chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few minutes after the injection the patient reported numbness on left side of face and arm. He was sweating and looked unwell. He reported no swelling, so I gave him a 25mg of benadryl and took his BP, which was 142/92. He did not eat breakfast so I got him some crackers and water and watched him. I recommended he call his doctor, he did and they told him to go to ER so I offered to call a squad and he declined. He did not want to go to ER, but wanted to get seen at urgent care. I walked him down to urgent care since the numbness had not improved. He came back to the pharmacy a few hours later and reported that when the benadryl kicked in the numbness subsided and he feels just fine now. He is going to follow up with his primary care doctor tomorrow.
Information has been received from a consumer concerning her currently 5 year old daughter with a history of "born with refluxed uriter" who on an unspecified date, at age of one, was vaccinated with a dose of VARIVAX (Merck) (lot# not reported). There was no concomitant medication. It was reported that the patient was born with ureteral reflux and for the first 2 years of life she was on medication BACTRIM. On an unspecified date, at the age of 4 years, the patient developed a serious urinary tract infection and had to be hospitalized. It also affected the kidneys and the patient had to have surgery done to correct the urinary problem. The patient was doing fine and her kidneys went back to normal since 2008. During that time she was also back on BACTRIM and was taken off sometime in 2008. On an unspecified date in NOV-2009 the patient developed a case of shingles and shortly after the first case, in DEC-2009, the patient developed another case of shingles in the same area but milder. The shingles were on her right side under the armpit, chest and shoulder blade. Unspecified medical attention was sought via office visit. There were no laboratory diagnostics studies performed. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
Information has been received from a physician concerning an 18 year old female patient. The patient's concurrent conditions, medical histories and concomitant therapies were unknown. On 14-OCT-1995, the patient was vaccinated with the first dose of VARIVAX injection (lot #, expiration date, strength, dose, frequency and route unknown). On 01-SEP-2010 the patient was vaccinated with the second dose of VARIVAX injection (lot # 668080/0721Z, expiration date 14-MAY-2012; strength, dose, frequency and route unknown). On 29-MAY-2013, the patient was vaccinated with the third dose of VARIVAX injection (lot # H018526, expiration date 09-OCT-2014; strength, dose, frequency and route unknown). On 10-AUG-2016, the patient had varicella titers drawn for an unspecified reason and the result of the varicella titers showed the "patient's immunoglobulin G (IgG) level was down". The outcome of immunoglobulin G decreased was unknown. No product quality complaint (PQC) was involved. The causal relationship between immunoglobulin G decreased and VARIVAX was unknown. Additional information has been requested.
1/11/2022   Chief Complaint:  Shortness of breath   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 49y.o. male with a past medical history significant for asthma, atrial fibrillation, congestive heart failure patient reported most recent EF 22%, chronic kidney disease, diabetes type 2, GERD, hyperlipidemia, hypertension, left ventricular mural thrombus, morbid obesity, sleep apnea.  He presents to a local HCF on 1/11/2022 for evaluation of shortness of breath.  Patient has recently started complaining of vomiting, cough, chills that started on 1/11/2022.  Patient states that he has been repeatedly admitted to the hospital system for the past 8 weeks for various infections(c diff and endocarditis, see below).  Patient states that he is currently being treated for C. difficile with oral vancomycin and IV daptomycin for recent endocarditis from infected AICD.  States that he is still having soft stools but they are improving incrementally.  States he is currently having about 4 bowel movements per day.  Denies any hematemesis.  He notes a wound on his left foot to which she is attributing his current infection and fever to.  He states that there is a dressing on it this was to be changed daily however he has not changed it since Friday of last week.  He does note shortness of breath but is denying any chest pain. Denying any excessive orthopnea from baseline.  Patient is on Eliquis long-term for the ventricular mural thrombus.  Patient is vaccinated for COVID, not boosted.   Per chart review patient recently hospitalized from 12 17-12 28 for AICD lead infection, tricuspid valve endocarditis, polymicrobial bacteremia blood cultures were positive for corynebacterium, staph hemolyticus.  TEE that was performed on 12/21 was positive for endocarditis at that time.  Subsequently the AICD lead was extracted on 1221 as well, patient supposed to be wearing life vest which he reports that he is not.  Culture was positive for corynebacterium stratum.  Subsequent the blood culture on 12/22 had no growth to date.  The patient was discharged on daptomycin and oral vancomycin with a planned stop date of 2/1 for the daptomycin and 2/6 oral vancomycin.  On TEE there was demonstration of old left atrial thrombus as well. Patient states that he was supposed to have AICD reinstalled in February.     In the ED, Vitals on arrival of T 100.3°F, BP 99/68, HR 104, RR 20, SpO2 99 % on room air
Monday night didn't sleep well. Tuesday ( following day), patient was cranky, clingy, had dry heaves and not sleeping well. No fever or rash.
Initially there was quite a bit of bruising and now today, 7 days out, the area is slightly raised and about the size of a half dollar. The edges are red and the area is warm to touch. I am not having pain or any other reaction, but have never had this response to a vaccine and didn't know if there was value in reporting.
This spontaneous report as received from a registered nurse concerning unspecified number of patients. The patient's medical history and current condition was unknown. On an unknown date the patients were vaccinated with 8 doses of PROQUAD (Oka-Merck) that were improperly stored at a temperature outside the patient insert. Concomitant medications were not reported. No adverse effects reported and no product quality issue reported. This is one of the two reports received from the same reporter. Additional information is not expected.
Two kidney stones: proximal left ureteral stone measuring 4x4x6 mm with resultant mild left-sided hydronephrosis, nonobstructing stone in the lower pole left kidney measuring 3mm. Treatment: Flomax 0.4 mg, increased water intake to 2-3 liters/day, I am still waiting to see the urologist (getting an appointment has been very difficult). Outcome: pain has decreased considerably in the past week or so, therefore I may have passed the stones. My migraines have increased in frequency since having the vaccine. They are managed with Ubrelvy, but I need to take two doses to ease them.
hospitalization (non-ICU) dose #1 on 3/16/21 dose #2 on 4/20/21
redness, swelling to rt upper arm (inj site); bruise to lt forearm secondary to TB tine test;
Pt was given Pfizer Peds and it wasn't Diluted. Mother of the Pt. Was notified. no adverse effects as of right now but she was told what to watch for per CDC. Was properly reported.
Moderna is only approved for 18 years and older but was erroneously administered to this patient who is 16 years old. Pt has had no known ill effects.
This spontaneous report as received from a registered nurse refers to a 96 days old male patient. The patient was vaccinated orally with 2 ml ROTATEQ (Lot# unspecified) on 07-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The reporter did not know if the patient had an adverse effect or not. However, mother of the patient called their office in the morning of 16-AUG-2012 and left message stating her son had had "3 bowel movements." The reported stated she would call the mother to obtain more details. The outcome of "3 bowel movements" was unknown. Additional information is not expected.
A 13-year-old patient received properly stored PROQUAD; No adverse effects reported; This spontaneous report was received from a registered nurse, referring to a 13-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unknown date, the patient was vaccinated with properly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (product administered to patient of inappropriate age)for prophylaxis, lot number S002490  expiration date on 23-JUL-2020 (dose, dose number, route of administration and anatomical location were not provided) and properly stored sterile diluent (MERCK STERILE DILUENT) lot # R019504 (expiration date unknown by reporter). No adverse effects were reported.
The night of the administration date, patient reported pain on both arms, induration at vaccination site, red and bruising on the left arm, warm to touch, and fever at night. Patient was evaluated by doctor in ER and was given treatment (IM DECADRON 8 mg).
Patient was given Moderna shot #1 by pharmacist.  She was waiting her  15 minutes afterwards and she fainted in her chair and then fell out of her chair.  There was no loss of consciousness.  She does not know if she hit her head or not. She was on the ground and we got her leaning up against the wall sitting down.  She said she was not feeling well before she fainted (did not report to staff) and then she did not remember passing out.  She felt nauseous and hot/clammy afterwards.
Pt crying prior to receiving injections. Once injections administered, parent states child became reddened generally from head to toe. Pt screaming and crying, flailing uncontrollably. Episode lasted approx 15 minutes. Dytan po tsp given and within 15 minutes pt happy without redness except at areas of pressure point (where held).
30 minutes after dose, onset cold sweats, chills, shaking, and nausea followed 1 hours later by muscle tightness and worsening shaking. Urgent Care treated with Benadryl and sent home to rest. Symptoms resolved within 3-4 hours. Now left with typical injection site pain, redness, swelling which is similar to the first dose site reaction. Did not have any systemic symptoms with first injection.
Information has been received from a physician's assistant concerning a female who was vaccinated with GARDASIL. Subsequently the patient turned white and passed out. The patient outcome was not reported. Additional information has been requested.
This spontaneous report as received from the director of a health department refers to an unspecified number of patients of unknown age and gender. Information on medical history was not reported. It was reported that on unspecified date every patient that received GARDASIL (lot#, expiry date not provided)(dose, strength, route, frequency, indication not reported) stated "wow that really hurts" (dates were unspecified by the reporter). The outcome of the event was unknown. The reporter did not assess relationship between the therapy with GARDASIL and the adverse event. This is one of several reports from the same source. Additional information has been requested.
Patient developed hives 6 hours after receiving vaccines. Hives disappeared and did not recur after one dose of BENADRYL.
Patient arrived to emergency department complaining of 3 day history of shortness of breath and coughing. He was found to have significantly elevated BNP and elevated troponins with significant ST depression on EKG. Echo findings included an ejection fraction of 15-20%. Left heart catheterization was performed and found 90% stenosis in left main artery, total occlusion in left circumflex, 99% stenosis in proximal left anterior descending artery, 80% stenosis in mid left anterior descending artery, 50-60% stenosis in proximal right coronary artery, and total occlusion in distal right  coronary artery. Impella device was placed and patient was transferred emergently to outside facility for evaluation for CABG.
SWELLING AND REDNESS AT SITE OF SHOT, VOMITING AND DIARRHEA. DR PRESCRIBED ZOFRAN.
feeling very sick; Vaccine administered incorrectly/went into my bloodstream; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell and wrong technique in drug usage process. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jun-2022  Reporter's Comments: This case was reported by patient via interactive digital media. The patient stated that the vaccine was administered incorrectly into the bloodstream and felt very sick. Additional Supportive Information: The vaccine was administered incorrectly into the bloodstream which led to wrong technique in drug usage process. The follow-up would not possible as no contact details were available.
Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (Lot#: J013394, expiry date: 25-AUG-2016; K010535, expiry date: 27-AUG-2016; K014548, expiry date: 27-AUG-2016; K018180, expiry date: 17-SEP-2016, exposure on 58 F for 13 hours from 28-MAR-2015 to 27-APR-2015; K026666, expiry date: 22-OCT-2016; L004754, expiry date: 10-NOV-2016, exposure to 57 F for 77.53 hours from 14-AUG-2015 to 29-NOV-2015; L016427, expiry date: 13-APR-2017; L018501, expiry date: 22-JUN-2017; L025738, expiry date: 14-AUG-2017, exposure on 55 F for 10.75 hours from 28-NOV-2015 to 29-NOV-2015). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
DAPTACEL was given to a 12-year-old patient instead of Adacel with no reported adverse event; DAPTACEL was given to a 12-year-old patient instead of ADACEL With No Reported Adverse Event; Initial information was received on 06-Aug-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (Reference number- 00714231).  This case involves a 12 years old male patient who administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of ADACEL with no reported adverse event (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 06-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (frequency: once, strength: standard, lot number and expiry date not reported) via an intramuscular route in the deltoid not otherwise specified (NOS) for prophylactic vaccination.  It was of actual medication error due to wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event reported.  It was reported as Caller stated that she had a nurse give DTap instead of a Tdap and she need to know the correct interval before she can give the correct vaccine. Caller states that they need to know the interval for when they can safely give the Adacel.   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. 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 available on the batch number for this case.
pt recvd vax 430PM 21NOV95 & back in office 545PM describing shaking of extremities;when in restaurant ordering dinner;pt blue in color had emesis started crying;sent to ER temp recording tympanic @ 103
Left arm pain from shoulder to elbow. Also outer chest area above left breast. Skin area red with blotchy raised area and hot.
Pt recvd vax 22JUL92 &  devel a sore throat, painful & stiff joints, h/a, muscle twitching, nausea, vomiting, flu-like sx; pt recovered; No further details were provided;
Information has been received through the pregnancy registry for GARDASIL from a 21 year old female consumer with no known drug allergies and a history of postpartum pre-eclampsia who on 12-OCT-2009 was accidentally vaccinated with a dose of GARDASIL, 0.5 ml, (Lot # not provided). Concomitant therapy included influenza virus vaccine (unspecified). The patient reported that she went to her OB/GYN on 12-OCT-2009 to receive the influenza virus vaccine (unspecified), but the nurse accidentally gave her a dose of GARDASIL instead. The patient then also received the influenza virus vaccine (unspecified). Unspecified medical attention was sought. There were no lab studies performed. No adverse event involved. The patient's last menstrual period was 07-MAR-2009 and the estimated delivery date is on 12-DEC-2009. Follow up information has been received from the physician who indicated that the patient gave birth to a normal infant with no congenital anomalies. Additional information is not expected.
Swelling and mild erythema at the injection site from deltoid down to mid triceps, itchy, mild temp and fatigue
Information regarding Prevnar was received from a healthcare professional regarding a 3-month-old patient who experienced pneumococcal meningitis. The patient received a dose in 2007. The patient developed pneumococcal meningitis on an unspecified date in 2007. It was reported that the child expired close to the date of 01-Sep-2007. The cause of death was reported as meningitis pneumococcal.  12/18/07 Received vax records.  1/18/07 Reviewed autopsy report which states COD as bacterial meningitis (days).
Vaccine was expired.  The Pfizer vaccine was delivered on 12/8  and is viable in refrigeration for 10 weeks from that date is 2/16/23. The vaccine was administered on 3/21/23. So about 4 weeks expired.
Pt states that since getting the vaccine, he wakes every morning with a headache and visual disturbances. He has since had little energy and c/o of pain in his right arm that he has never had previous issues with. He also states he has been sleeping poorly.
Severe fever, chills, malaise, myalgia, headache, arm pain, stiff neck for 24 hours after shot
6 hrs of unconsolable screaming & crying p/DTP/OPV/HBOC/HEP B @ 2mos of age, 20NOV92;
I HAD A FRIEND WHO HAD THE SHOT AND GOT IT ANYWAY/ Suspect vaccination failure; HAD THE SHOT AND GOT IT ANYWAY; This case was reported by a consumer via and described the occurrence of suspected vaccination failure in a 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 reported as follows: The reporter was patient's friend. The age at vaccination was not reported. The patient received Shingles vaccine and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms.   This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced throat and tongue started to feel weird and tight/throat got to the point of so swollen and itchy I couldn't swallow. The patient condition was life threatening. The patient described the events as follows: 40 min after injection my throat and tongue started to feel weird and tight. Pharmacy at my work hospital  gave me 25 mg Benadryl and 650mg Tylenol. At about 1 hr 45 min after injection my throat got to the point of so swollen and itchy I couldn't  swallow. I went to nearest  emergency room hospital they  administered Decadron orally, Pepcid  P.O. (orally), and Toradol via IM (Intramuscular). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a licensed practical nurse concerning a 26 year old male pt who was vaccinated with MMR II in the past. Subsequently, the pt is not immune to mumps. Unspecified medical attention was sought. In follow-up the nurse reported, "there was no adverse reaction." The nurse reported the pt had the MMR II as a child. She reported the titer revealed that he was " immune to measles, rubella but not mumps and the pt needed to be re-immunized." No further info is available.
Pt was given a Kinrix injection instead of Pediarix at 2 month well.
Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: Followed up with patient 3 days after the inital reaction and the patient still said was having issues with her arm having pain/soreness and if she moved her arm too far she would become dizzy.