chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient woke me up saying she was hearing voices and they had told her to overdose. She found her brothers medication and had overdosed. She was confused and didon't know why she was feeling this way. She was admitted to the hospital that night. The couple weeks prior she had been chewing off the skin on her fingers and reported feeling anxious.
Less than 10 minutes after administration patient complained of itching on shoulder/neck of injection arm (left.) 50mg Benadryl administered @12:09pm and by 12:15pm patient stated she was feeling better.
Palpatations 2 hrs. after injection, lasting several hours.  Nausea at night
Information has been received from a physician concerning a patient currently diagnosed with infectious mononucleosis who on 26-JUN-2007 was vaccinated with the first dose of GARDASIL (lot number unspecified).  On 26-DEC-2007 the patient was vaccinated with the second dose of GARDASIL (lot number unspecified).  The patient called the physician's office to schedule the third dose but is now diagnosed with infectious mononucleosis.  No other symptoms reported.  Additional information has been requested.
Fluarix given to patient who received Flulaval yesterday; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 4-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 95K95, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season).   On 27th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was 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 was a school nurse. On 26th October 2021, the patient received Flulaval at her healthcare professional office. On the day of reporting, the patient received Fluarix, for flu vaccine this schedule was earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter consented to follow up via email.
Patient is fully vaccinated with Janssen vaccine back in March. Patient presented to emergency department on 9/14/21 with SOB, couth with scant blood, and subjective fever. Patient was covid positive with consistent symptoms and recent household contact. Patient completed 5 days of steroids and remdesivir and was discharged on 9/23/21.
Evening of 1st shot:  arm too sore to lift over head.  Soreness lasted through next day 4 days after vaccine:  intense headache 10 days after vaccine:  "Covid arm" rash on left arm -- red, swelling, warm to the touch (rash still present at day 11)
December 23 through December 27 illness with chills, nausea, aches, feeling the whole covid experience in these few days all over again, extreme fatigue, tremors. Sunday January 10, Not feeling right, something wrong extreme fatigue, had to sit to do anything, January 10 pm and through the night severe chills, tremors. Monday, January 11 Knees left greater than right swelling and painful. Monday pm/evening ankles swollen and painful. 10 pm included wrists bilateral painful and not able to bear weight on wrists or ankles. Not able to perform knee flexion Tuesday January 12, severe joint swelling and soreness, bilateral knees, ankles, wrists to hand, stiff neck and not able to perform oral motor bite. Wednesday January 13, all joints swelling continues, difficult to move and weight bear.very painful at all joint sites Each night tremors and chills continue for at least one to 2 episodes. Thursday, January 14 continue including all joint swelling and pain Friday, January 15 attempt to see primary doctor, sent to urgent care. began Meloxicam. Symptoms begin to lighten on Monday January 18 with wrist pain continues as most severe.
This spontaneous report was received from a registered nurse, concerning a 44 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 16-JUL-2018, the patient was inadvertently vaccinated with PROQUAD with lot # R001541 and expiration date on 15-JUL-2019, at a dose of 0.5 ml administered once subcutaneously, for prophylaxis; instead of M-M-R II.
Case number PHEH2014US005900, is an initial spontaneous report from a pharmacist received on 20 mar 2014. This report refers to an 11-year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M12100, expiry date: Sep 2014) intramuscularly at a dose of 0.5 ml that reached 34 Fahrenheit (1.1 degrees Celsius) for up to 24 hours on 30 Dec 2013. No adverse event was reported following the maladministration (incorrect storage of drug).
Patient had an appointment in our office today for Moderna COVID vaccine fist dose. Minutes after administration patient was found to be lethargic. Patient responded slowly to calling his name. Upon touching patients arm, diaphoresis noted. Spouse present who stated patient has vasovagal reactions at times. Vital signs 80/42-112-99% on room air. Patient answered all orientation questions appropriately. Assisted patient to elevate legs, cool cloth applied to forehead and arms. Patient responding verbally and verbalized he was feeling better within a minute of his feet being elevated. Vital signs rechecked, 90/48-52-18-96% on room air. Per patient and spouse, patient has had vagal reactions while moving bowels in the past. Patient reports he has often felt nausea prior to this happening in the past. Patient stood and walked around exam room with supervision, no abnormalities noted. Patient continued to be monitored for a total of 30 minutes. Vital signs rechecked, 116/58-60-16-96% on room air. Per patient he feels "back to normal".   Informed patient that I would be notifying his PCP of this event with the request to add vasovagal episodes to his history to ensure providers are aware of this.    Informed patient with second COVID vaccine dose we would have patient on exam table to ensure we are able to assist with leg elevation in event that this occurs again. Patient and spouse in agreement with plan of care.
Gardasil vaccine was given to my daughter on August 5th, 2008. On the morning of September 11th, 2008 my daughter woke up with the right side of her face paralyzed. She is unable to smile on the right side. She can not blink well with the right eye. She also can not taste. She has had a headache on the right side of her head behind her ear. We went to the emergency room immediately and after a thorough exam she was diagnosed with Bell's Palsy. Needless to say she is not going to be getting the 2nd and 3rd dose of Gardasil. We have been reading that Bell's Palsy has been reported as a side effect of Gardasil. I feel strongly that others need to be aware of the possible serious side effects. Merck should not downplay these very serious side effects. We are very upset that it has been marketed as "very safe".  9/16/08 Reviewed ER medical records of 9/11/08. FINAL DX: Bell's palsy Records reveal patient experienced HA, taste alteration, right eye twitching x 2 days, right facial paralysis, mouth drooping & unable to completely close right eye x 1 day.  Had sore throat 1 week prior.  Tx w/steroids & referred to PCP on d/c to home.
the patient developed a "swelling of the arm by the injection site"; This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. No information regarding his pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown date in November 2019 (reported as last week), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 1 dose, lot # R012360, expiration date: 15-JAN-2020 (injection site and route of administration were not provided) for prophylaxis. On an unknown date in November 2019, he developed a swelling of the arm by the injection site. The nurse noted that she had not seen this patient back at the office.   The outcome of injection site swelling was unknown. The relatedness between the event and the suspect therapy was not reported.
Vaccine given by vaccinator at 1pm, pt being monitored by RN at 115pm pt had eyes open but did not respond to nurse commands, Breathing normal even, no distress noted, vitals 181/105 HR 98 96%on room air.  Director of Nursing  in room w/ pt &. called 911 for evaluation at 117pm pt responds to verbal command slow to move head in direction called prior to EMS arrival bp 171/105. EMS arrival at 127pm Paramedic at bedside for evaluation
Presented w c/o generalized weakness, diarrhea, status post fall with back pain; incidental finding of COVID-19+ but asymptomatic
Pericarditis; large pericardial effusion; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 16:00 (Lot number: EW0191) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ADVIL 12 HOUR. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 24Jan2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1284), administration date: 03Jan2021, for Covid-19 immunization. The following information was reported: PERICARDITIS (hospitalization, life threatening) with onset 03Jan2022, outcome "recovering", described as "Pericarditis"; PERICARDIAL EFFUSION (hospitalization, life threatening) with onset 03Jan2022, outcome "recovering", described as "large pericardial effusion". The patient was hospitalized for pericarditis, pericardial effusion (hospitalization duration: 3 days). The events "pericarditis" and "large pericardial effusion" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) negative, notes: Nasal Swab.  Therapeutic measures were taken as a result of pericarditis, pericardial effusion including NSAIDs.  Course of the event Pericarditis with large pericardial effusion, requiring surgical window procedure. 700-800 ml of bloody fluid drained from pericardium. AE Treatment: Surgery for drainage of pericardial fluid. Nsaids.  Follow up information has been requested; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and PERICARDITIS and PERICARDIAL EFFUSION cannot be completely excluded.
ENTIRE LEFT THIGH EDEMATOUS, TENDER, ERYTHEMATOUS.  CIRCUMFERENCE 3 1/2 CM. LARGER THAN RIGHT THIGH.
6cm x 8 cm raised red rash warm and tender to palpation. No evidence of phlebitis.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; Third dose received 0.5 ml  instead of 0.25; This spontaneous case was reported by an HCP and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and OVERDOSE (Third dose received 0.5 ml  instead of 0.25) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     Unknown if patient was ever been diagnosed with or tested positive for COVID-19.  Unknown if patient had acute illness at the time of vaccination and up to one month before.   On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and OVERDOSE (Third dose received 0.5 ml  instead of 0.25). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) and OVERDOSE (Third dose received 0.5 ml  instead of 0.25) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  Treatment medications were not reported.   This case was linked to MOD-2022-542869 (Patient Link).
Swelling; Warmth; Pain; Red blister; Injection site redness; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date unknown) for prophylaxis.   On 8th November 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 8th November 2019, unknown after receiving Shingrix, the patient experienced inappropriate route of vaccination. On 10th November 2019, the patient experienced injection site swelling, injection site warmth, injection site pain and injection site blisters. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site pain, injection site blisters and inappropriate route of vaccination were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site pain and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix subcutaneously and went on to experience swelling, warmth, pain, and a red blister at the injection site.  The reporter did not consent to follow-up.
day p/vax pt was seen in ER w/lt leg very swollen & red, given inject of benadryl & decadron
6/26/15 daytime....our son was "balling his fists"  and simultaneously saying "eeee" many times that first day.  6/26/15 8:00pm.  Woke up after 1 hour of sleep, in a cold sweat.  Awake from 8:00pm to 2:00am.  Our son was very hyper, acting as if someone gave him adrenaline.   Day 1 result per my wife, "psycho motor agitation".  Wife is a Child Psychologist. 6/27/15, various times and days until 7/2/15. Our son started "blinking repetitively" while watching television.  We stopped playing television and the Iphone as we realized this was causing the excessive blinking. 7/1/15 (approximate) Repeteadly asking "what is that noise" and became fixated on Sound.  He is perseverating on the noises. 7/3/15-7/5/15, had fever of 100-103.7 degrees. 7/6/15.  Has become fearful of some sounds and still perseverates on them.
Fever, chills,headache & body aches all lasting 24 hours.  Still having soreness ., fatigue; and hot,  hard  and swollen area at injection site on left arm 3 1/2" diameter Did not have issues from first injection on March 25th, except a little fatigue.
First outbreak of shingles, rash, nerve pain, body ache, about 3 weeks after vaccine
Febrile react following DTP several hrs a/parents described a cyanotic react @ home, but non reported in hosp; adm for observation;
Significant arm pain limiting mobility x 5 days. Rates pain 7/10. Resolved.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, PROQUAD underwent temperature excursion. On 19-AUG-2014, the patient was vaccinated with PROQUAD 0.5 ml, subcutaneous. No adverse effect reported. This is one of several reports report from the same source. Additional information has been requested.
This spontaneous report was received from a health care professional concerning a 1 year old patient of unknown gender. On 02-JUL-2013, the patient was vaccinated with a expired dose of M-M-R II (HSA) first dose, 0.5 ml, subcutaneously (lot #1025AA exp 30-JUN-2013). No adverse effects were reported. Additional information has been requested. This is one case of several cases reported by the same reporter.
Shingles on face -  5 day treatment of FAMVIR. Off work approximately 3 weeks.
Caregiver reported high fever, chills, body aches. weakness, SOB, extremely painful joints and pimple rash all over body (back, chest, neck and arms.  Caregiver stated she had the pimple rash after receiving the Covid vaccines but no other symptoms.  RN asked her to seek medical care d/t her SOB but caregiver declined since she is uninsured a this time.  Patient stated her symptoms lasts 3 days.
This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. Medical history and drug allergies were not reported. On 22-OCT-2013, the patient was vaccinated with RECOMBIVAX HB lot # H012250, expiration date 06-FEB-2015 (concentration, dose and indication were not reported) that was exposed to three low temperature excursions of 28F for 24 hours, 31F for 24 hours and 30F for 96 hours. No adverse effect has been observed or reported. This is one of severeal reports from the same source. Additional information is not expected.
Pt came in with R arm tenderness, redness away from site of injection.  Pain extends to wrist (pt described like tendonitis) and stated some neck tenderness.  Area of injection was R deltoid- area of injection not inflamed or any raised area.  Referred pt to follow up with physician and take ibuprofen for swelling, if fever, for pain.
Achy joints (elbows, knees, lower back, shoulders). Start Mon- Thurs. Tired (exhausted) general malaise unable to work for 3 days.
Patient was given dose at a vaccination site through County Health Department. Today in clinic she reported an allergic reaction to Pfizer vaccine. Approximately 30 minutes following vaccination had hives. Following morning had swollen lips and itchy throat with continued hives. Symptoms only treated with benadryl and improved. She then had hives again 4 days later. She did not report this to the vaccination clinic.
I received my 1st dose at 5:30 PM.  I woke up around 2 AM feeling chilled and achy with an excruciating headache.  By 4 AM I had a 102.4 fever. My left arm was sore as expected.  This felt worse than when I had covid!
On 03/20/2000, the patient received her first injection with Lymerix 30 mg for prophylaxis. Two days later, on 03/22/2000, she experienced a headache and dizziness. The information received on 04/05/2000 reported the symptoms resolved.
No additional AEs; the improperly stored vaccine was administered; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-AUG-2022, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, lot number 1775811, expiration date 07-DEC-2023, for prophylaxis (strength, dosage, frequency, route were not provided) (product storage error). No additional adverse event was provided. ; Sender's Comments:  US-009507513-2208USA008175:MSD US-009507513-2208USA008439:MSD
Starting in late May 2021, early June, I started to have a rash in certain parts of my body so my under arms and buttocks. Then a little bit on the inner thigh, in the groin area. It was red and very itchy. I tried myself to use triamcinolone on it because it was decent for most heat rashes and it would get better. I would stop using it and the same rash in the same spots would return with the itching. It got worse in September and so I finally saw a dermatologist on 9/11/2021. She prescribed triamcinolone but slightly stronger than what I had. 0.1% and applied that to the affected areas. In addition to the rash, I was starting to get it on the legs and arms more and they were starting to get some oozing, not quite a blister but similar. So, I was prescribed the triamcinolone to see what happens. It didn't do a whole lot, so then on 9/22/2021, I went back to the facility. She did a biopsy for my upper right arm between shoulder and elbow and tried clobetasol propionate 0.05% again to be applied to those affected areas for no more than 7 days at a time. She got back the results of the biopsy and it came back pretty conclusive for contact dermatitis and recommended that I see another doctor. He did over 100 patch tests and narrowed down the allergies all based off my bathing products, laundry products, house cleaning products, etc. did a core test and added more based off the products I was using. Based on the testing, it was concluded that I have allergies to benzoic acid, all benzoates, cobalt, linalool, limonene, hydrocortisone. Tests performed and concluded 11/01/2021 then 11/03/2021 patches were taken off, then on 11/05/2021 saw him for the last time and concluded his results based on the reactions. He did prescribe a different cream to use that I haven't used, but it does reduce immune system pimecrolimus 1.0% cream. Again, with what a doctor prescribed things were get better than they went back. I've had rashes from the top of my head all the way down to in between my toes. That happened around Christmas to New Year's and that was after seeing what my contact allergies were. I've continued since then to have rashes on buttocks and inner thighs. Itches, red, flakes, bleeds at times. Next appointment was Feb 18, 2022. She wanted to try with what rashes she saw, buttocks, arms and elbows, she wanted to rule out scabies. She prescribed a treatment for that as well since that was a onetime thing (body wash and repeat following day). Didn't really help a whole lot. I saw the doctor again on March 24, 2022. She wanted to try one more thing, especially with the buttocks area, she prescribed a shampoo to wash my buttocks with - ketoconazole 2.0% shampoo. I've been doing that with the clobetasol propionate, I've been doing that with my buttocks and inner thigh and the rash is still persistent. I have a follow up on May 12, 2022 and if it doesn't get any better, she may do another biopsy with the buttocks. She's unsure of what may be causing this and ruling out contact allergies. Prescribed 2 other ointments for 2 other skin issues but isn't related to this issue.
Information has been received from a physician concerning a 68 year old female patient who on 03-OCT-2007 was vaccinated subcutaneous into the upper left arm with a .65 ml dose of zoster vaccine live (Oka/Merck) (lot # 658212/0887U). On 11-APR-2008 the patient broke out in shingles. The patient went to an instant care clinic on 14-APR-2008 and then to physician's office on 15-APR-2008 and both healthcare professionals confirmed diagnosis of shingles. Additional information has been requested.