chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced neurological damage which was attributed to cumulative mercury toxicity. The following information was received via medical records, the subject was vaccinated with hepatitis B vaccine (unknown manufacturer) on 9/8/95, and with Engerix B on 10/9/95 and 3/14/96. He was also vaccinated with DTaP, OPV, MMR and HIB for prophylaxis. The subject took his first steps before twelve months. At two years of age the subject spoke his first understandable but poorly articulated words, and began speaking in phrases between tow and a half to three years of age. On 8/5/99, the subject was evaluated for complaint so frequent temper tantrums, mood instability, initial insomnia, possible articulation speech deficits, periods of high energy and aggression, and obsessive focus on particular subjects. He was diagnosed with Multicomplex developmental disorder (Pervasive developmental disorder). In Sept 1999, Ritalin therapy was initiated. On 12/14/99 the subject underwent a psychiatric evaluation due to concerns with social development. Problems included high strung and controlling behavior, spinning his body, jumping up and down and windmill arm action, poor eye contact, anxiety, use of repetitive phrases, aggression including biting and head butting, self injury including head banging, occasional daytime enuresis, and temper tantrum during transition periods. The subjects sleep was good except for occasional terror attacks. He was noted to have ADHD (hyper since birth), and oppositional defiant disorder. A mental status examination estimated average to above average intelligence. Diagnosis included anxiety disorder nos, rule out pervasive developmental disorder. In Dec 2000, he presented with complaint of ears stopped up with decreased hearing. At that time, it was noted that the subject had some difficulty staying on task. By 2001 the subject was receiving Paxil for anxiety in addition to continued Ritalin. Tenex therapy was also added. An academic evaluation performed at the time showed no cognitive deficits that would require remediation and he was described as an extremely intelligent and capable young man. Concerns included hyperactivity, atypicality, depression, attention problems, and adaptability. Upper limb coordination was below average, with average visual motor control and upper limb speed and dexterity. Occupational therapy was recommended. This case was assessed to be medically significant by manufacturer (OMIC).
fever; chills; Dry cough; This is a spontaneous report from a contactable nurse (patient).   A 35-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL3302) intramuscular at single dose at left arm on 15Jan2021 08:00 for Covid-19 immunisation, administered at hospital.  The patient medical history was not reported. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. There were no concomitant medications in four weeks. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unknown date for Covid-19 immunisation The patient experienced fever, chills, and dry cough on 16Jan2021 12:00 AM. No treatment AE received. Post vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.
Vaccine given 8:30 AM. Severe abdominal pain/N/V began 10:30. Chest pain and SOB --> Anxiety followed. Lorazepam given in Emerg. Room - EKG - normal.
Pounding heart; Arm pain; Vomiting; Feeling unwell; Nausea; Injection site redness; Fever; Joint pain; Chills; Muscle pain/pain in calf muscle; Headache; Tiredness; high blood pressure; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, at Pharmacy or Drug Store, administered via an unspecified route in left arm on 29Jul2021 15:00, at 46 years of age, (Batch/Lot Number: FA7485) as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jul2021 22:00 the patient experienced pounding heart, assessed as medically significant, arm pain, vomiting, feeling unwell, nausea, injection site redness, fever, joint pain, chills, muscle pain/pain in calf muscle, headache, tiredness and high blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on 29Jul2021 which included blood pressure measurement which was high. The patient didn't receive any treatment. At the time of the report the reported events were resolving.
I got a migraine on 2/8/21 at 8pm, and this lasted for 36 hours.
Intermittent weakness of the left arm, intermittent feeling as if I can't lift or move arm. Intermittent numbness and tingling of the left arm.
numbness in right hand fingers, stiff joints, poor circulation in feet (grayish blue in color), brain fog.  These are not symptoms of my age, they are new occurring morning after the shot.  They subsided a few hours after taking measures to stimulate circulation (caffeine, massage effected areas, hot bath).  The exception being, numb fingers which persist.
Pain at the injection site; sore muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Feb2021 18:44 (Batch/Lot number: unknown) at the age of 78 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time of vaccination was Given: 18:56, Vaccine location: Upper right arm, Route of administration: Intramuscular, batch/Lot Number: Not available/ provided at time of report completion), administration date: 28Jan2021, when the patient was 78 years old, for Covid-19 immunization, reaction(s): "Pain at the injection site", "sore muscle". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Feb2021 20:00, outcome "recovered" (25Feb2021), described as "Pain at the injection site"; MYALGIA (non-serious) with onset 22Feb2021 20:00, outcome "recovered" (25Feb2021), described as "sore muscle". Therapeutic measures were taken as a result of vaccination site pain, myalgia and treated with Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 28-NOV-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Mom phoned @ 330PM 12FEB92 stated pt lt leg swollen fr hip area to below knee cap; no redness noted; pt c/o pain; mom advised to take pt to MD for eval; 19FEB92 spoke w/dad stated pt dx w/early inject related infect vs hemotoma vs vax rxn;
Lt deltoid cellulitis - area red, warm, and painful to touch. Treated with AUGMENTIN 875-125 BID x 5 days. No fever or rash.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medication in 2 weeks. No known allergies reported. The patient received paxlovid from 10Sep2022 to 14Sep2022 for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax; high pitched crying 1st 24 hr p/ DTP, consolable if held; also had upper resp Infect at the time;
Pt began to cough, felt chest getting tight, tongue felt thick. She also developed a rash around the mouth. Pt given Benadryl by mother and then presented to our office where she was monitor for one hour more Benadryl was given as the dose given by mom was below the recommended dosage for child's weight. Pt's symptoms completely resolved before pt left the office.
Pt exp back pain, achy all over started 5JUL91; 17JUL91 still has back pain started on Septra 12JUL91;
Patient describes dizzy from panic attack/anxiety and lowered himself to the floor. Patient said he would be okay, it has happened twice before (before Dr. appointment). We helped him to a chair right next to him, I took his blood pressure (around 99/70). It was normal range, but low for the patient, he reported. We waited about 15 minutes and he said he was feeling okay and did not want EMS. We had the manager of the store take him home.
Fever up to 102.2/ chills/headaches/ body aches/ Fatigue/myalgia and arthralgia x 3 days.
noticed metallic taste right away after they got it within a couple minutes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266, Expiration Date: 31May2021) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "thyroid issues" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "her hair was falling out all the time" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM OXALATE taken for anxiety; LEVOTHYROXINE taken for blood parathyroid hormone decreased, alopecia. The following information was reported: DYSGEUSIA (non-serious) with onset 13Feb2021, outcome "recovered", described as "noticed metallic taste right away after they got it within a couple minutes".  Additional Information: It was reported that the patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient reported to pharmacist about the event and he said that was strange. She reported that the taste went away pretty quick within a couple days and doesn't recall when it went away. She also clarified that it didn't go into the next day.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300115041 same reporter/patient/product, different dose/event.;
As the lady jabbed me and started putting the vaccine in my arm, it started burning. It hurt so bad that I wanted to scream. I felt lightheaded and needed to sit for awhile after the shot. The next night I started getting pain in my right arm and I couldn't move it. My nerve endings in my arm, shoulder, and clavicle felt like they were on fire. The lymph nodes under my right arm and neck were swollen. I had three swollen lymph nodes in my neck, but one went down, and I still have two swollen nodes in my neck. My quality of life has suffered because the pain in my arm is so bad.
This spontaneous report was received from a physician via company representative refers to a adult patient of unknown age and gender. The patient concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient "inadvertently" received a pediatric dose of VAQTA (unknown lot and expiration date). No adverse effects were reported.
Mom called office - stated child had some redness, swelling and itchiness at (R) deltoid site from 2 shots. She was advised to do BENADRYL and cold compress to site, mark with a circle rxn area, if no better or increased in redness to call us back.
began to feel a cold run all over my body; felt pressure dropped; felt very weak; dizziness / felt that I was going to faint; Vision blurred; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3185) via an unspecified route of administration in the left arm on 27Aug2021 at 08:45 (at the age of 55-years-old) as a single dose for COVID-19immunisation. The patient did not have any relevant medical history. It was unknown if the patient had any allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Aug2021 at 09:15, after 30 minutes of taking the first dose, the patient experienced cold run all over body, felt that her pressure dropped, felt very weak with dizziness, vision blurred and felt that she was going to faint, all these feelings stayed for at least 4 hours. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events felt cold run all over body, pressure dropped, very weak with dizziness, vision blurred and felt faint were resolving at the time of this report.
Initial unsolicited report received from a consumer on 17-Oct-2017. This case involves 82-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH-DOSE, (batch number: UI824AA, expiry date: 13-Mar-2018) via intramuscular route on 11-Sep-2017. It was reported that no other vaccines or treatment were involved. Patient's medical history and concomitant medications were not reported. On an unknown date, since the day of vaccination, patient experienced cough and runny nose. Lab data and Corrective treatment were not reported. The patient had not recovered from both the events. List of documents held by sender: none.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. On 20-JUL-2015 the patient was vaccinated with improperly stored PROQUAD lot # L002213, expiration date 21-JUL-2016 (dose strength, route unspecified). No adverse effects reported. The outcome of events reported was unknown. No product quality was involved. This case is linked to the case 1507USA009788 via same reporter link. Additional information has been requested.
patient returned to store on 06/23/21 to notify and show her arm was beet red , swollen and painful.  The site of administration was not in the deltoid muscle but in the lower arm area.  Patient stated that she had seeked medical advise already and was told that it was administered to the incorrect site of arm.  She was recommended to apply warm compress and Tylenol.
Pt complains of pain in shoulder area when he tries to lift arm. Also experienced diarrhea and vomiting.
Reports on 9/3 felt a good amount of pain to the affected arm with the Shingrix vaccine however did not develop itching till 2 days later and the redness seems to be expanding with more itching and warmth.No fever, chills, tenderness, increased pain, blistering.Denies shortness of breath, dizziness, palpitations, CP, nausea or vomiting, hives, swelling of face/throat.Had been taking Benadryl and applying cool compresses. Clinical suspicion for possible localized reaction with early cellulitis: Advised patient on OTC oral antihistamines advised in taking both Zyrtec 10 mg once to twice daily and Pepcid daily. Advised in Calamine lotion OTC as needed. Cool compresses. Keflex 500 mg po QID as directed.
Information has been received from a physician and an office manager concerning an approximately 20 year old female who on an specified date was vaccinated intramuscularly with a first 0.5 mL dose of GARDASIL vaccine (Lot #660555/0279X). After receiving GARDASIL vaccine the patient fainted. At the time of the report, it was unknown if the patient had recovered from the event. Unspecified medical attention was sought. This is one of several reports received from the same source. Additional information ahs been requested.
Patient received Twinrix at 16 years of age.   Twinrix is for 18+ years
Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.; The vaccine was administered to about 9 to 10 patients before the excursion error was discovered; vaccine expired by 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008c21A and 008c21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-207778 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of sweating in a 33-year-old male patient who received FLUARIX QUADRIVALENT (batch number 359MH, expiry date 22nd June 2017. On 3rd October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 3rd October 2016, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced sweating, dry mouth, nausea, fatigue, taste metallic and vomiting. On an unknown date, the outcome of the sweating, dry mouth, nausea, fatigue, taste metallic and vomiting were unknown. The reporter considered the sweating, dry mouth, nausea, fatigue, taste metallic to be related FLUARIX QUADRIVALENT. It was unknown if the reporter considered the vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The pharmacist reported that she and others went to an office to give flu shots. They were alerted that there were 4 patients that experienced the same side effects from the vaccine afterwards. The patient concerned in this case received FLUARIX QUADRIVALENT in his right deltoid and on the same day at 10 hours, he experienced sweating, mouth dryness, nausea, fatigue (tiredness), metal taste and vomiting. The patient did not mention the severity of the side effects he experienced. The reporter did not have any further information about the patient. As per the reporter, there were also donuts at the clinic which might have been the cause for the adverse events experienced by the patient. This was one of the 4 cases reported by the same reporter.
Near syncope in parking lot after COVID vaccine. Walked out of hospital entrance, felt dizzy, sat down, and passed out for ~1 minute, met by code team and brought to ED. Pt reports epigastric pain x3 days w/ N/V; h/o pancreatitis, abdominal cancer w/ colostomy. POC BG: 111; A&Ox1 . VS @1409: Temp 98.2F, BP 134/96, HR 67, SpO2 99%, RR 18.
Shortly after receiving the vaccine, patient fainted and fell on his left side leaving a slight bruise on his face.  Both parents with patient at the time of event. Assisted to sitting position.  Ambulated with assistance by parent to observation area and placed in recumbent position. Vital signs obtained: @3;10 pm- HR =83 , 100% pulse ox on room air, BP 102/58. @3:20, HR=83, 100% room air, BP 105/66. RR =16.  Offered sips of water and snacks as tolerated. Patient observed for 35-40 minutes prior to leaving facility -ambulated independently with parents and younger brother.