chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group selected as an adult as the patient was employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the Glaxosmithkline response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 5 of 9 linked cases reported by same reporter.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling hands and face. Patient felt dizziness for approximately 30 minutes. She was laying flat on floor with feet elevated. EMT was called and she was transported to ER where she remained for 1 hour until symptoms resolved. Followed up with her about 6 hours later and she is feeling better but tired. she is going to contact her primary care physician
After a few hours of getting the second shot some fever minor headaches and a stuffy nose feel with no mu us present, pain and swollen area of shot and also all my left side from head to toe started to hurt significantly to the point that a walk to the bathtroom was difficult. A few of the symptoms fade away after a few days but the left side swollen area on my leg still an issue not letting me continue my workouts, went to my doctor got a sonogram doppler no clots were found and they sent me home. Told me to rest and elevate my legs been doing that nothing has changed and a few minor headaches have made a comeback.
Pt reported that day after vaccine on 11/22 swelling of shoulder, unable to lift arm and pain
Dull headache; Extreme Itching skin; This is a spontaneous report from a non-contactable other healthcare professional (HCP, patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 28Jan2021 11:45 AM, at single dose for COVID-19 immunization. Medical history included High blood pressure, known allergies to Sulfa drugs, shellfish. Patient is not pregnant. Concomitant medication included other medications in two weeks. No other vaccine in four weeks. Patient experienced dull headache for exactly 1 week. Extreme Itching skin from 1 week after and ongoing. Mostly in evening. event start date was 04Feb2021 07:00 PM. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Patient was not recovered from the events.   No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
shingle vaccine, before getting shingles/ suspected vaccination failure; severe shingles; pain; This case was reported by a consumer via interactive digital media 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, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with local anesthetic nos (Nerve Block (Nos)). On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got the Shingle vaccine 3 years before getting the shingles. His/her outbreak was severe and lasted all of 2020.  The patient was still taking the nerve blocker.  The patient also stated that, it was described perfectly, and nothing could be compared to that kind of pain. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
Patient was given ROTATEQ on 11-16-10 had surgery for Ileocolic Intussusception to the Transverse colon on 12-26-10.
Pain, warmth, swelling for > 2 weeks.   Peeling skin, loss of pigmentation of skin
Vision in right eye affected - flashing 'lights' no peripheral vision.  Suspected torn retina.
Patient received first dose of GARDASIL and may have been pregnant 7/31/08-LMP-5/15/08 received GARDASIL 16-1608
My mother began shaking and didn't know where her hands were and the hospital didn't ask me for consent first to administer morphine. They claim it was for distended stomach pain.
Patient received vaccines- KINRIX, MMR, Varicella. On 7/28/09 morning: Developed red rash on the left cheek same day in the afternoon (approx. 1:00pm) non pruritic, did not progress, disappeared, lose in afternoon; feels "achy".
severe arm pain/severely reduced ROM/numbness. Nausea and flushing. This occurred a few hours after injection and continue to this time a day later.
No additional adverse event (AE); A 6-month old child that received a dose of VARIVAX instead of VAXELIS.; This spontaneous report was received from medical assistant referring to a 6-month-old patient of unknown gender.No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 14-OCT-2022, the patient was vaccinated with a wrong dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milligram (mg), lot number W011624, expiration date: 06-APR-2024 who had been verified to be a valid number, instead of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) (wrong product administered).  It was reported, that the patient additionally received their scheduled doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and pneumococcal vaccine conj 7v (crm197) (PREVNAR) (strength, doses, frequencies, anatomical sites of injection, lot numbers and expiration dates were not provided). No additional adverse event was provided. The outcome of wrong product administered as well as the causality assessment were not provided.
Employee seen on 10/5/2017, from Varicella injection on 10/3/2017 to complete a two shot series since Varicella titer was negative, in Hospital with right upper arm swollen from elbow to mid bicep on under side and lateral side of right arm. Area was reddened with dark red center and light red on outer edges. Area of swelling was notably warm to the touch. Employee sent to Employee Health but would not see due to no insurance. Employee was referred to Urgent Care for follow up evaluation and treatment.
t104 the noc & morning p/shot irritability, unable to console for 24 hrs then gradually got better;
I noticed that I had a slight cough and runny nose. I just didn't feel well and got a headache. On May 30, 2022 I took an at home COVID-19 test and it was positive. It was like a head cold. I couldn't shake the cough. I quarantined for 10 days but still tested positive. I quarantined for another 5 days and then took another test and it was negative. That was as bad as it got. The cough I got rid of but I am still tired today. On May 31, 2022 I did a telehealth call with my doctor. My doctor prescribed me cough medication and an antibiotic. I only took the cough medication.
Red, sore, swelling arm on friday 7/29. Patient slept all day friday. Treated at urgent care for cellulitis on saturday.
Patient developed rash and swelling on her arm the night of her vaccination. She said they area remained itchy over the couple few days.  The swelling does seem to be going down slightly.
Shortly after my vaccine, I experienced a copper taste in my mouth, felt dizzy and I indicated to a paramedic that I was not feeling well. I continued to feel dizzy and my throat started to swell  up and had convulsions and had loss of consciousness. I also began to get hives on my chest, my throat was still swelling up which these symptoms continued over the next few hours. I went to the ER where they gave me an epi shot. I was admitted to the ICU where a kidney panel was performed and  Ialso had another event and they gave me another epi shot which my symptoms step down in intensity and was discharged home. I stayed one night in the hospital. For the next two weeks, I was still  having throat swell up, felt disoriented, was having mental fogginess and twitching.  Today I still experience some twitching, involuntary spasms but are in mild in intense.
Within 15 minutes, pt complaining of chest pain, not radiating, in center of chest. Coughing, stating sore throat. Given PO 50 mg Benadryl. Vital signs stable. No other s/s. Took private vehicle to hospital with RN.
Fever of 101 for 24 hours accompanied by chest pressure, body ache/pain, kidney pain and "brain fog"
1 month old was accidentally given the Fluzone Quad instead of their Hep B vaccine, no AE; 1 month old was accidentally given the Fluzone Quad, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 month old patient who received a dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date not reported) instead of HEPATITIS B VACCINE accidentally on 31-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was reported that nurse reporting on behalf of a 1-month old child that received Fluzone Quadrivalent in error and not the prescribed Hepatitis B vaccine. The nurse reported that the consumer, at the time of this report, has not received the prescribed Hepatitis B vaccine.  At the time of reporting, no adverse event was reported.   Information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
A report was received from a healthcare professional on 10/17/2003 concerning a 51 year old male vaccinee who received Fluvirin intravenously on 10/17/2003. On 10/17/2003 Fluvirin was administered via an intravenous push when the vaccinee was undergoing dialysis.  The vaccinee did not complain of any adverse symptoms at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 20 February 2004. A follow up report was received from a healthcare professional reporting no adverse event. No follow up pending, all information received.
shingles. symptoms began Wednesday, April 14  at approx 3 pm as a series of needle-like stabs below the skin on my right hip and extending outward 2-3 inches in all directions.  Acute pain started within 1-2 hours of the initial reaction and continued unabated.  On Friday evening, April 16 the classic shingles rash was visable at the site of the initial pain and became progressively more intense over the next three days.  A second, mall shingles erruption was visible on Sunday am (April 18).  As I write this report on Tuesday, April 20, the pain seems to have plateaued, i.e, is not getting worse.
Mesenteric Ischemia, leading to Aspiration Pneumonia, leading to Acute Hypoxemic respiratory failure, leading to Distributive Shock and death.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 27-OCT-2015 the patient was vaccinated with improperly stored ZOSTAVAX (lot # L0212039, expiry: 07-JUL-2016) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects are reported. Additional information has been requested.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fainted just after admisntration, he passed out for less than 10 second , all of the first aid requirments done, vitals were normal called 911 and they arrived at the location in 5 mintutes , patient monitored for about 30 minutes after and walked out the store himself
Patient was due for her second routine dose of Pfizer for her age and this nurse gave the Pfizer Bivalent instead, and the dose was 0.5ml instead of 0.3ml as it should have been. Pt did wait the full 15 minutes without any reaction.  Notified provider in the building of the error at the end of the day upon charting due to lot# not in our que.  Called CDC and mom the next day with instruction not to give any more doses to patient - she is done with her Pfizer series. Mom verbalized understanding. Person notified.
I felt the left side of the inside of my lower lip felt as if I bit it (which I. did not) as time ticked away , I felt it as an annoyance  but as it got a little later I felt it swelling some . This started in the 11 a.m. hour. by 4 p.m. the bottom left side of the lip was swollen a good bit. By 5:30 p.m. my entire lip was completely swollen so much I looked like the character Bubba off of Forest Gump. By 6;30 p.m. it was beginning to harden on the left side of my face by the mouth. By 7p.m the right side of my face is hard and my face is red.  I did take pictures if you need me to send them to you . This morning swelling is down but not all the way. I have a picture from this morning the swelling is not as discomfort as yesterday but still is not back to normal.
I woke up the next morning unable to stand up or walk. That was the worst moment of the reaction. I went to bed fine and woke up and couldn't move. I went to the ER, called 911. I was discharged at 3:30pm that same afternoon. The CT, EKG, blood work and chest exams showed nothing, no trace of COVID or anything abnormal. I got better quickly before entering the ER and after the examinations. I didn't require any medications before discharge.
This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 test positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to go work. Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 06-APR-2021, the subject experienced warm throughout right arm at injection site. On 06-APR-2021, the subject experienced severe headache. On 08-APR-2021, the subject experienced stomach/abdominal pain. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach/abdominal pain, and warm throughout right arm at injection site on APR-2021, had not recovered from severe headache, and fatigue, and the outcome of unable to go work was not reported. This report was non-serious.
Myocarditis - Sinus Tachycardia, chest pain, heart flutter, irregular heartbeat, shortness of breath, weakness on exertion, swelling of ankles, decreased apatite, fatigue, increased headaches
This case was reported by a pharmacist and described the occurrence of injection site pain in a 58-year-old female patient who received FLUARIX (batch number 5J9F9, expiry date 20th May 2015). Previously administered products included flu vaccine. On 7th October 2014, the patient received the 1st dose of FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX.
Moderate left Ear, head, and sore throat pain/stuffiness started 1/28/21 with fever of 100.7 with  Severe chills and muscle aches, fatigue  and arm pain, along with activation of migraine.  On 1/30/21, I went to urgent care with concerns over ear and throat pain and redness/pain at injections site to rule out an infection at these sites.  The physician said ear and throat showed no signs of infection, the arm redness was still in the expected normal reaction range, but I had Swollen left neck lymph nodes.  The doctor said I should Report that as an adverse effect.  Advised to take Tylenol - motrin, and hydrocortisone cream for arm if needed .
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.57 hours). Last temperature recorded -16. On 12-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
I gave a rash on my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (I gave a rash on my arm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (I gave a rash on my arm). At the time of the report, RASH (I gave a rash on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs and treatment medications were reported.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 17-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
ARDASIL 9 that experienced a temperature excursion was administered to a patient; No additional AE reported; This spontaneous report was received from a Medical Assistant, referring a patient of an unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 04-AUG-2021, the patient was vaccinated with an improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T029522 with expiration date on 13-APR-2022 (but upon internal validation established as 13-APR-2023), 0.5 milliliter dose (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis.    The vaccine administered was stored at temperature -4.8C for a time frame of 20 minutes. There was no previous temperature excursion. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient reported having chills and aches and also local soreness in his arm the day after receiving the FluzoneHD vaccine lasting 2 days