chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received SHINGRIX for prophylaxis.  In July 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 7 hrs after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, tremor, headache, nausea and malaise. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, chills, tremor, headache, nausea and malaise were recovered/resolved.  It was unknown if the reporter considered the influenza-like symptoms, chills, tremor, headache, nausea and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine, about 7 hours after the shot, the patient received strong flu like symptoms: chills, shaking, headache, nausea and malaise. The patient took Tylenol and wrapped her self in an electric blanket. The patient was better after about 15 hours and felt normal the following day. The patient wanted to have the 2nd shot on the day of reporting but the patient's physician said since she had such a bad reaction, it could be worse to receive a 2nd dose. The patient was very good health and she did not want to end up in the hospital from another dose. The patient asked about what have found regarding people who took the first vaccine, suffered flu-like symptoms and then took the second shot and asked about if it was safe or not.
76-year-old male with past medical history of morbid obesity, atrial fibrillation on Eliquis, anxiety, depression, insomnia, GERD, asthma/COPD, diabetes mellitus, hypertension, stage 3 chronic kidney disease with baseline creatinine of 1.2, and history of DVT in the left lower extremity presented to the emergency department complaints of worsening shortness of breath and cough.  Patient reports that he was usual state of health until approximately 1 week ago when he started noticing increased cough which was nonproductive.  Also continues to have worsening shortness of breath along with recurrent fevers.  Patient reports that he has not been able to eat much over this time frame.  Pati Tested positive on 12/09/2021  Patient reports that he may have been vaccinated in the past however, does not definitively know when and whether he received any blisters.  Regardless, patient reports that his symptoms have progressively worsened therefore, he eventually decided to come to the emergency department for further evaluation.   Upon arrival to the emergency department, patient was found to have acute hypoxemic respiratory failure secondary to sepsis with COVID-19 pneumonia.  Blood work also consistent with non ST elevation MI with elevated troponin at 155 along with elevated BNP of 9000.  Patient also noted to have lactic acidosis 5.3.  Lab work otherwise consistent with hyperglycemia, uremia, and acute renal failure. EKG independently reviewed and consistent with atrial fibrillation without any clear ST elevations or depressions.  Chest x-ray consistent with bilateral fluffy infiltrates.  Mild pleural effusion also noted.
A report has been received from a Health Professional concerning a subject, of unknown gender who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 milliliters. FLUMIST Quadrivalent (Intranasal) started on unknown date for Influenza. Nurse reported 5 or 6 doses of expired FLUMIST 1/4/16 were given since the expiration. The outcome of the event of 5 or 6 doses of expired FLUMIST were given since the expiration is unknown. The report was considered to be non-serious.
Developed a lump nickel sized after receiving her Tdap vaccination that is still present today.  Also had diarrhea and chills on 01/02/2008.
patient fainted after immediately after getting Moderna Covid-19 vaccination and became unconscious for about 15 seconds and woke up. patient skin color became pale and reported feeling light headed and dizzy.
Onset of fatigue and fever 9.20.23, decreased appetite and  vomiting, development of koplik's spots on buccal mucosa 9.23.23, eruption of measles-like rash on 9.25.23
Patient with no past medical history here with acute myopericarditis post 2nd dose of Pfizer COVID-19 vaccine.
Patient presented to Vaccine clinic 1/12/21 to receive COVID vaccination.  Patient denied any ill feeling, no fever, cleared for vaccination. Is chronically SOB due to COPD, but patient reported no different than usual.   Presented to the ED the next day c/o SOB and weakness for the last week.  Patients condition ultimately declined over the next few days and died 01/21/21 from pneumonia (not COVID).  Patient did admit she lied about her symptoms on the day of vaccination to get the shot.
24 hours later started with body aches and a "strange" lingering headache.  Also had severe chills with body temp dropping to 96°F.  Later that night had a low grade fever.  Day 2, chills, cough, and just not feeling well
Dizziness flushed & lightheaded Employee became flushed and light headed. Vitals were normal. Ice pack used, vitals monitored and patient returned to work once symptoms resolved.
pt felt tingling lips approx. 15 min after vaccine administration which resolved in 1 minute.
Patient felt well and completed school sports physical exam prior to vaccination; vaccination well tolerated; patient with significant anxiety prior to vaccination; approximately 5 minutes after vaccination patient leaned head back while still on examination chair where he received vaccine and was seen sliding off table and unresponsive for approximately 10 seconds; improved mental status without treatment; legs elevated, water provided, blood pressure checked; improvement in symptoms 30 seconds after onset; A x 0 x 4 30 seconds after event
This came 2 weeks after that i take the first dose of the vaccine, its like a rash, dryness, and red, at the beggining was 15, and know after the second dose of the vaccine more of this kind of rash appear.
Information has been received from a medical assistant via a company rep concerning a male physician who on approx 19Nov05 was vaccinated IM into the arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination at the same time in the same arm included a dose of influenza virus vaccine (unspecified). Subsequently, on approx 19Nov05, the pt was very ill for two days and experienced body aches, fever and severe site reaction involving a rash, soreness and swelling down his entire arm. Unspecified medical attention was sought. The physician was reported to have recovered. There was no product quality complaint involved. Additional information has been requested.
A report was received from a health care professional on 12/5/03 concerning a male vaccinee aged 9.5 months who inadvertently received two doses of influenza vaccine on 12/2/03. On 12/2/03, a vaccinee received a dose of Fluzone and on the same day was inadvertently administered a dose of Fluvirin instead of Fluzone. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 2/16/04: The health care professional indicates that further information is not forthcoming from the vaccinee.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 08-OCT-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 1056 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius) The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
On 3/16/22:  I had symptoms of a stroke.  Was taken to the hospital and they did a CT scan and found that I had a stroke in the left upper portion of my brain.  Many tests were done to rule out the cause of the stroke:  CT scan carotids-normal, ultrasound upper and lower legs-normal, echocardiogram-normal.  MRI-showed same stroke found on CT but no tumor. Lab test-normal.  Outcome was with deficit in speaking.  Treatment:  Plavis, Crestor, Aspirin Follow up with:  Speech Pathologist, Neurology, Cardiologist, Primary Care, Hematology
Initial report received from health authority (GB-MHRA-ADR-20584622) on 22 Mar 2010: This patient was vaccinated with pandemic influenza virus vaccine (manufacturer and batch number unknown), intramuscular, on an unspecified date. After vaccination, the patient experienced encephalitis, seizures and headache on 06 Feb 2010. Final outcome of the events was reported as complete recovery on 20 Feb 2010. Follow up report received on 17 May 2010: Two follow-up requests were sent to reporter but no response received so far. Hence the case was closed due to lack of response. This report combines internal review on 20 Oct 2010 for the data received on 17 May 2010 and follow up received on 11 Oct 2010. The suspect vaccine was recoded to Influenza virus vaccine unknown INN. In the follow up report, it was noted that no further information was available for this case. Hence the case was considered lost to follow-up.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 18th August 2018 13:15, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the injection site swelling was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the right deltoid. The pain and redness have subsided, but the swelling persisted.
This spontaneous report received from a patient via other manufacturer Pfizer concerned a 58 year old male. Initial information was processed with the additional information received on 15-JUL-2022 and 18-JUL-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: hyperthyroidism, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date at 12:00 to left arm for covid-19 prophylaxis. Concomitant medications included bupropion hydrochloride (Wellbutrin), levothyroxine sodium (Synthroid) and sertraline hydrochloride (Zoloft) for drug used for unknown indication. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received non-company Moderna vaccine (elasomeran) (dose number in series 2) (form of admin, route of admin not reported, batch number: 048L21A, expiry: unknown) dose was not reported, administered on 02-APR-2022 at 12:00 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of Moderna vaccine (elasomeran) (Dose number in series 2). The patient received another non-company Pfizer biontech Covid-19 vaccine (Tozinameran) (Dose number in series 3) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 02-JUN-2022 at 12:00 to left arm for covid-19 prophylaxis. On an unspecified date in 2022, patient had covid-19 (Dose number in series 3). The patient received non company suspect Paxlovid (form of admin, route of admin and batch number were not reported and expiry: unknown) dose was not reported, administered on 21-JUN-2022 for covid-19 treatment. Patient received last dose of Paxlovid on 25-JUN-2022.  On 04-JUL-2022 at 08:00, the patient experienced covid rebound after paxlovid five day treatment. (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and tozinameran was not applicable and action taken with Paxlovid was treatment discontinued. The patient had not recovered from covid rebound after paxlovid five day treatment. This report was non-serious. This report was associated with product quality complaint number: 90000242596. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related. Batch and lot tested and found within specifications based on the PQC evaluation/investigation performed. Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Nonspecif skin erupt NEC on 2013-05-30, clinician comment: maybe vaccination related rash.
PT'S MOTHER REQUESTED MODERNA FOR BOOSTER.  OUR INTERN, DIDN'T CHECK PT'S AGE (17) BEFORE GIVING THE VACCINE
14yo M initially presented to the ED with headache, fever, myalgia, abdominal pain, NBNB emesis, unsteady gait and soft/garbled speech, 6 days after returning from a recent trip to Mexico and 4 days after receiving 2nd dose of Covid-19 vaccine. In the ED patient had multiple tonic clonic seizures, total episode lasting about 5 minutes requiring ativan and keppra. Pt was admitted to PICU for management, found to have continued seizures on EEG resolved with fosphenytoin
Blurry Vision, extreme headache, rapid pulse, high blood pressure, tachycardia
First day Headache, tiredness Next day -headache, tiredness, nausea, fever, chills Third day- headache, arm red swollen Fourth day - headache , itchiness arm
I woke up Saturday morning and my throat was swollen, my armpits were hurting, my legs were killing me, and my head was aching. I called my doctor who told me to take 10mg Zyrtec and 125mg Benadryl every 4 hours. That helped for some days. On 01/18/2022, my lymph nodes had been swelling and I had a bad rash that kept itching and spread from my lower torso and up my back. I called my doctor who told me to continue taking the allergy medication and to contact him if things progressively got worse. When I went in for a follow-up appointment, I was given Fluconazole 150mg (1 tablet every 72 hours) to help reduce the rash and to help with my UTI.
Pt received a flu vaccine at a school clinic on 11/16/16. Pt tol vaccine well, walked back to his classroom. Approx 15 min later, pt was sitting at his desk, removed the bandaid saw a sm dot of blood at injection site and had syncopal episode falling onto floor. Pt's teacher said when she noticed pt he was unresponsive but breathing, laying on floor supine. Teacher summoned for assistance. School nurse and this public health nurse responded at 10:50 AM to find pt very drowsy but responsive laying on floor pale and clammy. P-99. R-20. Pt denies pain, no seizure act, no incontinence. 1058 B/P 90/60. P-71. R-16. O2 98%.  Pt A & O, answering appropriately to current events. Denies neck or back pain. Moves all extremities, passively and denies discomfort. No PMH. Verbalized he ate a donut for breakfast. PEARL. Grasp - strong and =. Mother notified 11A. Pt sat up and vomited approx 75 cc emesis. HR-170. R-24. O2 sat 99%. B/P 82/50. No obvious head trauma. No bleeding. No hematoma. Mom present and said pt has been dealing w/anxiety. Pt normally gets vaccines in a health care setting instead of school clinic. 1110A B/P 112/78. P-100. R-16. O2 sat 94%. Color pale and warm. Family Dr, contacted and mother to take for an evaluation. Pt sitting up again quiet but feeling better. 1117 AM - B/P 100/60. P-92. R-20. PEARL. A & ). to care in W/C. This nurse then spoke w/Dr staff. No lab, no x-rays ordered. No seizure act. DX - Syncopal episode R/t anxiety.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2 NOS), on 26Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Aug2023 at 20:00, outcome "recovered" (09Sep2023) and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 02Sep2023 to 07Sep2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever to 103 degrees on night of vaccines. Rash 2 days later-no vesicles, probably not urticaria, just fine macules on head and trunk.
local swelling & redness w/subcutaneous nodule subsiding gradually; 7/26/99 both sites itching 31/2x21/4 raised papular rash on lt arm- rt arm site redness w/inc size of nodule from nickle to quarter w/slight red rash
no adverse effects; Received a dose of GARDASIL 9 on 8/26/2019 and discovered she was pregnant on 9/7/2019; This spontaneous prospective pregnancy report was received from a medical assistant concerning to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.     On 26-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, frequency and route of administration were not reported) (lot # R009614 has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and establish as 30-NOV-2020) , the patient discovered that she was pregnant on 07-SEP-2019 (exposure during pregnancy); the last menstrual period, date of conception and estimated date of delivery were not known. The pregnancy outcome was outcome pending.    No adverse event was reported.
On 9/26/2013 complained of red, flat, itchy rash going from side to side across the middle of the buttocks. The rash was about 1 inch wide. Denies rash any where else, no difficulty breathing and no fever. By 09/27/2013 the rash was gone.
The next morning I had welts ion both forearms which are still with me 5 days later.
101.6 degree fever from 10pm on the day of the vaccination, to 5am the next morning. Fever accompanied by severe body aches, joint pain, and chills. Following fever, body aches and joint pain continued for 12 more hours, along with severe headache, fatigue, swollen lymph nodes in left armpit, and swollen glands in neck. Also had moderate nausea and abdominal pain, as well as mild diarrhea. Improvement of all symptoms after first 36 hours, with lingering fatigue.
Information has been received from a physician's assistant concerning an approximately 25 year old female who was vaccinated with the first and second dose of MMRII. It was reported on 11/01/01 that a recent titer showed that the patient did not seroconvert.  The patient sought unspecified medical attention. Additional information has been requested.
2-17-04 At 9:25 am was given shots DTaP and IPV right leg and MMR left leg. 8:30 pm on 2-18-04 as mother was getting child ready for bed right leg swollen from hip to knee (whole leg) Tight and hot was put on Cephalexin that night and started on Benadryl 2-19-04. Swelling gone on 2-24-04.
As I was laying with my eyes closed because I had a bad fever, bodyaches , headache and chills, I had very bright rapid flashes of light in my eyes.  And now my vision with my reading glasses has gotten worse. I can?t see without my glasses as well as I could before. I could see less than an arms length without having to wear my readers, now I have to hold my arm much further away to see. And the light of my phone bothers my eyes. And I have constant headache.
Cough, fever, body aches, mild runny nose started 3 days after H1N1 intranasal vaccine was given.
This spontaneous report as received from a other health professional regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9, lot # I004741, expiration date 04-MAR-2017 (dose strength was unknown). No concomitant medication was reported. No adverse event was reported. No PQC was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.