chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose of HAVRIX administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix 1440) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th August 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 25th August 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-AUG-2022 Reporter's Comment: The reporter reported that the patient received an expired dose of Havrix 1440 (Hepatitis A) vaccine. The reporter stated that the vaccine administration facility was the same as primary reporter. Additional supportive information: The patient received a Havrix 1440 which was already expired, which led to expired vaccine used.
Child seen in clinic 12-4-08 - well child visit with vaccines given. Child put to bed 12-6-08 on stomach. Unresponsive two hours later by parents at home.2/20/09-autopsy report received-Sudden unexplained infant death, prone sleeping position. Minute foci of pneumonia.
Next morning, I got up, went to bathroom. On the way back from the bathroom to the sofa, I became hot, sweatty and felt like I was going to pass out. I let myself to the floor gently, sweating profusely, and passed out. Not sure how much time had passed, but I came to and questioned where I was and how I got there. I crawled to the sofa. Was very weak all day. Started to feel human the next day.
Right after the vaccine, I felt bad for the day and the next day, I woke up and felt tired but nothing that kept me from doing anything And the next day after that everything was fine. On June 26, No fever or anything. I just had an earache and I gave it a couple of days to see if it would go away on its own. By Tuesday, I called the doctor and they got me in Thursday. It looked like my left ear was a little red - and right ear looked fine. Prescribed antibiotics for two weeks and I took those and I went back last Thursday and it looked better. She's my ear doctor and she knows me as she has done surgery on my ears. I have had a lot of ear issues before but this was the first time I have ever had an earache.
Patient started jerking/seizure for about 1-3 seconds.  Then had about a dozen episode's of the jerking/seizures for about 3-5 seconds.  The patient was taken to the ER and then transfered and was admitted for 3 days.  No other treatment was given.3/16/09-records received for DOS 2/16-2/17/09-DC DX-Movements that are not due to seizures (non-epileptic events). Presented with episodes that occurred day after immunization, bilateral arm abduction with head drop followed by irritability decreased activity for few days. Now back to normal prior to admission. Parents saw vidoes on internet related to infantile spasms and requested admission.
My child began demonstrating adverse reactions roughly 2.5 weeks following his one year shots. He woke up vomiting on 9/18/2020 and was unable to sit up, stand, or walk. We?ve been to an urgent care center and two hospitals (ER and inpatient stay). He has been diagnosed with acute cerebellar ataxia. He has not been sick in the past month, and all of his extensive medical testing came back normal. His vaccines are entirely responsible for this ataxia. He remains unsteady on his feet and is a fall risk requiring close monitoring.
heart racing, throat feels like its closing, hard to breathe, generalized weakness.  Evaluated by EMS-Cleared
This spontaneous report was received from a registered nurse, concerning 106 patients of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the 106 patients were vaccinated with an inappropriate storage doses of PROQUAD (dose, frequency and route not reported) for prophylaxis; 46 of them were vaccinated with the lot # M017334 with expiration date of 05-OCT-2017, 20 of them were vaccinated with the lot # M018635 with expiration date of 11-OCT-2017, and 40 of them were vaccinated with the lot # M018637 with expiration date of 11-OCT-2017. No adverse effects were reported. The prior temperature excursion of the vaccines was greater than -15°C degrees but less than -10°C (>5°F but <14°F), for a time frame of 10 hours and 15 minutes. The recent temperature excursion of the vaccines was greater than -10°C but less than 8°C (>14°F but <46°F), for a time frame of 14 hours and 18 minutes. No product quality complaint was involved (PQC). Data logger was involved. This is one of two reports received from the same source.  Additional information has been requested. Sender's Comments:  US-009507513-1702USA007854.
Client states when he went to bed his arm ached where injection was given. When client woke in AM he felt tired, general body aches and temperature of 100 degrees F.
Patient receiving 3 doses; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 26th October 2020) and Shingrix (received second dose on 9th February 2021).   On 1st November 2021, the patient received the 3rd dose of Shingrix. On 1st November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient had received the third dose of Shingrix, which led to extra dose administered. The reporter consented to follow up. Consent was given for FU
Pt. states that after receiving the 2nd dose of Shingrix 02/10/2022, started experiencing symptoms that evening of stomach pain, fatigue, chills, fever, dizziness, incontinence-Urine, uncontrollable shaking, headache, joint pain, shortness of breath, and rapid heartbeat. Symptoms subsided 02/12/2022, No noted Primary visit/communications.
It was sudden inconsonance of stool, with no warning. There was no cramping no nothing. I had to leave from work and it reoccurred for the next couple of days. I thought it was a viral thing. I did my usual  Brat Diet, soft diet. It got to the point I could not leave the house. I starting taking Imodium by pill and it was not working. My doctor prescribed Lomotil.  She then had me referred to a gastrologist, it was in 04/2021 and 8/2021. There they performed stool cultures and colonoscopy.  The doctor could not understand why I had active information if I did not have colitis.  The incontinences  reoccurred in September, It was never normal but came back as worse or the same as the first instance again.  I was put on a steriod Budesonide 3mg.  I now have to take this everyday with no dairy products I am pretty normal.  I don't know if this permanent until they do another colonoscopy.
Fever as high as 103.1 Weakness Body aches Headache Brief dizzy spells (twice)
Immediately following the vaccine (HPV), the patient felt lightheaded and slouched over. 15 minutes later, he had an unsteady gait. On my exam, he was stumbling with decreased strength in upper extremities, lower extremities and hyper-reflexic DTRs.
blisters on/ lower right mid section / mid section of her back/ diagnosed the blisters as shingles; blisters on/ lower right mid section / mid section of her back/ diagnosed the blisters as shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 31st December 2020, 3 days after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were unknown.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The patient had her first and only Shingrix vaccine in left arm and she noticed blisters on the lower right mid section. These blisters continued to spread around to the mid section of her back. The patient's physician diagnosed the blisters as shingles. The reporter consented to follow up. Note : Since patient received vaccine on 28th December 2020 and event onset date was reported as 31st December 2021, which is futuristic date(Typo) hence event onset date was captured as 31st December 2020.
Several hours after receiving the 1st vaccine, began to feel very dizzy. Checked blood sugar and it had spiked to 319, which is highly unusual for me. I kept an eye on it to ensure it did not increase further. Within a few hours it did go back down so medical treatment was not necessary. I just wanted to to report this so people with diabetes can be informed that this might happen.
Aching/pain in both shoulders; Pain 6 inches right of belly button; Swollen right hand feels sprained.; Swollen right hand feels sprained; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 01Mar2021 (at the age of 80-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any 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 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 08Feb2021, as a single dose for COVID-19 immunisation. On 15Mar2021, after 2 weeks of second dose vaccination, the patient experienced aching/ pain in both shoulders and 6 inches right of belly button. On an unknown date in 2021, the patient experienced swollen right hand feels sprained with certain actions after approximately 4 months. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, aching/ pain in both shoulders, pain 6 inches right of belly button and swollen right hand feels sprained were not resolved at the time of this report.
Morning after vaccination, patient woke up feeling very weak and nauseated for the entire day. No episodes of vomiting. Few episodes of diarrhea in the afternoon. By the following day, the patient's symptoms had subsided.
within 30 minutes of injection, felt twinge in left chest, shallow breathing and racing heart.  This twinge became a tightness in my left chest and radiating under my right armpit by next day.  It felt like a tight muscle contraction.  This tightness came and went for 5 days.  I sought medical treatment on the 5th day. This was the last day of reaction.
First symptom in evening was sore, stiff arm.  In early next morning, I woke up with terrible dizziness causing nausea, headache and terrible fatigue.  Site of injection very sore and swollen.  Spent the day in bed, slept a lot.  24 hours after the injection, I started to gradually feel better.  To my knowledge I had not been exposed to any type of virus/illness prior to the vaccine.
Pt presented to campus health urgent care 10/11/12 at 4:35 pm. Presented with red, raised, rash to arms, back, & chest which started 10/9/12. Rash is somewhat itchy and is improving (per pt) Pt. presented with abnormal  vital signs: oral temp 101.4 degrees, BP 139/69, pulse 131, RR 20, SPO2 97%. Treated with TYLENOL and given instructions to return if symptoms do not improve.
A medical assistant reported that on 7/13/00 the patient developed an injection site reaction characterized by a "50 cent piece" sized area of redness, swelling, and warmth on the left thigh. This is 1 of 2 patients from this facility who experienced this event following receipt of Acel-Imune lot 470-527 or the concomitantly administered vaccine. A copy of this report has been forwarded to Merck, manufacturer of MMR.
This is a spontaneous report from a contactable consumer, reporting for her son and from a contactable other HCP. A 18-year-old male patient received the second dose of TRUMENBA, via unknown route of administration, single dose on 10Mar2016 05:00. Medical history included attention deficit/hyperactivity disorder (ADHD) from 29Dec2011 and ongoing and Tourette's disorder from 2010 and ongoing. Concomitant medications included FOCALIN since 22Feb2014 and ongoing for ADHD at 10 mg BID orally. The patient had received the first dose of the same vaccine from batch/Lot MI3065, Exp: Apr2017 via intramuscular route on right upper arm on 06Jan2016 and had experienced local redness and swelling. On 10Mar2016 the patient experienced chills/teeth chattering, headache, shaking all over, all with outcome of unknown. Follow-up (19Apr2016): additional information received from a contactable other HCP includes past vaccination events, concomitant drug. Follow-up attempts completed. No further information expected.
5-6 days out had erythema around site with 1-2 very small 3 mm pustules.  ??secondary infection.
Patient stated that approximately 24 hours after receiving vaccine she developed shaking legs, cold then hot, off balance, and nausea. Patient's symptoms have resolved.
After receiving the Hepatitis B vaccine, within the hour, her throat and glands started swelling. Unable to swallow for 48 hours.
I felt extreme fatigue immediately starting the next day. Early that next morning, I was woken up in my sleep with a coughing spell and felt sick. I had to use my Albuterol nebulizer multiple times that day and each day following for many days. I used OTC medicines and Tessalon I had on hand thinking I had something else going on. I was scheduled to work night shift and failed the screening and was directed by my employer on Monday afternoon 10/11 to get tested for Covid-19. I was unable to get there that afternoon and went on 10/12 for the testing. I got results on 10/12 that I had Covid. I have not yet recovered to my pre health at this stage or been able to return to work. I got a sinus infection and was treated on 10/23/2021 with antibiotics and was sick until the end of the month. All this time I had a brain fog which gradually moved into a loss of memory in some areas, extreme concentration difficulties, processing delays, insomnia and an increase in headaches. Knowledge and information I knew before was gone and I could no longer function at my job. I went to my primary Dr. multiple times and virtual also during this time. On 11/4, I was examined for the cognitive difficulties and headaches and sent for bloodwork, had a CT ordered and was placed on medication. I also was given a neuro consult which changed later that day to a referral to the Covid clinic (physical medicine and rehab Dr. with multiple therapies. They wanted to wait until my medical evaluation was clear until they would see me which it was within normal limits. My first appt with Dr. was on 11/18 and presently still under treatment at this time. My level of functioning has not returned to normal and still have headaches when trying to concentrate or learn new things and when there is loud noises or sounds present.
Rash. Started under armpit and has spread over body. It is spotted and not a continuous rash. I thought it resembled psoriasis spots; Administration date= 04Feb2021/Other vaccine same date vaccine date=18Feb2021; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Feb2021 as dose 2, single for covid-19 immunisation from workplace clinic. Medical history included hashimoto's and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. On 25Feb2021, patient experienced rash started under armpit and has spread over body. it is spotted and not a continuous rash. Patient thought it resembled psoriasis spots and never had anything like it until vaccination. Patient see the doctor next week. The patient administration date dose on 04feb2021 and other vaccine same date vaccine date on 18Feb2021. The outcome of event rash was not recovered.
Moderna 9/9/21, 12/9/21. Positive on 7/26/22
Received DPaT and polio at 11:15 am developed fever around 7:30pm and had grand mal seizure. 911 called and seizure had stopped by time 911 arrived (seizure later about 5 minutes). Seen in ER. Exam neg and all blood work neg. Family history of febrile seizures.
Pt recd vax 25AUG92 & 26AUG92 exp severe flu-like sx;
Vaccine administration error related to temperature excursion from recommended storage temperature, not known to this writer to be associated with an adverse event. The  clinic has relayed to this writer that prior to the vaccine's thawing and administration to the vaccine recipient, the administered vaccine was stored in frozen temperatures for longer than recommended by the manufacturer. (This VAERS writer assigned to form completion was not the administrator of this vaccine.)
pt recv vax & devel sudden onset of SOB, vomiting, diarrhea & pruritus;pruritus persisted @ the date of this report (2 days post vax);
I had hives covering over 50% of the body, along with soreness and a headache
Information has been received from a health professional concerning a 4 year old white female student who on 10/30/00 was vaccinated with a second dose of varicella virus vaccine live. On 6/29/04 the patient developed spots and had a case of breakthrough chicken pox. The reporter noted that the patient had not been hospitalized and she recovered on approximately 7/12/04. No additional information is expected.
Ache/swelling at injection site; Ache/swelling at injection site; Body ache; chills; extreme tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 09:30 (Lot number: EL3248) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild hypertension" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; BYSTOLIC. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer/BioNTech, lot number=EL3247, lot unknown=False, administration date=19Feb2021, administration time=01:00 PM, vaccine location=Left arm, dose number=1), administration date: 19Feb2021, when the patient was 71 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 11Mar2021 23:00, outcome "recovered" (2021) and all described as "Ache/swelling at injection site"; PAIN (non-serious) with onset 11Mar2021 23:00, outcome "recovered" (2021), described as "Body ache"; CHILLS (non-serious) with onset 11Mar2021 23:00, outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious) with onset 11Mar2021, outcome "recovered" (2021), described as "extreme tired". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, pain, chills, fatigue.  Additional Information: Prior to vaccination, patient was not diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. known allergies to NSAIDS.  No follow-up attempts are possible. No further information is expected.
The night of vaccine- reaction started locally at injection site - kidney sized lump where injection progressed to approx  3 1/2 x2 in in size, raised, increased warmth to injection site followed by muscle pain and nausea. Pt also reports experiencing s/s of being unable to ambulate d/t severe whole body pain and a dizzy feeling. Pt was worried if she got out of bed she would fall because she was in so much pain.
I was given the live virus vaccine at 4:00 PM on Wednesday.  By Thursday my 3 mo. old baby started to get cold-like symptoms (I was nursing him and the nurse who game me the vaccine knew this).  By 7:00 AM Friday my baby was found blue and non-responsive in his crib.  He was basically dead.  I performed full-blown CPR until help arrived, and was able to get him breathing again and felt a faint pulse.  When the ER doctors asked us if anything had happened in the last few days we told them about the vaccines we all got (me, my husband, and our two toddlers- all live virus).  Although I asked the doctors to test my baby for H1N1, they did not.  He was in the hospital for days and then had seizures from lack of oxygen to the brain for so long.  We are not sure what the long-term effects will be.  He was a perfectly healthy little baby until I got the vaccine.  The CDC states in their paperwork that nursing mothers can get the LAIV, however, I seriously question this logic.  My baby very nearly died.  I have not been able to sleep since the event occured.  I have nightmares about seeing a blue baby.  It was horrific.  We don't even know if his brain will function properly as he gets older.  This is most serious and I would hate to see another family go through this amount of trauma.