chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-JAN-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Right arm is hurts and is stiff, difficult to move, patient had trouble, sleeping, patient later reported feeling better, but still a little stiff.
The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
This spontaneous report was received from a female patient of unknown age, reporting on herself. The patient's concurrent conditions included breast cancer diagnosed on an unspecified date. Due to it, approximately in 2004 (reported as "14 years ago"), she had some lymph nodes removed.   No other information was provided regarding the patient's drug reaction/allergies or concomitant medications. On approximately 2013, reported as "4-5 years ago", the patient was vaccinated with ZOSTAVAX for shingles prevention (dose, route of administration, lot number and expiration date were not reported). On an unspecified day in June 2018, the patient had one lymph node removed due to breast cancer in her left breast. The patient received an unspecified treatment for the events. The outcome of breast cancer recurrent was unknown. The reporter did not assess the causal relationship between therapy with ZOSTAVAX and the events. The patient was planning on getting re-vaccinated with "the new shingles vaccine" for an unspecified reason but had not been re-vaccinated at the time of the report. Upon internal review, the events of breast cancer recurrent was considered to be medically significant.
Site felt "hot" since Monday. Pain 1/10- slight redness 70 mm on underside of rigth arm.
A few days after the first dose in my right arm I developed a hive. Then after the second shot in my left arm i developed a hive on that arm too. Both of my arms keep popping up with hives since and now hives are appearing on the rest of my body.  They are itchy and are blister like and turn scabby. It is very uncomfortable and my skin is ruined. I never had any issue with my skin prior to getting vaccinated nor do I have any allergies toward anything. The itchy and burning are ruining my life and I am in constant agony. I have now developed an itch in my throat on the left side for the past 4 months that throws me into violent cough attacks. I am hoping that the hives have not began to start growing in my throat. My skin is permanently ruined from scarring and texture changes not to mention my mental health being negatively affected by my changed appearance of my skin since the hives.
At the time of the shot, I was 16 weeks pregnant. The estimated date of delivery is 13 September.  Approximately 8 hours  after taking the shot, which was administered between 1100-1130 am, I experienced pain in my Left arm. The following morning I was unable to lift my arm and I felt like I had "brain fog" or as if I was fighting a head cold. In the afternoon, I had to sit down after standing for about 10 minutes because I felt like I was getting dizzy and I was nauseated. Typically, I have been nauseated in the mornings because of my pregnancy, and this symptom does not usually effect me in the afternoons. Symptoms were gone the following day.
Feeling unwell; All over upper body itchiness/she itches all over; Fatigue/feeling very tired/little fatigue; Severe arm/injection site pain; Severe arm/injection site pain/very sore arm; Chills; Low grade fever; Headache; Lightheaded; Weakness/really weak; Itchy rash on chest/has a rash on her chest/little rash on my back; Nausea; Loss of appetite; She is flushed; tested positive for Covid and 6 days; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot: EL9265) in right arm via an unspecified route of administration on 08Feb2021 07:45 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included osteoporosis, Inappropriate sinus tachycardia, known allergies. Concomitant medication included estradiol benzoate (ESTRADIOL [ESTRADIOL BENZOATE]), calcium (CALCIUM), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]), naproxen (NAPROXEN), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) all at once a day. The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient had the first vaccine on 08Feb (complete date not clarified), two days after that it had most of the side effects, with the one very sore arm, headache, fever chills, nausea, feeling very tired, about 6 days after that she tested positive for Covid and 6 days after the first vaccine. She tested positive for Covid so for the last couple of weeks. She had Covid, the fever broke about 5 to 6 days ago, she had a low grade fever after that, also the symptoms were gone now, there was little fatigue and little rash on back. She was scheduled to take second shot now and was trying to find in research about taking the second shot inspite of having covid. She cant find anything, most of the people never heard this and primary care physician said to go ahead and take the shot, but some people and some researchers said you should not, because she might have symptoms later and she should wait. The treatment was not received for the adverse events. Outcome of tested positive for Covid and 6 days was unknown and for other events it was recovering.
Sore arm, sore joints, diaherrea, tiredness, migraines for 8 days, nausea
Chills, no fever, headache, body aches, loss of appetite, some heart palpitations, fatigue, muscle aches, shortness of breath.  Unable to do daily tasks for five days.  Swelling, redness and severe pain at injection site.
This spontaneous report was received from a female patient of unknown age referring on herself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On approximately 30-AUG-2017 (reported as "a month ago"), the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in approximately 2017, the patient experienced swelling in her eyelid and toothache. After a few days, the patient had recovered from the swelling in her eyelid and toothache. The causality assessment between the events and the ZOSTAVAX was not reported.
Erythema and tenderness in the LUE in the region of the vaccines given the day prior. Also, itchiness noted 2 days later. No treatment, to observe.
Patient became dizzy and passed out after returning to her car.  Guardian beeped horn and nurses evaluated patient.  Patient aroused easily.  Patient very pale.  Patient vomited x 1.   BP 88/50, P 53, R 14, Spo2 99%. 911 called, arrived within 15 minutes.  Vitals and blood sugar stable.  Patient denied any further dizziness and reported not eating prior to vaccination appointment.  Patient also reported similar incident one other time after receiving a shot.   Patient discharged home, no EMS transport.  Follow up phone call revealed patient was feeling fine.
h/a (dull), low energy level noticed late 22OCT; 23OCT felt draggy, h/a all day; later afternoon 23OCT ached all over-muscles sore; 24OCT abdominal cramps felt like diarrhea but did not actually have that; nausea but no vomiting;
My tinnitus has gotten much worse. It started getting worse about two weeks after the first vaccine and now it is pretty much constant and muchlouder.; My tinnitus has gotten much worse. It started getting worse about two weeks after the first vaccine and now it is pretty much constant and much louder.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2614) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 36-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included mild tinnitus from time to time, obsessive-compulsive disorder, anxiety, depression and panic attacks. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included sertraline (MANUFACTURER UNKNOWN); for unspecified indication from an unknown date and unknown if ongoing. On an unknown date in 2021, the patient experienced tinnitus had gotten much worse. It started getting worse about two weeks after the first vaccine and then it was pretty much constant and much louder. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events reported. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event tinnitus has gotten much worse. It started getting worse about two weeks after the first vaccine and now it is pretty much constant and much louder was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
My menstral cycle arrived a few days early on Nov 1, 2021 but was other wise normal.  Then immediately after my cycle (around Nov 4), I started experiencing classic PMS symptoms.   My breasts became swollen and tender and got progressively worse over two weeks.  I also was constipated and extremely emotional.  I also did not ovulate.  My period then arrived 12 days early. I have been tracking my cycle for 4+ years and this has never happened before. Furthermore, it is unheard of me to have PMS symptoms for more than 5-6 days, and this lasted for two weeks and vegans immediately after my last period.  I had no similar reactions to my first two shots
Fever, chiles, headache and loud ringing in ears on day of vaccine. Fever, chiles, and headache went away by day day 5. Ringing in ears is still happening which is making it hard to hear.
Red streaking- injection site on back of arm. Also R axillary lymph node enlargement.
Patient presented to the ED for evaluation of right arm and left leg weakness. She has some mild left facial droop. She also has right arm pain. Patient apparently had a 45 second period of unresponsiveness prior to us getting on camera with them. She opens her eyes to some painful stimuli but not always.  Seizure-like activity (HCC)  Presents from an outside facility intubated.  She originally presented to the outside facility with right arm pain though she also described it as heaviness and weakness when questioned.  During her work-up in the ER and while a peripheral IV was attempted she started having tremor of the right upper extremity.  She then went on to have an episode of unresponsiveness though did have stable vital signs.  After about 30 seconds or so she did open her eyes and stared at the ceiling, she was not verbal per report.  Later in her stay she became rigid, had tonic-clonic activity with associated jaw clenching, and bulging eyes per report.  She had several of these episodes and in between them had rhythmic tongue movements, she improved somewhat but then was noted to answer 'home' to every question.  She was emotionally labile.  Additional presumed seizure activity was observed with the attempt of any other IV placement.  The decision was made to intubate the patient and transfer her here.   Once at CT head showed no acute abnormalities.  There was a lateral right frontal probable meningioma.  MRI brain normal for acute findings as well.  She also had normal MRA head and neck.  She has had joint pains and body aches for a month and SOB for 2 weeks. She reports chills but no fevers.
BOWEL SOUNDS EVEN WHEN SHE IS NOT HUNGRY; COULD NOT SLEEP; INTENSIVE STOMACH PAIN ON THE RIGHT, LEFT SIDE AND IN THE MIDDLE; DID NOT HAVE BOWEL MOVEMENT; COULD NOT GET OUT OF BED; HEADACHE; LOW-GRADE FEVER; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: did colonoscopy and broke into rash (less rash), and concurrent conditions included: non alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced hives and rash severe all over her body and red and inflamed when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-SEP-2021, the patient experienced could not get out of bed. On 24-SEP-2021, the patient experienced headache. On 24-SEP-2021, the patient experienced low-grade fever. On 27-SEP-2021, the patient experienced intensive stomach pain on the right, left side and in the middle. On 27-SEP-2021, the patient experienced did not have bowel movement. On 27-OCT-2021, the patient experienced could not sleep. On an unspecified date, the patient experienced bowel sounds even when she is not hungry. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not get out of bed, headache, and low-grade fever on 26-SEP-2021, was recovering from intensive stomach pain on the right, left side and in the middle, and did not have bowel movement, and the outcome of bowel sounds even when she is not hungry and could not sleep was not reported. This report was non-serious.
Within 2 minutes of receiving vaccine, pt passed out, shaking, unresponsive, sweating.. Unresponsive lasted about 20 seconds. after awaking, blood pressure was 105/50. called 911, pt was evaluated by emergency response team and released
Patient received the Pfizer vaccine on 03/05/2021, due to the patient's age.  At the follow up visit for the second dose, a fellow nurse administered the Moderna vaccine to the patient. Patient was monitored for adverse events post vaccination. Per patient's parent, patient experienced body ache, headache and chills on the following day that lasted 24 hours.
Sick day of shot, bad cough within 5 days, misdiagnosed with bronchitis, started passing out, x-ray shows blood clots.
On the 4th day after the vaccine and around 3:30pm I started to feel itchy on both arms around the elbow area, but on the front side like where you draw blood, for about 1 hour but it stopped. The same evening my head started itching and that has continued,  it has no stopped.
emesis and diarrhea for 4 hours followed by fever, congestion, myalgia for 3 days. had covid-19 infection and was 96 days post recovery
A nurse reported the occurrence of an allergic reaction in a 4 year old male who was vaccinated with diphtheria and tetanus toxoids and acelluar pertussis vaccine adsorbed for prophylaxis. The subject had no known drug allergies. Other medical history, concurrent condition, and concurrent medications were not reported. On 02APR2003, the subject received his fourth injection of Infanrix injected into the right buttock, which is not recommended as a site for Infanrix administration. On the same date, he received a tuberculin skin test , his second injection of measles, mumps, and rubella virus vaccine, and his fourth injection of inactivated poliomyelitis virus vaccine. On 02APR2003, post immunization, the subject developed swelling and redness at the site of Infanrix administration. On 04APR2003, the child was seen by the physician to read the tuberculin test. At that time, the physician observed that the redness and swelling "went a little ways down the leg " of the subject. The physician made a diagnosis of "likely allergic reaction to pertussis" and prescribed prednisolone and amoxicillin clavulanate. The allergic reactions resolved on 05APR2003. The reporting nurse stated that the Infanrix immunization series had been discontinued; immunization "will likely proceed "with just DT (pediatric diphtheria and tetanus toxoids)"
Pharmacy administered  Fluad 65 +  to patient and he is only 60 years old.  When follow up with pt he states "he feels just fine."
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included vitamin d and hydrochlorothiazide. On 11th March 2018, the patient received the 1st dose of SHINGRIX. On 11th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site rash and injection site swelling. On 12th March 2018, the patient experienced bronchitis and sore throat. On an unknown date, the outcome of the injection site rash, injection site swelling, bronchitis and sore throat were recovered/resolved. The reporter considered the injection site rash, injection site swelling, bronchitis and sore throat to be related to SHINGRIX. Additional details were provided as follows: The patient did not think the injection itself was done very well, she thought the person doing it did not know what he was doing. The patient had an exceptional rash and swelling on her arm where she received the injection and the next day she developed bronchitis and a sore throat that lasted for weeks. She did not want to get the 2nd dose, but upon instructions by her health care professional she received the 2nd dose. This case has been linked to case US2018GSK112543 reported by the same reporter for same patient.
Pt. was given Rotavirus at 6 mo visit. It was Rota #4.
My arm is sore; Headache for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2020, the patient received the 1st dose of Shingrix. On 8th November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix an experienced arm sore and headache was recovered in 2 days. The information regarding consent to follow up was not reported. No further information was available
SUBJECTIVE: Pt. is a 15 year old male here vaccinated at our community vaccine event at high school last evening and received the Pfizer vaccine  Approx 10 min after receiving the vaccine the patient reported: weakness and lighheadedness  At approx 10 min post vaccination he was still sitting in the chair he was vaccinated in.  When I came to him he was clamy and pale and felt weak and lightheaded.  He also c/o of feeling tremulous This Hx of was obtained by pt and pt's mother who was with pt at the vaccine event.  Pt was feeling anxious but well prior to the vaccine.  He last ate approx 5 hrs prior to vaccine and had hamburger and root beer.  He had no significant activity during the day prior to the event.  He did wake up approx 4 hrs earlier then his usual time on day of event because of school orientation he had that day.   Pt and mom denied any prior hx of similar reactions after vaccines Pt reported it "feels like just got a shot"  No nausea, itching or resp distress No PMHx -Per pt. has been on IEP for adhd  No current medications NKDA SocHx: pt denied any recent drug or etoh use Sudden onset of symptoms/signs: yes Rapid progression of symptoms/signs:  Rapid progression that quickly improved    OBJECTIVE: General appearance: pale and clammy Skin:no rashes Resp:  CTA bilat CV: RRR  Vitals Vaccine given at 5:58 pm 6:05 pm BP 87/50, P 83, pox 98%- pt was given water 6:08 pm BP 134/84, - coloring in face improved and pt began to feel better- pt was alert and oriented x 3 at this point 6:13pm BP 130/66- pt was given granola bar and 2nd bottle of water BS: 118  DISPOSITION: After sitting in chair for approx 35 min, drinking two bottles of water and two granola bars pt was feeling better, appeared better with normal coloring and not clamy and had normal vitals signs.  He and his mom felt comfortable going home to rest.  I reviewed warning signs with mom to call or go to ED for I called the next day (7/29) and spoke with his mom and she stated pt was doing better after eating dinner and was feeling well this.  She plans to call pt's pediatrician to coordinate his 2nd dose in their office or affiliated clinic.
Expired Moderna was administered on 11/19/2021 lot# 046C21A. Patient was called back to the clinic and vital signs were taken and were within normal limits. Patient showed no s/s of any distress and when asked he states no s/s. Provider was notified and also Moderna manufacture and they will update with guidelines. Patient was released to facility.
Big rash all over my body. Throat sore and inflammation.  I went to emergency room and i got one shot of decadrol and one shot of benadryl. But the symptoms do not go away.
Developed chicken pox 7/23/05. Received Hib, PCV, MMR and Varicella on 7/8/05.
This individual was given her 1st dose of Moderna vaccine on 2-11-2021. She was then given this dose (dose #2) on 2-16-2021, only 5 days later. Patient self scheduled herself for dose #2 only 5 days after her dose #1. When she presented for dose #2, the short timeframe was not noticed and she was administered dose #2. The patient states she had no adverse effects, including arm soreness, after receiving dose #2 on 2-16-21. Patient is aware of the incorrect timeframe, but was counseled not to receive another dose based on CDC guidance.
No symptoms.  Vaccine Administration Error.  Vaccine was administered from an adult vial.  0.2 ml was given to this patient for approx 20 mcg of Pfizer vaccine.  This is calculated to be double the supposed dose.
Right after I felt dizzy, then. Nausea, around 4pm , my arm starte to ache tremendously  At night like prob 11pm body ache started Later early very morning fever n the pain n my arm was even worse took Tylenol  woke up at 7 signed in at work took Tylenol again But like  arnd 11am fever started again, my chest aches my heart was going faster than usual Nite easy to breath had to stop working. And May down took Advil  Today 3/24/21 pain in arm is almost gone, fever gone,  headache is still there, body ache mush less But heart beating fast. and from time to time  I feel it?s hard to breath
Mild cellulitis and soreness in left arm, where vaccine administered. treated with Tylenol and cold packs.