chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 33-year-old female patient who received ENGERIX B PEDIATRIC (batch number D344L, expiry date 1st June 2018). Co-suspect products included ENGERIX B ADULT and MMR vaccine. On 24th October 2017, the patient received ENGERIX B PEDIATRIC (intramuscular) .5 ml. On 1st November 2017, the patient received ENGERIX B ADULT and MMR vaccine, the patient experienced accidental underdose and adult use of a child product. On 2nd November 2017, the patient experienced generalized pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the generalized pruritus was recovering/resolving and the outcome of the accidental underdose and adult use of a child product were unknown. The reporter considered the generalized pruritus to be possibly related to ENGERIX B ADULT and MMR vaccine. Additional details were reported as follows: The patient was inadvertently given a pediatric dose of ENGERIX B in left deltoid, which led to accidental underdose and adult use of a child product. The patient came back on 1st November 2017 and received an adult dose of ENGERIX B in left deltoid along with MMR in right deltoid. The patient experienced generalized, intense itching on the evening of 2nd November 2017, after receiving ENGERIX-B and MMR vaccine. The patient woke up during the night and took BENADRYL, which improved her symptoms.
At injection site: swelling, redness, extreme itching, severe pain. Nausea, chills, severe headache, fatigue, body aches.
This is a spontaneous report from a non-contactable consumer or other non hcp.  A patient of unspecified age and gender received BNT162B2(solution for injection,Batch/Lot number was not reported)  first dose  via an unspecified route of administration on 28Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 28Apr2021 after the vaccine my arm started hurting from my elbow to my shoulder it started hurting a lot and than this morning I still have the pain in my arm and than my right breast started hurting. I wanted to see if that was normal. The outcome of the events was not recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
pt recvd vax & exp 2hrs of intermittent high pitched, inconsolable screaming;event started 3hrs p/vax;pt was not seen by MD;pt wa seen @ 3.5mos for well baby visit & nl;pt seen @4mo for scheduled vax;
Patient received COVID vaccine mixed with bacteriostatic 0.9% normal saline instead of plain normal saline 0.9%. This was discovered on 5.12.2021.
PATIENT RECEIVED THE ORIGINAL PFIZER MONO VALENT INSTEAD OF THE PFIZER BIVALENT DUE TO MY ERROR ,  PATIENT WILL HAVE TO RETURN TO US FOR ANOTHER VACCINE IN 2 MONTHS
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 17-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The FLUMIST expired on 08-Dec-2010. The patient received the expired FLUMIST on 10-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 01-Mar-2011: Reporter confirmed that the patient did not experience any adverse events.
Received flu shot 9/22/15 in (L) arm developed pain, swollen red arm, then extend down upper arm, gets ecchymotic and itchy.
fever, complained of painful urination, lethargic, refusing to eat, eyes had racoon look, abdominal pain, then what appeared to be a rash-started on face went down to neck and chest.  went to an after hours clinic-and they diagnosed him with measles from the vaccine.  I telephone the clinic of what took place and they refused to report this.
Onset was 12 hours Post shot and started with aches chills and headache.  24 hours later severe brain fog set in.  48 hours later severe dizziness and near fainting also began with a generally very unwell feeling.  I missed two days of work and then on five days later I started fainting.  All symptoms continued in intense aches and fatigue and on one week later I started vomiting.  Several days of stomach pain and inability to eat.  Today is one week post injection and all symptoms are still prevalent and preventing me from doing much but staying in bed
It started out where my bones and muscles hurt. I felt very depleaded. The next day I was lightly dizzy and got rashes. I got one on my left leg. Then the spot where I have gotten the shot looked like a rash as well. The next day I got like a splitting head ache pretty bad. I get cold sores so unfortunately this activated a cold sore each time I got the shot. I went to the doctor to get medication for my cold sore and talk to them about the rash. I had a persistent yeast infection under my armpit, also a molar in my mouth chipped and I looked it  up and it said it was because of lack of vitamin D. First time I went to the ER because my throat was sore and they did a Covid test and it was negative. The second time I went to the doctor and they just recommended steroid cream for the rash and antifungal cream for the yeast infection. I feel like I am more susceptible to rashes now. Now I am taking vitamin B12, vitamin D3, multi vitamin, calcium pill, antifungal cream, antibiotic for my teeth.
On approx 11NOV91 pt broke out in fine red rash w/fever lasting about 7-9 days; fever was low grade; pt also had ear infect developing @ same time; pt saw MD who dx adverse rxn to MMR vax;
6 days after patient received covid vaccination, was admitted for outpatient IV diureses due to CHF exacerbation.  Symptoms began on 2/15.
Pfizer 9/24/21, 10/26/21. Positive on 12/19/22
Patient was on Rotateq on 5-11-07, on 5-12-07 developed fever up to 103.6, mom took to ER, CBC showed increased WBC 21,000, everything else normal, loose stools x 1 day, rechecked in doctor's office 5/14/07. Back to normal.
Information has been received from a health professional concerning an 83 yr old male who on 14Sep05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot 650649/0790P). On 14Sep05 the pt complained of upper arm swelling and redness at the injection site, fever and chills. The pt took over the counter medication. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Pt developed fever, cough, chills, body aches, shortness of breath and loss of smell 2 days post 2nd COVID vaccine. Symptoms > 1 week in length. Does not follow typical expected post vaccine inflammatory reaction.
Chills, fever (99.9-101.9), extreme head and body pain,  for 30 hours, then diarrhea  every other day for two weeks.
Measles rash, high fever 104, pink eye, cough, diarrhea, runny nose.
Shortness of breath, heart fluctuations, tightness of chest and lungs, dizziness, soreness in heart and lungs.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe
fatigued; high temperature/temperature of 102 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued) and PYREXIA (high temperature/temperature of 102 degrees Farenheight) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigued) and PYREXIA (high temperature/temperature of 102 degrees Farenheight). At the time of the report, FATIGUE (fatigued) and PYREXIA (high temperature/temperature of 102 degrees Farenheight) had resolved.            No treatment medication was reported. No Concomitant medication was reported.
A patient was supposed to receive her Omnipod and received a shipment of VARIVAX and PROQUAD; No adverse Event; This spontaneous report was received from a physician referring to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was supposed to receive her "Omnipod" and received a shipment of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, lot #, expiry date, and route of administration were not provided), the vaccines were supposed to arrive at the clinic of the healthcare professional (HCP), but were packaged with the patient's "Omnipod" and sent to her home address (Drug dispensed to wrong patient). No additional adverse events (AEs) were reported.
Conjunctivitis (cleared up after 2 days). Facial itching, redness, burning which has continued for 5 weeks. Treated with over the counter antihistamines, prescription valocyclovir.
whopping headache; sore arm; This is a spontaneous report from contactable consumer (patient) via Pfizer sales representative. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 17Feb2021 (at the age of 66years (as reported)) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her second dose of the Pfizer COVID-19 vaccine yesterday (17Feb2021). The patient reported a mild "sore arm" and "whopping headache" as adverse events on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial unsolicited misuse report received from a non-healthcare professional on 8 June 2016. This case involves an infant patient (age and gender not reported) who was vaccinated with an extra dose of DTaP and possibly Acthib (batch number, expiry date, dose, route and site of administration was not reported) on an unspecified date in October 2011. The patient's medical history included infant had been born prematurely and concomitant medications were not reported. On an unspecified date, few months (reported as couple of months later) following the vaccination, the patient had experienced muscle weakness and poor muscle tone. It was a case of extra dose administered. Laboratory data and corrective treatment was not reported. The outcome of the event was reported unknown. List of documents held by sender: none.
Swollen Arm -- very hot-and itchy at the vaccine injection site----severe headache---
MD visit for on going observation rash extensive raised macules in gigantic confluent patches, erythematous mostly on trunk and LE and arms with relative sparing face > buttocks. Also on soles of feet/ hands plus a few areas of excoriation.
My daughter experienced fatigue, GI issues, heart racing, anxiety, jittery (these are signs that her thyroid is not working).  All her thyroid issues were off, her TSH value was up to 6.   My daughter still has her symptoms of anxiety, GI issues and anxiety.
Pt devel fever, chills, SOB & weakness, 24 hrs p/vax;
This case was reported by a healthcare professional and described the occurrence of incorrect route of drug administration in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine given on an unspecified date. There were no concurrent medications. On 2 November 2008, between 09:00 and 16:00, the subject received a dose of FLULAVAL 0.5 ml, subcutaneously, This was the incorrect route of drug administration. FLULAVAL should have been administered intramuscularly. Within 12 to 24 hours following injection of FLULAVAL, the subject experienced injection site pain, redness and swelling. The subject was seen by a physician who diagnosed her with a secondary infection and treated her with antibiotics and TYLENOL. At the time of reporting, the events were improved. In the reporter's opinion, the events, with the exception of the secondary infection which was not specified, were probably related to treatment with FLULAVAL. The reporter stated that approximately 200 adults were vaccinated with FLULAVAL via deep subcutaneous injection during a flu clinic. Out of these 200 plus subjects, four females reported local reactions of pain, redness and swelling within 12 to 24 hours of vaccination. One of these subjects was seen by the on-site physician who diagnosed it as a secondary infection and treated it with antibiotics and TYLENOL. It was reported that the adverse events were improving, but unknown if they resolved. Linked cases include: A0759176A, A0759183A, A0759188A and A0759189A.
Headache, nausea ,body aches and fever 100.2. Resolved with Tylenol and rest
DEATH; NON-RESPONSIVE; NOT FEELING WELL; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included on blood thinners. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,1 total, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The consumer had called and stated that their father had passed away and had received JANSSEN covid 19 vaccine 10 to 12 days before. On 26-Apr-2021 the patient was non responsive, lethargic, seemed out of it and was not feeling well. The patient was on blood thinners. On 27-Apr-2021 the consumer's father had passed away, the consumer was still waiting for the cause of death. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 27-APR-2021, and the outcome of non-responsive, not feeling well was not reported. This report was serious (Death, Medically significant).; Sender's Comments: 20210456243-covid-19 vaccine ad26.cov2.s -Death, Non responsive. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: CAUSE OF DEATH UNKNOWN
Suspected TIA event based upon visual symptoms. Lasting less than 1/2 hour and never reoccurred.
Within 5 minutes of receiving vaccine daughter felt something was not right as we sat in 15 minute holding period. She was holding her chest. I advised her to sit and I would get help.  as I turned she was standing next to me holding her chest saying she isnt feeling right.  they put her on a bed and was looking for a blood pressure cuff.  they placed a pulseox on her finger which showed 100.  then they placed another clip on her other finger and it showed her heart rate increasing to 138 from 93 in seconds. her face was red her neck was red and she said her heart was racing.   they finally found a BP cuff and her blood pressure was 148/94 which they said this was normal.  it was not. they they told us to seek medical attention.  She continued to complain about chest pain and racing and her face and next continued to be red.  the nurse then gave her 50ml of benadryl with no relief.  She was taking out by wheelchair to a waiting ambulance then to the Hospital Emergency Room.  They treated her with a Steroid and IV.  She was released after about 3 hours.  we came home and 2 hours later went back to the same Emergency room for the same chest pain and racing  at which point  she now had a rash on chest and neck.  this time they gave her medicine to slow down her heart which made her feel better.  she was then released.   Since then she continues to have heart papatations and rashes, and a heard time swallowing with a continue feeling something is stuck in her throat.
sx achy arms-extending to fingers;localized erythema, pain, warmth, h/a, inc temp;(did not specifically examine pt per phone message);
she had a metallic taste in her mouth; she couldn't taste anything half an hour after receiving the first dose; fatigue that made her fall asleep for 4-5 hours; tingling sensation in the top of her head/ tingling sensation on her right arm right after the shot; nausea; numb sensation on her right arm; sore sensation so bad she could not lift her arm; sore sensation so bad she could not lift her arm; This is a spontaneous report from a contactable consumer, the patient.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization.   Medical history included two strokes. The patient's concomitant medications were not reported.  On an unknown date, the patient experienced a metallic taste in her mouth, she couldn't taste anything half an hour after receiving the first dose, fatigue that made her fall asleep for 4-5 hours, tingling sensation in the top of her head/ tingling sensation on her right arm right after the shot, nausea, numb sensation on her right arm, and sore sensation so bad she could not lift her arm.  The clinical outcomes of metallic taste in her mouth, couldn't taste anything, fatigue, tingling sensation, nausea, numb sensation on her right arm, and sore sensation so bad she could not lift her arm, were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
No reaction until 9 days after injection. Five inches below injection site a red, swollen, hot area. Next day twice the size; still red swollen and hot. Appears to be spreading down arm at an angle.
Tingling in extremities 7 weeks after 2nd dose which persists/is worsening after 10 days; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Jun2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was notdiagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had tingling in extremities on 23Aug2021, 7 weeks after the second dose, which had persisted and worsened after 10 days. The patient visited a neurologist which resulted in magnetic resonance imaging (MRI) and electromyography (EMG) was ordered to be done as soon as possible. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tingling in extremities 7 weeks after 2nd dose which persists/is worsening after 10 days was not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Sweating, I like drip water; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): AE-2021-12948.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating, I like drip water".  Follow-up attempts completed. No further information is expected.
Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022; No adverse event; given bivalent booster dose which was beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination. No Medical History information was reported.    On 26-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by datey). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given bivalent booster dose which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 20Sep2022 and Date of administration of vaccine: 26Oct2022). No concomitant information provided. The vial did not undergo any temperature excursions.  The patient took previously fist dose on 30-Jun-2021,sencod dose on 02-Aug-2021 of unknown brand. No treatment information provided
Left thigh redness, increased fussiness - RN tx interventions: Tylenol q4' for pain, fussiness: monitor for increasing redness/swelling; call back if not better in 3-7 -RN
Severe headache, Muscle pain, bone pain, fewer, dizziness, coughing,  Short of breath, Eye  ball pain, Severe chills, Cold feet, Numbness in my arms.
This spontaneous report was received from a physician referring to a 5 year old male patient.The patient had no concomitant medications, pertinent medical history or drug reaction. On 25-SEP-2018 the patient was vaccinated with PROQUAD (therapy type: rHA (recombinant Human albumin), lot #:N023001, Expire date: 19-FEB-2019, dose and frequency was not provided) subcutaneously for prophylaxis. On 19-OCT-2018, the patient returned to the office and was discovered that he had developed "case of croup". The patient was prescribed an unspecified dose of prednisone for treatment. The outcome of croup infectious was reported as not recovered/not resolved. No lab diagnostics/studies were performed. The causality assessment was not provided. Upon internal review, croup was determined to be medically significant.
At site location ; COVID19 Vaccination, 1st shot light headache for a day. second shot symptoms of mild headache for 2-3 days, right arm sore for a few days, both feets swollen with red rashes top of both foots. (right top foot darker rash). Still have swelling on both foot.