chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix administered to a two month old; ordered Kinrix instead of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The reporter inadvertently ordered Kinrix instead of Pediarix and it was administered to a two month old patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The patient was fine. The reporter consented to follow up.
After 18 hours I ( patient) had normal chill/body pain which went away in another 12 hours. However after 70 hours of vaccination, approximately at around 6pm on May 3rd, I have sever rash all over the body. I tried Benadryl and other ani histamines such as Zyrtech / Claritin and saw no remission. At 9am on May 4th, I went to the urgent care where I was given steroids (merit). As of May 4th noon - I still have the rashes. The rashes are red spot all over the body. they are itchy. I do not have any weakness or swollen mouth etc.
had an outbreak of herpes; This case was reported by a other health professional and described the occurrence of herpes virus infection in a patient who received Herpes zoster (Shingrix) (batch number J3M5J, expiry date 6th February 2022) for prophylaxis.   The patient's past medical history included herpes virus infection (outbreak of Herpes on July 7 1998).   On 12th February 2020, the patient received the 1st dose of Shingrix. On 22nd February 2020, 10 days after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was not recovered/not resolved.   The reporter considered the herpes virus infection to be unrelated to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The batch number was reported as JRM5J, however it was changed to J3M5J as per sales sheet. The patient provided the NDC number as 5816082901. The patient received Shingrix and had an outbreak of herpes which had not stopped to date. The reporter at the time of reporting need to take the herpes medication for life. On 22nd April 2020, the patient received 2nd dose batch number H4H34, expiry date 27th November 2021 and NDC5816082801. There was no relation between the vaccine and herpes. But the reporter would like to know if there was a relationship between herpes and the vaccine.
This spontaneous prospective pregnancy report as received from a 22 years old female consumer with no Pertinent Medical History and no Drug reactions/Allergies reporting on herself. The patient was vaccinated SC with, 0.5 ml VARIVAX (Merck) (lot number not reported) as part of a pregnancy registry on 16-AUG-2012. There were no concomitant medications. The patient reported she was 18 weeks pregnant when got the vaccine. Her last menstrual period (LMP) was 13-APR-2012 and estimated delivery date (EDD) of 18-JAN-13. Initial exposure to VARIVAX (Merck) was at 18 week(s). The patient was exposed to VARIVAX (Merck) during trimester 2. No adverse reaction was reported. No Lab Diagnostics were performed. Additional information has been requested. 30-APR-2013. This is a correction. The onset date for the event of maternal exposure during pregnancy was removed.
Pt received a higher concentration dose of pfizer due to not enough diluent mixed with vaccine. Only 0.9mL of diluent was mixed instead of 1.8mL. No adverse effects noted at this time.
Client  received the 1st COVID vaccine Janssen 11/30/21.  Client reports that approximately 1 hour after receiving his 1st dose he started having left sided numbness and tingly from the shoulder to his waist.  Client  reports that the symptoms lasted roughly 1-2 days.  Client  did not follow-up with primary care physician.   Client  denies any medical underlying conditions, no known allergies, and not currently taking any medications.  Client  requesting Moderna as a booster dose.  At 1346, Co-lead  elevated medical consult to Vaccine Operation Team for review.  At 1350, Co-lead  received response from Dr. approving Moderna Booster Dose.  Client  notified of the approval and at 1356 Client  was administered Moderna Booster Vaccine (Lot #059H21A, Exp 3/27/22).  Client  was observed and no adverse reactions nor symptoms were noted.  Client education on adverse reactions and when to seek care.  Client  completed observation without complaint and left vaccination center with steady gait.
Inflammation around his heart; heart racing after his second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown.), for COVID-19 immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "Inflammation around his heart"; PALPITATIONS (non-serious), outcome "unknown", described as "heart racing after his second dose". Therapeutic measures were taken as a result of pericarditis.  Clinical course: Reporter stated, my son, started having heart racing after his second dose. Now months later he had inflammation around his heart and was on medicine for this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
normal reactions within 24 hours (fever, sore arm, light headache) that went away within 24 hours.   about 65-70 hours later (3 days) my neck began feeling swollen on the outside. not lymph nodes. my neck on both sides from shoulder to jaw line is swollen . doesnt hurt to the touch. slightly difficult to swallow but not as bad as when you had swollen lymph nodes or sore throat.
PATIENT COMPLAINED OF NECK PAIN AND LIGHTHEADEDNESS. ADVISED PATIENT TO SIT DOWN AND CHECK BLOOD PRESSURE. PRESSURE WAS VERY HIGH AT 199/113. CALLED PATIENT'S MD OFFICE AND THEY ADVISED US TO CALL 911. PATIENT WAS TAKEN TO HOSPITAL BY AMBULENCE.
feels hot to touch; Swollen; Having the redness on the arm/tiny redness; Arm feels hard inside like its inside the muscle; Redness on her arm (where the injection was given)/bit of redness, tiny redness, the size of a penny; This is a spontaneous report from a contactable consumer or other non-HCP. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Left Arm on 27Jun2021 10:00 as DOSE 2, SINGLE (at the age of 60-year-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180) administered in Left Arm on 06Jun2021 at 12:00 for covid-19 immunization and had a little bit of tiredness and sleepiness. On 27Jun2021 the patient experienced redness on her arm (where the injection was given) and bit of redness, tiny redness, the size of a penny. On 28Jun2021 the patient experienced feels hot to touch, swollen, having the redness on the arm/tiny redness, arm feels hard inside like its inside the muscle. The patient's arm feels hot to the touch and swollen: The next morning, 28Jun2021, in the morning, the caller finds out that her arm is swollen, not the whole arm, but the area where the caller received the second dose Pfizer Covid Vaccine, it was maybe 5 to 6 centimeters that it was swollen. The patient arm feels hard inside like its inside the muscle. Her arm was hard when touching the muscle, will feel hardness inside when touching arm. Her arm feels hot to the touch and swollen: The arm felt hot, warm, and swollen. Her arm feels hot to the touch and swollen: In the night hours, maybe about 2000, the callers arm swelling was already 9.5 centimeters, the swelling grew. All day on 28Jun2021, the caller was putting a little ice pack and wet and cold things onto the arm.  Today, 29Jun2021, in the morning the caller finds out the size is the same. Her arm feels hard inside like its inside the muscle: The hardness in the caller's arm muscle is a little less. The caller doesn't feel the big chunk inside of the arm. There is a little less hardness. Her arm feels hot to the touch and swollen: The swelling is the same. The size is the same on the arm. Her Has redness on arm where the second dose Pfizer Covid Vaccine was given: The color is the same on the arm.  Therapeutic measures were taken as a result of swollen. The outcome of event arm feels hard inside like its inside the muscle was recovering. The outcome of rest all events was not recovered.
Bad taste in mouth within 15 minutes of shot. Head to toe flushing and feeling hot and prickly within 1 hour of shot. shortness of breath and wheezing  followed. Treated with PO Benadryl and zantac and albuterol inhaler.
Pfizer TRIS COVID-19 vaccine was administered to patient on 4/24/22. Vial was placed in refrigerator on 2/10/22 and NP entered expiration date 5/31/22. 10 week expiration date was 4/21/22. Lot # FK9895; vial expiration date 9/2021; 59267-1025-04. No treatment completed. Outcome: Patient to be called and alerted to the error.
5 inch (diameter) red area, swollen, hot to touch, hard. Pt was complaining of itchiness. Started within 24 hours after vaccine.
Hives on different parts of the body. Swollen lips, throat feeling tight. Higher pulse rate. Dizziness. Feeling heat on skin.
administered DTAP+IPV instead of DTAP; administered DTAP+IPV to 2 month old child; This case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 3-month-old female patient who received DTPa-IPV (DTPa-IPV) for prophylaxis.   On 20th October 2022, the patient received DTPa-IPV. On 20th October 2022, unknown after receiving DTPa-IPV, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The patient's mother reported that they could not identify the brand name of the vaccine. The Kinrix was only approved in patents from 4 to 6 years of age. The reporter did not consent to follow-up. Additional supportive information: The patient received DTAP+IPV instead of DTAP vaccine at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. Suspect was coded as per narrative information.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, muscle cramps, lethargy Narrative:  Zofran 8mg once, Advil OTC and  Imodium once
The Pfizer Peds dose was given by mistake. This was identified immediately. Client and parent notified. The teen was vaccinated with the correct dose of Pfizer 12yo and up.
Right ear pulsate tinnitus for 36ish hours starting 4or 5 hours after vaccine administration.  After about 36 hours it is no longer pulsating but ever present tonal sound in right ear.  It sounds like an amplifier has been turned on.  Increased hearing sensitivity in same ear.
The following day I had a fever of 102 and was achy. In February, I developed a horrendous ringing in my ear. I went to the doctor and my BP was high, but the ringing persisted even when it was regulated. I was sent to an ENT and was told that tinnitus is usually a nerve issue. Initially, I didn't think it had anything to do with the vaccine until my neighbor told me about her experience. She said that there isn't any treatment for it, so I'm still dealing with the ringing.
Pain at Injection Site-Mild, Systemic: Shingles-Severe.
Pt recvd 2 doses of Hep B vax 20JUN91 & 18JUL91 & on 26JUL91 devel diffuse arthritic complaints, arthralgias, myalgias, tennis elbows & arm pain; also devel swelling in feet & hands; lab eval revealed pos ANA of 1:640 & EOS 10;
Pt's temperature went up to 102.7F, 24 hours, post vax.
Stiff neck, severe pain, inability to move head from side, slowly subsiding over 8 days with use of warm compresses and neck cuff on occasion ; accompanying difficulty opening mouth, facial numbness below right eye for duration of 8 days. Severe headache with strong pulsations at crown, sides and behind eyes; accompanying blood pressure at 160/78, days 4 through 7 post injection. Leg and arm muscle aches, not severe, days 1 through 8 post injection. Joint pain, not severe: ankles, knees, wrists, elbows; days 1 through 6 post injection.
Information has been received from a 75 year old female with no medical history, no known allergies, who on the first week of June 2008 was vaccinated with a dose of ZOSTER (Oka/Merck).  Concomitant therapy included unspecified blood pressure medication.  In approximately June 2008, shortly after receiving ZOSTER (Oka-Merck) the patient experienced a case of shingles on her head.  She had maybe one or two break-outs, however she was experiencing bad headaches and a little bit of nausea.  An MRI was performed: results not provided.  Unspecified medical attention was sought.  At the time of reporting the patient was recovering.  There was no product quality complaint  No additional information is expected.
FEVER; SLEPT FOR 2 DAYS; INJECTION SITE PAINFUL HUGE KNOT; FELT VERY SICK; A HUGE BLOOD RED SPOT AT THE INJECTION SITE ABOUT THE SIZE OF A DESSERT PLATE AND EXTREMELY HOT TO THE TOUCH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported .and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced slept for 2 days. On MAR-2021, the subject experienced injection site painful huge knot. On MAR-2021, the subject experienced felt very sick. On MAR-2021, the subject experienced a huge blood red spot at the injection site about the size of a dessert plate and extremely hot to the touch. On 24-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 25-MAR-2021, had not recovered from a huge blood red spot at the injection site about the size of a dessert plate and extremely hot to the touch, and injection site painful huge knot, and the outcome of felt very sick and slept for 2 days was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017, reported as since 20-APR-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M006104 with expiration date 01-AUG-2017, lot# M022400 with expiration date 01-NOV-2017 and lot# reported as M043581 with expiration date 28-OCT-2018 (dose and route of administration were not reported). On 26-APR-2017, 02-MAY-2017, 03-MAY-2017 and 14-MAY-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot# M035690, expiration date 06-FEB-2018 (dose and route of administration were not reported). On 01-MAY-2017, 02-MAY-2017, 16-MAY-2017 and 17-MAY-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot# M038860, expiration date 13-MAR-2018. All vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not provided). There was no adverse effect reported. From 20-APR-2017 to 18-MAY-2017, administered doses of vaccines experienced the temperature excursion between - 9 degrees Celsius and 8 degrees Celsius for about 315 hours and between -14 degrees Celsius and -10 degrees Celsius for about 376 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-00503517-1706USA001519.
Swelling, redness, hot area Lt upper arm 4"x4" in size. Low grade temp 100.2. No pain. Ice applied.
1 1/2 diameter indurated red raised area - Right deltoid area. Cool compresses & Benadryl.
Patient fainted shortly after administration. Patient woke immediately after falling and was alert. He walked under his own strength upon leaving the pharmacy.
Information has been received from a physician concerning a 76-year-old white retired male with hypertension and hyperglycemia who on 21-AUG-2007 was vaccinated subcutaneously in the left arm with a dose of ZOSTAVAX (lot# 658207/0883U). There was no illness at the time of vaccination. On 24-AUG-2007 the patient developed herpes zoster on right side of his neck three days after vaccination. There were no laboratory tests or diagnostic procedures performed. No medical attention was sought. The outcome was reported as still recuperating. It was reported that the patient did not have any adverse events following previous vaccinations. Follow-up information received indicates that the patient had a history of childhood chickenpox. There was no recent exposure to chickenpox or herpes zoster. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. It was reported that approximately dermatome C2 was involved, however it was not measured. The patient rated the pain as moderate. Additional information has been requested. There is in follow-up to report (s) previously submitted on 12/21/2007. Follow-up informaiton received indicates that there has been no new contact with the patient since the last report. Additional information is not expected.
Vaccine was expired on 01-Apr-2022, stored in the refrigerator on 04-Apr-2022 and administered on 08-Apr-2022; Vaccine was expired on 01-Apr-2022 and administered on 08-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in the refrigerator on 04-Apr-2022 and administered on 08-Apr-2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 08-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in the refrigerator on 04-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in the refrigerator on 04-Apr-2022 and administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Pharmacist initially thought that the expiry date of vaccine is Jun-2022 however, the vaccine expired on 01-Apr-2022. The number of doses/vials were 80. The vial was initially stored in refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursion.   No treatment medications were reported.
Fever reaching 100.6 that didn?t respond to NSAIDS.  Myalgia  Malaise
Patient mom says that son has tightness in chest when he breathes in and feels short of breath. Started sometime this morning.
Admitted via ER on 11/28/06 with paresthesias in both legs. Illness worsened and she now is in a coma in the neuro ICU with unknown diagnosis. On admit to ER, stated had received a flu vaccine one week earlier. Date of vaccination is estimated and not exact date. 02/01/07 records received and reviewed for DOS 11/26/06-01/23/07 DC DX: Acute disseminated encephalomyelitis Remote history of bulimina nervosa Spasticity secondary to acute dissseminated encephalomyelitis Diarrhea, chronic Respiratory failure with permanent tracheostomy, status post prolonged respiratory failure on vent previously. Methicillin resistant Staphylococcus aureus colonization, status post Baclofen pump placement for spasticity. Protein calorie malnutrition on feeds via percutaneous endoscopic gastrostomy tube. DC to long term care facility PE: positive for total paresthesia and now complete paralysis of arms and legs. No respiratory distress or chest pain. Pain in all 4 extremities. Developed respiratory distress and insufficiency, extensor posturing to deep painful stimuli, clonus and positive Babinski. Treatment included plasmapheresis and Solu-Medrol.  Developed bulbous type rash of buttocks and posterior thigh, suspect may be autoimmune.  WBC:range from 6.3-22.8, sed rate 47, ionized Ca 5.36-5.70, CRP 0.7-11.2, measles AB IGG positive ISR, mumps AB IGG positive ISR, blood culture enterococcus faecalis, pseudomonas mendocina, urine culture postive E.coli and candida albicans and pseduomonas aeruginosa, sputum culutre positive staph aureus MSRA and stenotrophomonas maltophilia, cath tip culture pseudomonas aeruginosa, herpes simplex PCR negative, Epstein Barr virus positive, CMV AB IGG 10.60, lymphocyte subset panel ABS CD4 177, CD8 998, CD3 1191, CD8 0.18, viral culture of brain negative.HIV1 negative, histoplasma antigen AG negative. Brain biopsy:intact myelin staining seems to make multiple sclerosis less likely. Vasculitis is not appreciated. A microinfarct may bet he cause although axonal staining is intact in the majority of the tissue. Macrophage infiltrates and reactive gliosis