chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Contact dermatitis; Lip swelling; This is a spontaneous report from a contactable physician. This physician reported for female (patient) that: A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced contact dermatitis and lip swelling. The reporter stated that a patient had a reaction to Pfizer's COVID vaccine and was asking if there may be information regarding if the patient should receive the second dose of the vaccine. The reporter stated that the patient had 2 types of reactions; the 1st reaction was worsening of contact dermatitis (where she was not concerned about it) and the 2nd reaction (which occurred 12 to 14 hours after the vaccine) was lip swelling with no hives or urticaria. The lip swelling resolved within a few hours without any treatment (type 1 hypersensitivity reaction). The reporter stated she thinks it was ok for the patient to receive the second dose but wanted to know if there was any additional information. The outcome of the event Lip swelling was recovered on an unspecified date while other event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PATIENT CALLED TO LET US KNOW SHE HAD BEEN EXPERIENCING HIVE SYMPTOMS.  THEY DEVELOPED APPROXIMATELY 24 HOURS AFTER THE INJECTION.  SHE INTIALLY DEVELOPED THEM IN ONE SPOT AND THEY KEPT SPREADING THROUGHOUT HER BODY WITH EACH ADDITIONAL DAY.  SHE HAS BEEN TAKING 2 TABLETS OF ALLEGRA TWICE DAILY.  BUT CONTINUES TO HAVE ITCHING ISSUES.   INSTRUCTED HER TO CONTACT HER ALLERGIST TO SEE ABOUT GETTING A SCRIPT FOR A STEROID AND ALSO TO SEE IF ITS APPROPRIATE TO RECEIVE HER SECOND DOSE.
My arm was sore the evening of the injection, but just "normal" soreness. The day after the injection, I was hanging plaques in my office in the afternoon and I noticed my arm was more sore and it felt weak when I was holding items.  By the morning of November 1, 2015, I couldn't lift my left arm to wash my hair, etc. in the shower.  There was considerable pain with trying to lift and some swelling.  The injection was given at my workplace so I contacted HR for guidance on Monday, November 2, 2015.  I have been seen by occupational health physician, orthopedic surgeon, and had physical and massage therapy.  Medications of ibuprofen, Flexoril, pain patch, and steroid injection to the left shoulder.
First night: Flu-like symptoms: body aches and tiredness, very sore feet, difficulty sleeping First 2 days:  Very sore right upper arm muscle Day 4: Developed itchy rash on left upper thigh and abdomen Day 5: Developed 3 very itchy fluid-filled bumps on right upper thigh Day 7: Developed 1 additional itchy fluid-filled bump on right upper thigh Day 8, 07/22/19: All rashes still present and itchy
This spontaneous report as received from a pharmacist via company representative and refers to a male patient of unknown age. Patient's medical history and current conditions were not provided. On 30-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date were not reported), 0.65 ml, subcutaneous, in arm. No concomitant medications were reported. On 02-FEB-2015, the patient experienced "softball sized" swelling with redness on the same arm that the patient received ZOSTAVAX. The outcome of "softball sized" swelling with redness was unknown. The relatedness between "softball sized" swelling with redness and ZOSTAVAX was not reported. Additional information has been requested.
I have a tremor in my hands when I'm in a stressful movement like to turn steering wheel in my car or a fine motor skill I will have a tremor. Pain in my left elbow joint. It feels like it's a bone bruise.
SHE COMPLAINED OF BEING LIGHT HEADED AFTER RECEIVING THE 2ND DOSE. ON SITE EMS REPSONDED AND VITALS ARE BELOW. sHE WAS RELEASED TO HOME
Pt given a vaccine mixed with the incorrect amount of diluent, .8 instead of 1.8  Pt experienced no adverse effects to date
Pharmist pulled blood back into the shot vial then pushed shot into my arm hurt immedaitley i felt dizzy he basically pushed me out the door 10 steps away i started feel sideways walking out of pharmacy it is all on video at pharmacy i went outside and someone outside helpe me to juice next door I went home and symptoms got worse chest pain so bad i had large block of ice on my chest for 4 hours flopping like a fish on the back deck of my home while my friends sat and watched cannabis is only thing and ice that go my past this attack. 2 years later purple toes instant blindness many new symptoms i never had before Bloody discharge from ears .
This spontaneous report was received from a registered nurse referring to a female patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 03-DEC-2015, patient was vaccinated with M-M-R II (strength, dose and route were not provided) lot # L011528 and expiration date 03-APR-2017, that were improperly storaged. No concomitant medications was reported. Symptoms Were Reported. No product quality complain was involved. This is one of several reports from the same source. Additional information has been requested.
PT did state she had been a decline since she received her last Covid vaccine Feb/March of 2021. PT has been using a Cane since that last Covid vaccine and has also cardiac issues with heart palpitations. She is now seeing a Cardiologist. She has also lost mobility of her left arm when she received her Covid vaccine for longer distance walks PT uses 2 sticks. She did loose her balance once in the last month when she took a step, doesn't consider it to be a fall and she didn't hurt herself. PT stated she gets relapses but she has not been diagnoses with Relapsing remitting since she has Neuromyelitis optica. PT has had a decline with her bladder retention due to a car accident October of 2022. She is self-cathering and stated has issues with retention. She did get Botox injection in Jan and it created more retention that before. She has an appt with a Urologist in April. PT was sick for a week starting Feb 1st 2023 and didnt' test herself for Covid, no lingering effects (possible had covid since her husband has it). She has missed a few doses of the medication for being sick and not being able to keep up with the every 12 hour window and going off schedule. She asked if that was okay but declined counsel and expressed the importance of Q12H. No concerns with the missed doses. PT pushes herself to do things around the house, goes to physical therapy once in a hwile and pelvic floor therapy about every 2 weeks. Intially to her Dx she had impaired vision and doesn't think there has been any changes since, stable.
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Individual received the Pfizer Covid-19 vaccine at 7:00 pm. She began to feel flushed and tingling feeling to her hands and behind her ears. Individual was given Benadryl 50 mg IM. Individual was later discharge home with her husband at 7:55 pm. She appear to be stable and in no further distress.
Patient was administered the booster dose before the 6 month time period was up given 23 days early
Arm started paining when I went to bed, during the night I felt feverish.  After shower I began to feel very nauseous and pains at the back of my head.  Started to eat cereal after 2nd spoon I felt so nauseous and the pains in the head felt horrible I felt I could not move my head, then I blacked out fell off the dining room chair on the floor fell backwards into my family room (it has one stair), when I came out of it I was lying in the family room my head and shoulders in the family room, my butt was on the stairs, my legs in the kitchen.  I spent the entire day in bed using an ice pack all over my body from the head (which was aching real bad), my elbow was bruised from the fall, my lower back was hurting as well as my (L) butt.  My temperature was 99.9 so I drank Tylenol Extra Strength twice during the day.
Four days of a fever between 102.4 and 103.8.  Severe, debilitating migraine and body aches.  Could barely move, drink or eat.
COVID vaccinated 12/2/2021, 2/26/2021, 1/29/2021. Hospitalized with COVID pneumonia 4/7/22.
At 2 am I was awaken by a strange heart rate.  I was very aware of a fast, irregular rhythm.  I listened with my stethoscope and the rhythm was all over the place.  I tried to take my blood pressure with our automatic machine but it just kept reading ?error?.  I also had a headache and heartburn.  The episode lasted about 45 min and stopped suddenly.  My pulse rate and rhythm were normal again.
APPROXIMATELY 4 MINUTES AFTER ADMINISTRATION, PATIENT REQUESTED TO LAY ON THE FLOOR DUE TO DIZZINESS AND BEING HOT. I ACCOMPIONED HIM TO THE FLOOR, AS PATIENT LAYED DOWN, HE LOST CONSIOUSNESS, EYES ROLLED TO BACK OF HEAD,SWEATING AND  UNRESPONSIVE TO MY VOICE OR TOUCH. DEEP SNORE. 60-90 SECONDS, LIFTED HEAD, THEN SLIGHTLY BUMPED BACK OF HIS HEAD. AS  PATIENT WOKE UP, HE ASKED WHAT HAPPENED. INSISTED AND REPEATED  HE WAS ALRIGHT. I KEPT HIM ON THE FLOOR FOR APPROXIMATLY 7 MINUTES UNTIL  FIRST RESPONDERS ARRIVED. THEY SAT HIM IN THE CHAIR, ASKED SEVERAL QUESTIONS AND TOOK VITAL SIGNS, AND EXAMINED BACK OF HEAD.  HE SIGNED OFF WITH THE AMBULANCE ATTENDANTS AND REFUSED TO GO WITH THEM. HIS  MOTHER ARRIVED AND STAYED WITH HIM FOR ANOTHER 7-10MINUTES.  PATIENT LEFT WITH FAMILY MEMBER, SIGNED OFF AT THE REGISTER .
My arm was sore almost immediately after receiving the vaccine. About 3-4 days later my arm started itching. The itches goes down from my shoulder to my elbow on my left arm and my right arm the itching goes from the shoulder to the wrist. My  left arm is also red around the area where I got the shot and was swollen, this lasted about 2-3 days then it went away. In the last couple of days the redness came back and puffiness came back. I do not see any bumps but when I feel my arms they bumps. I did try to put some anti-itch cream which helped with the itching but I quit putting the cream on it as I worried if it would react with the vaccine.
Patient developed tingling sensation immediately after Fluzone injection. Felt generally unwell within 2 hours and progressively developed upper respiratory symptoms described below. Took surface temp daily and ranged from 98.0-98.8 degrees Fahrenheit using infrared thermometer. Beginning on day 2, developed nasal congestion and unremitting cough, and moderately painful arm at site of Fluzone injection. Little or no redness. Illness progressed to unremitting cough, nasal and chest congestion lasting 7 days. URI symptoms accompanied by fatigue, body aches, and diarrhea (loose, brown stools; no blood). Confusing situation because she received 2 vaccines at once and granddaughter was sick with URI too (last exposure was 3 days prior to vax).
A non-serious spontaneous report of received expired vaccine was received from a health professional concerning a seven-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 29-Nov-2010. On 12-Dec-2010, the patient received the expired FLUMIST.  There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Shingles after first shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles after first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles after first shot). At the time of the report, HERPES ZOSTER (Shingles after first shot) outcome was unknown.            No treatment and concomitant medications were reported.   This case was linked to MOD-2021-150441 (Patient Link).
4 seizure episodes, lasting for 3-4minutes; A spontaneous report  was received from a consumer and other healthcare professional concerning a 37 years old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced 4 seizure episodes, lasting for 3-4minutes( seizure) .  The patient's medical history was not reported. Concomitant medications taken by the patient were not provided.  On 5 Mar 2021, prior to the onset of the event, the patient received his first  of two planned vaccine doses of mRNA-1273 (Lot number: unknown) through unknown route and dose, in the left arm, for prophylaxis of COVID-19 infection.  On 14 Mar202,1 at 3:00am, patient had a seizure episode which lasted for around 3-4 minutes. The event seizure caused for the hospitalization and was considered as medically significant. An ambulance was called and on the way to the hospital, he had 2 more episodes of seizure. While in the hospital the episode had again recurred. Blood work was done but the results were not provided. Patient was prescribed  Levetiracetam 500mg 2x a day.   Treatment for event was levetiracetam.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, experienced 4 seizure episodes, lasting for 3-4minutes, was unknown.; 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.
A LARGE RED BUMP FIRST SHOWED ON WEDNESDAY, 27 MAY, THEN AS THE DAYS PROGRESSED THE BUMP STAYED BUT THE REDNESS MOVED TO THE OUTSIDE OF THE BUMP.  THE REDNESS AND SWELLING ALSO BEGAN TO GROW FROM THE OUTSIDE AND FORMED MORE BUMPS SURROUNDING IT.  THE INJECTION SITE IS HOT TO THE TOUCH AND ITCHES.  WAS SEEN BY CLINIC YESTERDAY, 2 JUN, AND WAS DIRECTED TO RETURN TO IMMUNIZATIONS TO COMPLETE FORM.  WAS GIVEN ANTIBIOTIC AND ITCHING MEDICINE FROM CLINIC.
Patient was 11 years and 14 days on date of vaccine which is 11/11/2022. He received by accident the Pfizer Bivalent Booster for 12 years and older. He has already completed his Pfizer BioNTech COVID-19 vaccine primary series with us back in 2021 receiving 2 doses last one on 12/10/2021.
RASH AND HIVES TO NECK.  BENEDRYL AND PREDNISONE.  SYMPTOMS STARTED AT 4:00 VACCINE ADMINISTERED AT 1:00
patient was given an expired menactra with no reported adverse event; Initial information received on 04-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 73 years old male patient who was given an expired Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine Polysacch 23V (Pneumovax) for Immunization.  On 04-May-2023, the patient received 0.5 ml dose (dose 1) (total) of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (strength: standard) Solution for injection of lot U7268AA and expiry: 22-Apr-2023 via intramuscular route in the right deltoid for immunization.  On 04-May-2023, the patient developed a non-serious event patient was given an expired Meningococcal A-C-Y-W135 (D CONJ) vaccine with no reported adverse event (expired product administered) (latency: Same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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.
Information has been received from a health care professional concerning an approximately 17 year old female with no known medical history or allergies who was vaccinated in approximately 1995 (at the age of 13) with a first dose of varicella virus vaccine live. There was no concomitant medication. The patient did not receive a second dose at that time. In August 2003, at approximately 17 years of age, a titer was negative. On 8/27/03, the patient was vaccinated with a second dose of varicella virus vaccine live. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that the only problem we had was that she received her first dose at another facility a few days before she was nine years old, and her college required her to be nine. No further information is available.
Information has been received from a female health professional who on 19-JUN-2007 was vaccinated IM with a second dose of Gardasil. The registered nurse immediately was nauseous, weak and developed an elevated heart rate. The symptoms lasted a few minutes and the registered nurse recovered from feeling nauseous, weak and the elevated heart rate. Additional information has been requested.
Information has been received from the registered nurse concerning to an approximately 62 year old patient of unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 17-FEB-2015, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (lot number: K005402 with unknown expiration date) (dose, route and frequency unspecified). Concomitant medications were not reported. No adverse event was reported. The outcome of the event was unknown. The causality of the events with PNEUMOVAX 23 was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Patient received PNEUMOVAX and FLUZONE injections on 9/16/09. States that on 9/17 she noted swelling, erythema and pain in arm below injection site. "Rash" and tenderness now approx. 3 " below injection area. Pt given MEDROL dose pack with instructions for warm compresses, NSAIDS and elevation and instructions to follow up if no improvement or worsening occurs in 24-48 hours.
The nurse attempted to vaccinate the client and did not observe a wheel form. No signs or symptoms noted after the unsuccessful attempt.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 05-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sudden LOC onset about 10 minutes post injection with 10-15 seconds tonic posturing. Patient recovered consciousness in less than 30 seconds - BP 120/ 76 HR 68.
Information has been received from an 81 year old female with hypertension and a history of rash when taking sulfa drugs in the past who in December 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included atenolol and DIOVAN. In April 2010, the patient experienced itchy skin on the backs of her legs, buttocks, arms, back, neck and inside of her ears. The consumer stated that when she scratched her skin she experienced a "pebble-like" red rash in the areas that she scratched. The consumer stated that she was prescribed cortisone cream (manufacturer unspecified) and "SARDYL" cream (manufacturer unspecified) and neither cream relieved the itching. At the time of reporting, the patient had not recovered. No laboratory diagnostics studies were performed. The patient sought unspecified medical attention. The physician did not believe that the events due to ZOSTAVAX (Merck). Follow up information has been received via telephone call from the physician indicating that the reported adverse experiences of rash and pruritus were not related to the ZOSTAVAX (Merck) but to atenolol. Rash and pruritus had still not resolved. No further information is available.
daughter went from being a competitive varsity lacrosse player in high school to somebody whose chronically ill; This spontaneous report was received from a physician referring to his daughter who is a female patient of unknown age. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with the dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis, or the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. It was unspecified if the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On an unknown date, the patient experienced unspecified chronic disease as the reporter stated that his daughter "went from being a competitive varsity lacrosse player in high school to somebody whose chronically ill". The outcome of the event was unknown. Relatedness between the event and suspect therapies was not provided.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 07-DEC-2015 the patient was vaccinated with dose of improperly stored VARIVAX (Merck) (incorrect product storage) (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
PATIENT FELT LIGHT HEADED AND LIKE SHE WAS GOING TO FAINT, was monitored and released
Patient reports experiencing dizziness, dyspnea, dysphagia, headache, tingling along jawline, lightheadedness, flushing, and audible wheezing roughly 20 minutes after receiving his first dose of Novavax vaccine. Patient was assisted to emergency gurney, vital signs and initial assessment completed, and epinephrine 0.3mg/0.3mL plus diphenhydramine 50mg administered IM on left vastus lateralis. Patient reported slight improvement and was taken to our hospital's ED via gurney accompanied by RN.
Gave a dose of air to patient instead of the actual vaccine, we did correct our mistake and ended up giving the pt the correct Covid vaccine the same day and time.