.
I contracted COVID-19 on 04/25/2022 with symptoms of headache, cough, runny nose, congestion, fever, myalgia, fatigue, and diarrhea. I was prescribed PAXLOVID on 04/26/2022 when I saw my PCP's clinic. My symptoms began to resolve after 5 days, and I was fully recovered after day 7. I have fully recovered with no lingering symptoms.
Patient started not feeling well and told friends  and family that he was not feeling well and that his doctor believed he was having a side effect to the 2nd dose of his COVID-19 Vaccine. He died 11 days after receiving his vaccine.
Information has been received from a healthcare professional concerning a 1 year old male who on 3/8/02 was vaccinated with a dose of MMRII. On 3/16/02, the pt developed a fever and generalized "maculopapular rash". Unspecified medical attention was sought. He was treated with Benadryl. On 3/22/02, the nurse reported that the pt "is now fine". Additional info has been requested.  Received on 06/04/2003: "Information has been received from a health professional concerning a 14 month old Hispanic male with no known allergies who on 03/08/2002 was vaccinated SC with a first dose of MMRII (Lot # 639694/1212L).  Concomitant vaccination the same day included a first dose of varicella virus vaccine live (Lot # 639489/0573L) given SC.  There was no illness at the time of vaccination, the patient was seen for a well child visit.  On 03/18/2002 (previously reported as 03/16/2002) the patient developed a fever of 101 F and generalized "maculopapular rash".  The patient's fever lasted for 4 days.  Unspecified medical attention was sought.  He was treated with diphendydramine hydrochloride (BENADRYL) every 4-6 hours.  On 03/22/2002, the nurse reported that the patient "is now fine" and subsequently he recovered.  No further information is available.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case involves Adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (unknown latency), (poor quality product administered, latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   It is unknown if the patient experienced any additional symptoms/events It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Diabetic reaction after COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "recovered", described as "Diabetic reaction after COVID vaccine". The patient underwent the following laboratory tests and procedures: Blood glucose: High, notes: Diabetic reaction after COVID vaccine. Clinical course: High blood sugar after COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have small rush/spots (red, purple)all over my body since 4-13-21. I have no fever, pain or itchiness. Steroid for 5days from 4-23-21. Steroid cream since 5-7-21.  It still the same.
Tinnitis, Hand/wrist joint pain, weakness, and swelling began in hand of shot arm (right) at night, then next morning both hands are affected Moderna COVID-19 Vaccine EUA
Injection site pain, swelling, local rash, fatigue, myalgia, headache, mild fever to 100.4F, dizziness, confusion starting 2 days after vaccination, peak symptoms 3-4 days after vaccination.
nausea; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a male patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Not Provided), via an unspecified route of administration on an unknown date at a single dose for COVID-19 immunization.  On an unknown the patient received the vaccine and now after 2 weeks he was experiencing nausea. Outcome was unknown. Information on the lot/batch number has been requested.
Amazingly, I had a positive outcome from this vaccine. Within 24 hours, I went off my 2L of o2, and felt darn near back to normal for the first time in 20 months since my diagnosis. If this made me feel better after suffering for almost a year, can this vaccine be given to pts in the hospital fighting for their lives to potentially have the same positive outcome. Maybe keeping them off a vent?
after pt recv vax developed redness, swelling & pain, then developed tendinitis at inject site. m.d. stated probable inject into tendon. evaluation plus MRI negative. pt exp prolonged symptoms from tendinitis. pt recovered by 10/14/98
Patient had flu vaccine administered 10/18/23 in right deltoid.   Patient has raised , red area measuring 1 inch x 1.5 inches , tender to touch, warm. ? this reaction started a few hours after vaccination.
Since my son recieved the flu vaccine on December 4th, 2007, he has had recurring hives that break out all over his body.  The night after the shot the top of his foot began to swell with a huge hive and then he started breaking out on his stomache. I took him to the doctor who gave him a steroid shot and some antibiotics and he told me that it was either a side effect from the shot or MRS infection.  Only the hives went away and returned a couple of days later and my son was broke out on his stomache chest and back. This continues on every couple of days even with benadryl.  The Day I took my son to the doctor he was getting a physical and was approved to participate for athletics and while we were there I let them give him the flu shot so he wouldn't get sick and have to miss any school because of the flu.  Also prevously back in October my son was Allergy tested by doctor and they said that he had no allergies. Patient has missed alot of school because of the constant hive out breaks.  Family doctor has run two different blood tests and a sinus x-ray and said they came back normal.  Patient hives branched into his face and swelled his left side of his face including the eye and upper lip.  He was reffered back to Dr. for allergy treatment. He is now taking Zerteck, benadrl, singular, albuterol inhaler, nexium, and advair was prescribed for him. He has had two or three steroid shots and nothing gets rid of the hives for very long and they seem to be getting worse in the break outs. Dr said that every time he breaks out that it is affecting his   internal organs.   Please help me find a cure for this. Patient never had broke out in hives before the flu shot.  My son is scared and I don't know what to tell him.
Patient developed rash, swollen arm, warm to the touch.  Rash not on injection site, but near.