chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got vaccinated for shingles and still got them/ Suspected vaccination failure; shingles and still got them but just no rash still aotvof pain; still aotvof pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient got vaccinated for Shingles vaccine and still got shingles, but no rash and still a lot of pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Patient received dose 1 of Pfizer vaccine LOT ER8733 on 4/6/21 at 0955.  Patient had witnessed seizure at 0957. EMS called at 1000. Seizure lasted 15 seconds. Patient alert after seizure.  Appeared very pale. Advised patient mother that she needed to be seen at the ED for further evaluation.  1004 attempt made to call ED Lead but unable to reach.  1005 called House Supervisor to confirm correct number for ED Lead.  1007 EMS arrives. Pt mother declines transport to ED. EMS assists patient to car.  Patient and mother sat in car for long period of time prior to leaving lot. Further follow up documents there is no documentation of visit to ED.
Recipient states she "felt a hot sensation and pain in arm at injection that radiated through her whole immediately after the vaccine injection. She then described that her scalp started to itch  and she started to feel  dizzy and in a fog. She almost fell out of her chair. EMS called then her feet started itching and  progressed to her whole body.  Her breathing remained WNL.
fever of 104.9 4 hrs p/vax; high pitched cry; pt taken to ER had cxr, CBC done;
Swollen under the arm that shot was given. Swollen towards the chest, was more on chest than armpit but it was located on both. Small teeth chattering that could have indicated a fever but did not check for one. General soft tissue under my arm was swollen, not my lymph nodes. Lasted approximately a week or so.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced fever, malaise, headache and injection site pain. On an unknown date, the outcome of the fever, malaise, headache and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, malaise, headache and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The patient planned to follow-up with his physician on an unknown date.
After 1st covid vaccine I have a swollen lymph node under my right  arm. That is still there after getting my 2nd vaccine  in my left arm as Dr recommend using opposite arm. One week after 2nd vaccine I started to get palpation. After two days of this I went to er because my heart rate was in the 160s just walking around the house. I also experienced shortness of breath and chest pains. Er dr gave fluids, did ekg that showed tachycardia. They also ran labs and it showed my tsh levels were really high at 32 making me hypo which has not happened in years. My last labs were done just in July and they were great with my tsh being 1.67. I take my medicine daily first thing in the morning with no food or drinks besides water for several hours. I regularly fast till lunch. Now all of a sudden my levels are off the charts and my dr said she is blown away and has no idea why this is happening.  They have no clue if the vaccine causes this due to LACK OF STUDYING and you fools says it's safe. So this is a issue and needs to be looked into further because my Dr's have no clue why or what to do and that is very unsettling.
late for the second dose of Twnirx, first on March 31 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 31st March 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 31-Oct-2022 Reporter's comment: The pharmacist reported on 31st October 2022 that the patient was late for the second dose of Twnirx.  No adverse event was reported . The consent to follow up was granted.  The vaccine administration facility was the same as primary reporter. There was no lot number and expiration date provided. There was only the first dose which was administrated by the patient. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Twnirx, which led to incomplete course of vaccination.
Case called health department 12-12-22 after she had scheduled herself for covid bibalent dose on 12-13-22.She wanted to check with nurse regarding her previous experience back in November when she stated she got a case of shingles approx.2 weeks after receiving her Moderna booster in November.She stated it involved swelling of the right side of her face.So she was nervous about getting the bivalent.She states that this was a stressful time for her as she was having to do some holiday decorating at her church and that this is always stressful for her.She recovered from this but I told her she should check with her provider about getting another dose of Moderna.Case cancelled Moderna bivalent appt.subsequently.
Erythema to right arm.  Slight induration.  05/28/2003: Increased erythema to right arm with low induration 05/29/2003.
Case number PHEH2014US021304, is an initial spontaneous report from a pharmacist on 21 Oct 2014. This report refers to a 65 year old male patient. He received a FLUVIRIN (batch number: 146404) pre filled sryinge on 21 Oct 2014, after it reached an unknown temperature during a power outage for fours hours. Pharmacist mentioned that the documented temperature for the refrigerator was 40 degree F before the power outage and immediately after the power was restored. No adverse event was reported. No further information was provided.
This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On an unspecified date, in approximately 2013 (reported as "at 12 years of patient age"), the patient was vaccinated with the first dose of GARDASIL 9 injection (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On 24-MAY-2017, the patient at 16 year-old, would receive the second dose of GARDASIL 9 injection (dose, frequency, route, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
pt reported feeling dizzy after first dose so 2nd dose was administered while pt was laying down. After about 5 minutes pt reported feeling dizzy, was shaky and described difficulty focusing
Adverse event: Sudden hearing loss and tinnitus Treatment: 7 days of 60mg prednisone followed by 7 days of tapering the dose (orally) Hearing somewhat returned but tinnitus is constant
Developed lesions of various morphologies 3 days after vaccination on hands and arms after shingles vaccine. Some papule and vesicles. Pt started on Valtrex on 9/7/12 and continues to have new lesions each day.
burning sensation /I had burning in my hands; Hives; Stinging; they're a little swollen; tingling all over; I broke out in a rash at my neck; This is a spontaneous report from a contactable consumer who reported for herself, a 55-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in left arm on 10Mar2021 at 12:30 (at the age of 55 years old) as first dose, single dose for COVID-19 immunization. Medical history included allergic to penicillin. Concomitant medication included ibuprofen (ADVIL). On 10Mar2021 at 16:30, the patient experienced hives, stinging, burning sensation within 4 hours of the injection. She further stated that 4 hours after administration of vaccine, she broke out in a rash at her neck and was tingling all over. She had burning in her hands and they're a little swollen. Urgent care put her on BENADRYL and prednisone twice and she doesn't know what to do because it's 'burny'. She was still feeling the tingling. The patient did not have COVID prior vaccination, and was not COVID tested post vaccination. The outcome of the events rash and swelling of hands was unknown, while the outcome of the remaining events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received Moderna as 1st dose of COVID vaccine on 03-09-2021.  Pt. then was scheduled for 2nd dose Pfizer vaccine and was administered Pfizer vaccine on 04/13/2021.
The following day I had the aches associated with the shot. The following day it was better but on Wednesday I woke with a sore throat and a tightness in my chest. I went to a walk-in clinic for assessment but referred me to the ER. They gave me a shot to reduce any inflammation around my heart.
Right thigh at site of injection is red and diffusely so.  Mildly warm to touch.
received expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult patient who received HAV (Havrix adult) (batch number B4JL4, expiry date 21st February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th March 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 16th March 2022, unknown after receiving Havrix adult 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 details were provided as follows: The reporter did not had demographic details from patient. Registered pharmacist reported that an adult patient received an expired dose of Havrix, which led to expired vaccine used. The reporter also reported that it was an adult dose. The reporter accidentally forgot to ask for follow-up. The reporter did not consent to follow-up.
PPV Vaccine administered at 11:00am 11/17/03 11/18/03 - redness & swelling near and above elbow 11/19/03 - swelling increases, elbow pain, rash across back, shoulders and chest. Antibiotic & antihistamine administered 11/20/03 - swelling and pain diminished some, antibiotic discontinued 11/21/03 - swelling and pain continue to decrease, rash still present.
DAY 9  after shot - SYMPTOMS REAPPEARED!  Mild but concerning as to why symptoms returned 9 days later!? Slept for additional 4 hours today - still very tired with feeling of not well Fever/ chills - sorry I can not find my thermometer  Feeling of internal irritating shake - I feel this same way when I get my periods well Headache - I am not a headache person so when I have one something is wrong Upset stomach  Day 2 & 3 symptoms  were expected( All mild) fever, chills,  headache, stomach ache ( day 3), tired I also noticed by the time I walked out of the rite aid, I had head fog. I definitely did not walk in with head fog.
approximately 30 minutes after adminstration of seasonal flu vaccine increasingly severe radiating pain in deltoid to neck and ear began, facial flushing, swelling of both orbits.Went to onsite emergency dept. and was treated with IV benadryl, solumedrol, and tagament.
Severe pain and swelling at site of shot, headache, low grade fever, SEVERE aches in WHOLE body.....all for 3 days which I spent in bed unable to care for myself. Slept a lot. On 3rd day rash all over my torso and arms....Today feeling almost back to normal.....rash going but itching where it was. I had a similar reaction to the 1st shot, but not as severe...did not put me in bed. The 2nd was VERY unpleasant.....but hopefully I may now avoid Shingles. Thank you
This spontaneous report was received from a physician regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 04-DEC-2015 the patient was vaccinated with expired GARDASIL injection 120 Y lot # H021861, expiration date 09-OCT-2015. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Additional information has been requested.
None. Pt. had vaccine MCV-4 administered on 1-5-11 at another facility according to vaccine record.
Left arm feels numb about 3 days after the 3rd dose of HPV and last for a night before the symptom resolved. No medication or treatment involved.  Strong vertigo and nausea when head laying flat or when standing up and walking around. Symptoms are similar to BPPV but not confirmed. Symptoms started about 4-5 days after the 3rd dose of HPV and continued for 2-3 days before the symptoms resolved. No medication or treatment involved.
Patient was given what we thought was her first dose of the vaccine. Patient denied having received any other dose of vaccine. SDIR records list the same patient as having received a dose prior to this on 02/05/2021.
Pt. refers to feeling palpitations. Cold skin to the touch. Oriented in time, place and person. They were considered vital: P: 98, B/P:160/90, R:17, DEXTR. 94 Mother of patient refers pt. suffers from Anxiety. Consultation with Dr. who suggested 30 minutes in observation. Relaxation breaths were practiced. Pt. was re-evaluated with P: 92, B/P: 120/80 R: 18 DEXTR. 96, he says, recovered and left in good condition.
Narrative: COVID infection following COVID vaccine series 12/29/2020, Pfizer, dose #1 01/19/2021, Pfizer, dose #2 10/08/2021, Pfizer, dose #3 08/18 pt cc: cough, fatigue, loss of taste or smell, exposure: unknown 09/16 COVID swab, result: detected 09/17 clinically resolved
I was very sick to my stomach, I had  severe stomach pain. I started throwing up and was dry heaving, when I got to the hospital I found out I had C diff, a UTI, and the hospital admitted me I spent 3 weeks in the hospital. I was in 2 separate hospitals for a total of 7 weeks. I had serious complications, I went into A fib with my heart, I got neuropathy from my chest down I was numb all over. I had severe UTIs, they kept putting catheters in me. I was so sick I couldn't eat and I lost 35lbs. I thought I was going to die.
vaccines that are administered but have been deemed not suitable for use. the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM / No AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA267341, 2019SA267342, 2019SA267336, 2019SA267345 and 2019SA267346 same reporter.  This case involves female patient who received 0.5mL dose of vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ223AA, expiry-30-06-2020) via intramuscular route in the left deltoid.  It was a case of actual medication error due to incorrect product storage. Caller is saying the vaccines were on the truck on Thursday but didn't arrive to them until around 11 AM but they did not hear until late in the day not to use them stating they received a message around 4:20 PM. Caller states as soon as they arrived she started giving injections and feels they should have been told earlier in the day that the vaccines shouldn't have been given.  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 holder's 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.
It was a feeling of paralyzed type of thing/lip was drooping-eyelid; Feeling that went up to my neck, head, cheek, forehead around my eye; Feeling that went up to my neck; Right face looked funny; Whole right side did not look correct; Blood pressure has gone up\blood pressure was 215 over 90-something; Her right eyelid drooped; A spontaneous report  was received from a consumer concerning a 71 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a feeling that  went back her head, cheek, forehead around her eye/ facial discomfort, feeling that went up to her neck/ musculoskeletal discomfort,  It was a feeling of paralyzed type of thing/ facial paralysis, her right face looked funny/ feeling abnormal, lip was drooping/facial paralysis, right eyelid drooped/ eyelid irritation, whole right side did not look correct/ hemiplegia, her blood pressure had gone up/ Hypertension.  The patient's medical history as provided by the reporter included hypertension. Concomitant medications reported included atenolol,chlortalidone.  On 28 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 012A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021, the patient experienced a feeling that went up her neck, head, cheek, forehead around her eye. It was a feeling of paralyzed type of thing. Her right face looked funny, lip was drooping, eyelids, whole right side did not look correct. The patient's blood pressure was 215.   Treatment information provided included doctor gave her a little bit more unspecified medication.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, a feeling that  went back her neck, head, cheek, forehead around her eye, It was a    feeling of paralyzed type of thing, her right face looked funny, lip was drooping, right eyelid drooped were resolved. The outcome of events, whole right side did not look correct, her blood pressure had gone up were unknown.  Follow-up received on 17 Mar 2021, outcome of events updated.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded. However, patient is hypertensive and the blood pressure recording was 215. which also stands as a confounder and alternative etiology
gastrointestinal issues started in end of June 2021 Abdominal pain started in Oct 2021 Diagnosed with UTI in end of October, had PSA  then referred to Urologist Other symptoms started in late October early November, including dizziness, brain fog, memory issue, head/ear pressure, random tingling over my body, eye focusing problem. Had the symptoms for more than 4 months, now I still have brain fog , memory issue, and head pressure. Also, my high PSA is likely to be cancerous based on MRI but I'm scheduled for biopsy in 3 weeks, I should mention that I was pretty healthy (no overweight or something) and there is no one with prostate issue in my whole family.
2 DAYS OF FUSSYNESS, IRRITABILITY, CRYING, AND LOW GRADE FEVER. STARTED 2-3HR AFTER ADMINISTRATION OF VACCINES.
Redness, swelling, pain at injection site and down arm. Patient treated with ice and Ibuprofen.
Tender at touch, (L) arm hot painful 10/10, not cellulitis, allergic reaction per MD.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  The vaccine was stored in freezer and taken out one or two vials and placed in fridge each day as needed.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 56-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 22nd March 2018, the patient received SHINGRIX .5 ml. On 23rd March 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain. In March 2018, the outcome of the muscle pain was recovered/resolved. The reporter considered the muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The registered pharmacist reported that this patient said she always gets muscle aches after a vaccination. The registered pharmacist reported this to VAERS. This case is 1 of 4 cases reported by same reporter.
increased heart rate, hospitalized, received medications to lower heart rate then cardio version to stabilize heart
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown ages and gender. No information regarding the patients medical history was provided. There was a possibility that the patients were administered with improperly stored VARIVAX (Merck) vial dry SD vaccine. Lot number was reported as J000153 (validation pending) with expiry date of 07-JAN-2015. No concomitant medication was reported. No adverse effects were reported. No outcome was reported. Additional information has been requested.