chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed a circular reaction which was about 12 cm round. Area around the injection was pale/white and was about 6 cm surrounded by a 6 cm area of pink shade. Area was swollen, hard and warm. Pt took Benadryl at approximately 10:30 due to itching skin and noticed redness and swelling. Pt came to clinic at 2:00 pm  and was evaluated. Vital signs normal. Provider ordered 60 mg  Solumedrol to be injected IM.  Performed by reporter in right hip. Pt tolerated procedure and was feeling improvement. Pt was given instructions to take Benadryl and Tylenol as needed and use ice pack for swelling. Also given ER precautions.
Severe apnea, bradycardia, desaturation requiring bag/mask ventilation to recover (so far he has had 5 apnea episodes). 1/13/06 -  Review of 15-page record confirms apnea, bradycardia, & desaturations. Additional symptoms include cyanosis, tachypnea with subcostal retractions, decreased heart rate as low as 40 at times. Treated with IV fluids, caffeine, and antibiotics.
he had 3 blood clots in his lungs; hospitalized, pneumonia in both lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown, MANUFACTURER: UNKNOWN), for COVID-19 immunization. The following information was reported: PULMONARY THROMBOSIS (hospitalization), outcome "unknown", described as "he had 3 blood clots in his lungs"; PNEUMONIA (hospitalization), outcome "unknown", described as "hospitalized, pneumonia in both lungs". The lot number for bnt162b2 was not provided and will be requested during follow up.  Clinical course: Caller knows of 2 cases : "one was a cardiologist who had his primary series and was boostered. He came down with covid-19 and was hospitalized, pneumonia in both lungs and also he had 3 blood clots in his lungs." Caller also says she knows people who had the booster who got very sick and some people didn't get sick at all.
Patient came back to pharmacy 5 days later and said that she still had swelling in her entire right arm down through her hand. Stated that her arm and elbow were sore and the arm was hot to touch.  She said that the swelling started after the vaccine and got worse but was starting to improve but she was concerned since it was day 5.
10 days of 103 fever, severe headache, nausea, body aches, arm pain and chills directly following receipt of the vaccine
This spontaneous report as received from a male, 70 years old patient without drug reactions/allergies, refers to himself. The patient's medical history included asthma. In 2011 (reported as two years ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, lot number and expiration date were not reported) once, for preventions of shingles. Two years after receiving ZOSTAVAX (in September 2013) the patient experienced outbreak of shingles and post herpetic neuralgia (PHN). The patient was seeing a pain specialist. Location: top of the leg, knew and muscle weakness (right leg). Lab diagnostic studies included: MRI of leg, results not provided. The patient was treated with gabapentin 1200 mg 3 x daily (also reported as concomitant therapy) and ibuprofen. The outcome of events was not reported. The patient sought medical attention. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Received shot at 4 pm. Around 9 pm felt hot and had aches throughout body. I was uncomfortable to the pt. I could not sleep. In the middle of night heart started palpitating fast. Symptoms lasted until about 10 am next day.
Patient reported hives develop from head to toe around 7PM on day of injection, 4 hours after injection. Patient states that she took x6 tablets of Benadryl tablets (25MG) and then texted the vaccine coordinator to report event. Vaccine Coordinator contacted the medical director and he advised pt. to take Pepcid twice a day starting the same night of reaction until symptoms resolved. Vaccine Coordinator report this to patient and pt. voiced understanding. Pt. reported the following day that hives had resolved and only symptoms was a sore arm. Pt. reported that symptoms  of hives returned after resolved then resolved on 01/17/2021 in the night. Pt. reports symptoms still resolved today.
swollen glands in arm and neck; the glands were very uncomfortable under his left arm; This is a spontaneous report from a consumer (patient) via Pfizer.   A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: ER8729 and Expire Date: unknown) via unspecified route of administration, in left (upper) arm on 07Apr2021 13:45 in the afternoon (age at vaccination: 64 years) as DOSE 2, SINGLE for Covid-19 immunisation. Patient's medical history included diabetes and immune system disorder (immune system is not the same) from an unspecified date and unknown if ongoing. Since he was diabetic so he was skeptical to get the vaccine because he knew his immune system is not the same as most people. Concomitant medications were none. Patient previously received first dose of vaccine (Lot no: ER2613, expiry date: unknow) via unspecified route of administration, in left (upper) arm on 17Mar2021, as single dose for Covid-19 Immunisation. There were no other vaccinations taken within four weeks prior to the first administration date of the suspect vaccine. After second dose, on 08Apr2021 the patient reported he had swollen glands under his arm and neck. It was reported that when it first started swelling, it wasn't extremely painful but the glands were very uncomfortable under his left arm and then after a few days it got better but then on the 5th or 6th day all the glands got swollen. He confirmed that was still ongoing, it had pretty much been persisting the same since that 6th day after the shot. He said it had been almost 10 weeks. He went to his GP and they took one look and did a blood test and a urine test and it was all normal and because this was such a new thing no one knows what to do. Since the blood test and urine test was negative the patient was sent to the ENT and he looked at his under arm and neck and said come back in a month if he still has it, this is why he was calling because no doctor knows what to do with it. The patient underwent lab test on 30Apr2021 which included CNC, CMP and urine test, results of which were negative. The sample was collected on 30Apr2021 the report was given on 01May2021. The adverse event resulted in visit of physician's office. Patient believed that his other 2 sisters got the Pfizer shot, and they had no reactions and they also have immune compromised systems. The outcome of the events was not recovered.
She took a dose of aripiprazole 5mg immediately before receiving the vaccine. It caused her to have face tingle, which feels kind of heavy. She was able to drive home safely but feels extemely tired. I, the pharmacist, counseled her to skip her next dose and report to her psychiatrist immediately. Also recommended some bed rest for the next 24 to 48 hours with close supervision and to seek medical attention if any other symptoms appear.
Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; Malaise Myalgias arthralgias headache fever nausea from 12 hours post injection until 36 hours post injection; This is a spontaneous report from a contactable physician (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1283), via an unspecified route of administration on 09Jan2021 06:30 at a single dose on right arm for COVID-19 immunization. Medical history included depression, obesity, penicillin and bee sting allergies. The patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID prior to vaccination. Concomitant medications included venlafaxine, cetirizine and ibuprofen. The patient previously took ceftriaxone sodium (ROCEPHIN) and experienced allergies. The patient was given first dose of bnt162b2 on 19Dec2020 18:30 on left arm for COVID-19 immunization (lot number: Eh9899). No other vaccines in four weeks prior to COVID vaccine. On 09Jan2021 18:00, the patient experienced malaise, myalgias, arthralgias, headache, fever and nausea from 12 hours post injection until 36 hours post injection. Treatment was given for the adverse events which included acetaminophen and ibuprofen.  The patient has not been tested for COVID post vaccination. The patient was recovering from the events.
RED PRICKLY RASH STARTED AT BEDTIME.  WAS AWAKENED WITH SEVERE ITCHING.  IN THE MORNING, THE PRICKLY RASH WAS RED, HOT SWOLLEN ARE WITH A KNOT UNER THE SKIN.
Numerous bruises and petechaie over patient's body. Taken to pediatrician on 10/5/11. Blood platelet count was 1,000 (normal count is 250,000). Diagnosed with ITP. Referred to Hematologist same day. Started prednisone treatment and continued for 3 weeks. No long term results. On 10/25/11 patient was admitted to a hospital for an IVIG treatment. Temporary rise in blood platelet count, but no long term results. Homeopathy treatment started in Dec. 2011 that includes large doses of vitamin C, vitamin D, Licorice Root, and Moducare. Blood platelet counts continue to range between 0 - 5000. Patient continues to have numerous bruises and petechiae over his body. But so far no spontaneous bleeding issues.
Information was received on 24-JUL-2017 from a lawyer concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 05-NOV-2012 at a medical center, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAR-2016, the patient was treated in the emergency room for the onset of a blistering vesicular rash accompanied by a weakened immune system, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages Additional information has been requested.
A female patient developed serum sickness, joint pain and rash after treatment with RabAvert. The patient was bitten by a cat and received RabAvert on day 0 and 3 (dates unknown). On day 0, she also received immune Globulin. She had no significant past medical history and was not taking any concomitant medications., Approximately 7 days after the initial RabAvert injection, she developed serum sickness, rash, and joint pain. The outcome of the events was unknown. The reporter stated the event may have been secondary to Immune Globulin as well.
5/25/04: MMR injection 2400 noticed redness and swelling. 5/26/04: 2-3 inches in diameter, red/warm/ injection dark red/purple, very sore. 5/27/04: Continued same. Doctor looked at area. Employee health notified. 5/28: less swelling. Public health notified.
Top of arm swollen and very hot to the touch. Started about 30 hours after the shot. Went to urgent care two days later as it wasn't getting better. Doctor just said it was an adverse reaction to the shot and to keep an eye on it. If it grew in size or fever devolves bring him in to pediatrician. It was finally back to normal about 4 days after initial shot.
Pediatric Customer received incorrect dose of Pediatric Pfizer (0.3ml) IM;  nurse at the drawing table diluted 0.3ml of normal saline into the Peds Pfizer Vial drawing up just 6 vaccines.     when she noted the error this customer already received the dose of (0.3ml) and customer already left the observation area.  Customer didn't have any adverse reactions or symptoms.
Injection given in (R) deltoid - no swelling or redness noted at site - redness and swelling warm to touch a proximal medial upper extremity right arm.
Pt had Pfizer vaccine on 1/29/21, 2/19/21.  Was hospitalized for chest pain  and cough
had 3 "rough days"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Guillain-Barre syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "had 3 "rough days"".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NEUROPATHY 3/9/2023 &  3/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
1/2/21: Redness/warmth/in duration observed to right arm injection site. c/o pain to right arm 1/3/21: Redness/induration improving. Warm to touch with mild complaints of pain Resolved with no further action
Few hours after vaccine given developed severe headache and swelling to lymph node behind (L) ear.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-NOV-2015 17:21, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 7.5 and 2.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
patient received a expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a expired vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
was given MMR-II on 8/11/2001 and then given VARlVAX 18 days after/VARIVAX that was administered too early; This spontaneous report as received from a physician assistant refers to a 12-month-old (currently 10-year-old) female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-AUG-2001, when she was 12-month-old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 29-AUG-2001, 18 days after, the patient was administered too early varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). The school noticed this and has brought it to their attention and was questioning the validity of the vaccines. No PQC reported. No other information reported.
1 1/2 after vaccination - congestion, wheezing, coughing, chills, aching and vomiting.
She experienced 36-48 hours of pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 08:30 (Lot number: EW0151) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Vitamin d, notes: Started 2 years ago; Folic acid, notes: Started couple years ago, recommended by doctor; Armour thyroid for Thyroid, notes: Started 3-4 yrs ago. Vaccination history included: Shingles vaccine (She had a vaccine about 6-8 weeks before the Covid-19 vaccine, it was the Shingles vaccine.). The following information was reported: PAIN (non-serious) with onset 06Apr2021, outcome "recovered" (08Apr2021), described as "She experienced 36-48 hours of pain". Therapeutic measures were taken as a result of pain.   Additional Information: After the first dose: She experienced 36-48 hours of pain and then it went away with the Ibuprofen, 800 mg every 12 hours. After 48 hours she was fine. she started taking Armour Thyroid because the thyroid it had dipped down, it is controlled good with medicine. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no.   No follow-up attempts are possible. No further information is expected.
The vaccination was given approximately an hour and 5 minutes past the six hour expiration time when stored in the refrigerator.
I began to feel a little dizzy and sluggish a few hours after the vaccine and the night of the day I received the vaccine I felt extremely tired.  The next day, today 10/21 I am feeling very tired and breathing is tighter than normal.  It is not necessarily hard to breathe but my pulse seems slower and breathing is tighter.
A report has been received from a Health Professional concerning a patient born on 10-MAY-2011, male subject who has been receiving FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced Ataxia. The outcome of Ataxia is unknown. The report was considered to be non-serious.
Tdap indicated due to age, DTaP ordered and given. Discussed with RN BSN at Health Center per CDC no ill effects, still counts as valid immunization. Instructed to complete VAERS Report.
Several pain in her legs, hands, and arms. developed Several Vasculitis. Hospitalized for 4 months in pain. Acquired COVID in the hospital and died 5 days later.
Administration of an expired dose / to a patient / 3rd dose in the series; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 9794C, expiry date 13th June 2021) for prophylaxis.   Previously administered products included Engerix B (1st dose and 2nd dose of Engerix B received on an unknown date).   On 15th June 2021, the patient received the 3rd dose of Engerix B. On 15th June 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Engerix B which was already expired on 13th June 2021. The reporter did not feel completely comfortable sharing patient information but mentioned they would provide that in the follow-up. The reporter consented to follow up.
Pt received flu vaccine about 2 weeks ago, in the right deltoid. The deltoid pain began about 24 hours, post vax. In the past 2-3 days, she had increased pain, limited use of her shoulder, arm and hand. No erythema, inflammation, induration, masses or lesions. Positive abduction was limited to 45 degrees. Treatment: conservative; ibuprofen and cold therapy. Return if signs and symptoms increase or persist over 5-7 days.
Narrative: The patient received his 4th covid vaccine and did not feel well after. Two days later he felt palpitations so went into the ED and was diagnosed with A Fib with RVR.
Information has been received from a registered nurse concerning herself who in April 2011, was vaccinated IM with a dose of ZOSTAVAX (Merck) (lot # not provided). In April 2011, the patient developed redness, swelling and several pock marks on her forehead. She placed ice on the area and the symptoms resolved in 3 to 5 days. Additional information has been requested.
Migraine; Sore throat; General malaise; Muscle aches; Fever; Exhaustion; Bouts of sever chills; This is a spontaneous report from a contactable consumer, the parent. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 12May2021 at 12:00 (at the age of 13-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and COVID-19. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 12May2021, the patient experienced sore throat, fever, bouts of severe chills, muscle aches, migraine, exhaustion and general malaise. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore throat, fever, bouts of severe chills, muscle aches, migraine, exhaustion and general malaise was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
30min p/vax pt exp severe pain in shoulder causing n;pain cont 4 days later radiating to hand when arm moved;tx by pt w/anti-inflam & heating pad;exam by MD;dx brachial neuritis secondary to tetanus vaccine advised no further boosters;
Originally I got a sore arm but about 1 hours later got nausea, lightheaded, headache, diziness, fever of 101, swollen arm pit.
Perforation of duodenum; She was taken to the operating room and underwent laparoscopic Graham patch repair. Postoperatively she had an NG tube in place to low intermittent suction and was on IV Protonix after loading dose. She remained n.p.o. until postoperative day four when a CT scan with p.o. contrast was done which showed no evidence of contrast extravasation. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
10cm by 8 cm patch of erythema and induration just distal to the injection site on the right arm. The injection site is well below the deltoid, between the bicep and tricep muscle.
Couple of days immediately following vaccines patient had a low-grade fever. One week after vaccinations patient had chest tightness and difficulty breathing, necessitating the use of an inhaler several times throughout the day. 14 days after the vaccinations patient broke out in an extremely itchy rash.