chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected Vaccination failure; shinghles on left side and back; 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, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient got Shingles shot first and following year patient had gotten the shingles on left side and back. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, exact time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report as received from a healthcare worker via a company representative refers to a 13 year old female patient. The patient's concurrent condition, medical history and drug reaction/allergies were not reported. On an unknown date in October 2015 the patient was vaccinated with GARDASIL 9 (first dose of 0.05 ml, once, route of administration not specified). On an unknown date October 2015 the patient felt lightheaded, had fluttering eyes and felt numbness and tingling [location unknown] "immediately after receiving her first dose of GARDASIL 9. Two weeks later on an unknown date in October 2015 approximately the patient returned to the physician's office with anaphylaxis which included "swollen lips". The reporter stated that the patient will not be receiving any additional GARDASIL 9 series of injections due to her side effects. The patient visited the physician to seek medical attention. She was given an unspecified treatment for the adverse events. It was unspecified by the reporter if any lab diagnostics were performed. The outcome of the adverse events lightheaded, had fluttering eyes, felt numbness, tingling, anaphylaxis, swollen lips was not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Fever Fever & Chills & Body ache. Narrative: Employee got vaccinated with the second dose of Moderna yesterday, then today, complains of chills & the following temp checks around the same time using different devices: temporal 98.5, tympanic 100.5, 101.3. oral 99.5. tympanic 101.9. EE took Tylenol 1g Last night for body ache.
after receiving vaccine patient immediately felt warm, dizzy and started dry heaving. we dosed Zofran 4mg, gave one dose epi-pen, and 50mg Benadryl. patient still complained of chest pain and was dry heaving. she was then transported by ems to the hospital at 4pm.
Baby began to suffer of acid reflux, he would shake, throw up through nose. On 02/24/05- was crying more than usual, couldn't move legs at the hospital they discovered that the baby had broken leg and ribs were fractured. State took baby from mother. Will send medical records as follow up.
I'm having weakness in my arm and I can only have a little range of motion in it and it is very sore all the time and I can't lay on it in bed.
NO ADVERSE EVENTS REPORTED, adult dose of Hep A and Hep B was administered to 16 year old female.
Headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in right arm on 13Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included varenicline tartrate (CHANTIX), duloxetine hydrochloride (CYMBALTA), linaclotide (LINZESS), famotidine (PEPCID) and bupropion hydrochloride (WELLBUTRIN). The patient was not pregnant at time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced headache and fatigue on 13Jan2021 12:00. The outcome of the events was recovered on unspecified date. No treatment was given to the patient for the events.  No follow-up attempts are possible. No further information is expected.
Patient in clinic for doctors visit on 10/26/21 and received Pfizer COVID booster shot.  Patient lives in assisted living facility.  When patient returned to the facility they contacted the clinic and let them know the patient had previously received the booster shot on 10/6/21.  No harm to patient, but she did receive 2 booster shots within 20 days of each other.  The immunization documentation at the clinic did not include the vaccination from 10/6/21.
Minimal redness around injection site < 2 mm with minimal induration on right thigh. Also has congestion & redness on pharynx (+) for strep placed on OMNICEF for strep pharyngitis.
Patient tested positive for COVID-19 after completing full vaccination series.; Patient tested positive for COVID-19 after completing full vaccination series.; This is a spontaneous report from a non-contactable other hcp. A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/lot number: EN5318) via an unspecified route of administration on 29Jan2021 (age at vaccination 53-years-old) as single dose, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN5318) via an unspecified route of administration on 19Feb2021 (age at vaccination 53years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 26Aug2021, the patient experienced patient tested positive for covid-19 after completing full vaccination series. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Aug2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on information in the case, a possible causal association between the event Covid 19 and the suspect drug BNT162B2 cannot be excluded.
Within 10 minutes felt a rush of heat down right arm and  tingling in fingers. Then I felt it in the left arm, however the left arm stopped tingling within 24 hours, but my right arm still has the tingling , feels bloated in my hand and my arm feels restless.
Patient reported chest pain. Was taken to PCP, for evaluation. EKG negative. Then tested positive for COVID the following day.  Also reported unusual back pain shortly after vaccine. Has scoliosis.
Fever,dizziness, headache,nausea all occurred the day after the vaccine. was given.  rash below injection site also occurred
Patient has hard lump on arm. It is hot and sore. Complains of fever.
Post vax, within 2 hours, pt started to have tenderness at site. She applied heat to arm and by 6/18/01, arm at site, was swollen to baseball size, red, warm and complaining of tingling and numbness to arm. Instructed to see doctor. Pt has no temperature.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032LZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Oct-2020 and the estimated date of delivery was 08-Jul-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  On 22-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Fully vaccinated with J&J, not boosted.   Symptomatic COVID infection with admit to an inpatient medical unit.
Complained of 2" diameter to Lf deltoid. Swollen. Painful to touch, hot. Cellulitic. Given Ibuprofen. *F/UP on 4/1/03: Hot, red, erythematous*
Started having  skipped heart beats & high resting heart rate April of 2023. Have been to several physicians and was diagnosed with PVCs/PACs. Resting heart rates of 110-140. Extreme fatigue and exhaustion, working as a registered nurse . Never had issues before, had an echocardiogram years ago that was normal.Now seeing cardiologist for further investigation. Also on 9/28/23 diagnosed with pityriadis rosea.
Itchy, raised rash at injection site that occurred 7 days after vaccine received. Took 25 mg of Benadryl, applied OTC cortisone cream to area, took 1000mg acteaminophen, took 1 low dose aspirin.  Became less itchy for about 5 hours then became itchy again. Rash still at site, had not spread. Took 25 mg Benadryl, applied OTC cortisone cream to area.
Slight swelling up near neck area that has lasted approximately six hours has now seem to gone away also have small red dots on both hands and halfway up both arms and small area in the middle of upper part of chest not itching doesn?t seem to be spreading since this morning but also has not gone away took Benadryl at 730 this morning also at approximately 1 PM but does not seem to be helping will continue to monitor sure it does not spread cause other problems
One after after receiving dose patient noted change in voice, SOB.  Was home at onset EMS notified seen at local ED for monitoring.
Rash on chest and arms the first night along with flu like aches and pains. The next day more aches and pains but then my right eye started swelling and I broke out in hives all over. By the 3rd day my eye was swelled shut and more hives. On day 4 more hives and facial swelling. Doctor gave prescription for Prednizone. Day 5 still have eye and facial swelling alone with more hives all over body including eye and mouth.
Suspected Arthus reaction following tetanus booster- See clinical summary. Clinical summary 02/11/03 "I had a bad reaction after my last tetanus shot" 52-year-old ADPHS WF referred to the healthcare center by doctor for evaluation of an adverse reaction following tetanus vaccine in. Immunization-Tetanus (left arm), 8/1986 (per Employee Health note dated 4/30/87), Symptoms: Local: Within 15 minutes after receipt of vaccine, noted left arm pain and swelling from her left shoulder to her hand. Unable to make a fist. Vaccine was given in the ER and reported these symptoms to the staff. They had to cut off her shirt, and she was given and IM injection and a pill, but unable to recall specific details of treatment. Remained in ER until cleared to drive home several hours later. Recalls sleeping the remainder of the day. (Medical records from ER visit not available.) Swelling of left arm gradually decreased over the next 2 weeks. After 2 weeks off from work, all symptoms had completely resolved. No sequalae. Systemic: Does not recall experiencing fever, chills, myalgias, headaches, fatigue, rashes or wheezing/respiratory symptoms.
13 mos baby developed fever 101-106 degrees rectal 3 days after PREVNAR, lasted for 5 days. Patient had decreased appetite and irritability, hospitalized 7/20/10 x 24 hours for observation and tests.
Pt received Moderna vaccine on BAFB on 05/04/2021, then proceeded to go off base to receive two doses of Pfizer on 07/24/2021 and 08/15/2021.  Pt stated he did not have any adverse events from vaccines.
Pt presented to clininc complaining of redness at injection site.  3" reddened area at site, oval shape.  Reports that the site is very itchy.  States that the redenss was there the next am after receieving the injection.  Believes it is improving, but wanted us to see it.
Fever the first night resolved. Now redness, warmth and swelling to left upper around around the vaccine site consistent with cellulitis. Physical exam 1/7/23 and started on antibiotics.
Arthralgia & Rash  Narrative:  Employee has been experiencing lethargy since dose #1 and now,  since dose #2, has been having severe pain and inability to walk at times, along  with swollen lymph nodes and rash at injection site. She went to ED today and  unsure of treatment or admission yet.   Other Relevant History:
1/2 hr p/vax onset of high pitched, inconsolable crying x 3 hrs w/fever of 101-APAP given; napped x  1/2 hr & awoke screaming x 2 hrs & intermitt until bedtime;
Initial muscle soreness in upper left arm for a few days. A week later muscle and joint soreness/weakness and  pain in both arms and elbows. Pain has continued for months and has moved into muscles of both shoulders and joints of fingers. Controlling  pain with daily ibuprofen (which apparently has led to high blood pressure.)
Pt reported waking up the next morning with hives starting on her stomach, and then spreading to side, arms and then all over. Pt states no other issue, but that also  she has had all Pfizer COVID vaccines and never had a reaction.
approx 2hr p/vax became feverish & was less alert & playful-cry was more stressful & high pitched;@ 930PM was given APAP & responses improved & mom got to eat;would not take food till then;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-MAR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 168,32 and R; 816, 34 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a 70-year-old female patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st August 2018, 2 days after receiving SHINGRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The health care professional reported that a patient developed a red rash on their left arm between the injection site and the patient's elbow 2 days after receiving SHINGRIX. The healthcare professional stated that unsure of red rash had resolved at this time of not but as of now 9 by 2 rash was still there. The healthcare professional told the patient to call her if the rash got worse, stated that she had not heard from the patient. The healthcare professional reported a second patient with a different rash at the same time. This case has been linked with US2018161575, reported by the same reporter.
About 10 hours after shot I started having the chills.  I spiked a fever and developed body aches and shaking .  I developed a headache and nasal congestion. Followed by nausea and felt delusional. I took an advil at 1:30 am  and my symptoms subsided and I was able to go to sleep.   I took another Advil in the morning I think around 7 .  As of this writing @ 2 pm, I have low grade body aches , headache and feel like I have a cold.   I will take another Advil in an hour or two and expect to feel better by tomorrow.
Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: diagnosed with COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient wanted to confirm for his 2nd booster dose after completing the Paxlovid treatment. He was told to wait 90 days after being diagnosed with COVID. He was travelling therefore wants to be protected.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300176517 Same patient, different event/drug;
30 mins post injection dizziness - given water & reassurance, sm. bag of graham crackers c/o nausea after eating, some (L) arm tingling/numbness 3:01 pm BP 125/81, 92, 99% O2  3:23 pm BP 134/85, 68, 99% O2 Resolved numbness/tingling. Dizziness improved, able to stand
We administered a vaccine that had been improperly stored (kept in refrigerator after beyond use date.)
The shot is all red, swollen and itching; Bruising on the arm; Left arm was bigger than the right arm; Arm still swollen; Arm itches; Arm hard to the touch; Arm warm to the touch; Redness at the injection site; Arm swollen; Arm red; Arm hurting; The arm hurt immediately after receiving the vaccine; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PAIN IN EXTREMITY (Arm hurting), PAIN (The arm hurt immediately after receiving the vaccine) and PAIN IN EXTREMITY (Arm soreness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Penicillin allergy, Allergy to insect sting and Allergy to antibiotic (Ibuprofen antibiotic.).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PAIN IN EXTREMITY (Arm hurting), PAIN (The arm hurt immediately after receiving the vaccine), PAIN IN EXTREMITY (Arm soreness), CONTUSION (Bruising on the arm), LIMB DISCOMFORT (Left arm was bigger than the right arm), PERIPHERAL SWELLING (Arm still swollen), PRURITUS (Arm itches), LIMB DISCOMFORT (Arm hard to the touch), FEELING HOT (Arm warm to the touch) and INJECTION SITE ERYTHEMA (Redness at the injection site). On 26-Feb-2021, the patient experienced VACCINATION SITE REACTION (The shot is all red, swollen and itching). At the time of the report, PERIPHERAL SWELLING (Arm swollen), ERYTHEMA (Arm red), PAIN IN EXTREMITY (Arm hurting), PAIN (The arm hurt immediately after receiving the vaccine), PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE REACTION (The shot is all red, swollen and itching), CONTUSION (Bruising on the arm), LIMB DISCOMFORT (Left arm was bigger than the right arm), PERIPHERAL SWELLING (Arm still swollen), PRURITUS (Arm itches), LIMB DISCOMFORT (Arm hard to the touch), FEELING HOT (Arm warm to the touch) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other medications include asthma inhaler. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up was received on 26-MAY-2021. Reporter's contact information including address and email was updated. It contains non significant information.
Information has been received from a pharmacist concerning a 71 year old white female with no relevant medical history reported who at 06:10 on 28-APR-2005 was vaccinated subcutaneously in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient had pneumonia at the time of vaccination. At 12:00 on 28-APR-2005, the patient developed redness, warmth and swelling at the injection site. Subsequently, the patient recovered. The reporter felt that the patient's injection site redness, warmth, and swelling were other medical events (OMIC). No further information is available.
Client recieved a flu shot at 1045 on 120308 with Sanofi Pasteur vaccine Lot number U2760AA IM in the right deltoid by a nursing student.  1415 The client returned to the flu clinic compaining of shortmess of breath and spongie legs---felt like her legs wouldn't hold her up.  Client appears pale.  Skin is warm and dry to touch.  Blood pressure is 130/80, Pulse 65 BPM, lung sounds are non congested, no wheezing or rales.  Good S1 and S2 sounds.   Denies any tightnesss or feeling of the throat swelling shut.  1422 Administered 4 liters of O2----color returned to pink.  Client indicates Dr at the clinic is her Dr.  RN called the clinic and Dr is out of the office until 010609 and advised RN to call the ER and talk to Dr.  1425 RN clled the hospital ER and spoke to RN and PA called RN back.  PA felt this client had a reaction to the flu shot and indicated some of the shortness of breath could be anxiety and wanted client to wait 30 minutes at the flu shot clinic and to have 50 mg of Benadryl IM if client wanted the Benadryl.  Client refused to have her husband or family called and requested her co worker and boss to take her home.  Benadryl 50 mg/ml given IM in the left deltoid at 1452.  O2 discontinued and client tolerated this well and denied shortness of breath, but was feeling a little sleepy.   At 1515 client was walked down to first floor per elevator with assistence of RN and her bosss.  Client indicated she was sleepy and slightly dizzy.  Client was driven home by one of her co workers.  120408 1330 Telephone call to the client's work---she is home today.   Called client at home and she indicated she slept all of yesterday afternoon and all night.  Today she feels tired, weak, and feels like she has a fever (hasn't taken temperature).  Denies any shortness of breath but does feel letharic.  RN advised client to go to clinic or ER if she has any future problms and another RN will chck on her on 120808.