chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received ADACEL transdermal instead of Tubersol via intradermal route, with no adverse event; Patient received ADACEL transdermal instead of Tubersol via intradermal route, with no adverse event; Initial information was received on 02-Mar-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional).  This case involves a 60 years old female patient who received a 0.5 mL dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot 7SY34 and expiration date: 13-Jan-2023) via intradermal route in the left mid forearm for prophylactic vaccination instead of TUBERCULIN TEST [TUBERSOL] (lot number and expiration date were not reported) (Wrong product administered and Incorrect route of product administration) on 01-Mar-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   It was an actual medication error case due to wrong vaccine administered and inappropriate route of vaccination (on same day).  It was reported that nurse took out Adacel which was ordered, however got confused and injected the patient. This occurred because of the new nurse making an error and not because of any error with our product, Adacel or Tubersol.  The reporter asked if this dose is considered valid, if the patient should be re-dosed, and what AE's (adverse events) should they be on the look out for due to the ID injection. Escalated case to TA (transfer) due to no information regarding these questions in standards or PI.  The reporter would like a call back as soon as possible.  At the time of report, no adverse event was reported.  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.  There will be no information on the batch number for this case.
The night of the second vaccine, I experienced severe chills, sweating and uncontrollable shivering/shaking.  The next day I began experiencing headaches, body aches, nausea and continued hot flashes and waves of fever.  This has now persisted for over 48 hours.
sl fever controlled w/APAP;rash, itchy;missed 2 days of school;parents not concerned just wanted to let clinic know;
12/28/2022 pt brought to ED with hematuria after home health nurse changed suprapubic catheter; came from assisted living facility; in ED, pt was febrile, hypertensive, tachycardia and tachypnea; had a positive COVID test; admitted with sepsis and COVID; blood cultures positive for Klebsiella; antibiotic given; volume resuscitation; DNR; pt continued to decline with increasing tachycardia and tachypnea; transitioned to comfort care and he expired in the hospital
Pt came to receive booster dose of Moderna vaccine. She reported she had received her first two doses from pharmacy. She had brought her mom in with her to also receive her booster dose which she had received from us 6+ months earlier. Without checking her card, administered booster dose and noticed it had only been three months when entering into system.
This spontaneous report was received from a pharmacist via a company representative and refers to multiple patients of unknown ages and genders. The patients' concurrent conditions and medical histories were not reported. On unknown dates, the patients were vaccinated with GARDASIL 9 (dose, route lot number and expiry date were not reported) for prophylaxis. Information regarding concomitant medications was not reported. The reporter stated that, on unknown dates, multiple patients experienced pain after receiving vaccination with GARDASIL 9. The anatomical location of the pain was unknown At the reporting time, the outcome of pain was unknown. The reporter did not provide a causality assessment between the pain and the GARDASIL 9. Additional information is not expected, because the reporter did not allow further contact for follow up.
No adverse event; 2 elderly patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (2 elderly patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose) and NO ADVERSE EVENT (No adverse event) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (2 elderly patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (2 elderly patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (2 elderly patients received Pediatric (6-11Y) Moderna COVID-19 vaccine instead of Bivalent booster for a 5th dose).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-651849 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651849:
Chills for about 36 hours Fever for about 24 hours  Muscle soreness for about 48 hours
Fever of ~102 degrees with body aches lasting for 48 hours. In addition to normal pain at the injection site, severe joint pain in both shoulders nearest the injection site and arm numbness that lasted for 72 hours. Other body joints (knees, hips) were also painful, but less than shoulders and may have been side effect of the fever.
Information has been received from a physician concerning a 10 year old female patient with anterior and posterior endometriosis and SYNAREL allergy and a history of laparoscopic band surgery (2007) who on 08-MAY-2008 was vaccinated with first dose of GARDASIL (Lot # not reported). Concomitant therapy included LUPRON DEPOT on 06-NOV-2008, in December 2008 and January 2009. In June-2008 after administration of vaccine the patient experienced intermittent lower anterior abdominal pain on left and right side. The pain was below umbilicus more midline than lateral. Patient had lower abdominal wall tenderness. She also experienced anxiety, nausea and decrease in appetite. She was hospitalized in June of 2008 for a few days due to dehydration and abdominal pain. She did not experience pain in July and August of 2008. On 03-JUL-2008, the patient was vaccinated with the second dose of GARDASIL (lot # not reported). In September of 2008 abdominal pain returned. She was hospitalized 16-SEP-2008 to 18-SEP-2008 and then again in October of 2008. On 03-NOV-2008, the patient was vaccinated with the third dose of GARDASIL (lot # not reported). On 22-JAN-2009 to 23-JAN-2009 she was hospitalized for dehydration. She was unable to attend college because of her symptoms. She was being treated with PERCOCET and DILAUDID but was not currently taking either medication. In September 2008 laparoscopy was performed (results not reported). Also colonoscopy, computed axial tomography, sonogram and complete blood cell count were performed (results not reported). At the time of the report on 27-JAN-2009 the patient was recovering. The patient sought medical attention office visit. The physician considered intermittent lower anterior abdominal pain on left and right side, anxiety, nausea and decrease in appetite to be disabling. Additional information has been requested.   2/10/09 Received hospital medical records of 9/16-9/18/09. FINAL DX: pelvic pain, endometriosis Records reveal patient experienced lower abdominal pain, cramping since 9/8/08 & had been seen in ER several times since then.  Similar s/s in 6/08 & had been on BCP since 5/09.  Tx w/IVF & pain meds.  Laparoscopy done w/findings of multiple areas of endometriosis.  Tx w/endocoagulation.  Progressed well & d/c to home w/continued GYN f/u
There  was no adverse reaction just the wrong vaccine given. Pt was in for his second initial shot and received the  Bivalent shot instead of the Monovalent. Dr. was contacted by nurse and he educated that pt. would his second monovalent when he came in for his booster in 2 months.  Pt. has been difficult to reach to make him aware of this due to nurse being unable to get a hold of him . Nurse will keep trying to contact him to make him aware of this. incident report filled out and on file.
FEVER, THAT ELEVATED HIGH ENOUGH TO CAUSE A SIEZURE. TREATMENT: PATIENT WAS TAKEN TO HOPSITAL WAS THERE FROM FRIDAY TO SATURDAY AFTERNOON. BLOOD WORK/ AND UA DONE, IV FLUIDS AND OBSERVATION.
Instant swelling of body, panic and dissociation, tinnitus, heat rashes and nausea.  Now I have MCAS, an autoimmune disorder, tinnitus, poor concentration, chronic iron deficiency,  chronic insomnia and relentless fatigue. My muscles twitch all the time I developed allergies to most foods and live off of chicken. I am sick most days and unable to live a normal life.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with PROQUAD, L016394, 08-NOV-2016, M011661 08-SEP-2017, M029599 10-DEC-2017. No adverse experience was reported. Temperature was 8.3 Fahrenheit for 2 hours and 14 minutes and it was administered. There was no previous temperature excursion. Data logger was yes. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient had same symptoms as she did after her first shot: tachycardia, flushed face, feeling ill.  She was observed for 30 minutes and felt better.  Symptoms resolving.
Hoarseness/Laryngitis with no other symptoms that would normally accompany hoarseness/laryngitis. i.e. no cold symptoms prior or current, no drainage, no nasal congestion, no sneezing.
12 hours post injection pt was shakey , weak, afebrile, localized injection site symptoms.  symptoms worsened throughout the night with wide spread muscular malaese and generalized weakness.  Pt has continuous glucose monitoring which showed signs of distress and lowered glucose as well as insulin usage from pump. Pt slept fitfully thoughout the night and awoke feeling better and was continuing to recover.
fever; chills; body aches; headaches; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches) and DIZZINESS (dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), CHILLS (chills), PAIN (body aches), HEADACHE (headaches), DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 10/30/2021 around 10:30 Am, I mistakenly allowed a 16 year old to be given the 1st dose of Moderna, covid 19 vaccine, due to not appropriately going through the five rights paramedics and other health care personnel  are trained to go through before administering a drug or vaccine. I entered the residence that the minor was living in, went through my questionnaire with the minors mother, and obtained consent after I advised the mother that I was there to administer the 1st dose of the moderna vaccine to the 16 year old child. The mother understood some of the risk that could have come along with the vaccine administration and still proceeded to give me consent to allow the vaccine to be administered. After the vaccine was administered, we observed the 16 year old for 15 minutes since the 16 year old did not have a prior history of severe allergic reactions . We observed to ensure that the 16 year old did not have an allergic reaction after administration. After the observation period was complete, my partner and I proceeded on with our day to our other appointments. There was no treatment given to the child since there was no adverse reaction that occurred. Almost a month later when the minor was due for the second dose, scheduling from the company I work for saw that the minor was given the moderna vaccine when he wasn?t supposed to. I was notified of this error on 11/25/2021 sometime in the early evening. I then proceeded to remove myself from work and ultimately placed myself on suspension so that I could review protocols and await the result of my error.
Tingling and numbness in bilateral hands involving thumbs, index and middle fingers.   Limited extension right elbow with elbow intermittently stuck in flexion and pop or snap to get to extension.  Loss full extension.
Felt as if head was underwater (ear pressure), and headache on top of head, felt puny from time of administration, gradually lessening throughout the evening.
Severe outbreak of skin blisters and rash. Extremely itch. Much worse than normal.  Constant dizziness which is still present.
Dizzy and lightheaded; Over 24 hours after vaccine, still sore in joints and muscles; Over 24 hours after vaccine, still sore in joints and muscles; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 26Mar2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included gluten allergy. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 16:00, the patient felt sore in joints and muscles, dizzy and lightheaded. Over 24 hours after vaccine, the patient had still sore in joints and muscles, dizzy and lightheaded. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events dizzy, muscle soreness and soreness of joint. The clinical outcomes of the events dizzy, muscle soreness and soreness of joint were not recovered at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness, pain, rash for >10 days in the arm of the injection. The pain started the day after the injection, the rash and redness started after 48 hr.
stroke; This is a spontaneous reporter from a contactable Pharmacist via Pfizer Sales Representative.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as single dose (dose # unknown) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced stroke on 2021. The event outcome was unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event Cerebrovascular accident. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1 wk p/shot pt had redness & swelling below site;had soreness prior to the redness;told had a infect & placed on ATB;swelling went away in 3-4 days;
It looks like a 3rd dose of Moderna was given to the patient. 1st dose listed - 1/27/21. 2nd dose listed - 2/24/21. 3rd dose given 4/13/21.
Streaks of bright red blood in 2nd and 3rd stool after receiving ROTAVIRUS. Occurred one day after ROTAVIRUS. No treatment. Monitor at this time.
Woke up 3am with chills, body ache, joint aches, headache,  nausea, and felt fatigued.
I noticed after my 2nd shot in April 6 that at the 1st injection shot, there is no tissue for about 2 inches wide and at least an inch deep. The starburst brown discoloration is slightly going away..
On Monday, October 08, 2012 at approximately 2:00PM, my wife and I had our annual flu shot at the pharmacy. Around 4:00PM, that afternoon, I experienced mild stomach discomfort and felt nauseous. At 6:00PM ate a light supper after which I came down with a sore throat. Around 7:00PM, I experienced severe body chills and skin sensitivity to touch along with lower back pain and mild headache. Following the ceasing of the chills, became hot and sweaty. Temperature rose to 100.2F. Around 11:00PM, took two TYLENOL and went to sleep. Upon awakening the next morning, all of the previous symptoms with exception of the mild stomach discomfort & headache, were gone. That afternoon, around 2:00PM, I experienced a very strong burning sensation in my middle abdominal area. I took two doses of ZANTAC and MAALOX liquid. However, they did not give any relief. That evening, around 8:00PM, the abdominal pain diminished, but was replaced by severe lower back pain. Again, became hot & sweaty. Temperature rose to 100.1F. Again, took two TYLENOL and went to sleep. On Wednesday morning awoke with none of the previous symptoms. Since then, everything appears to be normal. Interesting note: My wife, age 69, only experienced a sore throat the first evening after receiving her flu shot. I hope this information can be of some assistance to you.
information has been received from a nurse practitioner concerning a 13 year old female who was vaccinated with Gardasil. Subsequently the patient fainted after the vaccination. Subsequently the patient recovered. Additional information has been requested.
Patient's Girlfriend called and reported patient to have a fever, chills, lightheadedness, and malaise starting early this morning after receiving vaccinations yesterday.  Patient self treating with Tylenol for symptoms.  Unknown if symptoms are vaccine related, but advised her to tell patient to call his physician about symptoms he is experiencing.
This spontaneous report was received from a physician via a company representative and refers to a 16 year old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 05-APR-2016, the patient was vaccinated with the second dose (of the three-dose regimen) of GARDASIL 9 injection, lot # L045711, dose reported as "1 shot" (strength, route and site of administration and expiration date were not reported). On 05-APR-2016, 7 to 8 minutes after receiving the dose of GARDASIL 9 (also reported as while on therapy with GARDASIL 9), the patient passed out. The patient did not seek medication attention. It was not reported if any lab diagnostic studies were performed. The patient was given water and had her blood pressure monitored. Product quality complaint was not involved. The patient fully recovered from the event on 05-APR-2016. The relatedness between the event and the therapy with GARDASIL 9 was not reported. Additional information has been requested.
Information has been received from a health professional concerning a 10 year old male pt with no known drug allergies who on 02/18/1997 was vaccinated with varicella virus vaccine. There was no concomitant medication. On 12/27/2000 the pt developed over fifty vesicular lesions and a mild fever. The reporter considered vaccine failure questionable. The reporter was inquiring about other cases where children acquired disease after immunization. It was reported that the pt sought medical attention. Additional info has been requested.
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 35-months-old male patient who received 0.5 ml dose of FLUZONE QUADRIVALENT on 28-Nov-2018 (lot number: UT6331LA and expiry date: 30-Jun-2019) (dose in series and route was not reported) in the right thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of Hepatitis A vaccine on same visit. It was a case of actual medication error due to overdose. It was not reported if any adverse event occurred following vaccination. 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. List of documents held by sender: none.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot#, dose, route and site of administration were not reported) for prophylaxis. Concomitant medications were not reported. On an unknown date, the patient experienced soreness, tenderness and redness closer to the elbow, not the injection site. No treatment was given for the adverse events. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
The lymph node in my right armpit has become swollen  and painful starting the Tuesday following receiving the shot. Currently it feels about the size of a grape.