chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ER said is either shingles/possible shingles; Facial rash; Hive at the end of her right eye; possible poison ivy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix (intramuscular). In June 2021, less than 3 months after receiving Shingrix, the patient experienced shingles, rash, hives and poison ivy rash. On an unknown date, the outcome of the shingles and poison ivy rash were unknown and the outcome of the rash and hives were not recovered/not resolved.   It was unknown if the reporter considered the shingles, rash, hives and poison ivy rash to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received 1st dose of Shingrix 10 weeks ago from the date of reporting. The patient asked was this a live virus vaccine, could the patient get shingles from it. The patient recently broke out in a rash on the right side of her face and had a hive at the end of her right eye.  The patient went to urgent care and was diagnosed with, shingles or poison ivy, one healthcare professional stated it might be shingles and another healthcare professional said it might be poison ivy. The patient states she did not believe it was shingles. Emergency room visit required. The reporter did not consent to follow-up. No other information provided.
One day following vaccination, patient became confused, fearful, anxious, and paranoid.  This progressed until hospitalization within one week.  After ER visit, spent one week in hospital.  Rapid eye movement, inability to focus, incoherrent speech, unable to walk up flight of stairs.  Was placed on heavy doses of psychotic drugs which seemed to make situation worse and had psychotic episode.  No prior history for patient and no family history of psychosis or any other relevant diagnosis.  Upon release to parental care and appointment with providers in home town, psychotic medicines were immediately tapered resulting in improvement to condition.  After six weeks was able to return to college.
Started with site of shot getting really sore, followed by general muscle and body aches everywhere, followed by (presumed) fever, chills, and racing heartbeat, followed by nausea and sleeplessness, accompanied by extreme fatigue? Symptoms began lessoning by noon the next day.
disintegrating feeling in her bones; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she had previous shingles). Previously administered products included Shingrix with an associated reaction of neck pain (received 1st dose on 28th December 2018, refer case US2019114051).   In 2019, the patient received the 2nd dose of Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received her second dose in 2019 and after a couple of weeks she was experiencing a disintegrating feeling in her bones which was similar to a feeling she had with her previous case of shingles. The reporter consented to follow up.
Nausea, dizziness, and faint. Checked out by the paramedics and then went home.
Sore, red, swollen arm. Chills, fever over 101, fatigue, headache, nausea and sore/ swollen glands in neck and under left arm
pt recv vax 2AUG95 & 12MAR96 pt exp a case of breakthrough chicken pox w/100 lesions;f/u from the pt MD indicated that the pt devel sx p/exposure to another child;no further details were provided;
10/17/02 L upper arm pain and swelling. 10/20/02 Benadryl.
patient states, she started to get a "purpura" reaction around her mostly right upper limb. blue/purple lesion. and one lesion on abdomen. one lesion on left hand.
At 5:45 PM I noticed one of my nostrils and part of my lip had a burning sensation.  It eventually went away.  Later that night around midnight my fingers started tingling and eventually my left hand fingers were burning, very strongly like they were on fire.  An hour later the burning sensation had subsided.
pt has a syncopal episode within 30 seconds. patient was sitting, went limp and fell forward off exam table onto floor hitting back of head on tile. provider was able to wake her up immediately,  but  pt continued to feel dizzy and was passing in and out of consciousness, c/o head pain from fall. After 15-20 minutes patient tried to walk again, but almost fainted again. 911 called and patient brought to ER by ambulance for further evaluation.
client received astrazeneca covid vaccine, no reaction. Previous vaccine unavailable in the  Janssen given as an alternative 9.15.2021
pt recvd vax; swelling & redness at area of shot; h/a; several flu shots in the past;
Initial report received from the health care professional on 29 Jul 2010: On an unspecified date, this patient inadvertently received a intramuscular dose of MenA component of MENVEO (batch number: not reported) that was diluted with sterile diluent instead of MenCWY liquid conjugate component.
hands stiff & thumbs hurt to squeeze things-spine achy, also neck (where spine is) rib cage kind of hurts)- no fever- fatigue-feet & hips ache-advised to seek medical care if sx persist; pts son had OPV vax same day;
After the 2nd dose/shot, the swelling in my left arm (still swollen from the 1st dose) has not gone down.  This has been since April. On 11/08/2021, visited Dr. and had a sonogram performed on the area.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 1:36 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 1:36 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date and time of vaccine administered provided as 02-FEB-2022 13:36:43 Patient received booster dose. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022 and they  no longer possess this lot number.  No treatment medications were reported.
Headache, Myalgia, Arthralgia, CoughWheeze,  Reports myalgias,arthralgias,headached, cough, dyspnea, sore throat and soreness of arm that received 2ndd COVID vaccine.  Narrative:  Reports myalgias,arthralgias,headache, cough, dyspnea, sore throat and soreness of arm that received 2nd COVID vaccine which resolved except arm soreness.
This case was reported by a pharmacist via call center representative and described the occurrence of erythematous rash in a adult patient who received Shingrix (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 5th October 2018, the patient received the 1st dose of Shingrix (intramuscular). In October 2018, less than a week after receiving Shingrix, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovered/resolved. It was unknown if the reporter considered the erythematous rash to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient received Shingrix on an unknown arm. After receiving Shingrix, the patient experienced red rash started around the injection site which moved to the entire upper arm. The pharmacist did not provide the patient information.
Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer.  A 22-years-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection) first dose (Lot number: EN5318) on 23Jan2021 and second dose (Lot number: EL9266) on 12Feb2021, both via unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 05May2021 (after 3 months of vaccination), patient was tested positive for COVID virus, after being fully vaccinated. Caller states that Covid positive is defined as having both vaccines, and testing positive for Covid longer than two weeks after both doses. Caller states they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Lab test included positive COVID-19 test on 05May2021. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075254 same reporter, drug, AE different patient.
ADULT OBSTRUCTIVE SLEEP APNEA ACUTE NON ST ELEVATION MI HYPOTENSION 2/13/2023,  2/26/2023,  1/15/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
318 patients received dose from vials beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The date of refrigeration was reported to be on 07-May-2021.  Treatment information was not provided.
Patient was admitted to Hospital on 11/29/2021 for COVID related symptoms. This is considered a breakthrough case.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There were no medical history and concurrent condition reported. Over 2 years ago, in approximately 2013 the patient was vaccinated with the first dose of GARDASIL (strength, dose, route and lot# not provided). There was no concomitant medication reported. At the time of reporting, the patient would like to receive the second dose. No adverse symptoms were reported. Additional information has been requested.
Pt called on 11/20/20 stating he has been to the ER 2 times c/o extreme pain to injection site.
Large, red area at injection site appeared 2 weeks after vaccine. Patient reports headaches x 3 days, few small blisters noted on back of neck and under right arm.
Transverse Myelitis, 3 weeks after vaccine. Treated with steroids and IV-IG. Prognosis unknown.
COVID 19 PATIENT STATED THEY DID NOT HAVE THEIR CARD OR ANY DATES
Pt  is a 16 yr old who received a moderna vaccine booster. At this time, Pfizer is the only booster authorized for this age group.
Today, one week after the Moderns vaccine, I have broken out with hives all over my body.  I am breathing fine. Is there any reason I shouldn't get the next Covid shot?
pt recv vax 27APR95 & woke up 6AM 28APR95 very sick to stomach; vomiting for 4 hr- 3 different times; remained nauseated for rest of day; was feeling nl by evening;
Extreme interior arm pain, redness below injection site that spread over a 48 hour period. Patient ended up going to urgent care and was given an antibiotic, prescriber was unsure why the pain and redness but gave her an antibiotic in case it was possible cellulitis. Patient has been improving to date. Patient was given flu shot at the same time as the PNEUMOVAX.
Swelling, Itching, and redness at injection site. Still apparent two days after. Day after injection I had a fever, cold sweats, chills, nausea, migraine, and drowsiness.
Pt recvd DTP/OPV 31MAR92; apparently had been exposed to chickenpox prior to vax;  On 2APR parent called to report fever of 100.5,  h/a, anorexia, chills, & aches;
I started to develop a stiff neck, and my tongue started to swell, this then followed by excessive mucus and headache.  Tongue swelling concentrated on right side of tongue until it was about twice normal size.
About 3PM noticed itchy at site, orange sized swelling and hot to touch.  By 5PM swelled to 2" above elbow and up to site.  by 6PM took Benadryl 50 mg po.  by 7 PM entire arm swollen to just below elbow.  Next AM swelling to mid forearm, hot and red.  Ached--Tylenol for pain.  (Had taken another dose Benadryl 50 mg po at 10PM).  Stayed red, hot and swollen for 4 days and went away.
Child had fever of 102 degrees for 1st 2 days.  On Nov. 15 when child was about to fall asleep he would have jerking movements about 8-10 in an hour, off and on during the night for 3 days.  Parents report child hitting his hands on his head.  Child better on 11-18-09.
immed p/vax pt had tonic seizure for 1 1/2min & subsequent urinary incontinence;3min combative/disoriented episode p/sz;
pt received vaccine that was stored improperly,, store in fridge past use by date of 1/29/23
weekly I get 2 days that may be functional and able to follow through with planned commitments; Raging inflammation throughout my body; throat collapses onto itself preventing me from exhaling; throat collapses onto itself preventing me from exhaling; muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician; muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician; Chronic fatigue; memory loss; brain fog; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0150) via an unspecified route of administration, administered in Arm Right on 12Apr2021 12:45 (at the age of 62 years old) as dose 2, single for COVID-19 immunisation at Public Health Clinic. Medical history included benign essential blephrospasms from an unknown date and unknown if ongoing, drug allergy (Known allergies: Yes). Concomitant medication taken within two weeks included cyanocobalamin (VIT B12), colecalciferol (D3), magnesium (MAGNESIUM), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: En6207) via an unspecified route of administration, administered in Arm Right on 15Mar2021 (at the age of 62 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced raging inflammation throughout my body, throat collapses onto itself preventing me from exhaling, muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician, chronic fatigue, memory loss, brain fog on 15Apr2021, weekly i get 2 days that may be functional and able to follow through with planned commitments on an unspecified date. Adverse event reported as, Raging inflammation throughout my body - throat collapses onto itself preventing me from exhaling - multiple muscles and joint pains that vary in location of my body from day to day thus being difficult to explain to a physician - Chronic fatigue - memory loss - brain fog - weekly I get 2 days that may be functional and able to follow through with planned commitments. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient did not tested for COVID post vaccination. Outcome of all the events were not resolved.  Follow-up attempts are completed. No further information is expected.
Patient was given an expired Act HIB, no AE; Initial information received on 02-Dec-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 13 months old female patient who was vaccinated with an expired dose of vaccine hib (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included hepatitis A vaccine (Hepatitis A); measles vaccine, mumps vaccine, rubella vaccine (MMR); pneumococcal conjugate vaccine (Pneumococcal Vaccine); and varicella zoster vaccine (Varicella Vaccine) for Immunisation.  On 26-Nov-2019, the patient received an expired Booster dose (4th dose) of the suspect vaccine hib (PRP/T) vaccine lot UI913AA, exp date: 22 Nov 2019 (Diluent lot# UI913AAA, exp; 11/14/2019) via intramuscular route in the left thigh.  It was a case of expired vaccine used.  At the time of the report, 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. 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.  No further relevant information was reported.
No adverse effects day of injection other than mild soreness at injection site for a day or two. Nine days later my arm was swollen, itchy with center being hot, raised and red. I had no fever and no other noticeable symptoms. The next day it had spread over the upper arm and I went to emergency room. ER Dr. said she thought it was cellulitis and prescribed an antibiotic. She advised me to see my primary care provider after the weekend. I went to my primary care provider and the Dr. and the N.P. agreed it was not cellulitis, but an allergic reaction due to it's appearance . In checking CDC site the Dr. found photos of vaccine reactions which looked identical to my arm. I went off antibiotics and took ibuprofhan and it slowly has returned to almost normal within 10 days.
Mom States Child had temp greater than 103 on Tuesday, today seems to be down (with Motrin and Tylenol). Broke out in red, small spots from trunk to arms and legs and toes and hair line on Thursday. Acting irritable no other symptoms. Advised maintain control temp some of the spots have white heads and no crust and no itching,  no lotions on skin. Observe, call if increase symptoms.
This spontaneous report was received from registered nurse refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored (temperature 7C, time frame of 25 minutes, because of data logger) VARIVAX, injection, lot # M000756, expiry date 06-JAN-2018 or lot # M000995, expiry date 06-JAN-2018, subcutaneous in the left arm, (dose and frequency not reported). Vaccine was back in temperature. No adverse effects were reported. Previous excursion were 13.6 F for 21 minutes and 9.2 F 43 minutes. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Child immunized with DTP/OPV vaccines on 11SEP90. Sudden Infant Death Syndrome.
Go over labs, pt lost all words 3.5 weeks ago, gradually starting to use words and interact, per mom he would hide his face, not respond to them, his speech therapist is concerned. He stopped using sign language as well. Mom denies that he had any fever, diarrhea, GI symptoms, ate well, but stopped interacting with them, stopped smiling, stopped talking. Since Sunday 9/11 he began saying mama and daddy and a few other words and smiling again. Now has 7 words and 3 signs. He received his shot on Tuesday, August 18 and by Thursday he seemed off and then got worse and worse. Within a week he lost 27 spontaneous words and 22 signs that had been tracked by his speech therapist. This was very noticeable and happened in a three day period. The speech therapist was "freaked out". Suddenly he did not want to have anything to do with the parents or the therapist. He started looking away and standing in the corner for four minutes at a time. He did not want to sit. He stopped laughing and interacting. In the week prior to the follow up visit today he did not say words or signs except for mama or dada when he saw parents.
Patient  had a phobia of needle. He was calmed down and made to feel comfortable.  Patient got his shot and was fine then after about 2 minutes he started saying " I am passing out" repeatedly then he started rolling  his eyes. then he started sliding down the chair but he held his weight up thruoughout.. Pt was encouraged to breathe. 911 was called. After awhile, pt was asked if he wanted to lay on the flow and he said yes. He was carefully lowered to the flow and a pillwas used to support his head. after a few minutes, patient said he was ok howevr he was advised to wait till emergy services arrive. 911 arrived shortly after and took over. No drug were administered.