chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ALTE- Mother checked on child while napping, and noted the infant was blue and not breathing.  Mother provided CPR and EMS was contacted.  Child resumed spontaneous respirations and was crying.  Child was admitted to the hospital for monitoring.  A fever had been noted on the day of admission with maximum temp 103.6 axillary.  A septic workup was initiated due to the fever, despite knowledge of recent vaccinations. 9/25/07 Vax record reviewed which confirms RO dose & lot # as reported.  11/13/07 Reviewed hospital medical records which reveal patient experienced fever, cyanosis, limpness & apnea. Parent initiated CPR & patient responded.  Transported by EMS to hospital.  Admitted 9/18-9/20/2007.  LP done & started IV antibiotics.  No further episodes in hospital.   D/C to home on apnea monitor. FINAL DX: acute life threatening event w/fever; apnea of newborn; status was cardiorespiratory; anemia, phpysiologic; & leukocytosis.
Woke up with horribly sore arm where shot was given, also mild sore throat, also headache and sore muscles throughout my body that aren?t improving with pain meds
Covid Arm. Hard painful lump turning into a very large painful lump with itchy rash and now 2 weeks later it looks like a bull's eye with red outer itchy rash ring
Covid19 breakthrough.  1st Vaccine received on 03/15/2021.  53 y/o with hx of ESRD on HD presented with respiratory distress, non productive cough. No fever or chills.  Noted to have sats in the 30% range on arrival.  Placed on NRB mask-O2 sats up to 94%.  CXR with pulm edema, Bilat effusions.  ABG obtained and pt placed on BIPAP.  Admitted to ICU and started on IV Abx/IV steroids and Remdesivir.
Huge bulge/enlargement, soreness and pain within my armpit. Soreness and pain at vaccination site around my shoulder.
The health event was that I got COVID-19. Tested positive on Sunday April 24, 2022. I felt pretty bad, not awful, but had really bad muscle aches. I had drainage from nose to throat. Had a bit of a cough, not major and a little difficult time with respiratory but none of this was extreme. Didn't feel good though. Went to the clinic to see if I would be eligible for Paxlovid antiviral medication. They agreed that I should have it because my oxygen levels were lower than they liked. It was close to 95, but NP was nervous and wanted to watch over it. Started taking the medication on April 24. I have one more dose today and tomorrow of the medication. Also was given a prescription for albuterol since the 24th that I've also been taking. Feel mostly better. Had a little bit of a stomach issues during this stretch as well.
pt recvd vax 11AM & mom stated @ 250PM pt screamed from 1PM to 2PM; has golf ball size red swollen area @ inject site; pt is also fussy & agitated; notified MD who advised to call clinic;
Left arm/bicep lump, redness, swelling. Patient reports fever 101.5 at home, headache, general achiness. Prescription written for Prednisone 3/11/10.
After the vaccine I had pain/soreness in my shoulder for the next two days but I knew that was to be expected from the shot.  After 2 or 3 more days the pain had subsided some but I was still experiencing a good amount of pain in my shoulder.  After 2 weeks or still having pain I scheduled an appointment to see my physician.  My physician prescribed diclofenac and told me to take them for 2 or 3 weeks to see if that would resolve my pain.  After 3 or 4 weeks I was still having pain so my physician referred me to an ortho specialist. At the time I was having trouble with waking up at night due to the pain so he gave me a cortisone shot and scheduled me a meeting with the physical therapist.  Initially, the cortisone shot worked and I no longer had any pain.  At this point the PT told me as long as I wasn't having any pain we didn't need to continue scheduling meetings but if the pain came back to call in and schedule an appointment. Right at the one month mark I began having pain in my shoulder again and scheduled an appointment for PT.  I had 5 PT sessions scheduled over roughly 2 months.  The pain did seem to decrease but an issue I continued to have was doing certain activities caused the pain to come back. On April 29th I had a follow up with my Ortho Dr. and he scheduled a MRI and an EKG.
RIGHT ARM WHICH IS WHERE THE INJECTION WAS RECEIVED IS SORE WHICH STARTED ON 05/20/21 STILL TO THIS DAY 06/07/21. PATIENT  HAS FULL RANGE OF MOTION. CAN LIFT ARM A LITTLE MORE THAN HALF WAY TO THE SKY WHEN THE PAIN IS FELT IN THE MUSCLE. AT POINT OF INJECTION THERE IS STILL A SCAB.
ended up pricking herself with the needle; ended up pricking herself with the needle; a part of the needle or a part of the, what you call the vaccination two things fell apart/ The syringe, the blue part on the syringe fell off while giving vaccination; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A female patient was exposed to pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 17Apr2023 at 15:00 as dose number unknown, single (Lot number: GD1168) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious) with onset 17Apr2023 at 15:00, outcome "unknown", described as "a part of the needle or a part of the, what you call the vaccination two things fell apart/ The syringe, the blue part on the syringe fell off while giving vaccination"; INJURY ASSOCIATED WITH DEVICE (non-serious), OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) all with onset 17Apr2023 at 15:00, outcome "unknown" and all described as "ended up pricking herself with the needle".  Additional information: It is PREVNAR 13 vaccination and a part of the needle or a part of the, what you call the vaccination two things fell apart while giving the vaccination to a baby. It happened on 17Apr2023 at 15:00, this was the third dose of the baby. The blue portion of the syringe of the vaccine shot came off while injecting. The nurse pulled it out quickly. However, it scratched the child, and she ended up pricking herself with the needle. When probed if the needle got injected to nurse accidentally, no. The blue part on the syringe or the needle broke off while giving the vaccine to the baby. So, when she pulled it out knowing that it is already broken, ended up scratching the baby and poking herself at the same time.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300163933 Same reporter/ drug/ event, different patients;
Product Complaint; Liquid shot out from the vial and got on her hand; Liquid shot out from the vial and got on her hand; This case was reported by a nurse via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number NF442, expiry date 5th October 2023) for prophylaxis. This case was associated with a product complaint.   On 18th August 2022, the patient received Shingrix .5 ml. On 18th August 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration and exposure via skin contact. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure while preparing product for administration, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comment: The nurse stated that when she went to put the adjuvant into the antigen bottle, the liquid shot out from the vial and got on her hand. The reporter said about 0.1 ml left after the adjuvant was put in the antigen bottle and there was stopper pierced in the circular area dedicated to perforation. There were no air injected into the vial.  No product quality complaint report was completed. Not enough of the vaccine was left to administer.  The reporter reconstituting the Shingrix was an experienced user.  The reporter will send pictures.  The reporter asked to send a single vial dose pack for replacement and also send a return shipping label for the clinic to send back the defective dose. The reporter did not gave consent to follow up. Additional Supportive Information: The liquid shot of the vaccine out from the vial and got on reporter's hand, which led to occupational exposure while preparing product for administration and exposure via skin contact. The product complaint event was captured as local and global reference numbers were reported and for further clarification follow-up request was raised.
suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a 96-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 98 or 97 years old at time of vaccination. The patient was diagnosed with shingles after having received two doses of Shingrix (both doses administered less than 6 months apart). The patient received the second dose of Shingrix more than 30 days before shingles diagnosis. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown. No further information was available.
My legs would not move correct I was matching as walking and I could not walk straight I was walking diagle; My legs would not move correct I was matching as walking and I could not walk straight I was walking diagle; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Aug2021 15:30 (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Kiwi" (unspecified if ongoing); "Known allergies: Tape" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MOVEMENT DISORDER (non-serious), GAIT DISTURBANCE (non-serious) all with onset 27Aug2021 15:30, outcome "recovered" (2021) and all described as "My legs would not move correct I was matching as walking and I could not walk straight I was walking diagle". Therapeutic measures were not taken as a result of movement disorder, gait disturbance.  Additional information: Prior to vaccination, the patient  was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
received Havrix expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 5th August 2022, the patient received Havrix. On 5th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: The patient received a Havrix expired dose. The reporter consented to follow up by email. Additional Supportive Information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Seizure, nausea, tingling in fingers, stiffness in arms, patient felt hot
Little to no symptoms for first and second dose, 3rd dose showed severe headache, swollen lymph nodes, fatigue, and nausea.
On 9/21/21 - all over body aches and chills, extreme fatigue On 9/22/21 - red rash under breasts, up middle chest, around neck and top of back
Pregnant adolescent in need of immunizations required for school entry (Hepatitis B and Td).  Vaccines provided in prenatal clinic without adverse event, but Hep B vaccine was an adult formulation rather than the indicated pediatric version.
BLOOD WITH NUMBER 2'S; COMPLICATIONS OF CHEST PAIN; This spontaneous report received from a consumer concerned a 56 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) start therapy date were not reported, 1 total administered on right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that, on 15-APR-2021 (last thursday)  the patient had complications of chest pain. On 17-APR-2021 (saturday), she went to emergency room. The team of doctors stated that nothing was wrong with her. The reporter was unable to provide specific information regarding the lot number, date of vaccine received or the location but informed that he can obtain the information and provide it. The reporter was contacted again on 22-APR-2021, where details (age, date of birth) of the patient was provided but was unable to recall the specific date of vaccination. Providing further information it was reported that on 22-APR-2021, the patient had blood with number 2's, but did not had chest pain anymore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from complications of chest pain on 22-APR-2021, and had not recovered from blood with number 2's. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210444704-COVID-19 VACCINE AD26.COV2.S-Blood in stool. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
07/11/06 received immunizations 7/12/06 stated during feeding on 7/11/06 stopped feeding, stopped breathing, color change apnea alarm went off.
pt recvd vax & was pale, disoriented to time & place; BP 92/70; incontinent of urine;
Hives, swelling, hard to breathe, breathing has gotten easier , hives and swelling are still bad, feel like crap
I've been experiencing pain my hands from the wrist to the fingers. First the pain was tolerable and then it became aggravating. The pain has been interrupting my sleep. The pain doesn't last long, but it can last to 3 to 10 minutes. The hand pain shows up off and on. I received instructions for at home therapy. I've been using a gel called diclofenac that I was prescribed. I've also been doing hand exercises. I was also told to use ice for the pain. I was prescribed NEURONTIN but it did not help. I've been taking methocarbamol which has given me some relief.
This spontaneous report as received from a Licensed Practical Nurse refers to a 19 year old female patient. In January 1996 (exact date unspecified) the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route, lot number and expiration date not reported) for varicella immunization. On 30-JUL-2007 the patient was vaccinated with the second dose of VARIVAX (Merck) (dose, route, lot number and expiration date not reported) for varicella immunization. There was no concomitant medication reported. The nurse reported that the patient has joined the military and lab titer was drawn to test immunity on 02-MAY-2013 and the result showed the patient failed to seroconvert for Varicella immunity. Nurse also reported that the physician at the center has ordered for the patient to receive a third dose, not yet administered. The outcome of the events was unknown. The patient did not seek medical attention. Additional information has been requested.
12/31/21 presents to EC ED for "failure to thrive". PMHx of "A-fib, CHF, CKD, COPD"
PATIENT RECEIVED TWO DOSES OF FLUAD. ONE WAS GIVEN LAST WEEK FROM A DIFFERENT PHARMACY AND THE OTHER AT PHARMACY, TODAY 09/22/22. THE CARE GIVER FILLED OUT THE FORM AND WROTE FLU SHOT.  RPH DISCOVERED THE ERROR AFTER GIVING CONSULTATION.
Client reports with both 1st and 2nd Pfizer COVID vaccine she developed numbness in both legs with onset at 6-8 hours post vaccination and lasting throughout the night.  Resolved without intervention, did not follow up with primary care provider.
Severe stomach cramping, fever, diarreha, vomiting lasting more than 24 hours; no treatment.
Having a headache/migraine almost every day since around the time; Having a headache/migraine almost every day since around the time; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Mar2021. Medical history included ADHD (attention deficit-hyperactivity disorder), depression, hyperhidrosis and allergy to sulfa and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included dexmethylphenidate (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) for unspecified indications, from an unknown date and unknown if ongoing. The patient previously received cefalexin (KEFLEX) and amoxicillin (MANUFACTURER UNKNOWN) on unknown date for unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. From 28Mar2021, the patient has been having headache and migraine almost every day since around the time, the patient received first vaccination (24Mar2021) . 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 reported events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events headache and migraine almost every day was not recovered at the time of report.  The patient received second dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 at 12:45  (at the age of 21-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Severe itchy painful rash on hands, arms, around mouth and eyes.; Severe itchy painful rash on hands, arms, around mouth and eyes.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer brand), dose number unknown via an unspecified route of administration, administered in Arm Left on 13Mar2021 12:15 PM (lot Number: EL3302) (at the vaccination age of 67-year-old) as single for COVID-19 immunisation. Medical history included Penicillin allergies and Eczema. The patient did not diagnosed as Covid prior vaccination. There were no concomitant medications. There was no other vaccine in four weeks. Other medications in two weeks was none. As reported, on 05Apr2021 03:30 PM, the patient experienced severe itchy painful rash on hands, arms, around mouth and eyes. It took about 2 months to clear up. The adverse events resulted in 'Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care'. The treatment for the events was yes with Antibiotics steroids and steroid creams. COVID tested post vaccination as nasal swab negative on 19May2021. The patient was not pregnant at vaccination. Therapeutic measures were taken as a result of severe itchy painful rash on hands, arms, around mouth and eyes. The outcome of the events was recovered on an unspecified date.
Two days after the vaccine, my eyes began to water profusely and I began to get dizzy spells, along with headaches. I did not associate this with the vaccine at the time. I had been experiencing a stuffy nose, so I had an appointment with my ENT the following week. He could not pinpoint anything, so he had me get a CT scan and hearing test, which both came out clear. He had no explanation for the sudden dizziness and headaches, and has scheduled me for a VNG in late December. Like I said earlier, I thought this was a sinus issue, but have to look into the possibility of it all being caused by the Shingrix vaccine. I have contacted my GP's office to follow up with them, but was told I should report this to you also.
Narrative:  Pt states that shortly after receiving vaccine, his blood sugar went to 500-600's, which is unusual for him. He was hospitalized overnight and was treated. Patient also states that he started having difficulty swallowing following the vaccine.
3 DAYS POST INJECTION DEVELOPED MODERATE TO SEVERE CASE OF SHINGLES. (SCALP TO FOREHEAD AND AROUND RIGHT EYE).  NEW LESIONS STILL APPEARING ON THIS DATE OF REPORT (2/4/21).  PRESCRIBED VALACYCLOVIR 1000 MG PO TID X 14 DAYS.
fever, bulging fontanelle, fussiness, decreased PO intake within a few hours within 1 day after receiving 4 month vaccines
Patient developed itchy neck, ears, chest and arms, approx 30 min after vaccine, also received fluvaccine, history of allergies to latex, strawberries, banana morphine and shellfish, went to own office and took benedryl with no relief, patient escorted to ED for further eval
Injection given started to swell some and itch slightly after injection, better with band aid removed.  Arm sore and bruised with in a few hours of injection on December 26th.  Arm remained very sore and bruised at injection site until Wednesday December 30th around 1400 itching started at injection site, lasted about an hour and subsided.  January 1st I woke up with the site really itching.  Around 1400 on January 1st I noted a raised area around the injection side, no erythema noted.  Erythema started around 1800 and was much darker by morning on January 2nd.  Did not appear to be increasing in size.  Left eye was also itchy on the same side as the injection in my left deltoid.  These symptoms subsided some with 10 mg of Claritin.
8-6-10 welt raised red at site of injection. About size of 3 quarters across. Has little blisters or bumps.