chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed blood clots after the second shot; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Developed blood clots after the second shot) (seriousness criterion medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Developed blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            No concomitant medication provided.  No treatment information mentioned.  Patient was in her 60s. Patient got blood clots after the second shot of Moderna which resulted in a stroke as well.  Company Comment:  This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected serious (medically significant) adverse events of special interest Thrombosis (Developed blood clots after the second shot), and Cerebrovascular accident, that occurred on an unknown date after receiving second dose of mRNA-1273 vaccine (Latency between vaccine and events cannot be established).  Outcome of the events was reported as unknown. No information was provided on the first dose of COVID-19 vaccination. There is limited information for further medical review. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-566808, MOD-2022-566718, MOD-2022-566814, MOD-2022-566839, MOD-2022-566821, MOD-2022-566822, MOD-2022-566828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Reporter Information and event was added.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with no medical history reported, who experienced the unexpected serious (medically significant) adverse events of special interest Thrombosis (Developed blood clots after the second shot), and Cerebrovascular accident, that occurred on an unknown date after receiving second dose of mRNA-1273 vaccine (Latency between vaccine and events cannot be established).  Outcome of the events was reported as unknown. No information was provided on the first dose of COVID-19 vaccination. There is limited information for further medical review. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
I had the flu shot on Thursday and felt a little funny immediately afterward along with a headache. I started to lose control of my body temp but chalked it off as hot flashes although I have not hand any for a long while. I got home and my whole body ached. Took a Motrin and went right to bed. Woke up Friday 6:30 am and still had the headache that really never went away and my whole body hurt. Worked, complained about the headache and I felt funny but I was functional. I got home around 5:48 pm. The house was chilly and I was going to put my little heater on then my whole body locked up and my jaw locked too. I started shaking very hard I could not move for 28 minutes. Was so scared. When the muscles released I felt cold unbearably cold. Went to my room I got my thermal blanket out but it didn't help. I kept shaking and my teeth were chattering. I felt like I couldn't catch my breath. I knew I needed help but I couldn't move again. Then I woke up around 9pm. Didn't remember falling asleep. My hair was so wet like I got out of the shower and my clothes were soaked. I was so weak I couldn't move. When I was finally able to get up and go to the bathroom I had no muscle control and urinated in the hallway. By the time I got to the toilet I was vomiting. I was so weak. Walked to laundry room felt like I wanted to faint. Put on sweats and went back to bed and tried to stay warm. I woke up again around 9am and my muscles in my body felt exhausted and I still had that headache. By 6 pm Saturday my sister called. She said I was having a reaction to the flu shot. She is a pharmacist. She told me to go to the hospital. She called my neighbor who called 911. In the ambulance they were trying to take my BP. They kept saying something is wrong with the cuff my BP was only reading 77/35. When I got to the hospital at around 7:30pm they got a similar low reading and said they thought their cuff was bad too when my first reading of 77/35 after a few minutes got a reading of 98/58 and said that was much better. My BP kept dropping and they never paid attention to it. Spoke to the doctor and told her I was fine up to the flu shot. Explained about the headache and feeling funny right after the shot. She gave me Toradol, an antibiotic, and Benadryl and treated me for a UTI. She gave me a prescription for Cephalexin 500 mg 4x a day. Got home at 12:30am Sunday morning. Fever returned after hospital meds wore off 102.8, so did fatigue, nausea and vomiting.
On May 26, 1999 the pt received her first dose of Lymerix. Seven days later on 6/2/99, the pt had flu-like symptoms and a sore arm which lasted through 6/10/99. From 7/3/99 through 7/4/99 she had an extreme migraine. On 7/5/99 she found that she was bumping into things. On 7/6/99, she found that her perception was off and she had a minor car accident (fender-bender) due to this. There were no injuries. On 7/19/99 the pt had a headache, slurred speech, and was disoriented. On 7/25/99 the pt had a severe migraine so severe she couldn't talk. She went to the ER where she was given Demerol and sent home. On 8/27/99 she had a brain scan and western blot. The scan was normal, the western blot showed positive for Lyme disease. She was treated wit tetracycline but reacted with an upset stomach, she was switched to Doxycycline.  Since 8/99, she continued to be very tired and disoriented. She had body soreness. At times she is so sore she cannot get out of bed. She missed on week of work in July and many other days as well due to adverse events. She cannot drive because she is afraid of being disoriented.  The most recent information received on 11/2/99 reports the condition of the pt as ongoing.
Hematuria onset around 7:00 AM 12/28/21 with three incidents. Contacted PCP at 8:45 AM and referred to Urgent Care. Hematuria seemed to resolve around 9:30 AM. Continued to Urgent Care and was referred without being seen to Emergency Room. Urine sample given around 11:30 AM showed small blood clot. Urine sample, blood panel, and CT scan showed no abnormalities. Muscle aches began to develop around 8:00 AM and continue to worsen throughout day, responding to Aleve taken around 4:30 PM and resolving completely overnight.
Single non-febrile convuls 5APR92 placed on Phenobarb; EEG 9APR92 nl (pt taken off phenobarb);
Vaccine administered 0853. With history of anaphylaxis was required to stay for 30 minutes for observation. began to experience tingling lips, "tight" throat, and anxiety at approximately 0908. Writer gave her water and 2 oral 25 mg Benadryl at 0910. BP 142/82, HR 90, RR 22. 7 minutes later BP 135/78, HR 88, RR 22. Employee slightly less anxious. Throat feeling less "tight" and more dry. Lips slightly less tingly. Kept for observation until symptoms continued to decrease. Was escorted to her clinical work area by co-worker at 0933. She returned to the vaccination area around 1030 because her throat continued to feel "kind of tight". Writer explained at this point in time post vaccination, and care for her symptoms would need to be addressed through  a medical provider such as a clinic or emergency department and not through the vaccination clinic. She then went back to her clinical work area. Writer received a phone call later in the day from her stating she sought care at the Hospital Emergency Department around 11:20a.m. after she went home for the day as her throat was continuing to feel tight. She received an exam from the provider, but no medications.
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for single left lung transplant. Vaccination took place on 10/13/08. According to physician relationship is 'None'.
pt recvd vax 30AUG93 & felt hot & sweaty (90 outside) ate & then felt shaky; pt came back to clinic felt warm & sweaty-t98.7 & shaky;
Started with ringing in ear and lost total hearing. It's the same ear that he was injected on.
inj 30MAR95;that PM c/o nausea & chills & aching arm that PM;31MAR95 achy, flushed, nausea, arm hurt, hand burning;fever 100.6 orally, rash around inj site, inc swelling on 1APR95;pt went to hosp 31MAR95-was so sick;
A patient received the first dose of the vaccine and it was an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received the first dose of the vaccine and it was an expired vaccine) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received the first dose of the vaccine and it was an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received the first dose of the vaccine and it was an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up received on 23-AUG-2021 patient demographics, lot number was updated.
Symptoms: Sore throat, Trouble breathing, chills, fever, neusea, muscle aches. Outcome: "Patchy hazy opacities/infiltrates are present of the right upper lung and left lung base raising concern for covid-19 pneumonia"
The heart inflammation from the shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDITIS (medically significant), outcome "unknown", described as "The heart inflammation from the shot".  Additional information: Brief description of event: Heart inflammation from the shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe swelling, pain and erythema of leg from knee to lower abdomen. Difficutly with ambulation due to pain.
GOT INJURED; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got injured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got injured was not reported. This report was non-serious. This case, from the same reporter is linked to 20230708559 and 20230639668.
45 to 50 minutes after receiving the vaccine, my entire throat went numb, including my jaw.  My tongue felt swollen at the base, as well as surrounding tissue.  My lips were tingling and so were my teeth.  I had shortness of breath, rapid heart rate, and my chest became tight.    I immediately went to the nearest ER.  They made me wait 3.5 hours until any kind of treatment.  I went to the front desk people several times and told them it was not getting better and my chest was getting tighter.  They did not care.  Once I finally saw a doctor, he insisted that this was not because of the vaccine and that I was likely having a panic attack and this was purely in my head.  I refuted this notion and asked him to administer medication, via IV.
Slight soreness in arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Slight soreness in arm".  Additional information:  Slight soreness in arm 24 hours after receiving Pfizer/BNT COVID-19 vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The primary symptoms were sore throat and coughing. I also had some fatigue. I was on a camping trip. I do not think I ever had fever. By the time I came home I was feeling better. I was diagnosed with COVID. I did receive an infusion for treatment.
12 hours post vaccine had vomiting, tiredness for 48 hours post vaccine, arm pain lasting 48 hours post vaccine
It was reported that a 19 year old female received Imovax Rabies vaccine on 6/26/02, 6/29/02, 7/3/02, 7/10/02 and 7/30/02 due to rabid raccoon exposure. Two weeks after started post exposure, on 7/10/02, the pt developed muscle aches in her extremities, nausea and diarrhea. Events are unresolved. Follow up on 08/20/2003: "Administrative case closure (no additional information anticipated)."
Incorrect vaccine was given.  This was the patient's first dose and pharmacist thought in error that bivalent booster was okay to give for first dose.  Pharmacist contacted patient who said the only adverse effect he noticed was a sore arm.  Pharmacist specifically askes about fatigue the following days, and patient said there was no other side effects.
An expired dose that had been left in the fridge the previous evening was administered to the patient the following morning
Headache, body aches, chills during the night. Ten straight nights of a fever as high as 102.8.
developed lower abdominal pain the day after receiving vaccine and he feels like his abdomen is twisting.
Information has been received from a consumer concerning her 19 year old daughter who on approximately 17-JAN-2006 was vaccinated with a dose of Gardasil. Subsequently the patient developed a "rash from head to toe." It was reported that the patient had followed up with her physician. At the tiem of the report, the patient's rash persisted. Additional information is not expected.
PT developed the anticipated fever and chills about 12 hours after the vaccination.  However, as his fever resolved, he developed hives and slight angioedema.
24hrs later I had Covid arm, Bad headache Dizzy ness Tiredness, sickness and swollen lymph node on my neck the same side as my injection. Sore throat and ear ache.  Still in bed now day 5  Called tele doctor who said there wasn?t anything he could do and all my symptoms have been reported before by patients who have received Moderna vaccine.  I?ve just had a bad reaction to it!
pt recv vax & 24hr p/vax rash on lower arms, rash on upper thighs & redness w/a burning sensation;didn't seek MD visit;
Patient received Pfizer COVID vaccine on 9/19/2021 as documented in this report. After patient was vaccinated- patient reported being fully vaccinated with Sinopharm on 5/13/2021 and 6/3/2021.
Shortness of breath doing any activity, arm soreness, couldn't lift arm up for over 1 week, rash on face, arms and chest and heart ejection down to 39 from 49, and heart muscle tightens, chronic fatigue.
I had cold sweats, a low-grade fever, a headache, body pains, and extreme exhaustion. The symptoms started a few hours after I received the vaccine and got significantly worse the next morning. I had to call out of work because I physically felt that my knees would give out when I was standing. I also could not rest my wrists on anything because it caused too much pain. The next day, I felt much better and was able to go to work.
Symptons:Day 1: Skin sensitive to touch (like sun-burn)on left side of neck.Poison-ivy-type rash appeared in two spots on neck, left side. Headache, increasing in intensitiy during the day. Stiff neck and pain extending up back of head, left side.  Day 2: Sensitivity of skin spread to left cheek. Headache. Another small patch of rash appeared in front of neck under chin. Sensitivity of skin extending to upper chest, left side.VISITED DOCTOR AND WAS DIAGNOSED WITH REACTION TO IMMUNIZATION.PRESCRIPTIONS GIVEN.  Day 3: Slight nausea and vomiting during early morning. Severe headache and stiffness and pain in neck, left side throughout the day. No more outbreak of rash. Fatiqued.
Pt received TD injection on 8/1/00 and on 8/2/00 pt came into office complaining of extreme muscle pain, fever and nausea.
Patient immediatley felt chills and tremor in left arm after vaccine.  Subsequently, had progressive symtpoms and has been diagnosed with parkinsons disease manifested by tremor, rigidity, bradykinesia on the left.  Abnormal DAT scan.  His imaging also showed a CVA which likely occured while sick after receiving the shot.  He reports after the vaccine, he developed a 105'fever and was very ill.  unable to go to hospital due to COVID lockdown.  9/9/21 was driving at 5a. He ended up in a ditch. No warning. GTC for unspecified amount of time. confused afterward. Police found him wandering around the car and was disoriented and couldn't answer questions appropriately. He had another seizure in the ER.
28 Jan 2017 admitted medical center transfer to another hospital for Guillain-Barre syndrome (GBS) d/c 07 Mar 2017 to home health and physical therapy. Currently with Dr.
FLUZONE HIGH DOSE vaccine coming back out of the patient's arm at injection site/ No AE; a patient was given partial dose of Fluzone High Dose/ No AE; the pharmacist misjudged patient weight and used a 1 inch needle/No AE; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown demographics who was given partial dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and the pharmacist misjudged patient weight and used a 1-inch needle and vaccine coming back out of the patient's arm at injection site (lot number and expiration date was not reported) via an unknown route in the arm for prophylactic vaccination on 05-Oct-2020 (wrong technique in product usage process).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant drug was not reported.   It was a case of an actual medication error due incorrect needle gauge used and it was also a case of vaccine underdose and exposure via skin contact (Latency: Same day).  At the time of reporting, patient had no adverse event.   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 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.
Several hrs p/immun pt had t 105.4; pt was seen in ER @ hosp; pt was treated w/APAP & sent home;
mom called MD @ home the evening shot was given; during the noc t104 @ 2AM; pt seen by MD 6APRR94; dx w/ear infect;
Symptoms from high temperature; Body chills; Long lasting side effects; A spontaneous report was received from a nurse concerning a female patient , of unknown age, who experienced long lasting side effects (vaccination complication), symptoms from high body temperature(pyrexia), and body chills (chills).   The patient's medical history was not provided. Concomitant product use was unknown.  On unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  The patient reported symptoms from high temperature and body chills. The patient stated that she can't take it anymore. The patient experienced long lasting side effects for 3 days (since 30 Dec 2020). Treatment information was unknown.   Action taken with mRNA-1273 in response to the events was not unknown.   The outcome for the events of long lasting side effects (vaccination complication), symptoms from high body temperature (pyrexia), and body chills (chills)was considered as unknown.; Reporter's Comments: 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.
PT is a 73y.o. year old female with a past medical history of essential hypertension, gout, and diabetes mellitus who presented for 7-8 days of weakness, shakiness, subjective fevers/chills, and body aches. She reports anosmia, dysgeusia, myalgias of the lower extremities, productive cough of yellow sputum (now non-productive), and diarrhea (resolved) since her symptoms began. She was vaccinated for COVID on 3/18/2021 and 4/8/2021 (pfizer). She has no sick contacts and no known COVID exposures. She denies any chest pain and denies any dyspnea either at rest or with exertion. She has not received the boosted vaccine   In the ED on initial presentation the patient was noted ot be hypotensive BP 81/46 (responded to 1.5L bolus). Patient was also noted to be in afib with RVR. Her SpO2 was stable and the patient did not require supplemental oxygen. She was found to be COVID positive, had a D-dimer of 1722, and her chest x-ray showed multifocal airspace disease involving the L>R lung fields. Her strep and legionella resulted negative.  She was also noted to have a contaminated UA that did contain bacteria and WBCs and was started on rocephin as a result with a urine culture and blood cultures pending. She has no urinary tract symptoms.   The remainder of her labs were only significant for an AKI present on admission that resolved after IVF, and anemia Hgb 10.5 from 12.5 after receiving 1.5L fluid resuscitation (likely dilutional component).    ID was consulted for COVID-19 and evaluation for remdesivir administration. She is not requiring 02 and states that her symptom onset was approx 10-12 days ago (reaffirmed x 2 in differentt discussions with her    Review of Systems:
At first, I did not associate my symptoms with the vaccine. My hair started to fall out two weeks after I received my fourth dose. I had gone to visit my daughter, I noticed a lot of my hair was falling out. When I got back home, I basically ended going to a dermatologist. My dermatologist asked if me if I got the vaccine in September 2022, and I said yes and they told me it was probably due to the vaccine. I also have type I diabetes. I probably lost 1/3 of my hair, where I had super thick hair and lost also my eyelashes. They looked at my scalp. They gave me some Minoxidil to help with my hair loss. At this time my hair has started to come back slowly and I am doing much better now.  I am getting good progress with the treatment.
Brown spots appeared on right arm, 5 days, post vax. Continued spreading in deltoid region for 2 weeks. Appears to be dark pigmented "splotches", no conformity. Advised to follow-up with Dermatologist if it persists.