chrisvoncsefalvay/vaers-outcomes huggingface dataset:
medication error due to possible administration of TENIVAC after its expiration date with no reported adverse event; Initial information received on 09-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had medication error due to possible administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adults [TENIVAC] after its expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adults Suspension for injection (lot U7183AA, expiry date: 24-Sep-2023 with unknown dose, strength) via unknown route in unknown administration site as Immunization which was a medication error due to possible administration of tenivac after its expiration date with no reported adverse event (expired product administered) (latency: same day).  It was reported "a nursing supervisor reports that they had vials of TENIVAC which had the expiration dates printed on them as 24SEP23 and 24JUN23; reports that they found this dating method confusing and it caused 3 doses from LOT U7183AA, EXP 24SEP23 and 5 doses from LOT U7092AA, EXP 24JUN23 to possibly be administered to patients after the expiration. She states that this is the only medication that they have which shows the expiration date in that format. The nursing supervisor is unable to provide any additional AE information; she states that they will need to run an internal report to confirm how many doses of expired TENIVAC were actually administered and to which patients. The nursing supervisor reports that the way that the expiration date is printed on the tenivac vials is confusing and easily misinterpreted. she reports that it was confusing to them whether they should read the expiration date printed on the vial, 24sep23, as september 24th, 2023 or september 23rd, 2023. the same issue occurred with the second vial of tenivac with expiration dated as 24jun23. the way that the expiration date was printed may have caused them to use the product after its expiration"   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 the Directive and Regulatory Authority 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.
patient woke up at around 3am with extreme ankle pain felt like it was broken and it took a couple of hours before she could fall back asleep. she said it was very painful
31 Y/O MALE HAD C/O ARTHALGRA,MALAISE, LOW GRADE FEVER OF 100.4 FOR 48 HR. PT WAS PUT ON SICK IN QUATERS FOR 48 HR. AFTER 48 HR PT START TO FEEL MUCH BETTER
Information has been received from a 19 year old female consumer for GARDASIL, a Pregnancy Registry product. Patient had idiopathic edema, degenerative disc disease, bipolar disorder, fibromyalgia, fibrocystic breast disease, MTHFR gene mutation and allergic to iodized salt who 2 months ago, on approximately 08-JUL-2010 was vaccinated with the first dose of GARDASIL (Lot # not available). There was no concomitant medication. On 07-sep-2010 she found out she was approximately 2 months pregnant, LMP: 08-JUL-2010, EDD on 14-APR-2011. Patient stated that she was never told that GARDASIL was a 3 dose series so she did not return for her second dose. Three home pregnancy tests were performed on unspecified dates. Patient did not seek medical attention. Follow-up information has been received from a certified medical assistant (CMA) via telephone call, who provided pregnancy outcome information. She reported that the patient delivered a full term healthy baby boy via C-section on 04-APR-2011 at approximately 38 weeks gestation. The neonate weighed 8 lbs, 3 oz. The delivery was reported uneventful. No neonatal congenital anomalies were reported in OB delivery record. Upon internal review, C-section was considered to be an other important medical event. No further information is available.
Two minutes post vaccination patient became dizzy and nauseous. Patient felt like they were gonna pass out and ears were ringing.
Pt experienced swelling of thigh left to 2 X normal about 12-24 hrs after Dtap, ipv,hib,prevnar. Minimal erythema or tenderness. No fever, mental status change, vomiting or chills, slight limp on right present prior to immunizations. Swelling lasted 3 days and resolved. Did not present to MD until 1 week following vaccination - dose 1 lederle dose 2,3 skb
She started itching, got hot, said her tongue felt funny. I sat with her asked her if was ok breAThing short of breath, she said no. I ASKED IF SHE WANTED A BENADRYL AND SHE SAID NO. MY TECH WAS AN EMT AND CAME OUT WHILE I WENT TO GET BLOOD PRESSURE CUFF, WE WATCHED HER AND SHE STARTED GETTING ITCHIER BUT BLOOD PRESSURE WAS FINE. WE CALLED EMS . SHE WAS RESPONSIVE, DIZZY, AND ALERT WHEN SHE LEFT WITH EMS.
Rash, possibly shingles herpes zoster developed aboutr 2-3 days after 2nd dose of pfizer vaccine. still present one month later.
I had dr look at me i had xrays then a series of shots in neck  also had 2 sessions of therapy which did no help I went back months later had 2 more injections and was set up for mri but havent had it yet,  My foot collasped  totally I d=see Dr at orthopedics, I had a MRI and will be talking to him September 14th about surgery
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 31Mar2021 as dose 2, single (Lot number: EN6204) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient had no known allergies. The patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID 19 treatment starting from 27Sep2022 to 02Oct2022.
Migraine and headaches for two weeks.  Hot flashes.  Fatigue, weakness in legs, nausea, menstrual bleeding,  right arm lymph node inflamed and sore, right breast sore to touch for 5 days.  Sudden shaky and weak feeling, (sudden, like going hypoglycemic), foggy brain.  I felt like I was poisoned.  Took a full week before I felt functional.
Symptoms: high pitched, prolonged screaming, fever, leg pain, projectile vomiting, listlessness, dehydration, crossed eyes, and no bowel movement for eight days. Stopped smiling until roughly 3 weeks after the vaccine was administered. TYLENOL was given twice to help with leg pain and fever on 02/17/2016.
Dizziness; A spontaneous report was received from a consumer (patient), concerning himself, an 84-years-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness.  The patient's medical history included major brain surgery one year ago due to a major fall off a ladder, a blood clot in his head, seizure and a pacemaker placement several years ago. Current condition included needs cane or walker. Concomitant medications reported were levetiracetam, pantoprazole, allopurinol, apixaban, carvedilol and rosuvastatin.  On 02 Feb 2021, prior to the onset of the event, the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A), intramuscular for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient experienced dizziness that was pretty severe and needs cane and walker when standing. Patient stated that he was feeling better today on 10 Feb 2021, than past two days. Reportedly, patient was inquiring about his second dose scheduled on 02 Mar 2021. Treatment details were not provided.    Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, dizziness was recovering.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Heart failure discovered 6/30/22, severe shortness of breath, being treated with Entresto and Spironolactone.
Shot area oozed then scale. Repeat & repeat. Told I had reaction to vaccine! Derma biopsy = squamous cell carcinoma! Removed.
Patient received injection of flu vaccine on 11/4/04. That night developed fever to 102. Next day, febrile; responded to Tylenol. At 11/5 2 PM, gasped, became lethargic , temp to 104. Rushed by EMS to ER.
cried all the way home, during the noc, excessive crying-somewhat inconsolable p/last DTP;
Blood clot in the lung; A spontaneous report was received from a consumer concerning a 70-years-old, female patient who received  Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lung/ Pulmonary thrombosis.  The patient's medical history included hyperthyroidism.  Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine for hyperthyroidism.  On 10 Mar 2021, approximately five days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) via unknown route for prophylaxis of COVID-19 infection.  On 15 Mar 2021, the patient developed a medically significant event of blood clot in her lung and was hospitalized for 2 days followed by short of breath and cannot walk very far.  Treatment for the event included blood thinner.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, blood clot in the lung/t Pulmonary thrombosis was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
broke out in hives; Local reactions in injection site; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves female patient who experienced hives (urticaria) and local reactions in injection site (injection site reaction), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and other dosing details were not reported] via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious hives (urticaria) and local reactions in injection site (injection site reaction), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  Final diagnosis was urticaria and injection site reaction.   It was not reported if the patient received any corrective treatment.  Event outcome was Unknown for reported events.  Information on the batch number was requested.
Information has been received from a physician concerning a 24 year old female patient with CARBATROL allergy and a history of neuralgia who was vaccinated IM with the first 0.5 mL dose of GARDASIL last Wednesday (on 14-APR-2010).  On approximately 17-APR-2010, 3 or 4 days after the injection, the patient experienced a rash under her knees and on her calves.  It was reported that the patient developed rash/hives on both legs below the knees.  Treatment recommended was BENADRYL.  Client was not pregnant.  The patient sought unspecified medical attention.  Client did not follow up with physician so patient's present status was unknown.  Physician stated that he did not think GARDASIL caused this reaction.  Additional information has been requested.
pt brought to ER by ambulance for apparent febrile sz w/t104;evaluated for infection;begun on Bactrim for presumptive UTI, urine cult subsequently negative recv vax 12hr prior to sz;
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 14-JUL-2015, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, once, subcutaneously (strength, anatomical location, lot number and expiration date were not reported), which was improperly storage. No adverse events were reported. Additional information has been requested.
Dizziness & NauseaVomiting Narrative: Pt in bathroom with c/o nausea, vomiting, and dizziness. VSS. Transporting to ED for further evaluation.
Temp of 102 took Tylenol stated to go down them Spikes again 24 hours later back to 102 took more Tylenol and has finally gone below 100 Hives  on chest back behind knees back of legs and bottom of feet.  Stated in one spot and progresses thought out the day and night. Took Benadryl and put Benadryl cream on  has calmed down after several doses of Benadryl
Ringing in my ears (tinnitus) - Doctor says it's not because I'm congested.  I do have some hearing loss that he thinks might be associated with previous exposure to loud noises, but he doesn't think the ringing can be conclusively linked to that.
RE: Patient DOB 08/24/1994  12:45p Received first dose Janseen vaccine, instructed to wait 15 minutes.  12:55p Self-reported while waiting he became nauseous ?a few minutes? after administration of vaccine, walked to bathroom, began feeling ?worse? and returned to Health Department office. Upon entering the HD office, observed client to be pale, three small reddish blotches on left cheek, no verbal response, leaning and stumbling to left, holding onto furniture. Client took two steps and began falling forward toward floor. Landed on floor, slightly on left side, head did not impact floor, eyes closed, no verbal response. 911 called. Smelling Salt effective and began responding to questions, remained lying on left side. 1:00 Paramedics arrived, client sitting upright on floor, drinking water, responding appropriately. VS within normal range. Able to stand up on own, unassisted gait slow and steady. Color natural, red blotches fading, skin remains diaphoretic. States he is ?feeling better?. Declined transport to hospital.  1:10p Remained in office drinking water, talking. Encouraged to follow up with physician. Left building without further incident.
Swelling and red reaction with induration approx. 10 cm in size less than 30 minutes following vaccination. These reactions noted at VARIVAX vaccine site. Applied ice pack and administered BENADRYL (liquid, PO) to patient. Patient stated site felt "itchy";  and stop itching.
Series of migraines and cluster headaches. Occurred in mid august and lasted until mid September. Also have experienced nausea, indigestion, and diarrhea since the administration of the vaccine.
After receiving her 1st in series Hepatitis B vaccine, patient sat down on the floor and stated that she felt weird. She stayed at the doctors office and ate crackers and water until she felt better. Fatigue, tingling of hands and feet, feeling cold.
Nose and lip went numb; throat tightening; Nose and lip went numb; face flushed; Upper lip swollen/lips swelled again; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (face flushed), LIP SWELLING (Upper lip swollen/lips swelled again), HYPOAESTHESIA (Nose and lip went numb), THROAT TIGHTNESS (throat tightening) and HYPOAESTHESIA ORAL (Nose and lip went numb) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FLUSHING (face flushed) and LIP SWELLING (Upper lip swollen/lips swelled again). On 07-Mar-2021, the patient experienced HYPOAESTHESIA (Nose and lip went numb), THROAT TIGHTNESS (throat tightening) and HYPOAESTHESIA ORAL (Nose and lip went numb). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) on 06-Mar-2021 for Adverse event, at a dose of UNK dosage form, prn and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) on 07-Mar-2021 for Adverse event, at a dose of UNK dosage form. At the time of the report, FLUSHING (face flushed), LIP SWELLING (Upper lip swollen/lips swelled again), HYPOAESTHESIA (Nose and lip went numb), THROAT TIGHTNESS (throat tightening) and HYPOAESTHESIA ORAL (Nose and lip went numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021:
Pt had large hive/welt on back of arm 4 days after receiving ZOSTAVAX. Large inflamed area on arm where shot was given.
First seizure was observed on 6/7. We found patient in his bed. He was having a seizure with convulsions and he vomited. There may have been a possible seizure the week before (we could not remember the date) -Patient was found acting strangely in the night. He had thrown up and was not  making sense. We did not witness any seizure at this time. The second seizure we witnessed was on 8/28. Patient quickly became tired and laid down on the floor. within a minute or two he went into a full seizure in the presence of his family. On 6/7 and 8/28 patient was taken by ambulance to the emergency room. Patient has now been diagnosed with epilepsy.
Underage before the 5/12 approval for Pfizer vaccine. Suspected falsification of DOB ? guardian ?unsure? how DOB error occurred.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: Patient had a vasovagal response after COVID-19 Vaccine. He was monitored in clinic for over 30 minutes and completely recovered from incident prior to disposition home.
Started getting aches and pains within 30 min of vaccine. After two hours my temp was up to 100.7 and I had flu-like symptoms (aches, pains, chills, etc). After 24 hours a rash showed up above my left ankle. Managed symptoms with ibuprofen and bed rest. This was the second vaccination in the two part series. I had no issues with the first vaccination.
This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age who on 16-MAY-2012, was vaccinated with a dose of VARIVAX (lot number 669557/1700Z, Exp. Date: 12-SEP-2012) (dose and route not reported) that was stored in the refrigerator since it was received in the pharmacy in April 2012. No adverse symptoms were reported. Additional information has been requested.
Within minutes of receiving vaccinations, child became dizzy, nauseous and pale. Said her vision was becoming dark. Sat child down and asked nurse to get a doctor and to take her blood pressure, pulse and blood sugar. Child was hypotensive with a low heart rate. Had child drink some juice. Within 10 minutes Childs color began to regain and child stated she was feeling better. Remained in doctors office for 2 hours until her blood pressure recovered to a more normal level. Less than 24hrs later child was complaining about being shaky and dizzy. Soon after she had a low grade fever (99-100 F), complained of a bad headache, no appetite, nauseous, lethargic which lasted 6 days. PCP is referring her to cardiologist for continued hypotension.
suddenly passed away; This is a spontaneous report from a contactable healthcare professional reporting on behalf of friend's husband. A 43-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr20201, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient suddenly passed away on 11Apr2021. It was unknown if an autopsy was performed or not. The patient passed away at home and he was otherwise healthy. The reporter stated there was not a way to know if it was related to the vaccine as of right now.  Information on lot number/batch number has been requested.; Sender's Comments: Limited information precludes a medically meaningful assessment of the case. A possible contributory role of the suspect product BNT162B2 to the development of event Sudden death cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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.; Reported Cause(s) of Death: suddenly passed away
Swollen, red area on upper left arm, warm to touch and itchy, instructed to take Ibuprofen and Claritin QD for a few days per Dr.
Pt. has localized edema on her Rt. thigh sensitive touch and hot. Pt. was crying and uncomfortable.
Weight gain, difficulty walking, difficulty bending, difficulty sitting, could barely get out of bed, hard stools, difficulty getting in and out of the bathtub or upstairs, insomnia, odor in urine. 06/13/2021- deep cortisone shot and they aspirate the fluid from my arm- all the muscles pain went. I could do everything easily. It's been 3 months and I started feeling the pain again.
Patient waited in office for 20 minutes after administration of her Hep A #2 and HPV #3 vaccines without reaction. She returned to clinic later in day stating that approximately 20 minutes after she left, she developed hives on her neck, shoulder, and arms. She applied an OTC anti itch cream at home since the lesions were pruritic and got some relief. One lesion on her elbow fully resolved. She denied shortness of breath, cough, nausea, vomiting, or swelling of face/lips/tongue/throat. On exam, she was alert in no acute distress and her exam was notable for 6 isoated wheals (hives) - 2 on R forearm, 2 on R side of neck, 1 on R shoulder, 1 on L upper arm. HEENT/CV/RESP exams were normal. She was advised to use 1% hydrocortisone cream for itch and OTC Zyrtec 10 mg po once daily for itch/hives, and to seek care in ER ASAP if symptoms worsening or developed shortness of breath, swelling, or vomiting. I conducted phone follow up with patient/mother on 6-19-2012 and patient was doing well. Only developed 2 new hives since I saw her. No other new symptoms occurred. We have referred patient to local allergist for furthet evaluation.
4 1/2 months after I got my Moderna booster, I tested positive for COVID.