chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experiencing an allergic reaction; Hives all over her face and neck/hives on face and neck; This is a spontaneous report from a contactable Physician (patient). A 30-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL0140, Expiry Date: 31Mar2021) via an unspecified route of administration in left upper arm on 31Dec2020 13:25 at single dose for COVID-19 immunisation. Medical history included crohn's disease from Jul2005 and ongoing, ongoing psoriasis, gastrooesophageal reflux disease (GERD), hand tremor. Concomitant medication included ongoing infliximab (REMICADE) for Crohn's, ongoing esomeprazole sodium (NEXIUM) for GERD, ongoing propranolol for hand tremor, copatsol topical steroid for Psoriasis, ongoing Multivitamin, ongoing vitamin B complex (B COMPLEX), ongoing biotin, ongoing iron, ongoing Calcium/Vitamin D, ongoing curcuma longa (TURMERIC). The patient had an allergic reaction after getting the COVID vaccine. She had an allergic reaction after getting the vaccine. She had hives all over her face and neck. She already had a Medrol Dose Pack at home and some Benadryl. She contacted her doctor who prescribed an Epi Pen for her, but she did not have to use the Epi Pen. She stated she used the Benadryl for three days. She started to get hives all over her face and neck the same date she got the vaccine. It started 2 hours after she got the vaccine (31Dec2020 15:25). She confirmed this was the first dose of the COVID Vaccine. She asked that if it is safe to take the second dose after experiencing an allergic reaction to the first dose. Symptoms include hives on face and neck. Patient had no trouble breathing. Took steroids and Benadryl for 3 days or until symptoms have been managed. No any of the events require a visit to emergency room. Reporter seriousness for hives all over her face and neck was reported as medically significant. Events outcome was recovered on 03Jan2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Allergic reaction and Hives cannot be totally excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-DEC-2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the intended purpose of long-term prevention of shingles and zoster related injuries (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In or about December 2015, the patient was treated at a physician office and Emergency Room for herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pneumonia; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200) via intramuscular, administered in Arm Right on 19Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient is not pregnant. No other vaccine received in four weeks. Patient experienced pneumonia after first injection on an unspecified date in 2021. Event resulted in Doctor office visit, Emergency room or urgent care, Hospitalization, Life threatening illness. Patient admitted to hospital for 5 days and received treatment. Unknown if patient had COVID prior vaccination. Unknown if COVID tested post vaccination. Outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event pneumonia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified. Linked Report(s) : US-PFIZER INC-2021423487 same patient/product, different dose and event
pt had t102, rash, sz, staring spells, very active; when had sz called 911; went to hosp to be looked at; but they didn't give anything; just APAP for the fever; pt had EEG;
RESIDENT REC'D FIRST DOSE MODERNA VACCINE LEFT DELTOID AT 1334.  PROGRESS NOTE FROM FACILITY READS:  8/18/21  @ 15:11-  "RESIDENT IS ALERT AND WATCHES TV IN HIS (?) FOR ENTERTAINMENT. RESIDENT RECEIVES ROOM VISITS AND MONITORING NEEDS AND INTEREST."  8/18/21  @ 20:50-  "RESIDENT WAS UNRESPONSIVE WITH SHALLOW BREATHING, EYES OPEN BUT VERBALLY NO SOUND, PLACED RESIDENT ON 02 @ 3 LITERS PER NASAL CANNULA, NOTIFIED  NP OF RESIDENTS STATUS RECEIVED ORDERS TO SEND RESIDENT TO HOSPITAL VIA 911, NOTIFIED 911, 911 UNABLE TO GET A BP ON RESIDENT, RESIDENT SAFELY TRANSFERRED TO STRETCHER FOR TRANSPORT TO  ER, RESIDENT FAMILY NOTIFIED,  RN NOTIFIED."   RN STATES THEY REC'D WORD THAT PT HAD EXPIRED BETWEEN 8:50 AND 10:14PM.
Pt. was given flu shot & Pnumovax on 11/8/99. Arm where Pnumovax was given, became swollen and site was painful x 2-3 days. Applied ice pk. & edema & pain gradually resolved over "one weeks time".
Feeling of  sever dizzyness and lightheadedness very strong and continuous for more than 48 hours. Even when lying down. Major weakness. Felt like I suddenly developed some kind of neurological issue or long term adverse reaction. Was scary and this was not listed on the cdc website as a possible side effect. Started feeling better after 48 hours of this side effect starting and 5 days of side effects after booster shot.
After immunizations 10/04/2001, she began to throw her leg out when she walked, no knots no limp.
Swelling, redness, and itchiness at injection site came on approximately 7 days after vaccine injection and maintained for about 3 days. Swelling and redness approximately 3 inches in diameter from injection site. No fever.
Extreme pain in arm that had shot and can't use that arm without pain. Have had pain now for six weeks and it is not getting better. Unable to use arm, limited mobility. Pain now moving up and into my back.
passed out; became very pale grayish-blue; Was hard to wake and stay awake; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 10:30 (Lot number: fk5618) at the age of 7 years as dose 2, single for covid-19 immunisation.  The patient's relevant medical history was not reported. No covid experienced prior vaccination. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1. Batch/Lot No: fk5127. Location of injection: Arm Left), administration date: 04Nov2021, when the patient was 7 years old, for COVID-19 immunization. No other vaccine received in four weeks. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 26Nov2021 11:45, outcome "not recovered", described as "passed out"; PALLOR (non-serious) with onset 26Nov2021 11:45, outcome "not recovered", described as "became very pale grayish-blue"; SOMNOLENCE (non-serious) with onset 26Nov2021 11:45, outcome "not recovered", described as "Was hard to wake and stay awake". The clinical course of events was as follows: Patient became very pale grayish-blue and passed out. He was hard to wake and stay awake. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) unknown results, notes: Covid test result: Pending. Therapeutic measures were not taken as a result of loss of consciousness, pallor, somnolence. Follow-up attempts are completed. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX. On 25th March 2019, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills, fatigue and feeling miserable. On 26th March 2019, the outcome of the influenza-like symptoms, fever, chills, fatigue and feeling miserable were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, fatigue and feeling miserable to be related to SHINGRIX. Additional details were provided as follows: The patient experienced side effects fever, chills, fatigue, flu-like and feeling miserable. The patient experienced symptoms on the same night after 1st injection and resolved the next day. No additional data provided.
Patient complains of headache, lack of concentration, fatigue. Patient denies any fever. Patient stated she took OTC Tylenol after a long while she stated she felt slightly better.
This spontaneous report was received from a licensed practical nurse refers to a multiple unknown patients of unknown age and gender. No pertinent medical history, drug reactions/Allergies and concomitant medications were reported. On an multiple unknown dates, the patients were vaccinated with improperly stored (incorrect product storage) doses of VAQTA (lot #M027879 and expiry date 24-JAN-2018) (dosing regimen was unknown by the reporter) for prophylaxis. The vaccine was exposed to temperature of 0.2 degree Celsius for 4 hours and 51 minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was filed. Follow up information has been received from an office manager (OM) on 13-DEC-2016. The OM stated that she would research it and fax in the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested. Reporter and narrative were updated. Sender's Comments: US-009507513-1611USA000375: MERCK 1611USA000480:Mfr number.
This spontaneous case reported by a patient, describes the occurrence of nausea in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nausea. At the time of the report, nausea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 56-year-old male subject who received Flu seasonal TIV Dresden. This case refers to patient 9 in the literature article. Concurrent medical conditions included penicillin allergy. On an unknown date, 1 hr after receiving Flu seasonal TIV Dresden and dTpa vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included angioedema with serious criteria of GSK medically significant, shortness of breath, vomiting and fatigue. The subject was treated with antihistamine. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included angioedema (recovered/resolved), shortness of breath (recovered/resolved), vomiting (recovered/resolved) and fatigue (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema, shortness of breath, vomiting and fatigue may have been caused by Flu seasonal TIV Dresden and dTpa vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of vaccine-triggered anaphylaxis in a 56-year-old male patient who had received an unspecified Tdap (manufacturer unknown) and an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a male. The subject's medical history included atopic disease with amoxicillin allergy. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January 2009 and the 31st of December 2011, the patient received an unspecified dose of an unspecified Tdap and an unspecified trivalent influenza vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within 60 minutes and less than 90 minutes after the vaccination, the patient developed angioedema, shortness of breath, vomiting and fatigue. This was classified as anaphylaxis by the family practice doctor. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by oral antihistamine. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
Behavioral changes. Patient had flu vaccination (FLUMIST) administered Wednesday October 28, 2015. We have seen the following incidents during the week: Thursday October 29, 2015 patient develops a cold, temperature (99F), sneezing, stuffy nose; Friday October 30, 2015 Incident reported from School transportation driver about patient getting aggressive and behaving not safe so he had to be transported back to school. Saturday October 31, 2015 patient is more unfocused than unusual, crawling during part of the day, was getting on his hands on the ground. Seemed aloof, not listening to parent's voices. Sunday November 1st, 2015 He is very hyperactive at home, crashing against the walls, unable to seat or stay still. Monday November 2nd, 2015 Incident reported from school. Patient gets very aggressive towards teacher. Biting, bolting. This incident is being investigated. Tuesday November 3rd, 2015 Incident at Speech therapy. Aggressive behavior, bolting, meltdown. This never happened before in 8 years he is being attending this place. Wednesday November 4th, 2015 We visit the library, patient was unable to sit, unfocused, anxious, repetitive behaviors, fast speech. Far from his usual attitude at the library, he did not even acknowledge the librarian which he always does. Thursday November 5th, 2015 Patient wandered away from the house. He was found walking down the street towards downtown half a mile away from our home. He had wondered before around our property (2 acres) but he had never left premises before. Patient is a 10 year old boy with autism who was doing significant progress at school and at home. During this week following the administration of the flu vaccine patient has shown regression in all areas of development along with aggressive behaviors. It is reasonable to suspect that the FLUMIST had caused a severe allergic reaction that have changed his behaviors and I want this to be reported to CDC for investigation.
Patient reported to the pharmacy today that she still felt like her arm swells up and forms a not at the site of injection. Patient was advised to contacther PCP
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-DEC-2008, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On or about 01-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Received Flu Shot at 3pm on 10/11/10 and woke up next AM with hives to posterior left arm and back.
Urticaria, treated with diphenhydramine, pepcid, prednisone.  Improved.
I had the shots and I'm still getting it three times/Suspected vaccination failure; Getting it three times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shots and still got shingles three times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
WORSENED UVEITIS; UVEITIS; FACILITATED COLLECT  This is a Solicited report based on the information received by Pfizer from AbbVie Pharmacovigilance (Manufacturer Control No: 21K-163-4075510-00) from a contactable female consumer reported for herself.  A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on an unspecified date in Jan2021 and the second dose on 13Feb2021, at the age of 32-years-old, (Batch/Lot number was not reported), via intramuscular route as single dose for covid-19 immunisation and ADALIMUMAB (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, for Non-Infectious intermediate, Posterior and Panuveitis.  The patient medical history included uveitis. The patient's concomitant medications were not reported. On unknown date in Jan2021, the patient had worsened uveitis. The outcome of the event was recovering.   The reporter's causality for the event with HUMIRA(adalimumab) was not provided.   The reporter's assessment of the causal relationship of the event with bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and considering drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the reported events of worsened Uveitis cannot be completely excluded. Case will be reassessed upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
At the store the patient received the Moderna covid-19 vaccine (lot 027L20A) as the first dose on 01/20/21; injected into the right deltoid. At the store the patient received the Pfizer-BioNTech covid-19 vaccine (lot EM9810) as the second dose on 02/09/21; injected into the right deltoid.
No additional adverse effect reported; On 25-FEB-2020 patient received a dose of improperly stored ROTATEQ.; This spontaneous report was received from a Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.     On 25-FEB-2020, the patient received one dose of an improperly stored dose (product storage error) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis (strength and frequency not reported) (lot # 1660112 had been verified to be valid lot numbers; expiration date: 18-OCT-2020). The temperature excursion was at below 2 degrees Celsius (C) (1.28 C), for a time frame of 2 hours and 30 hours, and no had previous temperature excursion. It was reported that the call was due to data logger. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA005842:
While nursing, baby was not normal. Baby stopped nursing, head back, eyes rolled back, as a convulsion. Loud crying for at least 15 minutes. Baby had high fever. Left arm was limp. After crying, baby seemed exhausted. Baby slept in crib. Baby given water and breast milk when awoke. Leg seemed to jerk. Arm somewhat limp. Had arm and leg jerkiness about a week-would notice twitch/jerky type of movement in leg and arm.
65+ Flu vaccine; Fluad PFS 2020-21 INJ 0.5 ml