chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE's and no PQC's were reported.; The nurse stated that improperly stored vaccines were administered to patients.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 08-APR-2022, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live Albumin status rHA (recombinant Human albumin) (PROQUAD) lot# U022724, expiration date reported as 16-JAN-2023, use as directed to prevent measles, mumps, rubella and varicella infection (prophylaxis) (strength, dose, route and frequency were not reported) (Product storage error).   The temperature excursion was of 7.5 Fahrenheit degrees (°F), during 15 minutes. A previous temperature excursion was not reported. No additional adverse event and no PQC's were reported.
chills; headache; soreness in my muscles; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, headache and muscle soreness. On an unknown date, the outcome of the chills, headache and muscle soreness were unknown.   It was unknown if the reporter considered the chills, headache and muscle soreness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient woke up with chills, a headache and soreness in muscles. The patient asked if that was a typical reaction.
Only the second dose:  The injection site became itchy, swollen, red, and sore after about two days.  After about a week, a rash developed.  The rash persists as of June 15, 2021.  The site remains itchy, but is no longer swollen, red, or sore.
Hot red patches on the left bicep the same night as the flu shot. Next morning I had a fever of 102 degrees continuing for 4 days. Along with diarrhea, stomach pain, lower back pain, severe weakness,  vision impairment, confusion, and problems with my fine motor skills, burning and tingling all over my body. This all occurred within 2 weeks, and continued to worsen.
Patient presented to the clinic for a varicella vaccination and was incorrectly given the ZOSTAVAX vaccination.
On 2/13, I fainted while sitting on the couch.  Went to see Dr on 2/17 who found an abnormal EKG.  On 2/18 and 2/23 I had an ECG and Chemical Stress test.  Both were normal  On 2/27 I woke up during the night unable to breathe, and became nauseous.  We were at our daughters in another state at the time.  My wife accompanied me to Medical Ctr, where I was found to be in complete heart blockage.  My BP on admittance was 156/90 and a pulse of 21.  I was put on an external pacemaker immediately and a permanent one was implanted on Monday, 2/28.  We flew back to CT on Friday 3/4.    I have since followed up with Dr., Dr. (Cardiologist) and will see Dr. on 5/5
Information has been received from a physician concerning a 23 year old female patient who on an unknown date was vaccinated with a dose of GARDASIL. Within 24 hours of receiving GARDASIL the patient went into a coma. The patient sought unspecified medical attention. The patient's final outcome was not reported. Upon internal review coma was considered to be another important medical event. Additional information has been requested.
10/18/13 - sore at injection site. 10/19/13 - sore and red on back side of arm. Pt called 10/20/13 - sore and swollen on front side of arm from bend to shoulder.
patient is complaining that her arm is still sore. because of this she went to an orthopedist to check for possible damage. she still has full range of motion of her arm and shoulder. This was her first flu vaccine.
nausea, headache, diarrhea, general feeling of being unwell. Most concerning to me is the affect on my left eye and eyes in general and headache. My left eye is wandering, like a "lazy" eye. It is as if my eye floats, and when this happens I am not able to focus. With the eye is also a frontal area headache and i get an uneasy feeling in my body just prior to this happening.  My reaction started around 5 hours after the vaccine shot. It is now four days later and my symptoms are less but still present around my eyes and headache.
Red hot burning; skin rash in the middle half right arm; Red hot burning; raised skin rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning skin in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAY-2023, the patient received the 1st dose of Shingrix (right arm). In MAY-2023, 4 days after receiving Shingrix, the patient experienced burning skin (Verbatim: Red hot burning), rash (Verbatim: skin rash in the middle half right arm), erythema of extremities (Verbatim: Red hot burning) and swelling arm (Verbatim: raised skin rash). The outcome of the burning skin, rash, erythema of extremities and swelling arm were resolved.   It was unknown if the reporter considered the burning skin, rash, erythema of extremities and swelling arm to be related to Shingrix.   It was unknown if the company considered the burning skin, rash, erythema of extremities and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-JUL-2023 The reporter was the patient who stated that she received Shingrix in her right arm.  4 days later, she developed a red-hot burning and raised skin rash in the middle half right arm.  The symptoms lasted a couple of weeks then went away.  The reporter consented to follow up.
Information has been received from a registered nurse concerning a currently 76 year old female patient with osteopenia, high blood pressure and high cholesterol. She was allergic to amoxicillin, CIPRO, aspirin, epinephrine and penicillin. On an unknown date several years ago, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose and route unspecified). Concomitant therapy was not reported. The patient developed shortness of breath since an unspecified amount of time following administration of PNEUMOVAX 23. The patient sought medical attention via an unspecified method. The outcome of the event was resolved on an unknown date. The reporter considered the shortness of breath as life threatening. Additional information has been requested.
About 30 min after Moderna vaccine dose #1, the patient complained of nausea and pounding pressure above his left eye. He had not taken his 3 HTN meds that day. Prior history of EMS transport to ER due to severe high BP. Initial BP at time of symptoms was 250/140 left arm. EMS called. Patient advised to relax. No other treatment at vaccine clinic. At time of transport, BP 190/140.
For two days, I didn't go to work. I was feeling very weak and had fever-like symptoms after taking the 3rd dose. In November 2021 while I was driving, my vision became distorted and it was hard to see the traffic lights. I saw an ophthalmologist. I was then recommended to see a retinol specialist. I had photo therapy and laser surgery.
This is in follow-up to report (s) previously submitted on 5/14/2004. Information has been received from a RN concerning a third grade male pt who on 25Sep1996 was vaccinated with a first dose of varicella virus vaccine live. No other vaccines were given on the same date or in the months before and after. Follow-up information was received from the registered nurse who indicated that the patient was not vaccinated at her facility. The patient was vaccinated elsewhere, the location of which was unknown. It was noted that reporter's office began providing immunizations to the patient in 2000. Chickenpox was diagnosed on 19-Jan-2004. No further information is expected. It was noted that pt's from the same source had a similar experience (WAES 0403USA02086, 0403USA02109, 0403USA02110, 0403USA02111, 0403USA02112, 0403USA02113, 0403USA02114).
muscle aches; Fever; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient) reported for herself.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included renal transplant, immunosuppressant drug therapy, covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. on Mar2021 the patient experienced muscle aches, fever, and other side effects. she wants to know if she should be concerned about these side effects and if she should get second dose. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient received Shingrix third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concomitant products included Herpes zoster (Shingrix).   On 27th August 2021, the patient received the 3rd dose of Shingrix. On 27th August 2021, unknown after receiving Shingrix and an unknown time 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 age at vaccination was not reported. The pharmacist stated that, the patient received Shingrix third dose a month apart from Shingrix second dose by error, which led to extra dose administered. Adverse event was already reported by pharmacist´s colleague but there was no reference number or any other detail about this situation. The reporter did not consent to follow up.
This spontaneous report was received from a healthcare professional, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of vaccinated with RECOMBIVAX HB with lot # L025738 and expiration date on 14-AUG-2017 and with lot # L048848 with expiration date on 09-AUG-2018 for prophylaxis. It was stated that, RECOMBIVAX HB with lot # L025738, was exposed to a temperature of > 8°C but < 25°C, for a 677 hours time frame and RECOMBIVAX HB with lot # L048848 was exposed to a temperature excursion of > 8°C but < 25°C for 568 hours and 30 minutes time frame. Data logger was involved. Furthermore, RECOMBIVAX HB was never exposed to previous temperature excursions and a product quality issue was not reported. No adverse effects were suffered. This is one of several reports received from the same reporter. Additional information is not expected as consent to follow up was not provided.; Sender's Comments: US-009507513-1702USA006117: US-009507513-1702USA009047: US-009507513-1702USA009048:
Ache at injection site with some redness.  Ache continues to present (3-25-2017. Initial treatment with cold compresses and ibuprophen for 2 days. Ongoing treatment with ibuprophen.  Ache getting progressively worse.
Chills, Bodyaches fever 101.8, headaches, swollen aRm with redness and heat fRom 1-7-2021 - 1-8-2021 1-8-2021 to 1-13-2021 - headaches + swollen arm with Redness and heat. 1-12-2021 - Present itching at vaccine site headache
Administered at 8:00 pm 1/7/2010. 1/7 10:00 pm diarrhea 1/8/2010 8:00 am severe body aches, chills, clammy -  did not take temperature 1/8/2010 8:00 pm ear ache, sore throat for only 2 hours. Legs hurt.
Seizure type symptoms.  Appeared as if he was having hiccups and his eyes were rolled back.
PATIENT REPORTED FEELING LIKE HE WAS BURNING UP, SWEATING, THROAT TIGHTNESS. OCCURRED APPROXIMATELY ONE HOUR AFTER INJECTION.
Client was given her second dose before reviewing her vaccine card on her previous dose. She received her dose 3 days earlier than the earliest it should have been given. She did receive the appropriate second dose but to soon.
By the second day of ?second shot all of my symptoms from being sick (previously cured by 1st vaccination shot) returned with a vengeance. fatigue, shortness of breath, cough, sinus infection, ear infection, swollen lymph nodes, dizzy spells, fever off and on, muscle and joint pain.
Rash, fever, chills, swelling in injection site. Patient was given Ibuprofen and Benadryl and recovered.
After making my PCP aware of my allergies and got the ok I got a shot a covid - 19 shot. I made person who administered the shot that I had allergies and that it was best to stay for 30 minutes.  The people at this facility were great and I left at 4:40.( no symptoms ) My arm was tender Sunday night but I didn't think anything of it. The next morning it was very sore and sleeping was difficult but I really didn't investigate till Tues 10AM when I felt a lump on the injection sight. ( It was 12 straight days of freezing temps so I was bundled up))  I called my PCP and spoke with  and was not happy with the response that this happens a lot and nothing to worry about. (Covid - Arm 2% / 9% ) I read up on adverse effects and what to do on the internet and started an ice pack, and took an IBprophine and a Benadryl. Which Dr  concurred per MyChart after viewing the picture of the injection site I sent her.   So its day 3 and I will continue observation.
tired still tired on the 4th day after shot, body aches still,  head ache still, chills went way on the 3rd day, arm soreness on the 3rd day, diarrhea went away after taking anti diarrhea meds on the second day.
Urticarial rash - the day of vaccine had a transient rash on his arm.   was itchy all night and woke next morning with hives all over his stomach, later that day there were hives on his legs as well.  By the next day(2d after the vaccine), it was fully resolved.
Around 5:00 felt nauseated, runny nose and mild sore throat.  He still has the sore throat, took his vitamin C with zinc, and is pretty much feeling better.   Gargled with aspirin solution.
After receiving the Moderna vaccine, I immediately felt strange, seeing lights flashing and my throat feeling tight. I flagged them down, drank some water and stayed awhile. That night I felt pin and needle sensations throughout my body, with burning sensation down my lower back and spine, felt tired and weak. Stayed in bed for a few days. Still feel the pins and needles and sensation. I figured maybe it would go away after 14 days. I don't know, should I worry and see a doctor? I did leave a message at the doctor office and they made a note. I'm a little nervous if I should take the second one since, I also experienced pains in my head.
Headache for one week.   Left arm swelling, pain, red, raised, lumpy/bump like a goose egg and itchy, continuous since vaccination about 10 days.
Initially pain, swelling, itching right breast. Progressed to itching rash - swelling right side of neck then pain in neck and right ear. Rash on right wrist - then right waist (tiny blisters in a line).
This spontaneous report as received from a physician via company representative refers to a currently 1 year old male patient. No medical history and concurrent condition were reported. On 08-DEC-2015, the patient was vaccinated with first dose of MMR II (lot # L008684, expiration date 02-MAR-2017) (strength, dose, frequency and anatomical location unknown). On an unknown date after the vaccination the patient developed a rash and went to see an unspecified dermatologist, who diagnosed the rash to be popular urticarial. On an unknown date the patient had a western blot test and a PCR test for lymph disease and both the tests were negative. On an unknown date, the patient also developed swollen lymph nodes after the vaccination. The reporting physician mentioned that the mother of the patient stated that the patient scratches the rash until he bleeds. The patient sought medical attention by visiting physician office. An unspecified dermatologist prescribed ORAPRED, CLOBETASOL and ZYRTEC (for itching) to treat the events. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. No product quality issue was involved. Additional information has been requested.
Information has been received from a physician concerning a 15 month old patient ( four year old) who in "approximately 2.75 years ago", was vaccinated SC with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  Subsequently, the patient developed antibodies to mumps and rubella but not to the measles component of the vaccine.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
94-year-old man with past medical history of HTN, CKD, HLD,  spinal stenosis and sacroiliac joint disease who came to the hospital due to fatigue, decreased appetite, weakness, dizziness and falling at home.  Fell in the shower. To be COVID-positive upon presentation, chest x-ray was reviewed and is not concerning for COVID-pneumonia, on room air.  Sodium of 133, hemoglobin of 9.4, troponin is negative.  Head CT was done due to the fall and was negative for acute event.  Lumbosacral x-ray with stable anterior wedging with vertebral body height loss at T12 and L1, approximately 50% loss at each level.  Oriented x2.  Daughter reported mild confusion. Received 2 doses of Pfizer vaccine in 2021.  Started on IV fluids,
Noticed today where my shot was, it?s red, in a circle, tender and itch. It?s been 8 days since my shot. Is this normal?
Patient complained of soreness and swelling of her left deltoid. She also had rashes near the site of injection and the armpit area. According to the patient, the rashes were painful and felt like there is a rock or a bump when pressed on them. The rashes were developed on the night of 03/06/2019 as well as her headache. Patient did not have fever. Patient was admitted to the hospital on 03/08/2019 and was diagnosed with cellulitis.
This initial spontaneous case, was received on 16-Oct-2017 from a pharmacist, concerning a 26-year-old adult male patient. The patient's medical history and concomitant medications were reported as none. On 11-Oct-2017, the patient was administered with FLUCELVAX QIV (dose:0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On 14-Oct-2017, 3 days after the vaccination, the patient experienced severe back pain and pain at the injection site. The patient was treated with TYLENOL. The outcome of the event injection site pain was recovered and outcome of the event severe back pain was ongoing. The reporter assessed the events as non-serious.
Pain in shoulder joint immediately following flu vaccine.  Pain has continued; went to Urgent Care on 11/1/2013 for physical exam.  Dr. stated inflammation/injury to rotator cuff, possibly caused by injection.  Dr. wants MRI scheduled next week - but I need to contact my insurance company first.  Injury is pending.
diffuse urticaria starting 21SEP97;rx DPH IM/PO;urticaria;started a/recv polio/meningococcal vax;
Got a COVID break through in September - diarrhea, body aches from head to toe,  cough that wouldn't stop, shortness of breath, low O2 count - lasted 4 weeks - still have shortness of breath.
Intense burning of my skin all over my body. I have multiple food allergies that cause this type of reaction so I dealt with the burning in the same way that I do got good allergies. It helped. After two days the burning stopped.
Left arm where shot was given became very warm, swollen, experienced alot of pain and arm was very red.  Upper part above the left breast had pain like when a person becomes upset.  Had the shot on Friday 3/23/07 and did not go into work the following Monday, still experiencing pain and weakness, more pain at the elbow area, cannot lean it on the desk without the soft gel pad under my arm.
Pt was over 50 yo. and received the FLUMIST vaccine normally. Clinic notified 9/20/08 and advised to watch pt closely next 24 hours. On 9/21/08, pt was contacted and is doing well.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid started on 15May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the reported event COVID-19 is considered related to BNT162b2, BNT162b2 omi ba.4-5 and BNT162b2.
Drowsiness by 6 pm. (I slept 24 hrs in the following 32 hrs).  Soreness in left arm for 30+ hrs after vaccine administered. Migraine by 1:30 am on 21-jul.  Disappeared in 3-4 hrs but headache persisted until noon on 21-jul.  Fever between 100.5F and 101F when checked on 21-jul afternoon. Felt dehydrated even though I ensured that I had at least 2 liters of water each day.  Lack of appetite. Had to force myself to eat by 5pm on 21-Jul to fight fever.
S: allergic reaction   B: received vaccine at 1415.    A: Reported itching, throat constriction, and coughing. Ambulated to wheelchair to bring to ED. Epinephrine was administered on the way to ED. See MAR.    R: Sent to ED, See note.
7 X 4 1/2 inch swollen area around injection site on rt thigh surrounded by erythema. Area was warm to touch.  Encouraged cold packs and Ibuprofen if needed.
Missed menstruated cycle. Had some light spotting in March and skipped cycle in April. Not pregnant
Received vaccine on 9/20/2021 at  9/21/2021: I was at work and at 2pm, I became dizzy and sweaty. I went to the hospital on base. My fasting blood sugar was 67. I was given juice to increase my sugar. Although I do not have a history of blood sugar issues.  9/24/2021: approximately 2am, I woke up dizzy, unsteady gait, sweating, nausea and vomiting (liquid only).
Information has been received from a physician concerning an 83 year old female patient with an iodine allergy who in 21-Dec-2005 was vaccinated in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine. At the time of vaccination the patient had "PMR", low back pain, atrial arrhythmias, and hypertension. On the same day, 21-Dec-2005, following vaccination, the patient experienced a systemic reaction "following revaccination" and became completely white and stiffened up. Unspecified medical attention was sought. Subsequently, the physician's office called the pt on 28-DEC-2005 to check her status and the pt noted that she had recovered completely, as of 21-DEC-2005. No product quality complaint was involved. The reporter considered the adverse experiences to be other important medical events (OMIC). Additional information is not expected.