chrisvoncsefalvay/vaers-outcomes huggingface dataset:
~11;30 Patient was given Dtap, IPV, in her left deltoid and MMR (SQ) in right deltoid by nurse. After the shots the patient complained of "burning" at the injection site.  The nurse noted some redness and rash around the site. 11:35 The nurse notified the doctor who examined the patient who at that point was audibly wheezing, the injection sites were red, and swollen and she had several hives on her body.  MD order a albuterol nebulizer,and  Benadryl Liquid 25mg.  Patient was closely monitored.   ~11:50 Wheezing resolved, redness at sites still present and 1-2 new hives noted on abdomen. 13:00 Patient sent home with instructions to give Benadryl every 6 hours and call if symptoms return or worsen. No wheezing noted when sent home, redness still at injection sites. Patient does have a history of previous reaction to unknow substance several days prior but no history of problems with immunizations. Patient also had nasal congested with cough prior to immunization. No fever noted or reported at home.   Patient also has a history of asthma.
Client received immunizations.  DTaP was noted to be expired after administration.  VFC, CDC, MD, supervisor notified of event, pending CDC return instructions for re-vaccination.  CDC recommendations received one month later, follow up being completed currently.  Child to be scheduled for re-vaccination, with parent notification.  No adverse event reported back to clinic r/t child receiving expired vaccine.  Reporting as per VFC guidelines for administration of expired vaccine.
Pt described extreme itchiness in a band under the injection site. She said it was so itchy that not even steroid creams worked on it. It was red and warm to the touch.
Arm still hurts to lift at times pain from shot site. Also hurts to lay on that arm
PVC?s after first vaccine in 12/2020, none after 2nd or 3rd but 3 days after 4th dose started having frequent PVC?s and became symptomatic with chest pressure, dizziness, near syncope and shortness of breath. Was admitted to the hospital for 4 days with VTach and am now on beta blockers. MD?s were unsure if it was related to the vaccine or not
5 days after injection patient's arm became red, hot to touch, swollen and itching - not painful. Taking ALLEGRA and putting cold compress on it.
Pt started with fine rash 24-48 hours after vaccine, severe itching. Saw her own doctor-given BENADRYL, rash cont 5-6 days, increased to legs, arms, trunk. Itching cont. Will not get vaccine next year. Had similar reaction last yr (not reported) (not as severe).
Patient received PREVNAR 13 and PNEUMOVAX 23 the same day, instead of PREVNAR 13 now followed by PNEUMOVAX 23 1 year later. This caused a sore arm but no other reaction.
Pt recvd pneumococcal vax & 2 days p/vax pt developed a red raised, hard area on the arm @ @ inject site; No further details were provided;
Patient presented to walk up vaccination tent on 6/5/2021 complaining of her injection site being painful since 4/5/2021 when she received her second dose. Her deltoid on the right arm is very firm compared to surrounding skin and mildly tender to palpation. Her shoulder is very tender with movement. The area had no drainage, redness or warmth to suggest infection. She was referred to her PCP.
Covid rash, red, raised bumps  Started on neckline, moved to right side chest, right wrist, right hand then upper right arm.  Worse today - only right side
Flublok  was given to pt, It is recommended for 18 years and older. Pt is 10 years old. No symptoms at this time. Mother aware to watch for s/s of adverse reactions.
Case number PHEH2014US025137, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 78-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 20 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Arthralgia, Fever, Rash, ErythemaMultiform, NauseaVomiting, fatigue, chills, enlarged lymph nodes , injection site pain Narrative:
Caller stated that a male 23 month old patient was supposed to receive ACTHIB but only received the diluent with no adverse event; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case from Nurse.  This case involves a 23 months old male patient who received 0.5 ml once dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (batch number: U6849AA, expiry date: 22-JAN-2022) via an intramuscular route in right thigh (product preparation error) on 11-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment and family history were not provided.  Concomitant medication included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Immunization.  Caller stated that the 23 months old male was supposed to receive ACTHIB but only received the diluent with no adverse event.  It was an actual medication error case due to product preparation error (latency : same day).  No laboratory test was reported.  At the time of reporting, 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.
Large welt formed (covered most of upper arm), had heat to it, small knot. Patient took Benadryl per pharmacist recommendation. Welt and knot had resolved within 5 days.
On 07/13/2022 I was feeling really hot and felt as if I couldn't catch my breath and lightheaded. I was getting a high heart rate the next day when I reached out to my doctor. I was prescribed lisinopril. Around 09/2022 I went to the hospital because I started feeling lightheaded at work with elevated heart rate. I was diagnosed with AFIB.
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 06-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
I contracted COVID-19 on 06/14/2022 with symptoms of sore throat, headache, nasal congestion, hoarseness, and extreme fatigue. I was prescribed Paxlovid on 06/15/2022 via a virtual visit. I was ill for 8 days before my symptoms began to resolve. I am fully recovered now with no lingering symptoms.
This spontaneous report as received from a licensed practitioner nurse regarding 2 patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VARIVAX lot # L021215/expiration date- 10-JUN-2017. No adverse event was reported. No concomitant medication was reported. Excursion temperature was 10.5 F and timeframe was 4 hours and 45 minutes. There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC(product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
first Shingrix vaccine "over a year ago" / not had the second dose; rigors/uncontrollable shaking; fever; rigors / uncontrollable shaking / chills; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml and the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tremor, fever, chills and incomplete course of vaccination. On an unknown date, the outcome of the tremor, fever and chills were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the tremor, fever and chills to be related to Shingrix.  Additional details were provided as follow: This case was reported by patient herself. The age at vaccination was not reported. Over a year ago, the patient received 1st dose of Shingrix in unknown deltoid and after 12 hours the patient developed rigors/uncontrollable shaking, fever and chills, which lasted for 24 hours. The patient was not sure if she should take 2nd dose and till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient was referred to her healthcare professional and spoke from PI (package insert) on adverse events, offered copy. The reporter declined to provide healthcare professional information. The reporter did not consent to follow up.
fatigue, arm pain, dizziness.  Patient is at home resting.  Took 500mg tylenol.
No known adverse effects; 19 years old patient received a pediatric dose of VAQTA; This spontaneous report was received from a medical assistant and refers to a 19-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 21-JAN-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # S023499, expiration date 24-AUG-2020 (route of administration was not reported), for prophylaxis. The patient received pediatric dose of hepatitis a vaccine, inactivated (VAQTA). No known adverse effects reported. The outcome of the event was unknown.
Vaccine was given at wrong time interval, approximately 2 weeks early. First dose 3/30/2021. Second dose 4/22/2021.  Patient will be notified of this error.
About 3 minutes after the shot I was standing in the checkout line at the pharmacy and started to feel agitated. After about a minute I began to feel flushed, then nauseous, then very sweaty. I started to black out and had to sit on the floor. After 10 seconds or so my vision came back and I stood back up, but a few seconds later almost blacked out again and had to sit on the floor very quickly. I left my items and went outside, thinking fresh air might help. I made it to my car, about 15' away, opened the back door and sat on the back seat, and then almost immediately fainted. When I came to the car door was still open and somewhere between 1-10 minutes had passed. I still felt sweaty and dizzy and also very emotional, and cried for a few minutes. Then I realized I was shivering (it was winter and I didn't have a coat on), so I closed the car door. It took about 30 minutes before I felt well enough to drive safely home. I didn't faint again but over the next 18 hours or so I frequently felt dizzy and lightheaded and had to sit down.
Patient received primary vaccination 14 MARCH 2015 and 9 days later, he noticed disseminated small pustules/ macules on an erythematous base to trunk, arms and legs. Pt denies fever, chills, nausea or vomiting. Describes initially 6-7/10 headache yesterday and today, about a 3/10 rating. No cough, chest pain or shortness of breath. Vaccination site is clean and healing well; no necrosis or satellite lesions.
Redness about 1 inch from the injection site; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 2nd August 2019 and experienced injection site pain,refer case US2019187941).   On 14th October 2019, the patient received the 2nd dose of Shingrix. On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th October 2019, the patient experienced injection site erythema. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The patient received Shingrix on left arm. On the same day after receiving Shingrix, the patient experienced injection site pain. On the day of reporting, the patient noticed redness about 1 inch from the injection site with diameter of about 3-4 inches. The reporter consented to follow up. This case is 1 of the 4 cases reported by the same reporter.
Pain in his left hand and left arm that has not gone away; Second dose taken after 39 days of first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in his left hand and left arm that has not gone away) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken after 39 days of first dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his left hand and left arm that has not gone away) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken after 39 days of first dose). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken after 39 days of first dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in his left hand and left arm that has not gone away) had not resolved. Not Provided          Concomitant product use included pills for sugar. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-May-2021 has no new information.
Pt. states that she had soreness in her muscle where her flu shot was administered since the date she receive the vaccine.
I can't get my hearing back; There's a continuous loud ringing in both ears; Got an upset stomach; My hearing started getting weak, like turning volume down, then it started ringing; Muscle weakness; I slept for over 30hrs straight; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (My hearing started getting weak, like turning volume down, then it started ringing), MUSCULAR WEAKNESS (Muscle weakness), HYPERSOMNIA (I slept for over 30hrs straight), ABDOMINAL DISCOMFORT (Got an upset stomach) and HYPOACUSIS (I can't get my hearing back) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Allergy: Penicillin), Allergy to chemicals (Allergy: Sodium pentothal), Blood pressure and Hemochromatosis. Concomitant products included CARVEDILOL and LOSARTAN for Blood pressure, SIMVASTATIN for Cholesterol, METFORMIN for Diabetes, DOXAZOSIN for Prostate infection.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness). 30-Mar-2021, the patient experienced HYPERSOMNIA (I slept for over 30hrs straight) and PYREXIA (Fever). On 30-Mar-2021 at 2:00 PM, the patient experienced HYPOACUSIS (My hearing started getting weak, like turning volume down, then it started ringing). On 31-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Got an upset stomach). On 19-Apr-2021, the patient experienced HYPOACUSIS (I can't get my hearing back) and TINNITUS (There's a continuous loud ringing in both ears). At the time of the report, HYPOACUSIS (My hearing started getting weak, like turning volume down, then it started ringing), HYPOACUSIS (I can't get my hearing back) and TINNITUS (There's a continuous loud ringing in both ears) had not resolved and MUSCULAR WEAKNESS (Muscle weakness), HYPERSOMNIA (I slept for over 30hrs straight), ABDOMINAL DISCOMFORT (Got an upset stomach) and PYREXIA (Fever) outcome was unknown.            Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-079991 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up was received on 22-Jun-2021. Patient details like height, weight, race, ethnicity were updated. Patient's allergic and current conditions were updated. Concomitant medication details were updated. Events outcome was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079991:
Red warm tender macular firm area developed around the innocuation site.  No fever or systemic symptoms.
Throat became very sore and staff member left work abruptly and went to an urgent care clinic. She had a negative strep test and a negative covid test. She also complained her right eye was twitching. Symptoms subsided in approx. 48 hours.
fever, chills, temp of 6 hrs p/vax; 24 hrs later, large area of erythema w/central induration from site inferior to deltoid; indurated 6 cm, few tender rt axillary nodes;
First event - Rash on chest and torso 2 days after vaccination (3-10-21). Slight itchiness. Went away after about 2 days.  Second event - rash on beck and arms, aching in bones 2 weeks after vaccination (3-22-21). Went away after a few hours.
A constant buzzing in my ears. I did not recognize it at first as Tinnitus until I realized it wasn't stopping and started interfering with my ability to fall asleep. My former doctor tried Meclizine HCL after my second dose but it had no effect.
Pregnant (patient wants to sign up for pregnancy registry); This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (patient wants to sign up for pregnancy registry)) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Penicillin allergy.   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) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 06-Aug-2020 and the estimated date of delivery was 18-May-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (patient wants to sign up for pregnancy registry)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (patient wants to sign up for pregnancy registry)) had resolved. Not Provided          Estimated date of conception was on 22-Aug-2020 and number of fetus was one. Patient wanted to sign up for pregnancy registry.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
The Moderna bivalent booster was identified by the health department as nonviable due to a refrigerator excursion.
I have had Tinnitus my entire life, I have learned how to live with it by tuning it out and keeping noise always in the background.  Day 3 after the shot my Tinnitus shot to a level that I have never experienced before, I cannot tune it out, it is deafening and will NOT stop or subdue.   I absolutely did not have the 2nd dose, I was afraid of the Tinnitus getting even worse, reducing my quality of life even further.  I would rather battle Covid, at least the suffering would end - this is never ending! I cannot get a full nights sleep, it wakes me up! I am in tears writing this. Who will help me and the others suffering this adverse reaction when the government and certainly not the drug makers acknowledge it as a side affect. I pray for relief from this nightmare of trying to do the right thing  by getting  vaccinated.  I have no underlying medical conditions am healthy, take no prescribed medications.
Body aches and sweats, headache, joint aches, muscle pain in the neck, fatigue and vomiting (once) .  My temp was up to 102.  Last about 24 hours.
Hospitalized 11/19/2021; COVID-19 positive 11/16/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: PA-C  Admission Date: 11/19/2021 Discharge Date: 11/21/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia of right middle lobe due to infectious organism  COVID-19    HOSPITAL COURSE:  Patient is a 51 y.o. female who presented to hospital today with a 6 day history of congestion, cough with occasional sputum production and decreased appetite, fever, weakness. The patient is vaccinated against COVID-19 with the J&J vaccine. She was admitted to the hospital with COVID-19 viral pneumonia with hypoxia, onset of symptoms 11/13/202, date of confirmation test 11/16/2021. While hospitalized she received 3 days of remdesivir and decadron. Will discharge home with an additional 7 days of oral decadron. She required up to 2L NC but has since been weaned to room air. Recommend post-hospitalization follow-up with PCP in 1-week.
Felt like he was going to die; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Felt like he was going to die) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart failure and AFib.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like he was going to die). At the time of the report, FEELING ABNORMAL (Felt like he was going to die) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The treatment information was not provided.