chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylactic Attack; Sudden onset of severe asthma that has been chronic since the date of the shot, 8/23/21. Body aches particularly arms which hurt and have a deep ache, itchy chronic hives on left arm, waves of nausea, chronic coughing,  pneumonia diagnosis shown on Xay, increased heart-rate/panic attacks due to inability to breathe normally.  Fatigue and exhaustion, bodily weakness overall. Prescribed: Albuteral inhalers, BREO ELLIPTA inhaler 100 mcg/25 mcg,   LevoFLOXacin 500 mg, Benzonatate 200 mg prescribed.
Red bumps resembling bites on both arms, worse on arm that was not used for vaccine administration.
ELEVATED - TSH 10.300 uIU/mL ELEVATED - Thyroid Peroxidase Ab 198 IU/mL NORMAL - T4, Free (Direct) 0.94 ng/dL * An elevation of TSH with a normal FT4 in the presence of antithyroid peroxidase antibody is suggestive of Subclinical Hypothyroidism. ** NO SYMPTOMS *** NO PREVIOUS ISSUES; NO FAMILY HISTORY
Patient has known Sjogrens  syndrome. Had first flare up in November 2019 after a knee injury. Two days after her covid booster she had her second flare up of Sjogrens years from the first she thinks the vaccine triggered this. She says this flare up is alot worse then the first flare up she had years prior. She says she feels like her skin is burning all over and is on fire. She is not able to straighten her back because of the pain in her skin. her Back and Hip  feel like skin is burning. Pain gets better and worse at times. Benadryl and aloe vera  helps . Pain is still not resolved. Was given Gabapentin., samples of epiceram given for burning skin and irritation due to sjogrens patient will increase to 400 mg of gabapentin at night for burning skin sensation. Advised to return in 6 weeks for follow up on burning skin.
Information has been received from a registered nurse concerning a 12-month-old male who on 02/15/2001 was vaccinated with then first dose of varicella virus vaccinee live SC in the left thigh. concomitant therapy included the first dose of measles  virus vacine live (second generation) SC in the left thigh, diphtheria toxoids/ pertussis vaccine/tetanus IM into the upper left thigh and poliovirus inactivated SC in the left upper thigh. On 02/28/01, the patient developed a "small red bumpy rash from head to toe. Many , many red spots" it was also noted that the pt was fussy and had a low grade fever prior to eruption. On 03/21/01, the pt developed a "small red bump on the tip of nose, mom says it had been there for x 1 wk. now looks crusting-scabbing- has smaller red spot on back of lower area, back of head, on upper back and top of foot. No temperature or fussiness at the time of the report. it was noted it was unknown if the patient recovered. it was noted that the patient had no adverse reaction following previous vaccinations, and no illness at the time of vaccination.
malaise; Fever; aches; fatigue; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57-year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL. Vaccination history included: Bnt162b2 (Dose Number: 2, Prev dose product=COVID 19, prev dose brand unknown=True, prev dose brand name unknown=COVID19 Vaccine, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot unknown=True, prev dose lot unknown reason=Not available/provided to reporter at the time of report completio), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "Booster"; MALAISE (non-serious) with onset 01Dec2021, outcome "recovering", described as "malaise"; PYREXIA (non-serious) with onset 01Dec2021, outcome "recovering", described as "Fever"; PAIN (non-serious) with onset 01Dec2021, outcome "recovering", described as "aches"; FATIGUE (non-serious) with onset 01Dec2021, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise, pyrexia, pain, fatigue.  Additional information: Patient did not have covid prior vaccination and has not been tested for covid post vaccination. No allergies were reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pounding headache; Feel like I have the flu.; Extremely tired; Body started aching; This is a spontaneous report from a contactable consumer, the patient.   A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration in the right arm on 23Mar2021 at 15:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), via an unspecified route of administration in the right arm on 02Mar2021 at 16:30 (at the age of 54-years-old), as a single dose for COVID-19 immunization and patient experienced just a little tired. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 20:00 (also reported as early evening), the patient was extremely tired. Then, overnight, the patient's body started aching. On 24Mar2021, in the morning, the patient experienced pounding headache and felt like she had flu. The patient did not receive any treatment for the reported events. The clinical outcome of the events tiredness, body ache, headache and felt like flu were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
mother told the medical assistant her daughter needed to get a Flu shot so the medical assistant administered another Fluzone Quad without looking at the chart with no adverse event; Initial information was received on 23-Oct-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 26-months-old female patient came in with the mother for a 3 year check up on 21-Oct-2020 and received the influenza quadrival a-b vaccine [Fluzone Quadrivalent] and a Hepatitis A vaccine (Concomitant medications). Then the mother brought the child back today and went to the outside drive up clinic and told the medical assistant her daughter needed to get a Flu shot so the medical assistant administered another influenza quadrival a-b vaccine without looking at the chart (extra dose administered). (formulation and strength were unknown) (lot number: UT7065MA and expiry date: 30-Jun-2021) at 0.5 ml twice via intramuscular route in the right thigh for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  This was an actual medication error case due to extra dose administered (latency 2 days).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
10 days after vaccinations, generalized rash appeared and fever. CBC taken on 8/13/04 WNL Calamine lotion to rash BID, Benadryl for itching,Tylenol for fever. Seen by doctor 8/13/04. 8/18/04 ; Rash cleared per parent verbal report.
Patient received vaccine at 11:14 and had an episode of syncope of at approximately 11:20. Patient received a laceration on his chin approximately 2 cm in length. He was rolled on his back and left supine, direct pressure was placed on the laceration until EMT arrived. Patient's mother denied EMT transport and did transport the patient to the Emergency Department for assessment.
Subject, an 18 year old male with a history of 1 previous dose of Anthrax vaccine developed body aches, loss of energy and loss of appetite on 25Jan00 following a vaccination with Anthrax on the same date. The pt had received prior Anthrax vaccine on 06Jan00 and Rabies vaccine on 20Jan00. Treatment information was not provided. The event resolved on an unspecified date.
Hot to touch at injection site itchy huge red welt welt is 5-6 inches around
Severe localized reaction with swelling, pain, and itching on left arm extending into left shoulder and under left clavicle on day of injection (day 0) Generalized reaction began at 32 hour mark with headache, fever, chills, nausea, and dizziness.  Fever, chills, and nausea resolved on day 2.  Still unable to walk or stand unassisted on day 3. Headache and dizziness persisted into day 4.  PA prescribed tapering dose-pack of 4mg Methyprenisolone.
Muscle pain in the arm, shoulder, neck, back, Tiredness.   8 days later redness of the vaccine area, itching, and muscle pain.
6/10/2009 Patients Mother called office and reported that Left arm at site where daughter received vaccine is red, hot and swollen.  Provider Dr. made aware orders received: apply warm moist on off every 20 mins., elevate, apply cortisone cream. 6/11/2009 2:48 p.m. Mother calls back office arm worse hard, hot, and swollen. Pt scheduled for appointment with Dr.  4:30 Pt at office for appt exam preformed found to have cellulitis of the Left arm at injection site. Prescribed Keflex 250/tsp 1 tsp four times daily
Steady headache; arm only slightly sore around injection site; Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8732) via an unspecified route of administration on left arm on 25Mar2021 at 09:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergy to compazine and codeine. The patient had received concomitant medications within two weeks of vaccination. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 10:00, the patient experienced sore arm and on 26Mar2021, the patient experienced steady headache that did not respond to ibuprofen but not debilitating, and arm only slightly sore around injection site. The patient was treated with ibuprofen (MANUFACTURER UNKNOWN) for steady headache. The patient did not receive any treatment for the events sore arm and arm only slightly sore around injection site. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events sore arm, steady headache that does not respond to ibuprofen but not debilitating and arm only slightly sore around injection site was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Myalgia, Fever, lightheadedness bp 107/66, fatigue temp 100.5 body aches Narrative:
Pt was given the first in a series of 3 gardasil immunizations at the end of his visit today. He was fine s/p vaccine administration. While at the checkout area he passed out. The time frame between receiving the vaccine and passing out was approximately 2-3 mins. The pt was revived and taken to an exam room via wheelchair where the pt once again became unconscious. He then became very rigid and urinated on himself. At that time, the office called 911 for EMS which arrived about 10mins later.  The time frame between the 2 episodes was approximately 6mins. EMS arrived and pt refused further treatment or transport to the hospital.
Inflammation of knee  and ankle causing pain when walking and requiring a walker and a dose of steroids
A patient was received expired FLUZONE HIGH-DOSE QUADRIVALENT with no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via consumer/non-health care professional via Medical Information (Reference number- 00801040) and transmitted on 06-Oct-2021.  This case is linked to case 2021SA334081 (same reporter).  This case involves a 78-year-old male patient who was received expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 06-Oct-2021, the patient received a first dose (0.7 ml) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ454AB, expiry: 30-Jun-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Nurse calling in regards to expired FLUZONE HIGH-DOSE QUADRIVALENT (QIV HD) being administered to two patients. Caller would like to know how to proceed and if there is a safety issue."  No other 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. 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.
Exhausted starting 2 hours later, diarrhea starting that night and still present. Extremely bad cramping started about 2 hours ago (nearly 3 days later). Mild muscle pain starting day after. Pain, swelling at injection site and red. Redness has went away, still painful.
The patient presents today with a history of recurrent urticaria and angioedema.  She received a dose of the Pfizer COVID-19 vaccine on Thursday Feb 25th (lot number EN 6206).  She felt fine after her shot, but the next day felt fatigued, had chills, body aches, and left arm soreness (at the site of the injection)--she attributed her symptoms to her vaccination.  Friday evening, prior to bed, she noticed the onset of several scattered hives.  The next day, she noted that she had more extensive hives over her body, including her eyelids, and she said that she has been having dyspnea; she presented to the ER and was treated with steroids and antihistamines.  The symptoms or urticaria returned the next day with significant angioedema of the lips, and the patient had dyspnea and nausea/abdominal discomfort, and the patient went back to the ER.  With antihistamines and steroids, her symptoms improved significantly and she was sent home.  Her symptoms returned today, now accompanied by throat globus as well as abdominal discomfort--she self administered an Epipen, which she said significantly helped her symptoms.
Donor received Tetanus Vaccine.  He c/o fatigue, muscle aches and joint pain for 2 days starting on 10/06/2023
After receiving Pfizer # 1 vaccine, patient complained of feeling lightheaded/dizzy.  She was sitting on a chair in exam room and was instructed to bend over and put her head between her knees and take some deep breaths which she did.   Within 1-2 minutes, she stated she was feeling better and the lightheadedness was resolving.   She was able to sit up without difficulty.  I held her arm and accompanied her out to the Health front desk for further observation.  She was able to walk without problems.  Upon arrival to the office, I had her sit down in a chair and she was provided a bottle of water.  While standing next to her, she again complained of feeling lightheaded/dizzy, her skin turned pale in color and she slumped forward in chair.   She lost consciousness for approximately 30-45 seconds.  No loss of pulse or respirations noted.    Consciousness regained spontaneously and she was able to respond to questions and verbal commands.   Myself and 2 other coworkers assisted her into wheelchair and she was immediately  taken to Urgent Care for further evaluation.
Client received J&J vaccine on 3-4-21, then recevied first Pfizer vaccine on 9-10-21 and second on 9-29-21.
NEGATIVE REACTION TO THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced negative reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative reaction to the vaccine was not reported. This report was non-serious.
Life threatening episode requiring emergency transport: clammy skin and vomiting leading (8 minutes) to difficulty breathing (wheezing and flared nostrils-2 minutes). Turned blue, limp, non-responsive. Fully stopped breathing for two minutes.  After several chest compressions started breathing again, rolled over, and threw up.
Pt developed type I diabetes. The annual follow-up report states that the pt was diagnosed with type I diabetes in April 2000. He started on insulin injections 3 times a day. In December 2000 he was asymtomatic and discontinued insulin. The tests were positive to the antibodies for type I diabetes, yet has not taken insulin for the past eight months.
Patient exposed to Varicella, patient experienced 35-40 blisters, felt sick but no fever.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 03Apr2021 as dose 2, single (Lot number: EW0150), in right arm, on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28Apr2022 at 18:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "depression" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Diclofenac, reaction(s): "Known allergies: Diclofenac"; Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Recurrence. Therapeutic measures were taken as a result of vaccination failure, Covid-19. No other medication in 2weeks. Treatment of COVID-19 with Paxlovid (Lot number : FY5657) from 04May2022 to 09May2022. Recurrence of Covid symptoms on day 3 after finishing 5-day treatment of Paxlovid. Chest tightness and congestion, cough, runny nose, sore throat, and headache. Exhaustion continued. Also nausea is a new symptom. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received Pfizer 5-11 year old COVID vaccine. Patient waited 15 minutes post injection with no adverse reactions. Vaccine administration error was not realized until patient left the office and LPN was documenting vaccine administration. Nurse manager contacted mom to inform of vaccine administration error.  Mom denied adverse reactions at time of phone call. Advised mom to continue to monitor for adverse reactions. Mom verbalized understanding.
3/1/2021  moderna, #1 shot,  fine initially , slight discomfort in L arm  , resolved in few days, Day7 3/8/2021  noticed L arm tender ,   Day 8    3/9/ 21  noticed redness  at site, approx 2 inch diameter.. not a real circle.. area tender, slightly swollen  as day progressed overall feeling of fatigue, chills, aches .... took ibuprofen   3:00 PM,   benedryl @ 9:00 pm Day 9,   injection area remains swollen , pink area more than red,   feel better than yesterday not quite normal yet,