chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seizures and convulsions; collapsed few minutes after the shots/blacked out; his eyes rolled up; head injury; behaviour changed and he doesn't look the same smart super intelligent kid; Initial social media information received on 30-Jul-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 10 years old male patient who experienced Convulsive seizure associated with Loss of consciousness, Gaze palsy, Head injury and Abnormal behavior, while he received vaccines DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE and MMR VACCIN (unknown manufacturers).  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a single dose of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient received a single dose of suspect MMR VACCIN not produced by Sanofi Pasteur lot number not reported.  On an unknown date, the patient collapsed few minutes after the shots, was blacked out (Loss of consciousness) with head injury and experienced seizures and convulsions (Convulsive seizure) with his eyes rolled up (Gaze palsy) few minutes post vaccination, patient also had behaviour changed (unknown latency) following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE and MMR VACCINE. The events (Convulsive seizure, Loss of consciousness, Gaze palsy and head injury) were assessed as medically significant.  No lab test was reported.  Final diagnosis was Convulsive seizure associated with Loss of consciousness, Gaze palsy, Head injury and Abnormal behavior.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: Patient experienced Loss of consciousness, Gaze palsy one day after vaccination and thereafter and Abnormal behavior (unknown latency) after vaccinations with MMR VACCIN and DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE .Time to onset is compatible with the role of vaccine for all events, except Abnormal mental state. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of an individual vaccine cannot be assessed.
Received flu shot left deltoid. Noted this morning pin size red dots from shot site to elbow. Non raised, no itching. Stated approx 50 spots. Instructed to notify MD.
My arm started hurting after 2 days. It lasted about a week, I could not breathe, and I received asthma treatment.
LIGHTHEADEDNESS, FEELING OFF BALANCE, LESS STEADY GAIT, INCREASED FATIGUE, FEELING OF ANXIETY.
red/never ever had fillers or Botox, or anything like that; warm; Cheek swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red/never ever had fillers or Botox, or anything like that), FEELING HOT (warm) and SWELLING FACE (Cheek swelling) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 025A21A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack. Concurrent medical conditions included Blood pressure, Breast cancer, Cholesterol and Asthma.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced ERYTHEMA (red/never ever had fillers or Botox, or anything like that), FEELING HOT (warm) and SWELLING FACE (Cheek swelling). At the time of the report, ERYTHEMA (red/never ever had fillers or Botox, or anything like that), FEELING HOT (warm) and SWELLING FACE (Cheek swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: cancer (abnormal) Cancer.         Concomitant products included 9 prescription medications, Blood thinners, Blood pressure pills, Cholesterol thing, and Inhaler in the morning for asthma. Patient has a surgery scheduled for November 6th. No treatment medication details was reported.   This case was linked to MOD-2021-366737 (Patient Link).
Pt had SOB, watery eye, cough and itchy throat and nose after 10 minutes after administering Varicella and Hep A. Vaccines on 5/21/11 at 3pm. Pt received Epinephrine Jr. 0.15mg injection and ambulance was called.
14 days after second shot having for two days the side effect symptoms usually seen 24 to 48 hrs after vaccination.   Aches, lethargy, 100.1 100.6 fever, joint pain,  Slight mental fog while feverish. Fever broke on march 3 about 3 am and felt fine. All symptoms returned on 3rd about5 pm including fever.   No symptoms after 1st shot
This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a female patient of an unspecified age. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper (explicitly coded as product leakage). On of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole (explicitly coded as product closure issue) where the medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. On 03-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial (explicitly coded as drug administration error). No adverse events were reported after administration of the vaccine. This case 201804829 is cross-linked to the original case 201804823 due to the same reporter. This case was associated with product quality complain, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018-2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling (explicitly coded as wrong technique in product usage process). The reporter assessed this case as non-serious. Follow-up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in the event tab. The narrative and case comment was amended accordingly.
tingling pains that keep occurring randomly throughout my arms & my legs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling pains that keep occurring randomly throughout my arms & my legs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling pains that keep occurring randomly throughout my arms & my legs). At the time of the report, PARAESTHESIA (tingling pains that keep occurring randomly throughout my arms & my legs) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Left upper area swollen/red. Size 11 by 14 area redness and inuration left upper arm, no pus, onset 24 hours. Treatment: Tylenol, cool compress.
Vaccine administered at 6 PM on October 12; patient developed generalized pruritus around  12 AM October 13 and around 7-8AM noticed hives in the bilateral upper extremities and bilateral lower extremities on October 13.
Pt called on 07/03/2021 to report pain/swelling in the right arm. No rashes or discoloration and no restriction on the movement. Pt described pain going through right armpit to right breast Pt will observe for few more days and seek doctor's advise if needed.
I have had an out of control eruption of eczema. I have a history of eczema, but have never had it like this: complete underarms, all around neck (front and back), done my back, behind knees, in bends of elbows, on my forehead and by ears (that area is peeling, as are the underarms) and around my mouth and chin. All of it itches incessently and sometimes burns. The dermatologist has given me prednesone, an antibiotic and a prescription cream. I first began this, but only under the arms, after the first dose of COVID 19 vaccination on March 6, but I attributed it to my chronic eczema. Then it got worse after the second shot on April 3, but again I did not think about it until the third dose on Novermber 12, especially since it ramped up so terribly, began to spread like wildfire and itched. It began on my face after dose 2, but only in one spot, so again, I did not put all of this together until after the third dose when it got way out of control.
pt said she had a reaction, it was the size of a golf ball at the site of inj. and the size of grapefruit with big whelps outside the inj. point.  She said it was really hot, red and stung and felt like pins being put in.  She said she went to the doctor.  She said that she still had red around the inj. site and has blisters and it is still the size of a golf ball or bigger.  She notified the store on 8-5-09 in the evening.  She said the doctor gave her a double dose of penicillin in the hip, steroids for 10 days and benadryl.  She said she was also on augmentin now.
Patient reported dizziness immediately after injection. Patient has a history of vasovagal response to injection.  Patient was placed in recumbent position, given fluids, and a granola bar.  Patient reported improvement in dizziness after 45 minutes of monitoring. Patient ambulated around gymnasium without issue. Patient reported that she felt better. BP 108/78. Patient reports that this her normal pressure.
Developed redness and swelling at injection site. All itchy pain like a bee sting and a red rash extending down to left elbow beginning the next evening and lasting 5 days. No fever. Ibuprofen taken.
Tiny red, fluid filled bumps, and crusted over bumps all over abd, back and legs.
Headache, neckache, ringing in ears. Also a little nausea. Headache & neckache continued for 2 days and subsided in the afternoon of 10/27/2009.  Ringing in the ears is still ongoing today.
administered after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HAV (Havrix 1440) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd June 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 3rd June 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 03-Jun-2022 Reporter's Comments: Certified medical assistant (CMA) administered Havrix after the expiration date. The reporter consented to follow up via postal. Additional Supportive: the patient received dose of Havrix vaccine which was already expired, which led to expired vaccine used.
Patient did well when TDAP and MCV4 were given in left deltoid but as soon as I gave the HPV in right deltoid, patient's head fell back and his eyes rolled back and he started jerking movements that lasted a total of 5-7 seconds. He came to when I called his name. He was diaphoretic, pale, and felt nauseous. Mom stated that he had not eaten anything yet today and it was 10:50AM. I attempted to give him Kool-Aid that mom had in her possession and cookies that the clinic provides, but he immediately vomited both. I applied an ice pack to his neck and took vitals. His O2 was 98-100% and his heart rate was 65-70 and he was able to answer my questions, "What's your name, how old are you, what school do you go to" but after observing him for a few minutes, he remained lethargic and both mom and I agreed to call 911 and EMS came and transported him to the hospital.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves (an elderly) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the right deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
MOM STATED SHE WANTED FLUMIST FOR HER CHILDREN WHO SHE SAID WERE 6 YRS OLD AND 2 YRS OLD. FLUMIST ADMINISTERED, BUT WHEN ENTERING INTO STATE IIS I NOTICED THE CHILD WAS ONLY 19 MONTHS OLD. CHILD HAD NO ADVERSE REACTION
p/vax pt arm swelled w/significant pain & went into atrial fib for which was hosp for 24hr;
Patient states the pain in the right arm started the next morning of the vaccine, the pain started to get worse the next days to the point he couldn't hold a cup. he also feels numbness in the arm and the pain is getting worse and worse each day, patient says he's in excruciating amount of pain till this day, he's going to see a neurologist for this.
profound malaise, nausea, vomiting, fever, chills, back, neck and head aches
patient received an expired dose of product with no reported adverse event; Initial information received on 03-Dec-2021 regarding an unsolicited valid non-serious case from a consumer (patient) via phone.  This case is linked to case 2021SA411214 (CLUSTER).  This case involves a male patient of an unknown age who received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 14-OCT-2021, the patient received a 0.7 ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ500AB, expiry date: 30-JUN-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Patient states that she was told by the facility where she and her husband received their FLUZONE HIGH-DOSE QUADRIVALENT vaccines on 14-OCT-2021 that the product had expired on 30-JUN-2021. Caller wanted to know what was contained in the 2020-2021 FLUZONE HIGH-DOSE QUADRIVALENT vaccine and asked for a strain comparison between 2020 and 2021. Patient states that she does not know how long the vaccine that she received on 14-OCT-2021 will remain in her body and is unsure if she should be revaccinated at this time. Caller states that she will reach out to the facility to determine if they have reported this to Safety first."  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain at her injection site; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 as Single Dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced pain at her injection site. The reporter also wanted to know what happens if she receives vaccine (unspecified) instead of the Pfizer-BioNTech Covid-19 Vaccine when she goes back to receive the 2nd dose after 4 weeks. She said that from the facility where she received the Pfizer-BioNTech Covid-19 Vaccine, they were scheduling people 4 weeks after the 1st dose, she wants to know if this is permissible. She wanted to know the efficacy of the Pfizer-BioNTech Covid-19 Vaccine after the 1st dose, if it is within the 50% range. She took a shot yesterday in (County Name) at the (Vaccination Facility Name) in the (Facility Type) District. That should be in the list there for vaccination sites. She has had no reaction to the shot what so ever. She was given a card with the date that she is in disagreement with. They were giving out dates for four weeks for the second shot instead of the three weeks. Everyone in the facility yesterday received a date for one month later. She knows it is supposed to be three. She is wondering if they were giving (Vaccine Name) the week before and didn't change the computer. Is that permissible. Caller clarified product as COVID19 Vaccine. What can she do about the facility giving out that date? She is not handy on the computer. If she were to go back to the location in four weeks and they are giving vaccine (unspecified) and not giving out Pfizer what will happen to her second shot. If she can't get it there, she will be pushed four weeks on. She really needs to know where to go to get the second shot. She needs to be able to talk to a person. She is not good on the computer. The outcome of the event was unknown. There was no product quality complaint (PQC) present.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Rash on abdomen and spread to back with itching, stinging and pain. Pain constant treated with VALTREX 1g tid x 7 days and NEUROTIN 500mg bid. Herpes Zoster.
Approximately 12 hours after receiving vaccination pt reported a raised area of injection site spreading to about 2 inches with no discoloration. Size of area had decreased since then.
Vaccinated and boosted patient tested positive for covid infection during inpatient admission. Vaccines per pt history. No documented evidence or information available.
Itching (RUA) with rash. Redness and heat at inj site.  Redness Approximately 4" circle.  PCP prescribed hydrocortisone 2.5% to be applied 2 times per day.
This case was reported by a physician via a sales representative and described the occurrence of limb swelling in a 15 moth-old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date in May 2006, the subject received a dose of Infanrix (dose and lot number not specified). On an unspecified date in My 2006 before 30 May 2006, at an unspecified time after vaccination with Infanrix, the subject experienced swelling of limb. At the time of reporting, on the event was unresolved. Causality was unknown
Injection site erythema; wrong drug administered. Information has been received from a certified medical assistant and a physician concerning an 8 week old female with no previous medical history who on 22-AUG-2005 was vaccinated intramuscularly one time with a first 0.5ml dose of hepatitis A virus vaccine inactivated (lot# 649456/0400R) instead of scheduled dose of 'PediVax" (therapy unspecified). There was no illness at the time of vaccination. On the same day post vaccination 22-AUG-2005, the patient developed a mild 3-4cm area of erythema at the injection site. Unspecified medical attention was sought and the patient was treated with cephalexin (KEFLEX) and was reported as recovered on the same day. No laboratory or diagnostic tests were performed. No product quality complain was involved.  Additional information is no expected. 02/11/2010 Follow-up information received from a medical assistant stated that hte patient was diagnosed with torticolis on 25-SEP-2005. A computerized tomography scar of the neck and head were within normal limits. The patient began physical therapy from12-OCT-2005 to 12-JAN-2006. No additional symptoms or treatment were mentioned. Unspecified medical attention was sought. No product quality complaint was involved.
Information has been received from a physician concerning an 20 year old female who was vaccinated IM, first dose, with Gardasil. Subsequently the patient experienced itching both arms after receiving the vaccine. Additional information has been requested.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage. Patient experienced moderate to severe body pain and pain and redness at administration site for 48 hours