chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. Concurrent conditions, medical history, historical or concomitant drugs were not reported. The reporting medical assistant informed that on 30-MAY-2018, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 Injection, lot # M018810, expiration date 28-MAY-2018, for prophylaxis (strength, dose, dose number, route and anatomical location were not reported). No adverse effects reported.
5 minutes after receiving vaccination,  child stood up and fainted, lost consciousness for about 1 minute, appeared to shake like having a seizure then regained consciousness, chipped front tooth from fall Called 911, gave child ice pack and water Normal respiration, heart rate, temperature, no swelling of lips and tongue, bruising of cheek from fall, full range of motion
Pt recv vax on 1/19/99; immediately post vax pt fainted x3 w/ seizure activity, incontinent of urine, sleepiness; tx=15 min lying down,
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. On or about 2014, the patient was treated by a physician's assistant for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
STERILE WATER FOR INJECTION WAS MIXED AS THE DILUENT.  NO ADVERSE REACTION REPORTED YET BACK TO PHARMACY AT TIME OF THIS REPORT.
High fever of 103F, vomiting, diarrhea and weak X 7 days.
Adult patient received Infanrix; Expired Infanrix administered; Infanrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 63-year-old male patient who received DTPa (Infanrix) (batch number G5BE3, expiry date 25th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th December 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th December 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced adult use of a child product, expired vaccine used and wrong vaccine administered. On an unknown date, the outcome of the adult use of a child product, expired vaccine used and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-DEC-2022 Reporter's Comment: The healthcare professional reported that an adult patient received an expired dose of Infanrix instead of Boostrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The adult patient used expired dose of Infanrix instead of Boostrix, which led to adult use of a child product, wrong vaccine administered and expired vaccine used.
Pt reporting redness in the area of the vaccine, roughly a 3 by 6 inch area, that is warm to the touch. It has been going on for around 24 hours, and it started about 24 hours after administration. He had not tried any treatments, but said he would try some tylenol to help with the heat in the area, have not been able to follow up to see if that has helped
2/26/23  I began to feel numbness in my right cheek . My ear started to feel congested. I started to feel something towards my eye. I went to Urgent Care and was then taken by ambulance to the hospital. I had a CT , an MRI and bloodwork, They were ruling out a TIA or Bells Palsy. I was put on a low dose aspirin in case it was a TIA.  I was discharged from the hospital on 2/27/23.  I was told to watch my diet.
Pt was given an expired immunization - has had no adverse reactions - Pt was given a varicella - Lot # K003412 Exp 3-6-16 Merck - Pt's mother was notified and pt is having no reaction. Will repeat vaccine in 30 days.
Tasted metal immediately. Within 4 minutes I felt burning in throat and got very itchy. My throat started itching, I got hives all over my body. Lips went numb.
It was found that when the pt received vaccines on 11/25/16 the PENTACEL powder was mixed with sterile diluent not the liquid component of the PENTACEL vaccine.
L DELTOID SQ, REDNESS, SWELLING, AND HEAT TO THE AFFECTED AREA. A SIZE OF 60MM. TREATMENT: ADVISED PATIENT TO APPLY WARM COMPRESS, AND TAKE IBUPROFEN FOR PAIN AND SWELLING. IF THE PROBLEM PERSISTS PATIENT WAS ADVISED TO SEEK MEDICAL ATTENTION AT A PRIVATE SECTOR.
Child was evaluated on 6/30/09 and noted to have confirmed case of diffuse varicella. Child's rash involved dozens of varicella lesions on trunk, back, abdomen, arms and legs, only a few on face. He appeared otherwise well without fever or other symptoms. Mild case.
Significant swelling, pain, edema of entire arm.  Pain with range of motion of her right upper extremity. Throat tightness.
For two days (the 4th and 5th day after the dose) I had constant dizziness, nausea and a headache. My dizzy spells were consistent throughout the 48 hours. The headache never fully went away, lasting over a week.
DEVELOPED COUGH, SORE THROAT, HEAD CONGESTION, AND EYES BURNING 1/5/21 (DAY 7 AFTER VACCINATION), ALSO HAD +ANTIGEN TEST 1/5/21, +PCR 1/7/21.
Parents complain that they noticed pain/decrease left lower extremity use since vaccinations. Increased fussiness 2 days after vaccines. Full ROM noted by MD, not standing on both legs, appears to be due to pain. Left leg pain, neurologically intact. No treatment, follow up in 1 week.
High Fever; Extreme chills; Extreme dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 15:00 as dose 3 (booster), single (Lot number: GH9703) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Trigeminal neuralgia" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: iodine" (unspecified if ongoing). Concomitant medication(s) included: VARICELLA ZOSTER VACCINE taken for immunisation, on 19Sep2022 as dose 2, single; INFLUENZA VACCINE taken for immunisation, on 19Sep2022 as dose 2, single; ROBAXIN; NEURONTIN; SINGULAIR; LIPITOR; LISINOPRIL. Past drug history included: Zinc oxide, reaction(s): "Allergy"; Coricidan, reaction(s): "Allergy". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FTZ9993, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 22Apr2022, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FM9992, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 14May2022, when the patient was 63-year-old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 13Oct2022 at 08:00, outcome "not recovered", described as "Extreme chills"; DIZZINESS (non-serious) with onset 13Oct2022 at 08:00, outcome "not recovered", described as "Extreme dizziness"; PYREXIA (non-serious) with onset 13Oct2022 at 08:00, outcome "not recovered", described as "High Fever". Therapeutic measures were taken as a result of pyrexia, chills, dizziness.  Additional information: Patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination. Patient took Tylenol as treatment for the events.
Localized pruritic, erythematous rash in an oval shaped area surrounding vaccination site, over the deltoid approximately 6 cm x 10 cm
Participant received J&J COVID-19 vaccine on 4/11/21 and should not have received Moderna COVID vaccine. participant answered 'no' to ever receiving a COVID-19 vaccine in the past on the prescreening questionnaire.
Mother reports that her son was a very healthy young man until the past 4 months, post vax. On 1/1/2000,the boy experienced liver failure and was hospitalized for 2-3 weeks. He was put on a liver transplant list during this time but recovered by the end of February. On a follow-up MD visit 2/28/2000, the boy was re-hospitalized due to occurence of aplastic anemia detected by CBC. Bone marrow biopsy confirmed dx of aplastic anemia. The pt was hospitalized for 2 weeks during which he received growth factor. He is currently taking cyclosporine. No further information about his condition is available. The mother states they are in a "wait and see mode", for the son may require a bone marrow transplant. The mother says her son was healthy as a horse until now. Her son's MD told her that he has seen other children experiencing the same reaction. She is just starting to put together that the vaccine may be the cause of her son's health problems. 60 day follow-up dated 7/10/00 states that the child is not responding to medications and will probably require a bone marrow transplant.
Entire right thigh red & swollen. Hot to touch. Patient complains that it hurts. Fever up to 102 degrees.
pt recv varivax & gamma hep A;pt may return in 6mo for 2nd varivax/instructions given;weight 44#-gamma 5cc given IM;
Left SQ of arm with erythema and swelling about 1.5cm in diameter.
Site of HIB injection entire thigh swelled immediately.  Baby cried for 2 hours.  Swelling decreased next day, bruising at site.  Parent reported fever.
Information has been received from a physician via a company representative referring to a 65 year old male patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient received a dose of PNEUMOVAX 23 (dose, strength and route unknown) in his fifties. There was no adverse effect reported post PNEUMOVAX 23 administration. The physician stated that patient had unspecified co-morbid conditions that met indications for a dose of PREVNAR 13 which was administered to the patient (dose, strength and route unknown) on an unknown date at the age of 65 years. Then on an unknown date the patient developed urticaria post PREVNAR 13 vaccination. At the time of reporting, the outcome of urticaria was unknown. The causality was not reported. Additional information has been requested.
Patient came in showing her arm having a large red patch around the injection site.  She said it was raised and warm to the touch yesterday 9/19 but now just red.  She went to the doctors office and doctor prescribed an antibiotic for cellulitis.
Woke up the next day with body ache (arms, legs, lower back, chest). extremely exhausted. looked pale. cold sweats, fever. dizziness/headache.
14 hours of continuous crying & fussiness.  Had 3 hours of fussiness with 1st vaccine 2 m before.
The patient's granddaughter called on 11/14/2001 to report the patient has tingling in her fingers and legs and joint aches less than 24 hours after vaccination on 11/07/2001. By day 7 the condition had resolved except for the right index finger is still tingly and the left leg is weak and achey.
Client explained she felt dizzy and then vomited 5 minutes after receiving vaccine. Vitals signs were: BP 110/72, 98% O2, HR 72, RR 16. Client status improved after some rest and water mouth rinse. Client explained she doesn't like needles and was feeling anxious before and after receiving the vaccine. Client educated on importance of eating a full meal and to call doctor if vomiting continues.
Next day after the flu shot at 3:00 am patient got up and left side was paralyzed and could not speak well and had a headache.
Pt received dose 1 of Moderna COVID Vaccine today.  Was observed 15 minutes, and was free to go as patient was fine.  Pt left the vaccination clinic, was outside on the sidewalk, became dizzy and fell to the ground.  His wife was able to help him down, without any head trauma.  Pt was clamy, and heart rate was lower than his normal.  Pt noted that he always gets nervous when getting blood drawn, vaccines or at the Dr's office.  Pt felt normal otherwise and mentally alert and oriented.  Pt was given water and was observed for close to 1 hour.  Pt improved without further intervention and was allowed to return home from the clinic.
Patient incorrectly received Pfizer for his third dose after receiving Moderna for his first two.  No AE.
I started feeling achy two days after the shot and I was also dizzy and light headedness. I was achy in my shoulders neck and down my arms with a little in my thighs. The achiness lasted a full eleven days.  I went to the doctor and they took blood work and advised Extra Strength Tylenol. The pain reliever didn't seem to help. I took a Magnesium supplement, and the achiness went away the next day. I am not sure if they were related. I got the second dose and I did not have the same symptoms.
16 year old received vaccine; A spontaneous report was received from a Pharmacist concerning a 16-year-old, male patient with unknown race who was administered Moderna's COVID-19 mRNA-1273 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, patient received a dose of the Moderna vaccine mRNA-1273 (Lot number: unknown) by injection for prophylaxis of COVID-19 infection.  On unknown date, a minor patient received the mRNA-1273 vaccine at mass vaccination site.   Action taken with mRNA-1273 in response to the event was not reported.   The event, "16 year old received vaccine" was considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 16-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Product administered to patient of inappropriate age.
Both Legs Became Completely Numb; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730), intramuscular in the right arm on 28Dec2020 07:45 at a single dose for COVID-19 immunization. The patient's medical history included diabetes and blood pressure (BP) abnormal. The patient was not pregnant. Concomitant medications included losartan potassium (LOSATAN), metformin, and amlodipine besilate (NORVAC), clopidogrel bisulfate (PLAVIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and experienced allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 29Dec2020 19:00, the patient was sitting and both of her legs became completely numb for 20 minutes and then the symptoms went away. This never happen before. No treatment was received for the adverse event. Outcome of the event was recovered on 29Dec2020 19:20. The event was considered non-serious.  Information on the lot/batch number has been requested.
9pm - 7 hours after receiving the shot I was extremely itchy all over and took Benadryl  2am- I woke up unable to move my arms, hands, legs, and feet. I wasn?t able to wake my husband and remained as calm as possible. I drifted in and out of sleep. By 4am I was able to wake my husband. He used our elevating bed to sit me up and gave me ibuprofen and water through a straw (not sure why that was his solution and just thankful I?m here today to type this response). By 6am I had terrible shooting pains in my hands, fingers and then Charlie horses in my feet and calves. That is when the ability to move came back. At that point I was extremely fatigued and exhausted and felt like I had a terrible flu. I was in bed for the next 6 hours clammy and  sweaty and in a very achy.  24 hours after the vaccine I was back on my feet.  50 some hours after the vaccine I still have an aching in my hip on my left side and tenderness at the injection site.
Breakthrough case admission after 3 vaccines Pfizer 1/20/21 lot# EL3249;  Pfizer 2/10/21 lot# EL9265;  Pfizer 10/19/21 lot# FH8020
I had low O2 levels 83-93, loss sense of smell, loss of taste, low grade fever, dry cough, pain in my left side, pain behind right knee, headache, blurred vision, high respiration rate, my middle finger got swollen and purple. I tested positive for COVID-19. I drunk lots of fluids and took my vitamins. I was sick for all the February. To this day I still have headache either everyday or a couple times a week.
RECEIVED FIRST DOSE AT HEB PHARMACY ON 2/26/2021. RECEIVED SECOND DOSE TOO EARLY (ONLY 14 DAYS) ON 3/12/2021. RECEIVED ADDITIONAL THIRD DOSE ON 4/9/2021.
I was very lethargic, just wanted to sleep, headache, really sore arm for 3/4 days, depressed and on day 8 after the shot the sit injection turned, red and hard and painful and I was sweaty but no fever for about 3 days and then it went away
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Sep-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2023, SARS-CoV-2 test: Positive.         Concomitant medication not reported.   Patient already received 5 Moderna COVID-19 doses, 2 doses of the primary series and 3 boosters, but did not remember the dates. On 8 Sep 2023 he tested positive to COVID-19 but did not have any symptoms and was in quarantine for 5 days.  Treatment medication not reported.   Reporter did not allow further contact
Large, red, swollen area at injection site. Warm to the touch. Patient has been scratching at area.
Stiff, achy muscles & joints, nausea, headache, vertigo all culminating in Shingles.
Moderna COVID 19 Vaccine PATIENT WAS GIVEN THE VACCINE PASSED 30 DAYS AFTER THAWED.  NO NEGATIVE REACTIONS NOTED
Large local reaction w/ redness and itching. Nausea, vomiting, exhaustion (flu like symptoms).
Within 10 minutes of receiving the vaccine, I had severe itching and burning at the site of injection. The site became swollen and hot to the touch. The area was dark reddish purple (1 x 2 inches) with induration. Reaction lasted approximately 4 weeks.
I received a flu vaccine at my doctor's office.  Later that evening my arm was really sore, to be expected, but the pain got worse, it felt liked I had been punched in the arm along with a large, red, hot, rash around the injection site.  It was about the size of sliced kiwi.   The pain was worse at night and I had to sleep with a cold compress on my arm.... it took about 5 days for the redness to fade and the pain to subside.  It's now 2/6... there is a shadow of the rash on my arm still and a tolerable soreness that when I'm still and quiet am aware of its presence.   I did report this to my doctor and was told to keep an eye on it and let them know if it got worse.  I never called back as it did get better.  Last year I received a flu vaccine at a pharmacy and had no reaction at all.
Upper arm became very itchy around 11am (about an hour and a half after vaccination). Within 12 hours, inner arm was very swollen down to elbow. Took ibuprophen. Swelling reduced in am.
The evening of the vaccine, Wednesday, I was extremely tired.  By the next day, my right hip and right leg were throbbing.  I have not slept well since the vaccine.  By Friday, I was so sore that I visited a Chiropractor.  By Saturday, I could not stand, sit or lie down without extreme pain.  I called Dr. on his cell and he met us (my wife drove) at his clinic.  After treating me, he sent us to Urgent Care.  At the urgent care facility I received a Toradol shot and a prescription for prednisone.  Both Doctors said that this was a likely "inflammatory response" to the vaccine.  (continued below)
no additional AEs; PROQUAD was administered to 4 year old patient on 2/9/23 who had just received VARIVAX on 1/6/2023; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 09-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, once, lot #W024972, expiration date: 05-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of product administration). No additional adverse events details or product quality complaints were reported (no adverse event).
Initial report was received on 12 October 2011 from an investigator participating in the study under the reference number M5A11. A 17 month-old female patient with no reported past medical history experienced respiratory arrest due to aspiration (resulting from vomiting) 123 days after receiving dose four of PENTACEL, lot number C3747AB (route and site of administration not reported) on 27 April 2011. Additional vaccine history included a first dose of MMR, lot number 1644Z (route and site of administration not reported) received on 01 July 2011. According to the investigator, a representative from the coroner's office was told that the "child likely choked on a ravioli as fed by a parent". No autopsy was performed as it was not a coroner's case. The outcome was fatal. According to the investigator, the event was not related to the trial product. Documents held by sender: none.
seizure adm to hosp x 3 days; sudden jerking motions, eyes rolled back then became very limp; had blank look; listless; poss apnea or reflux or metabolic disorder, arrhythmia, hypoglycemia or anaphyl react to vax;
INADVERTENTLY VACCINATED BEFORE AGE 12 YRS OLD. INFO COULD NOT BE CLARIFIED.  WRONG DATA ENTRY SUSPECTED.
pt c/o tingling in bilat hands, dizziness & c/o nausea;pt laid safely on floor & states wants to lay down in case faints;pt given epi immed;pt pulse down from 130bpm p/5min to 90 bpm;pt given 02p;
Injection site reaction - red and inflamed area at site, approximate dimensions: 2x3 inches.