chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt exposed to varicella vax strain through contact w/sibling WAES97052819 who contracted chickenpox via secondary trans through contact w/individual WAES97052772 who recv vax;pt devel vesiculopustular rash on erythematous base;
53 years old patient was administered a pediatric dose of Engerix-B; 53 years old patient was administered a pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 53-year-old male patient who received HBV (Engerix B 10 mcg) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 04-OCT-2023, the patient received Engerix B 10 mcg. On 04-OCT-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: 53 years old patient was administered a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: 53 years old patient was administered a pediatric dose of Engerix-B).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter reported that the 53 years old patient received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter also notes that she thoughts that the patient may had received hepatitis b series years ago, but he received an alert from his medical chart from PCP's office stating that he was overdue for certain vaccinations, so he came in to request hepatitis b series.  The reporter did not had any information on possible prior hepatitis b series. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Information has been received from a 70 year old female consumer reporting herself with seasonal allergy that many years ago a nurse gave her the wrong type of "syrum", and put a (DPT) "under the skin" who on an unknown date, was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). Concomitant therapy included levothyroxine Na, ZYRTEC, PREVACID and losartan potassium (MSD). The patient mentioned that after she received PNEUMOVAX 23, she got sore at the injection site. Then the next evening, when she looked at the size of it, it was about three inches and very red and inflamed. Late that evening, the patient ran a fever of 101.4 and the patch grew to about inches. This is one of two reports received form the same patient. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Information has been received from a physician via Pfizer on 08-AUG-2016, referring to 3 patients of unknown age and gender. The patients' medical history and concurrent condition were not reported. In approximately 2006 (reported as ten years ago), the patients were vaccinated with ROTATEQ orally (dose, dose number and lot# were not reported), which caused intussusception. The outcome of intussusception was not reported. Upon internal review, intussusception was determined to be medical significant event. Additional information has been requested.
The patient "lost head control", stopped rolling over and became listless for 1 1/2 weeks.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 17:00 (Lot number: FC3183) at the age of 43 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: ST JOHN'S WORT; LION'S MANE; VITAMIN D [ERGOCALCIFEROL]. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 24Aug2021 21:00, outcome "unknown", described as "stomach cramps"; DIARRHEA (non-serious) with onset 24Aug2021 21:00, outcome "unknown", described as "diarrhea"; NAUSEA (non-serious) with onset 24Aug2021 21:00, outcome "unknown", described as "nauseous". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhea, and nausea. Additional information: Adverse event: I have been having stomach cramps, diarrhea, and nauseous for the last 3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
There was no adverse events reported by patient. Due to the refrigerator temperature excursion on 8//2/16. Manufacture determined the vaccine is not viable and CDC recommend revaccinate.
Patient noted to have difficulty closing Left eye and chewing normally while in the shower approximately one week after vaccine administration.  Went to local ER where he was diagnosed with a "Bell's Palsy" and treated empirically with Prednisone and acyclovir.  Patient was referred to a neurologist who evaluated him on the 21st - at that time patient was noted to have some facial droop, weakness in closing the eye and changes in taste sensation and hyperacusis consistent with a 7th nerve palsy.  Patient came in on 6/13/2008 to report to me this incident.  At the time of entry he has regained most of his facial muscle strength and no longer requires the use of artifical tears. 8/5/08 Reviewed ER medical records of 5/14/08. FINAL DX: Bell's palsy Records reveal patient experienced left facial droop, unable to close left eye or smile on left side w/abrupt beginning few hours prior.  Tx w/antiviral, steroids & eye drops.  D/C to home w/referral to neurologist as outpatient.
This case was reported by a pharmacist and described an adult male pt who did not respond to hepatitis B vaccine recombinant (Engerix-B).  The pt's medical history, concurrent conditions and concurrent medications were not reported.  The pt was identified as "high-risk for hepatitis B."  The pharmacist stated that the pt had received "two full series" of Engerix-B and "has not responded."  The pharmacist clarified that the pt had received six adult doses and "his titers are still negative."
Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown 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 provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Information has been received from a physician concerning a 2 year old patient who in September 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) due to a nursing error. No adverse effect reported. There was no product quality complaint. Additional information has been requested..
Swelling & redness to (rt) thigh. Med: Diphenhydramine 12.5/5ml.
feeling like I might faint; Heart beating very fast; feeling dizzy; This is a spontaneous report from contactable consumer (patient).  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: Ew0170), dose 1, single dose,  via an unspecified route of administration, administered in the left arm on 21Apr2021 at 09:45 (at the age of 39 years-old) for covid-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. The patient did not receive any concomitant medications. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. The patient experienced feeling like I might faint, heart beating very fast and feeling dizzy on 21Apr2021 at 12:00. The patient underwent lab tests and procedures which included heart rate: heart beating very fast on 21Apr2021. No treatment was received for feeling like I might faint, heart beating very fast and feeling dizzy. The outcome of feeling like I might faint, heart beating very fast and feeling dizzy was recovering.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.   Information on Lot/Batch number was available. Additional information has been requested.
Patient received dose #1 of COVID vaccine shot was given and when bandage was applied, Pt had episode of fainting. Pt was not provided acute treatment. Pt was out for 10 seconds.
On 11/5: patient's wife called concerned that patient was experiencing chills and fever. On 11/6: 9:39am fever is down, patient is very weak. 7:30pm large rash around site of injection measuring 5x7 inches. On 11/7: 10:29am rash much worse and much larger measuring 7x7 inches. Patient went to pcp - given antibiotic for rash.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-APR-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-JUN-2016, the patient was treated by a physician at a medical center for a blistering vesicular outbreak, which was diagnosed as shingles. The patient was prescribed prednisone, gabapentin, acetaminophen and oxycodone (PERCOCET), and valacyclovir (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Developed very sore arm the day after the flu shot. Lasted over a week, with entire arm being sore. Denies pins/needles, limitation to movement, swelling, numbness, redness.
Numbness in left hand 4 minutes after administration of shot Hives on arms back chest thighs and stomach within 10 minutes of shot Severe headaches evening of off and on until present day especially at night Cough one day after shot
few hours later my founge turned white; I lost my taste.; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOLOURATION (few hours later my founge turned white) and AGEUSIA (I lost my taste.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced TONGUE DISCOLOURATION (few hours later my founge turned white) and AGEUSIA (I lost my taste.). At the time of the report, TONGUE DISCOLOURATION (few hours later my founge turned white) and AGEUSIA (I lost my taste.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Nausea, dizziness, change level of consciousness, diaphoretic. Patient transferred to floor, feet elevated, patient alert and oriented x 4. No shortness of breath or throat swelling.  Pulse lowered from 57 to high 40's briefly. Patient transferred to doctor's office. Vital signs stabilized and symptoms resolved. Patient was then discharged home with his mother.
This spontaneous report as received from a physician refers to a 12 month old patient. On 30-AUG-2017, the patient was vaccinated with M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 30-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
Client had Moderna vaccine for Covid19 on February 4 and March 4, 2021.  Client developed Covid symptoms on 7/11/21 and tested positive for Covid on 7/16/21.  Reported to VAERS because this is a case of a fully vaccinated person developing  Covid illness after full vaccination.  Symptoms are mild.
This spontaneous report was received from a healthcare worker (immunization administrator) concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of M-M-R II (Lot # not provided) which were exposed a supported temperature excursion, continued to be administered to unspecified patients on unspecified dates since 07-AUG-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a 31 year old female Doctor Of Pharmacy who in approximately 2000 or 2001 was vaccinated with RECOMBIVAX series (unsure of which vaccine/manufacturer not reported) and failed to seroconvert. The patient sought medical attention and a booster was given. A PQC was not reported. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Nov2022 as dose 5 (booster), single (Lot number: 6H9702) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Penicillin" (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 "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2weeks: No. Anti viral details, Product=COVID 19 Treatment, Brand=Paxlovid, Treatment start date=05Feb2023, Treatment stop date=10Feb2023, Indication=Treatment of COVID-19
Shortness of breathe, entire right side of face blew up like a balloon, inside mouth swollen up, lip became deformed, dry mouth, coughing, under neck swollen up like a pelican, itching & feeling that ants were crawling on my back,neck & face, phelm producing cough, swelling in leg on right side, hot flashes, feeling like my face couldn't breathe
My son had the HPV series starting almost 2 years ago. It was pushed hard at the doctors office. Ever since then he has had stomach aches, headaches, psychiatric symptoms, periods of rages, periods of depression, etc. He has NEVER experienced any of this before the vaccines. After each vaccine he was very sore and very moody for a week or so after, the last one was the worst. I am disgusted that our society is pushing these vaccines onto CHILDREN and even the HPV to BOYS. I should have known better. This vaccine should be taken off the market.
Patient received Moderna vaccine 0.5ml at approximately 12:20pm.  During 15 minute observation period, patient became lightheaded and sweating.  Patient was transported to the provider area via wheelchair at approximately 1230.  Vital signs were obtained and patient received 25mg Benadryl after complaining of throat scratchiness.  Vital signs continued to be monitor and patient recovered and provider discharged patient at 1331 via care of his father.
With second covid vaccination, temperature rose to 100.2; This is a spontaneous report from a contactable physician. A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 04Feb2021 12:05 (at the age of 74-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3248, expiration date: Exp Apr2021) via intramuscular route of administration, administered in arm right on 14Jan2021 12:05 (at the age of 74-year-old) at dose 1, single for covid-19 immunisation for which patient experienced temp increase 102.0 on 14Jan2021 17:00. Causal relationship: Yes. On an unspecified date the patient experienced with second covid vaccination, temperature rose to 100.2. On an unspecified date the patient underwent lab tests and procedures which included body temperature: 100.2 Temperature rose to 100.2. Patient did not require treatment. Adverse event did not require a visit to emergency room, physician office. Outcome of the event was resolved on an unspecified date.  Information regarding lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
FEVER, CHILLS, ARTHRALGIA AND PAIN AROUND INJECTION SITE. SYMPTOMS LASTED APPROX. 24HRS.
pt became hot & sweaty 3 to 4 hr p/vax;next day devel gen rash & looked like had measles;8 days post vax devel blisters w/red & white spots on tongue & roof of mouth;skin became puffy, red & hot then peeled;seen by specialist dx allerg rxn;
slept for almost 24 hours straight; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in left arm, administration date 15Feb2021 15:00 (Lot number: EN6201) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "traumatic brain injury which causes a lot of fatigue" (unspecified if ongoing); "Heart conditions" (unspecified if ongoing); "taking ritalin to be able to function" (ongoing). Concomitant medication(s) included: RITALIN taken for loss of personal independence in daily activities, start date: 1995 (ongoing). Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EL9262) at 09:45 AM, intramuscularly in left arm), administration date: 25Jan2021, when the patient was 78 years old, for COVID-19 immunisation. The following information was reported: HYPERSOMNIA (non-serious) with onset 15Feb2021, outcome "recovered" (17Feb2021), described as "slept for almost 24 hours straight".  No follow-up attempts are possible. No further information is expected.
Severe tinnitus, blurred eyes/difficulty focusing, cognitive impairment, face and neck nerve pain, and hypertension.
Moderna 2/12/21, 3/13/21. Positive on 2/16/22
At 11:30pm on 3/9/2021 over 12 hours after my 1st COVID-19 vaccine , I awakened from my bed and went into my bathroom to urinate.  As I was using the restroom, I noticed my arm where I got the vaccine was very sore, and raised it slightly. Immediately after raising my arm, I became very dizzy  and passed out, fell off of the toilet and hit the left side of my temple and eye on the marble ledge of my shower. As I came to, my whole body had chills and I was shaking. I applied a cold compress and took 2 Tylenol. I alternated between sweating and chills for the rest of the night. The next morning I had a headache and felt fatigued,  but the dizziness had subsided and I rested.
Palpable area (2 cm) at injection site that is subcutaneous and tender. No change in size from initial vaccination 8/29/19
Perianal Crohn's disease, with abscess -S/p incision and drainage of perianal abscess. He had no fistula. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine. Second ED visit for Colitis - treated and relseased.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SORENESS; This spontaneous report received from a patient concerned a 51 years old. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure (Takes Medication). The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, after vaccination, the patient stated that she did not experienced any adverse effects except for some soreness.  On 18-AUG-2021, the patient said that she had done the nasal swab test which came out to be positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The patient stated that she believed that the vaccine did what it was suppose to do in lessening the symptoms from acquiring COVID-19. She also said that following that confirmed diagnosis, she experienced nausea, diarrhea, fever, headaches, sinus congestion, and loss of smell. The patient said that currently all symptoms had gone away with her sense of smell just recently recovering within the past few weeks. Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a Product Quality Complaint: 90000198689 This case, from the same reporter is linked to 20211043252 and 20211043945.; Sender's Comments: V0; 20211043553-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
4am woke up felt sick with lose stools & threw up a couple times felt chilled could not get warm. slept on & off thought was getting better, the started throwing up several times again. today I feel better & was able to keep coffee & cerel down.
Boostrix and Menactra given to a newly pregnant female. Given before + pregnancy results obtained.