chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a physician concerning a 15 year old female who on 11-JUL-2008, was vaccinated with a third dose 0.5ml of GARDASIL (lot# 660393/0067X) intramuscularly in the left arm.  On 11-JUL-2008 the physician  reported the patient fainted approximately 3 minutes after receiving GARDASIL at the physician's office.  The patient hit her head.  The patient was also dizzy, nauseous and began vomiting.  The patient was sent to the emergency room.  On 11-JUL-2008 the patient was recovered.  Medical records were received.  A 15 year old female who was sent to the emergency room by her pediatrician's office for evaluation of a head injury, status post a brief syncopal event after receiving her third GARDASIL injection in the office. The patient stated she received a third GARDASIL injection in the office and approximately 30 seconds later, she had a witnessed syncopal event for a "couple of seconds".  Her mom and her sister were there, as well as the pediatrician staff.  The patient struck the back of her head on the floor below and since that time, vomited once and had been extremely dizzy and complained.  The patient denied any history of previous head injury or concussion.  There was no abrasion or laceration noted to the scalp.  The incident occurred approximately 30 minutes to 45 minutes prior to arrival in the emergency department.  A physical examination was performed and the vital signs were stable and the patient was afebrile.  The patient appeared nontoxic in no extremis.  The patient's head revealed a mild posterior scalp hematoma with tenderness to palpation in the occipital region.  A CT scan was performed of the head and was negative for acute pathology per the radiologist's interpretation.  The emergency room physician reported "given the fact that this did occur directly after an injection this might be vasovagal in nature".  This was discussed with the patient and her mother and no further diagnostic work-up was indicated at the time.  The patient was discharged home with symptomatic supportive treatment and PMD follow-up in the next 48 hours for reevaluation.  Aftercare instructions were given on vasovagal syncope, head injury with wake-up and the patient was instructed to take TYLENOL when needed for pain, ice to the head for discomfort as needed, rest, activity as tolerated.  Diagnosis was status post GARDASIL injection, vasovagal syncope and closed head injury.  On 11-JUL-2208 the patient was considered recovered.  Additional information is not expected.
Information has been received from a pharmacist concerning a 26 year old employee who on 13-Nov-2006 was inadvertently vaccinated with a dose of varicella-zoster virus vaccine live. No symptoms were reported. The pharmacist reported that the error occurred due to three factors. There was some confusion with the name of the vaccines, even though "zoster" does appear on the varicella-zoster virus vaccine live label. The varicella-zoster virus vaccine live was kept in the same cubicle as varicella virus vaccine live was kept. They were very busy at the time and had a lot of interruptions and did not have enough time to assess the order. He also noted that the packaging of varicella-zoster virus vaccine live and varicella virus vaccine live is different, "which is good". Additional information has been requested.
personality change was noticed almost immed; pt appeared to be drunk p/a couple wks started shutting down-could not hold him, would not play & acted deaf;
9-6-06 4pm increased fever to 102F. Very fussy and difficult to console throughout night. Tylenol every 4 hours decreased fever and discomfort. Increased need for breastfeeding. Voiding within normal limits. 9-7-06 Client was not as fussy this day-but he was "tired" and "not himself" and "warm". One dose of Tylenol given. Decreased appetite. Increased breastfeeding. Voiding within normal limits. 9-8-06 appearance of rash noticed by clients mom on extremities, palms of hands, torso, face and ears. Rash describe as "lots of tiny dots-some flat and some raised, with no fluid." Mom says that in some areas, there were so many dots, that it created a "solid red area"-(most notable on torso and legs). She says that rash did not appear to cause itching or pain to client. Client afebrile this day. Behavior appearing more normal. Still wanting increased breastfeeding today. Mom called doctor about 5:30pm and left a message. 9-9-06 mom attempts to reach doctor again. Leaves message. symptoms same as 9-8-06. 9-11-06 mom contacts doctor who recommends calling Public Health for concern. At this time, mom reports that client is "back to himself", afebrile, appetite and behavior are within normal limits. Mom says rash is clearing up today.
pfizer vaccine was in fridge beyond 30 days at time of administration. pharmacist did not know of this until after administration. discussed with pt. pt stated tired and headache following vaccination. advised repeating vaccination.
Order obtained for patient to receive Covid booster injection (Pfizer) for 21 year old patient.  RN presented to Med room and drew medication from Pfizer clipboard for 12years and older.  Documented Lot number and provided patient with IM injection.  Upon documentation of injection, lot numbers did not match.  With assistance of staff member, vials were noted to have been switched.  Medication patient received was Pfizer 5-11 yo.  Event reported to NM, provider and Director of Medicine.  Incident report filed and patient notified and was offered appt for repeat Booster.  Pt did not keep appointment
Info has been received from a health professional concerning a 10 year old white male, with no medical history and no allergies, who on 2/23/95 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 4/13/05, the pt experienced chickenpox breakthrough, during a middle school outbreak, described as a generalized, moderate rash with no fever. There were no complications. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
MOVED ARM AWAY BEFORE GETTING THE FULL DOSE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: Alzheimer's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-NOV-2021, the patient experienced moved arm away before getting the full dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of moved arm away before getting the full dose was not reported. This report was non-serious. This report was associated with product quality complaint: 90000204359. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.
Pain in left shoulder in muscle caused limited range of motion. This went on for two months.  Went to doctor and got arthritis cream and then referred to sports medicine doctor and prescribed with Bursitis due to SIRVA.
running nose; Cough; sneezing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (running nose), COUGH (Cough) and SNEEZING (sneezing) in a 2-year-old male patient who received mRNA-1273 (Spikevax) (batch no. AS1414B) for COVID-19 prophylaxis.     No allergy, concomitant diseases and risk factor were reported.  Concurrent medical conditions included Food allergy (Patient had anaphylactic to a few food).    On 11-Aug-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Jan-2023, the patient experienced RHINORRHOEA (running nose), COUGH (Cough) and SNEEZING (sneezing). At the time of the report, RHINORRHOEA (running nose), COUGH (Cough) and SNEEZING (sneezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2023, SARS-CoV-2 test: Negative.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Patient was scheduled for Moderna Bivalent Booster, but he was sick with a runny nose, cough and sneezing all week, so his appointment was cancelled for tomorrow.   He first showed symptoms on Monday 1/23 and home COVID test was done on 1/24 but it was negative.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2023: Live follow up document received on 26-Jan-2023, which contains date of lab data and event information were updated. On 26-Jan-2023: Live follow up document received on 26-Jan-2023, which contains non significant information.
Papular, erythematous rash, papules that did not coalesce. Followed expectantly.
Prior to vaccination, blood pressure well controlled on hydrochlorothiazide only.  Following the booster of Moderna , significant elevations in blood pressure began.  Multiple antihypertensives have been added, including maximally dosed losartan and amlodipine, a clonidine patch, and HCTZ switched to chlorthalidone.  Evaluated by cardiology for persistent symptoms on 1/25/22.  Previous covid vaccines: 2/19/21 Pfeizer lot EM9810, 3/12/21 Pfeizer lot EN6208
This spontaneous report was received from a pharmacist concerning a patient of unknown gender and age who was immunocompromised. On an unspecified date several years ago, the patient was vaccinated with an initial dose of PNEUMOVAX23 (dose, route and lot # not provided), then received a second dose of PNEUMOVAX23 on an unspecified date 2 to 3 years later. No adverse effect was reported. Additional information has been requested.
1. Diarrhea at 7pm of injection day (11 h after injection) then the following day at 11:30am, noon, and 12:30pm (27.5, 28, and 28.5 h after injection). Will be taking imodium.  Thus, as of this report, the problem has not definitively resolved.  2. Fever (101.5 degrees F) measured at 11:30pm of injection day (15.5 h after injection).  Treated w ibuprofen and cooling (fan, AC).  Resolved over 1-2 hours.  3. Headache from about 4pm (8 h after injection) through 1pm of following day (29 h after injection).  Treated with ibuprofen at 11:30pm (15.5 h after injection) and at 11am the following day (27 h after).  Will continue treatment if symptom persists.
Initial report collected from Case Reports in the literature in 11 January 2012 through the local affiliates under local reference number A201200014. The Case Report: Lesson from patient who had a moderate generalized reaction following vaccination - Predicting allergy and chronic EB virus infection. Objective: The patient had a generalized adverse reaction after he/she received vaccination at the hospital and he or she was hospitalized. It was revealed that he/she had allergic disposition. We would like to report the handling of child patient with allergic disposition, which is considered to be a risk factor for adverse reactions. Experience: In the hospital, we performed an allergy test on child patients who are suspected to have allergy disposition or who have worsened local reaction after several vaccinations. We recommended those with allergy disposition to take oral anti-allergic drugs before and after vaccination, and for those with high-risk patients, we perform a prick test (risks are lower than an intradermal test and a result can be obtained in 15 minutes), which is normally used to predict development of anaphylaxis. Case report: A child patient (gender and age not reported) with allergic disposition and no concomitant therapy had simultaneously received a subcutaneous dose of ACT-HIB (batch number unknown) and a dose of PREVENAR (Other manufacturer, batch number unknown) on 18 January 2011. On 19 January 2011, the patient had a fever of 38 degrees C and mild nasal discharge and was hospitalized for poor oral intake. Severe swelling was noted at both injection sites, which were associated with redness and induration. A blood test showed WBC of 12800 (Eo 0.5%), CRP 0.86 and AST/ALT 30/16. Fluid therapy and intravenous and external treatment with anti-allergic agents were started. The patient became afebrile on the next day, swelling at the injection sites and poor oral intake improved. When the patient was discharged on 21 January 2011, induration on both sites still remained. T-IgE was 71.7 IU/L, which was higher than the normal value for the patient's age. Discussion: It is said that if patients with history of severe hypersensitivity to mosquito bite do not receive appropriate treatment, chronic EB virus infection may cause death in about one third of them as they develop EBV related malignant lymphoma or hemophagocytic syndrome during the course of five to ten years. A serious generalized reaction has been reported to occur in the same mechanism when an additional vaccination is given for DPT vaccine, which requires multiple shots, and in also in these cases, EBV-infected cells were reactivated due to the vaccine which had been given previously and a serious generalized reaction occurred. This patient was found to have allergic disposition, and thus in future we will take anti-allergic measures when administering vaccination and ensure that adverse reactions are reduced.
11/19/2022 I had the vaccine around 10:30 AM, came home and within two hours I noted my resting heart rate had gone up. My normal rate is around 60-70, kept that way by my pacemaker. My heart rate went up to 100 and stayed that way for about 36 hours, even when I went to bed. Also, I was having back pain and used a massage chair that appeared to shut down my pacemaker. My resting heart rate went down into the 50's for about 30 min. 11/20/22 I noticed during the night my heart rate went down to 75 which lasted for about 24 hours. On 11/21/22 I went to the doctor and saw the pacemaker tech and they checked out my pacemaker. The doctor reported that everything was good. On 11/21/22 in the evening, my heart rate returned to normal. I have recovered from the accelerated heart rate. I am having some other accelerated heart rates which may be related to the resetting of the pacemaker, but I have to check with the doctor regarding the settings of the pacemaker.
redness  11-27 swelling Hot to touch lowgrade fever 11-28 puss pockets drainage - measured 5.5" by 5.5" Treated with Cephalexin, Benadryl + Claritin
Massive fatigue, arm soreness from injection site Fever 101.7, then 100,  then 99.3, then normal after a day Took Tylenol and slept profusely
Fever 102-103 (took fever reducers after 24 hrs) Chills Sweats Severe pain in left ear, throat, and down rib cage on left side  Severe armpit pain (left)  Severe headache  Eye pain  Overall discomfort
she removed it and put it back in a second time when she experienced a soreness, stinging or nerve pain in her elbow to her wrist; I took Benadryl in case it was an allergic reaction; arm was red and swollen; arm was red and swollen; pain in her shoulder, her neck and down to her thigh all on the same side.; pain in her shoulder, her neck and down to her thigh all on the same side.; pain in her shoulder, her neck and down to her thigh all on the same side.; spasms; my arm still stings; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 68 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that the needle was removed and it was put back in a second time when she experienced a soreness, stinging or nerve pain in her elbow to her wrist leading to wrong technique in product usage process on an unspecified date with outcome of unknown. she took benadryl in case it was an allergic reaction leading to product use issue on an unspecified date with outcome of unknown, her arm was red and swollen causing erythema on an unspecified date with outcome of unknown, arm was red and swollen causing peripheral swelling on an unspecified date with outcome of unknown, pain in her shoulder, her neck and down to her thigh all on the same side causing neck pain on an unspecified date with outcome of unknown, pain in her shoulder, her neck and down to her thigh all on the same side causing arthralgia on an unspecified date with outcome of unknown, pain in her shoulder,her neck and down to her thigh all on the same side causing pain in extremity on an unspecified date with outcome of unknown, spasms causing muscle spasms on an unspecified date with outcome of unknown, her arm still stings like arthropod sting on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of this with Benadryl in case it was an allergic reaction, ibuprofen for the inflammation and muscle relaxers for the spasms.  Follow-up (18Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported that: The patient was concerned about the second dose its side effects and the period she had to wait for it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A report has been received from a Health Professional concerning a 14 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 11-Oct-2013. The patient received only half dose of FLUMIST QUADRIVALENT on 11-Oct-2013. The outcome of the event of patient received only half dose of FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
feeling Dizzy; she felt like "garbage" and felt like she was going to throw up; she felt like "garbage" and felt like she was going to throw up; This is spontaneous report from a contactable nurse reported for slef. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose (lot: ER8732) in left arm on 01Apr2021 09:30 AM for COVID-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included allergies to dairy and eggs. Concomitant medications were not reported. The patient got her first vaccine on 01Apr2021 (Thursday morning). About an hour and a half after she got her vaccine, she started feeling "super dizzy" that got worse throughout the day because she was driving. She felt like "garbage" and felt like she was going to throw up. By the time she got home that day it was a little better, but she had to lay down, and any time she got up or moved too fast she experienced the dizziness. The next day she felt it again when she was in the car and then reported that by that night she felt better. She started feeling dizzy and it didn't go away until Friday evening, no treatment received for the adverse event. The patient wanted to know if she should get the second vaccine. She is due to get her second dose next week on Thursday and is concerned if it is safe for her to do so. She is worried how bad her reaction is going to be after the second dose. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
DIARRHEA; ABDOMINAL PAIN/ABDOMINAL CRAMPING; ABDOMINAL DISTENTION; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUN-2021, the subject experienced diarrhea. On 08-JUN-2021, the subject experienced abdominal pain/abdominal cramping. On 08-JUN-2021, the subject experienced abdominal distention. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea, abdominal pain/abdominal cramping, and abdominal distention. This report was non-serious.
he got a little ill; no longer detect diabetes or hypertension. A1C levels went from 11 to 5.3.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he got a little ill) and THERAPEUTIC RESPONSE UNEXPECTED (no longer detect diabetes or hypertension. A1C levels went from 11 to 5.3.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Diabetes and Hip replacement. Concurrent medical conditions included Allergy (Maxvibe), Drug allergy (ACE inhibitors), Drug allergy (Motrin/NSAIDS) and Drug allergy (Tramadol). Concomitant products included COLECALCIFEROL (VITAMINE D) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced ILLNESS (he got a little ill) and THERAPEUTIC RESPONSE UNEXPECTED (no longer detect diabetes or hypertension. A1C levels went from 11 to 5.3.). At the time of the report, ILLNESS (he got a little ill) and THERAPEUTIC RESPONSE UNEXPECTED (no longer detect diabetes or hypertension. A1C levels went from 11 to 5.3.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Weight: 405lbs to 298lbs (Low) 405lbs to 298lbs.         Patient Height was reported as 5'11. Concomitant medication included heavy doses of diabetes and hypertension medications (unspecified). It was reported that after the second shot patient got a little ill,  Covid test was negative. 4-5 months after they did blood work. All blood work came back normal. They could no longer detect diabetes or hypertension. Now does not have hypertension or diabetes anymore. patient  A1C levels went from 11 to 5.3. weight went from 405lbs to 298lbs. Patient took heavy doses of diabetes and hypertension medications.  The vaccine improved baseline health issues.