chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A day and a half after the booster I started experiencing ringing in both ears that has continued to grow louder as the weeks passed. I suddenly started getting mild bloody noses after I blew my nose every day. Extreme insomia set in. And if I did fall asleep I woke up with a rapid heart beat. I started experiencing anxiety with the constant noise and withdraul from people. I do not feel like the same person any more. All of these symptims are still with me almost 2 months later. I have tried Corticosteroid for the ringing in my ears as well as perscription Corticosteroid ear drops. I have a referral to see an ENT Dr in July. But so far nothing has helped give me any relief.
The shot / i got it and about a year later i got the Shingles again / no fun/Suspected vaccination failure; The shot / i got it and about a year later i got the Shingles again / no fun; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a bad case of shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient stated that vaccine did not keep you from getting the Shingles. You just get a lighter case. The patient had a bad case and when the shot to prevent it was offered, patient got it and about a year later he/she again got the Shingles but it was a lighter case. This case was considered as suspected vaccination failure as details regarding vaccination schedule and laboratory confirmation were unknown at the time of reporting. No other information was reported. The follow-up would not possible, as no contact details were available.
the patient was inadvertently immunized with an expired dose of Tenivac with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a physician and other health care professional via Medical Information (Reference number- 00643928) and transmitted to Sanofi on 16-Jun-2021.   This case involves a 52-year old female patient who was inadvertently immunized with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, suspension for injection [TENIVAC] (expired product administered) On 16-Jun-2021 [lot number: C5578AA and expiration date: 28-Jan-2021] at 0.5 ml dose via intramuscular route in unknown administration site for prophylactic vaccination.  It was unknown if the patient had any medical history, concomitant disease or risk factor, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  It was unknown if there were lab data/results available.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Subsequent of receiving one and two doses of varicella virus vaccine live the pts laboratory evaluation revealed negative seroconversion.
NAUSEA; CHILLS; BODY ACHE; FEVER; VOMITING; HOT FLASHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced body ache. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced vomiting. On 08-MAR-2021, the subject experienced hot flashes. Laboratory data included: Body temperature (NR: not provided) 102 F. On 08-MAR-2021 20:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, chills, body ache, fever, vomiting and hot flashes was not reported. This report was non-serious.
Patient received  the second dose 77 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received  the second dose 77 days after the first dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received  the second dose 77 days after the first dose). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received  the second dose 77 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.
Patient was hospitalized; This spontaneous report was received from a Healthcare worker via a company representative referring to a female patient of unknown age. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 11-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, route, lot # and expiration date were not reported), for prophylaxis.  On 15-OCT-2019, the patient was hospitalized (adverse event) and discharged on 18-OCT-2019. No further information was provided about where or why the patient was hospitalized. The outcome of the event was unknown.  A causality assessment was not provided by the reporter.
Pt seen in hospital on May 11, 2009 with bilious emesis, and low grade fever. She was sent home with the diagnosis of acute gastritis. The patient presented to our clinic on Tuesday morning with same complaint and also report of no bowel movement for three days. When Dr. examined baby she had a palpable mass in her left lower abdomen. He then noted after examining her rectum, a grossly bloody stool. Patient was then sent to hospital where she was diagnosed with intussusception. She underwent bowel resection oon May 12, 2009.  6/15/09 Hospital records received DOS 5/12/09. Assessment: Intussusception. Patient presented with abdominal pain, bilious vomiting, crying, blood per rectum, bloody stool, fussy, lethargic. Congestion past 24hrs. Decreased skin turgidity. Tachycardia.6/22/09-ICD-9 codes received 560.0, 787.03. V 641. 9/28/09 Discharge summary received for date of service 5/12/09 to 5/17/09 DX: Successful surgical open reduction of the intussusception
inadvertently given to a patient that was only 62 years with no adverse event; Initial information received on 30-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves a patient for whom reported inadvertently given vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] that was only 62 years old (product administered to patient of inappropriate age). No adverse event was reported.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 28-Oct-2020, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ537AB, Expiration date: 30-Jun-2021) via intramuscular route for prophylactic vaccination, inadvertently given to a patient that was only 62 years old (product administered to patient of inappropriate age)  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   No other relevant information was reported.
Her firs was on 12/24 and she reports 7 hours later she had blurry vision and passed out.  She continued to have nausea and couldn?t eat missed several days of work and lost 5 kg due to nausea.  She received the second on 1/24 and she reports that 3 ½ hours later her heart rate was high, blurry vision and soa.  She reports she does not remember much other than resting and her husband picking her up.  She stated that she couldn?t remember much after that and was difficult to wake up by her family. Was off work a few days and is now back but feeling weak.
approx 30 mins after dose given patient started to feel tingling and burning in his tongue. He had a similar reaction after his first dose of  Moderna on 3/12/21. vital signs taken and 50 mg of Benadryl given PO. Patient monitored in clinic.30 mins after administration patient said he felt like the tingling and burning was less and improving. Patient to return to clinic if symptoms worsen.
I had severe swelling in my eyes and eyelids and under my eyes. My face also swelled. My vision was and still is blurry. My eyes hurt so bad like I had a sty. The glands above my eye were hard and swollen. My eyes itched and burned and every time I blinked it felt like sandpaper. It still feels like sandpaper when I blink and I have very dark circles under my eyes that look like bruising. I have seen my primary doctor and an eye doctor. The eye doctor gave me eye drops yo use 4 times daily but I am still feeling irritation so I have a follow up next week.
The next day after the shot, I had a small rash on my wrist.  It disappeared during the day.  Saturday evening, my right thigh felt like it received a trauma like a hit, but I did not have an injury.  An area the size of my hand is slightly pink on the thigh.  On Tuesday, I tried starting ibuprofen, but it did not really remedy the pain.  I went to urgent care Wed. evening.  They sent me for an ultrasound to rule out blood clots.  No blood clots, but lymph nodes were visible in ultrasound.  They suggested I follow-up with PCP.  On Thursday and Friday, the leg felt crampy but less painful.  Friday night the pain traveled down my right leg to ankle as well as right lower lung had dull ache.  Returned to urgent care.  They are treating the leg for cellulitis (1000mg daily of generic Keflex.)  They said if the leg felt better in 24 hrs, probably cellulitis, but if not, it might be a response to vaccine.  There is no relief after 3 doses and 24 hr + later.
Injection site pain and tiredeness day after injection. Severe left sided low back pain centered in sacroiliac joint, next day radiating into left leg and left thorax on Sunday, five days after injection.  Severe disruption in all ADLs necessitating narcotic pain medication and an emergent visit with chiropracter. This pain is somewhat better but still persists today 14 days after onset!!  This is absolutely miserable. I think I'd rather have COVID
DTaP Lt delt IM red/swollen 10x10cm, itchy warm to touch, non tender 24 hours after injection.  TX Tylenol, Benadryl.
76yr old male presents to the ED from the clinic with complaints of shortness of breath, fatigue and not feeling well.  Has been to the clinic 3 times in the last 2 weeks.  Patient denies having any pain.  Diagnosis: pneumonia, bilateral pulmonary embolism with suspected right ventricular strain,  positive d-dimer, hypotensiontransferred  via helicopter.
booster; sore arm; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose 01), when the patient was 53 years old, for Covid-19 immunization, reaction(s) sore arm, tenderness; Bnt162b2 (Dose 02), when the patient was 53 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious), outcome unknown; PAIN IN EXTREMITY (non-serious), outcome unknown; FATIGUE (non-serious), outcome unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
By 5 minutes after receiving the vaccination rash began on bilateral arms, then moved neck, stomach, back, under arms, and legs.
nonreactive antibody test; 'Drug dose administration interval too long; 'Drug dose administration interval too long; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 51-year-old female patient who received HBV (Engerix B) (batch number 29ZB7, expiry date 29th June 2021) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 54A32, expiry date 12th November 2021) for prophylaxis and HBV (Engerix B) (batch number L5C49, expiry date 17th May 2022) for prophylaxis.   On 29th June 2019, the patient received the 1st dose of Engerix B. On 7th August 2019, the patient received the 2nd dose of Engerix B. On 8th March 2020, the patient received the 3rd dose of Engerix B. In August 2019, not applicable after receiving Engerix B and Engerix B and unknown after receiving Engerix B, the patient experienced drug dose administration interval too long. In March 2020, the patient experienced drug dose administration interval too long. On 3rd June 2020, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and drug dose administration interval too long were unknown.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient received the complete 3-dose series of Engerix-B but had a nonreactive antibody test on 3rd June 2020. The patient received 2nd and 3rd dose late which led to lengthening of vaccination schedule. The reporter consented to follow up.
The wrong vaccine was given for this patient. PCV-13 was suppose to be given. PPV was given. No adverse reaction noted. Mother notified of incident.
I am a nursing mother. I started nursing June 22, 2021. The first shot gave me a reduction in breastmilk. I?ve never really been able to get back to where I was even with additional pumping.  I exclusively pump and Measure after each pump. Fire king vaccine, I was pumping 16 to 18 ounces per day. I dropped is low and 12 ounces and I?m currently between 14 and 16 ounces per day. It has been four weeks since my first vaccine.
Admitted for left PCA CVA after presenting with dizziness and right sided visual field deficits. MRI showed Medial left occipital lobe infarct. He did have a bit of hemorrhagic conversion that precluded the ability to give him anticoagulation for a few days.   He was eventually started on Eliquis and developed recurrent gross hematuria. He was taken to the OR for Limited Bipolar transurethral resection of prostate, fulguration of bleeding vessels, clot evacuation.  His Eliquis was resumed the next day and he has not had further hematuria.  Discharged to home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pt's arms were mildly edematous and warm to touch.  There was a slight redness to the site of the injections.
Information has been received from a registered nurse from a hospital infusion center concerning a 22 year old female with sulfa allergy and no pertinent medical history who on 26-JAN-2007 was vaccinated with first dose of Gardasil (lot# 655619/1427F), 0.5 ml, IM in left deltoid.  There was no concomitant medication. On 27-JAN-2007, Saturday morning, the patient called and reported she experienced pain at the injection site and the pain had increased.  The patient sought medical attention. No diagnostic tests were performed. On 31-JAN-2007, the patient experienced pain and tingling down her left arm. At the time of reporting, the patient had no recovered. The patient was referred to her primary physician for follow-up.  Additional information has been requested.
210 PM-Received flu shot. 240pm-Returns to clinic stating her neck feels blotchy with difficulty swallowing. No redness or blotching noted. 3:20P Examined by MD. No medication given. Observed for 40 mins and then discharged. Patient states she feels better.
Severe nausea lasting from late afternoon accompanied by stomach cramping, through the evening, with one incident of explosive vomiting around 8 pm. Nausea lasted through the night but was gone by 5 am.
Moderna COVID - 19 vaccine EUA  Started with a mild head ache that progressed as the day went on. By 10:00 that evening my head was busting. Sometime during the night I woke up drenched from sweating out my fever. it went as high as 102.5. I was delirious, had chills, and severe body aches. The site of the injection is super sore. The shot was on Wednesday. The symptoms started in less than 12 hours and I did not feel better until today which is Saturday. And honestly, I am still wiped out.
Headache, Fever, feeling tired and fatigue, chills off and on. Narrative:  Received 2nd Vaccination approx 1430p and approximately 9-10 pm on 4/16/21. experience fever, chills, H/A, and feeling very tired yesterday. Fever has resolved, has chills on and off and fatigue. Advised these are normal symptoms. Hydrate and rest. Seek Medical attention if not resolved in 48 hours and update employee health & supervisor
This spontaneous report was received from a licensed practical nurse regarding to 2 patients of unknown age and gender. There was no information about patient's concurrent condition and historical medication. On 08-JUL-2015, the patient was vaccinated with improperly stored VARIVAX (Lot number, expiration date, dose and strength were not reported). No concomitant medication was reported. No adverse event was reported. No PQC involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax; devel few lesions; 4mar96 exp breakthrough chicken with about 100 lesions on the face,scalp,and trunk;
Pityriasis rosea developed within 2 weeks of vaccination.; This is a spontaneous report from a contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 15:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation.  The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Mar2021 at 17:30 (at the age of 26-year-old) as a single dose for COVID-19 immunization.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient developed pityriasis rosea within 2 weeks of vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event pityriasis rosea and included treatment with antihistamine and triamcinolone acetonide (MANUFACTURER UNKNOWN) cream. The clinical outcome of the event pityriasis rosea was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shortly after exiting the pharmacy, the patient's dad came back to the pharmacy propping up his son. Stated his son got light-headed and almost fainted. The pharmacist had the patient come into the vaccine area, sat him down, and took his blood pressure (106/80). His breathing was monitored and when it checked out, the pharmacist gave a single dose of diphenhydramine 25mg. The patient drank 2 x 16oz of water. Paramedics were called as a precaution. The patient was able to walk out on his own. The pharmacist made a follow up call at 2PM and the father acknowledged that his son is doing fine.
Redness and swelling from shoulder to elbow. Visited Dr office and was told to use Benadryl, cold compress, and Tylenol.
Severe vomiting and acute stomach pain for 10 hours, 100.1 fever for 12 hours, and body aches.
a patient of 18 months of age received a dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a patient of 18 months of age received a dose of Kinrix). The outcome of the inappropriate age at vaccine administration 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: 19-JUL-2023 A nurse called to inform that earlier that day, a patient of 18 months of age received a dose of Kinrix, which led to inappropriate age at vaccine administration. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Severe swelling of face, lips,  tongue breathing restricted and hives on left side of body and on tongue. Was in Hospital 7/25/21 AND 7/27/21. Second visit much more severe and happens faster. I now have hives on my back when I have an alcoholic beverage and still determining what foods are causing allergic reactions also.  Still undetermined.
About 45 minutes after l received my vaccine, my eyes started to water and nose was runny ( most of the entire day! No allergies before this! About 4 hours after vaccine l had a drink of water had was chocking on a sip( couldn?t breathe ( spitting and sweating) couldn?t catch my breath! Very scary. Shortly a few minutes later ( tried to suck on a piece of melted chocolate and could pass throat. Another chocking event occurred. I find by gagging and spitting to get relief and breathe. Heavy feeling in my chest lasted until evening ! Still very sore arm today