chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 3-4 hours after receiving vaccine my left side of my face went numb. Also started experiencing pain down the entire left side of my body and just a general unwell feeling. Lasted about a week.
Patient initially seen in clinic on 6/17 for increasing chest pain and shortness of breath. Due to symptoms, she was advised to be seen in the ED. She reported she has been on chronic oxygen since previous COVID infection from last October (2021). She has been trying to titrate off oxygen, however had increased oxygen use since worsening shortness of breath. She was seen in the ED on 6/17 and admitted from 6/17-6/18 for additional evaluation. Additionally, patient tested COVID PCR positive on 6/17. This meets criteria for vaccine breakthrough case review.
0.5 ml H1N1 given 10/26/09. Mother brought in 10/27/09 with urticaria, temp 99. No other sx.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored GARDASIL 9 (lot # L016429, expiration date: 08-AUG-2017; lot # L037339, expiration  date: 08-FEB-2018; lot # L027282, expiration date 21-SEP-2017; dose and route were not provided. The vaccine underwent temperature excursion of -1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Inclusion body myositis! Muscle weakness: over approximately 10 years! Website lists Hep B vaccine as suspect. Progressive and degenerative!
Suddenly felt really, really cold.  I was shivering then shortly after my heart started racing.  It raced non stop for approximately four hours.  I could not get to sleep.  I have a skipped beat feeling normally but have not ever experienced something like this.  I didn't go to the hospital although I should have.  It was late at night when the event started and I tend to avoid hospitals when I can, especially during these COVID times.
DIED FROM COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via Social media through a company representative concerned a male of unspecified age, race and ethnicity The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in DEC-2021, the patient died from covid (coded to suspected covid-19 and suspected clinical vaccination failure). It was reported that "My younger brother died from covid in December. He was vaccinated. I contracted covid in 2020 and the Omicron variant two weeks ago. Each time the symptoms were similar to a mild cold. I have not been vaccinated." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from covid in DEC-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000216369.; Sender's Comments: V0: 20220216139 - COVID-19 VACCINE AD26.COV2.S- Died from COVID. This event is considered unassessable. The event 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.  20220216139- 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: COVID
Information has been received from an 83 year old male consumer reporting on himself with no drug reactions or allergies and who had experienced peripheral neuropathy in his feet for years, who on 17-MAY-2011 was vaccinated around 3:00 p.m, with the first 0.65 ml "shot" of ZOSTAVAX (Merck) (Lot number not reported). Concomitant therapy included atenolol and terazosin. The consumer reported that on 19-MAY-2011, at 1:30 am he awoke to a burning sensation on the bottom of both feet, he had shooting pain every 10-15 seconds on the top side of his left foot. The nerves were shooting out pain. He got up several times to try to walk it off. He slept maybe 3 hours out of 6. No lab diagnostics studies performed. No treatment was given for the experience. The consumer stated that upon awakening, the shooting pain on the top of the left foot was gone but he still had the burning sensation on the bottom of both feet and was recovering. The consumer did not seek medical attention however he was advised to call his physician. No further information is available.
10 days post MMR 101 fever and increased to 102.3 by 11 days post vaccine, back to normal after 48 hrs. Gave half dose of acetaminophen before bed on day 2 of fever. 10 days post MMR a mild rash developed on face/trunk/legs, more red on day 11, slightly fading day 12 and hardly visible on day 13, lasted 3.5 days total.
DIARRHEA; VOMITING; DEHYDRATED; FASTER HEART RATE; LIP SWELLING; TONGUE SWELLING; FEELINGS AROUND MOUTH; CHILLS; TIRED; OXYGEN LEVELS DROPPED DOWN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 admin not reported) dose was not reported, administered on 06-APR-2021 09:10 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, shortly after about 5-10 minutes of vaccination, the patient started experiencing feelings around mouth and lips and tongue got swollen. The Paramedic on site gave 2, 25mg of Benadryl and monitored the patient for 45 minutes and things settled. The patient was released to come home where, the patient began experiencing chills that lasted for about 2 hrs. The patient was tired which was normal but oxygen level dropped to 90 so, the patient had oxygen in house for a breathing situation; then the patient was okay about 3 hours later. On 07-APR-2021, approximately about 4:00 am, the patient had severe vomiting and diarrhea. Vomiting and diarrhea lasted for about 5 hrs. The patient was dehydrated and went to the emergency room (ER) where an electrocardiogram (EKG) was done as the patient had a fast heart rate. The patient was administered IV fluids and monitored for about 3 hrs. Chills returned but the patient came home at about 1:00 pm. The patient stated that the reaction showed that immune system of the patient kicked in. The patient was slowly advancing the diet and was doing better at the time of this report.  Laboratory data included: OXYGEN LEVEL (NR: not provided) on 06-Apr-2021 was 90, ECG (NR: not provided) on 07-Apr-2021 was UNKNOWN, and Heart rate (NR: not provided) on 07-Apr-2021 was FASTER. Treatment medications (dates unspecified) included: 2 doses of diphenhydramine hydrochloride of 25 mg for lips swelling & tongue swelling and feelings around mouth and oxygen for oxygen level dropped and IV fluids for diarrhea, vomiting, dehydrated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen levels dropped down, and lips swelling and tongue swelling, on an unspecified date and from diarrhea, and vomiting on 07-APR-2021, and was recovering from chills, tired, faster heart rate, dehydrated, lips swelling and tongue swelling, and feelings abnormal. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210421308-covid-19 vaccine ad26.cov2. s- oxygen levels dropped down, Severe diarrhea, vomiting, dehydration ,lips swelling and tongue swelling, faster heart rate. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
After getting the 2nd vaccine, I starting  having chronic diarrhea.   I have tried different probiotics for several months which did not help.  I have also tried taking metamucil for 4 months and did not have any significant improvement.  I do take immodium daily.  I did go see my PCP, who suggested I go see a specialist- Gastroenterologist.  I have an appointment coming up.   I have been having chronic diarrhea for 6 months.
2 days p/vax pt had rash over entire body to include palms of hands & soles of feet;no fever or other sxs;went to family med ctr was told probably rxn to Hep B vax;
BOOSTER DOSE OF MODERNA. PATIENT REPORTS HAVING PAIN IN ARM THAT HAS NOT GONE AWAY 11 DAYS AFTER VACCINE. STATES PAIN IS OF 4-5 SEVERITY ON A SCALE OF 1-10 (SCALE=1 BEING THE LEAST PAIN, 10 BEING THE MOST PAIN).
Had chills, head ache, body aches threw up for three(3) days could not keep anything down  took promethazine did not help.  Still felt bad a few days after vomiting  stopped.
On day 10 I woke up with a red itchy rash at tbe injection site.
Pt recvd vax & exp immed pain w/inject followed by persistent induration, erythema & pruritis, induration & pruritis lasted approx 1 wk;
I contracted COVID-19 on 07/17/2022 with symptoms of headache, body aches, and fatigue. I was not prescribed any medication. This was very mild, and I would not have known that I had it, if not for my sister testing positive on the end of our vacation. I am feeling recovered.
Hot, red rash; Hot, red rash; Swelling; A spontaneous report was received on 26-Jan-2021 from a non healthcare professional concerning a 52 years old female patient who received Moderna's COVID-19(mRNA-1273) vaccine and experienced hot, red rash, swelling.  The Patient medical history was  not provided. No concomitant medications was reported.  On 14-Jan-2021, 9 days prior to the onset of events, patient received her first dose  of mRNA-1273(Batch:012L20A) intramuscularly on her left arm for the prophylaxis of covid-19 infection.  On 22-Jan-2021, patient experienced hot, red rash, swelling.  No laboratory information was provided.   Treatment information includes benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events were recovering/resolving.
This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-DEC-2014, the patient was vaccinated with the dose of PEDVAXHIB lot # K008680 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with a dose of PROQUAD lot # J002933, expiring  12-SEP-2014 (dose and route not provided) that went through an unsupported temperature excursion. No adverse effects were reported. Additional information has been requested.
Redness, warmth, swollen, tender right deltoid. Pt taking BENADRYL, BENADRYL cream, hydrocortisone cream as needed.
Very hard to do daily tasks like getting dressed/interfering with daily activities like getting dressed; Her arms hurt/right arm aches; Hands and ankles swollen; Hands and ankles swollen; Difficulty bending her finger; This spontaneous case was received on 13-Nov-2020 from other non-health professional via regulatory authority and concerned a 75-year-old, female patient.    The patient's concurrent condition included high blood pressure controlled with medication. The patient's concomitant medications included ramipril, HCTZ (hydrochlorothiazide) unspecified probiotics, vitamin D and Loratadine D (loratadine, pseudoephedrine hydrochloride), all used for unreported indications.   On 23-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, right arm) for flu prophylaxis. The batch number was not reported.   On 25-Sep-2020, two days after receiving Fluad Quadrivalent, the patient experienced right arm aches, her arms hurt, hands and ankles were swollen. The patient had difficulty bending her finger and found it very hard to do daily tasks like getting dressed.   On an unknown date in 2020, the patient started taking ibuprofen, three in the morning and before she went to bed at night. Symptoms went away with ibuprofen, but they were getting worse and were interfering with daily activities.   At the time of initial reporting on 13-Nov-2020, the patient had not recovered from the events, as the symptoms had not resolved and had been getting worse overtime.  The reporter did not provide a causality assessment.   The event of 'activities of daily living impaired' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 75-year-old, female patient was administered Fluad Quadrivalent vaccine. Two days after receiving Fluad Quadrivalent, the patient experienced pain in extremity, peripheral swelling and joint swelling. Reportedly, the patient had difficulty bending her finger and found it very hard to do daily tasks like getting dressed. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.; Sender's Comments: A 75-year-old, female patient was administered Fluad Quadrivalent vaccine. Two days after receiving Fluad Quadrivalent, the patient experienced pain in extremity, peripheral swelling and joint swelling. Reportedly, the patient had difficulty bending her finger and found it very hard to do daily tasks like getting dressed. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related, due to plausible chronology and no alternative aetiology provided.
pt recvd vax & exp inj site rxn-leg was black & swollen;hospitalized 4 days p/vax;rx w/ATB/DPH;@ 15mos not talking-dx developmentally delayed;started walking @ 3yrs old
On 8-8-2022, I was in a hot area with other people and felt abdominal discomfort and started sweating and felt like I was about to get diarrhea. I passed out and woke up with an ambulance on the way. One of the ladies I was playing cards with told the paramedic that I had an irregular heartbeat. I was nauseated in the ambulance and they gave me a pill for nausea. I was taken to the ER. They drew blood and done an EKG. I stayed overnight in the ER but was never put in a room on a floor. They told me my heart was in and out of Atrial Fib and this was my first time I have experienced this to my knowledge. They gave me IV fluids with Cardizem drip and it brought my heart rate down. On 8-9 they done a Cardiac ECHO and told me my heart looked good. I was discharged on 8-9-2022 with a prescription for Cardizem and Pradaxa. I am feeling good now.
Patient c/o pruritus she has been experiencing since HPV shot that she received on Friday, 6/2/17. The skin irritation (pruritus and burning started Sunday, 6/4/17. Right after receiving the injection on Friday, patient reports just feeling normal soreness at injection site. However, on Sunday, 6/4/17 patient reports still feeling soreness at injection site, but with some burning and itchiness at injection site. She did not notice redness and raised, reddened skin in itchy areas until yesterday on 6/6/17. Reports still having burning and pruritis in left armpit, left upper forearm, and upper area on back side of left arm. Patient had no fever. Temperature of 98.4F; afebrile. Denies wheezing, SOB, and dyspnea. Denies recent changes in body lotions, soap, and clothing material.
Child received Hep A #2 in office. When mom was checking out at front desk child passed out.
At the time of the vaccination, this patient was 17 years old and 6 months but received an adult dose
My arm stayed kind of firm/hard the entire time, a hard lump like the size of two quarters side by side, but two days ago a red oval appeared and it has stayed red since then so I looked it up and that?s how I found out about this reporting system.   It hasn?t effected my general health in any way but it seemed worth reporting. I?m completely fine and super happy to have gotten the vaccine! It is just red and hard to the touch and sore.
Information has been received from a registered nurse concerning a patient who on 12/15/99 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on 4/20/02, the patient developed chicken pox. The patient was seen in the office. The reporter also indicated that 30 other patients were vaccinated with varicella virus vaccine live and developed chicken pox (WAES0409USA00600, 0409USA01045, 0409USA01046, 0409USA01047, 0409USA01048, 0409USA01049, 0409USA01050, 0409USA01051, 0409USA01052, 0409USA01053, 0409USA01054, 0409USA01055, 0409USA01056, 0409USA01057, 0409USA01058, 0409USA01059, 0409USA01060, 0409USA01061, 0409USA01062, 0409USA01063, 0409USA01064, 0409USA01065, 0409USA01066, 0409USA01067, 0409USA01069, 0409USA01070, 0409USA01071, 0409USA01072, 0409USA01073, 0409USA01074). No further information is expected.
sore arm; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious social media case received from a consumer/non-healthcare professional.  This case involves a patient (unknown demographics) who had sore arm (pain in extremity), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medications(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "this is a social media case. The following potential adverse event has been found on a public post for Flu Shots. Since this is a public post on the Sanofi flu shot campaign, we are assuming the consumer is referring to the Sanofi flu vaccine. Got mine at Pharmacy no side effects just sore arm."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
MY ARM HURST AND THERE A A LARGET THAN GRAPeFRUIT LUMP under my left arm
Patient is highly sensitive to medications and can't remember the last time she had an immunization.  She received the Pfizer vaccine on 5/7.  We monitored for 30 minutes after administration.  Immediately after injection she reported an odd taste in her mouth.  About 12 minutes after vaccine administration, she noticed her lips mildly tingling (no swelling) which radiated up the right side of her face.  She received 50mg of benadryl.  The tingling subsided and she was able to safely leave after 30 minutes.
This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6205), at the age of 40, via an unspecified route of administration, left arm, on Mar 8, 2021, at 17:30, single dose, for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included obesity and COVID-19 (prior to vaccination). The patient's concomitant medications: none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took penicillin and experienced allergies. The patient experienced arm pain, swollen lymph node and fever on an unspecified date. The patient did not receive any treatment for the events. The outcome of the events: recovering. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts needed. No further information expected.
Narrative:  Patient with h/o legally blind, CKD stage 4, Emphysema (recent chest X-ray okay), A-fib,cardiomyopathy, and ICD. He continues to wear a C-collar from a s/p fall on 4/29/21 at medical appointment. Per database note, pt passed away at medical center on 5/14/21. It was noted that he was unresponsive and it was intended that he would be removed from Life Support on this day. It appears this death is unrelated to the covid vaccines previously administered on 2/24/21 & 3/24/21.
Child received vaccines at 1040am on 3/7/12. Call from mom same day at 250pm to report rash right side of face, buttocks, back & legs. Rash red with puffy white spots in center. Spots are oval & oblong. Ran fever 100 that night. Hives spread both sides of body by evening.
1-2-08-Diag. with thrombocytopenia, platelet count dropped to 8000.  Plt transfusion x2.  Easy bruising began Nov. 07. 1/16/08-records received for DOS 1/4/08-consultation for C/O headache since 1/3/08 now improved-admitted on 1/3/08-with easy bruising and platelet count of 7000. No other systemic symptoms. While receiving treatment with IV gamma globulin, C/O severe headache, throbbing with sensitive to bright lights and some nausea. Saw spots in her eyes. Denies neck stiffness, but has some mild neck discomfort.
45 MINUTES LATER, PATIENT HAD A FALL.  BLOOD PRESSURE WAS LOW.  PATIENT DID NOT SEEK IMMEDIATE CARE (911/EMT) BUT WAS STRONGLY ENCOURAGED TO DO SO OR AT LEAST CONTACT HIS PCP.
Polyarticular pain, B/L hand and forearm pain, upper back fibromyalgia.
Within the first few minutes I had a flushed red face and pins and needle feeling on top of my head  6 hrs after shot I started with chills and a temp of 101.7 Achy and uncomfortable  Insomnia  Next day headache and no appetite  Day three headache persisted with diarrhea  and arm pain at injection site
Rash on left groin appeared within 2-3 hours of shot. Was itchy and red for a couple days then began to blister. Started becoming painful a 3-4 days later. Day 5 went to doctor at local office and it was diagnosed as Shingles.
pt recvd vax & exp droopy & swollen face on the lt side; pt was seen by MD; Bell's palsy dx;
Fully vaccinated, and boosted on 11/15/21.   LOT NUMBERS OF VACCINES NOT LISTED.   COVID infection breakthrough.  Inpatient hospital admit.
1000-29/F presents to post vaccine area after being vaccinated 2nd dose of Moderna . 1015- Reports having a mild headache 2/10. slightly lightheaded. Pt AOx4, resp even, speaks in clear and complete sentences. Denies blurred vision. No PMH and only takes birth control. VS #1 110/78, 98%, 72, 15. 1025- Pt states she feels better and headache is "going away" and is ready to go. VS #2119/80, 98%, 73, 15.  Pt ambulates with an even gait. Appears in no apparent distress. Educated regarding signs and symptoms, and when to seek medical attention.
Within 45 minutes, started feeling flushed, lightheaded and a little dizzy.
Single red rash like bumps on top of right hand, left wrist, under both arms near armpit, calves.