chrisvoncsefalvay/vaers-outcomes huggingface dataset:
said superficial blood clots/red spots all over the back lower area; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A male patient received bnt162b2 (Pfizer-BioNTech COVID-19), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "said superficial blood clots". The event "said superficial blood clots/red spots all over the back lower area" was evaluated at the physician office visit and emergency room visit. Clinical details: Patient got the Pfizer vaccine about 2 months ago. Right after taking the vaccine his feet had red spots all over the back lower area. The reporter thought could be blood clots. Patient thought may be reaction from vaccine but didn't want to worry about it. About 2-3 weeks later. He went to urgent care. Primary, dermatologist, hematologist and podiatrist who finally said superficial blood clots.  The lot number for bnt162b2 was not provided and will be requested during follow up.
The AE started AFTER the 2nd dose on April 9th. 1st dose was March 19th. Both in the am. 3 days after receiving the 2nd dose, I woke up with pain in my legs, up and down the legs, both legs, mostly down the back of my legs. It has developed into, at times, very achy ankles, knees , right hip and lower back.  None of this occurred prior to receiving the vaccines. It is not constant, varies in severity.
3 days of wide area of redness and swelling at site of injection. Area was warm to the touch. Patient referred to clinic. Told to use cold compresses.
Arm tender on 12/6/01 and 12/7/01. Then on 12/8/01, felt flu-like symptoms with runny nose, slight sore throat and achy (neck especially). On 12/9/01, symptoms continued but by 12/10/01, noticed stiffness in left arm. That night it was very stiff. On 12/11/01, the symptoms decreased (general) but left arm stiffness increased, back of shoulder area. Difficult to lift arm.
pt recvd vax;exp discomfort near wrist,soreness, swelling,induration & warmth at inject site to the elbow;tx w/ apap; to md w/ redness & induration;
Evening of shot began experiencing severe left upper arm pain at site of injection. Over the course of 1 1/2 weeks, pain continued and began radiating down arm. Has experienced weakness in left arm and decreased range of motion. No numbness or tingling. No erythema or edema at injection site.
PT IS 16 YEARS OLD. SHE RECVEIVED MODERNA VACCINE. PATIENT COMPLAIN OF BEING TIRED AND HAVING DIZZINESS.
Vials were being used past the recommended 12 hour post puncture time; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials were being used past the recommended 12 hour post puncture time) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials were being used past the recommended 12 hour post puncture time). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vials were being used past the recommended 12 hour post puncture time) had resolved. Not Provided      The dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was decreased.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
2 1/4 in x 3 in area of erythema on R arm.
pt recvd vax 1AUG95 & 8AUG95 presented w/h/a, fever (100.2), dec appetite, fatigue, rt sided ear pain;pt was started on Ceclor for ear infect;11AUG95 father reported pt devel leg stiffness & fever;
On the day of vaccination, the pulse rose to 100-105 from any activity. It was accompanied by a feeling of tightness in the chest. Everything was in order in rest. Second day and subsequent week: - Sensations of high blood pressure, chest tightness, but the indicators are normal. - Very severe and painful heartburn. I had not felt this before, but the condition of my throat on examination previously indicated that I was suffering from reflux. However, before the vaccine, I did not have such painful attacks. The pain went away after I started taking Protonix.
pt reported rash, gen body aches, severe h/a, nausea, joint pain, edema in hands & face;
Woke up morning of 10/30/13 with congestion, body aches, headache, nasal drainage. Took ALEVE and Aspirin and a allergy medication with minimal results. Arm where injected was also sore to move. Today is 11/01/13 and I'm feeling very tired yet even with adequate rest.
my arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 18th September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age vaccination was not reported. The patient got shot and he/she felt like the arm was killing him/her. The patient said he/she rather get the vaccine than shingles.
Herpes zoster lesions right arm. The follow up states info unknown vaccine was not administered by our office.
Cold/virus caught from my 3 year old granddaughter who attends preschool. Cold went away after 2 weeks; cough has lingered and is persistent.
Shortly after leaving vaccine site tingling, slight numbness to left side of ace, and left feeling "cold".. Cheek flushed, tingling and numbness.  numbness to tongue. Facial flushing resolved within 1 hour.  Numbness-tingling resolved by morning of next day.
Received IM Influenza vaccine 31 Oct 2003 to right deltoid w/mass and tenderness to site area. Approximately 01 Nov 2003 he noted slt tender mass rt supraclavicular area. Denies dental procedure, fever, chills, n/v, shortness of breath, cough, sore throat, dysphagia, smoking. DID have hx abd pain, loose stool prior to vac. HX HTN, lipomas, migraines. Seen by Surgery clinic and Occ health with dx enlarged rt supraclavicular node, poss hilar adenopathy rt upper lung field  11 Oct 2006: 1 Node still present @ 1/2-1cm size, mobile to mid subclavicular nodal region; mobile and non-tender.
Pt received flu shot in right arm on 11/14/01, Pneumonia in left arm on the same day. Pt awoke early the next morning with pain and swelling of right upper arm. Pt presented to physician with 6" X 4" of redness and warmth. Treated with Epinephrine and Depomedrol.
This case was reported by a nurse via sales rep and described the occurrence of chills in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 26th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced chills, muscle pain, fever, injection site pain and rash. On an unknown date, the outcome of the chills, muscle pain, fever, injection site pain and rash were unknown. It was unknown if the reporter considered the chills, muscle pain, fever, injection site pain and rash to be related to SHINGRIX. Additional details were provided as follows: On 27th June 2018, the patient stated that, she had a significant reaction to SHINGRIX, described as severe muscle aches, chills, temperature of 102, severe pain at the injection site and rash on face. There was no anaphylaxis. The reporter agreed to be followed up .
WEAKNESS; DIZZY; This spontaneous report received from a patient concerned an 80 year old female. The patient's height and weight were not reported. The patient's past medical history included endometriosis surgery, mild hydro nephrosis, gastric ulcer, thyroid removed and tonsil removed and concurrent conditions included atrial fibrillation and other pre-existing medical conditions included no history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included warfarin sodium. On 08-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy and weakness on 12-APR-2021. This report was non-serious.
The pt developed numbness from the shoulder to the knees. Was admitted to the hospital for observation for several days.
all the typical side effects for the vaccine but they lasted for a month; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (all the typical side effects for the vaccine but they lasted for a month) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (all the typical side effects for the vaccine but they lasted for a month). At the time of the report, VACCINATION COMPLICATION (all the typical side effects for the vaccine but they lasted for a month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
She got her vaccine, initially she had just general reaction.  Her arm was sore for about a week.  The day after she did not feel great, but was okay, but nothing that she would have ever complained about.  The arm hurt more than a flu shot but not severe.  Then she started to have leg pain and didn't know what it was, and trying to figure out what may have happened, and was putting on Ben-Gay and arthritis creams and nothing was helping.  At some point it would seen okay, and then got a little worse.  When she woke up on Wednesday morning on 6/2/21 the pain was excruciating and moved her leg and tried to get up it was like a wall had hit her.  She then started to sweat profusely and her blood sugar was also sky rocketing, and triggered that.  She said she felt awful, was nauseous.  She ate breakfast and then called her orthopedic surgeon who sent her to the Ortho office.  She was able to get in the car and drive herself as it was the left leg that was hurting her.  They took x-rays and they finally came to the conclusion that it was sciatica.  She has a FU appointment with her surgeon in a couple of weeks to make sure that she is okay.  He did ask if she had any vaccinations and she informed him that she had the Shingrix vaccine.  She was put on Prednisone to help with the pain, and it has helped but she has only been on the medication for 3 days.  She also has been told to go to PT and the medication is helping.   She then went home and did some research and realized that the sciatica was a rare occurrence with shingles vaccine, and feels it is related with that.  She has never had this type of problem in the past.   She talked to her pharmacist and her endocrinologist and told her that possibly it was related to the vaccine so wanting to report it.    She feels that if this is an issue related to the vaccine that it be put on the literature to make people aware that this may be possible.
Death  04/23/2021 Causes of death listed on death certificate: 1) End Stage Renal Disease  2) Diabetes Type 2 with nephropathy  3) Hypertension  4) Coronary Artery Disease
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 27-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9702) for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6204), on 03Apr2021 as dose 2, single (Lot number: ER8735), on 03Sep2021 as dose 3 (booster), single (Lot number: FP2588) and on 18Jun2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation. The patient's relevant medical history included: "Chronic Bronchitis (as a child)" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "chronic high blood pressure (as result of COVID infection)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) negative, notes: Tested negative for 3 days; (unspecified date) negative, notes: Tested negative for 3 days; (unspecified date) negative, notes: Tested negative for 3 days; (01Mar2023) Positive, notes: tested positive again on 01Mar2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient received treatment of Paxlovid started on 21Feb2023 and stopped on 25Feb2023. No known allergies.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 09-FEB-2015, the patient was inadvertently administered an expired dose of M-M-R II lot # H018181, expiration date: 05-OCT-2014 (dose and route of administration were not provided). No adverse effect was reported. Additional information has been requested.
Local reaction (itching, redness, numbness spread to fingers on left arm) and around the injected site. Observe patient every 15-20mins x 1 hour. Follow up with patient within 24hrs.
recurred Covid 19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (recurred Covid 19) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.  Concurrent medical conditions included Asthma. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 04-May-2022 to an unknown date and TERBINAFINE HYDROCHLORIDE (LAMISIL [TERBINAFINE HYDROCHLORIDE]) from 04-May-2022 to an unknown date for an unknown indication.  On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (recurred Covid 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 16-May-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (recurred Covid 19) had not resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, SARS-CoV-2 test: positive (Positive) Positive.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient received other unspecified medications/products within 2 weeks of starting COVID-19 treatment. After 4 days completing Paxlovid, symptoms of nasal congestion and generalized achiness recurred. Patient had been symptomatic for 3 days after developing Covid 19 on 11-May-2022. Symptoms were nasal congestion and achiness and diagnosis made by rapid Ag test. patient began Paxlovid on 13-May-2022 and was symptom free by 16-May-2022. The COVID-19 recurred again on 20-May-2022 at 17:30. The device date was 21-May-2022.   Company comment: This is a spontaneous case concerning a 71-year-old male patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19 (reported as recurred Covid 19), approximately 7 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per source document, he received Paxlovid as treatment and 4 days after completed it, symptoms of nasal congestion and generalized achiness recurred. A positive SARS-CoV-2 was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old male patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19 (reported as recurred Covid 19), approximately 7 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per source document, he received Paxlovid as treatment and 4 days after completed it, symptoms of nasal congestion and generalized achiness recurred. A positive SARS-CoV-2 was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
7cm x 9cm area of induration at left deltoid 2 days after vaccine admin. Pt was treated with a 10 day course of Augmentin 600/5 1 tsp PO bid.
Rashes developed over many areas of the body (neck, ears, legs, chest, torso, groin) following the vaccine shot. The first rashes started to appear the evening after getting the shot and more appeared the days that followed.
Soar arm for the first 3 days. Day 7 rash around injection site. Itched and red for about 5-6 days.
Moderna vaccine vial expired on 04/29/22, expiration located on box not vial.  Nurse pulled and discarded vial.  Contacted Moderna and report made and lot analysis sent.  Analysis of involved lot # maintained activity necessary to protect against the SARS-COV-2 (Covid-19) virus at the time of administration.  RN and FNP made aware.  Not necessary to notify patient or repeat dose.
Arm was hot to touch; Soreness in arm; Redness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot to touch), VACCINATION SITE PAIN (Soreness in arm) and VACCINATION SITE ERYTHEMA (Redness in arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm was hot to touch), VACCINATION SITE PAIN (Soreness in arm) and VACCINATION SITE ERYTHEMA (Redness in arm). On 26-Jan-2021, VACCINATION SITE WARMTH (Arm was hot to touch), VACCINATION SITE PAIN (Soreness in arm) and VACCINATION SITE ERYTHEMA (Redness in arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sunday, October 1, about 5:00 pm, started chills, fatigued by 7:00 pm, retired to bed 8:30pm. Monday, October 2, morning and throughout the day experienced swollen and painful axillary lymph nodes, left greater than right, and swollen and painful biceps, left greater than right. Bilateral tinnitus noticed. No fever noticed or recorded, but experienced chills. In the evening, right side of face (cheek) flushed, but not left side. Fatigued enough retire at 6:30 pm. The chills remained for an hour after retiring and prevented sleep. Tuesday, October 3, still experiencing tender and swelling in axilla and pain in biceps, still left side greater than right. Appointment with Dr. Recorded blood pressure and temperature. Palpated axilla, Ordered chest x-ray, results were normal. Noted ongoing bilateral tinnitus. Still fatigued and retired at 8:30 pm. Wednesday, October 4, Still some swelling in axilla and tenderness in biceps. Not so fatigued. Thursday, October 5, well enough to go to work. Today, October 30, bilateral tinnitus remains.
Bruising at injection site about 3 inches in diameter; Red spot at injection site; Pain to touch at injection site; Fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE BRUISING (Bruising at injection site about 3 inches in diameter), VACCINATION SITE ERYTHEMA (Red spot at injection site), VACCINATION SITE PAIN (Pain to touch at injection site) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain to touch at injection site) and FATIGUE (Fatigue). On 02-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Bruising at injection site about 3 inches in diameter) and VACCINATION SITE ERYTHEMA (Red spot at injection site). On 22-Mar-2021, FATIGUE (Fatigue) had resolved. On 24-Mar-2021, VACCINATION SITE PAIN (Pain to touch at injection site) had resolved. At the time of the report, VACCINATION SITE BRUISING (Bruising at injection site about 3 inches in diameter) and VACCINATION SITE ERYTHEMA (Red spot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non-significant Follow-up.Email updated
Vaccine was given too low on arm. Not in the deltoid muscle.  Currently have pain and swelling.
This initial spontaneous report was received on 14-NOV-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. Additional information has been requested.