chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range; expired ipol vaccine administered to patient; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case is linked to cases 2019SA125066, 2019SA125087, 2019SA125008, 2019SA125094, 2019SA125047, 2019SA125041, 2019SA125033 and 2019SA125054 (same reporter).  This case involves a four years old (reported as 5 years) female patient who was vaccinated with a 0.5 ml dose of expired vaccine IPV (VERO) [IPOL] (lot number N1K931M and Exp. Date 19-Nov-2018) via intramuscular route in the deltoid NOS and a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and Exp. Date not reported) via intramuscular route in the deltoid NOS both on 08-Mar-2019, which were exposed to multiple excursions.   The patient's medical history not reported and concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and TUBERCULIN PPD.  It was an actual medication error case due to expired vaccine used and incorrect product storage.  It was reported that, vaccines (Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra) stored at temperature outside the recommended range. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown whether the patient experienced any adverse event post vaccination.  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 and Module VI of the 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.  Information on the batch number was requested.  List of documents held by sender: none.
dizziness, nausea,          over 3-5 minutes that subsequently releived with water and rest.   HR 50's-60's  #21 advised to see doctor or other healthcare professional office/clinic.          #21 advised to visit
This Patient came into the office to get the 2nd dose of the covid 19 moderna Vaccine. He came in on 9/9/2021 at 9am. At the time we had a PA student  in a rotation and she administered the vaccine to the patient at 9:05am. Later in the day it was noticed that the vial that she used was the same vial that was used the day previous on 9/8/2021. The vial had been punctured for more then 12 hours when administered to the Patient. We informed the patient of this event
Patient was given a total of 4 shots at her 11 year check up, two in the back of both arms, her physician's office , listed, should have record of the lot numbers and manufacturer. We left the doctor's office about 1225, at 1240 pm on our ride home my daughter said that she had "funny purple spots on her arm and leg" we were on our way back to her last day at school. I parked in the school parking lot to assess her and she had hive radiating down from the injection site down her entire left arm, and down her left leg.. hundreds of plaques of hives , I stopped, got her 25 mg Benedryl and gave it to her immediately at 12:50 and called her doctors office.. I took her in to see them at 1:30 and they had begun to fade. Additionally, she is very emotional following the injections and is reporting significant pain radiating from  the left injection sites. she has had no other symptoms . We were instructed to continue heavy antihistamine use for the next 72 hrs and go to the ER with any new or worsening symptoms.  The ARNP that saw us in follow up stated That it was impossible to know which injections caused the reaction. I'm scared now to vaccinate against in the future. Will the reaction become more severe?
p/vax pt devel an inj site rxn characterized by an 8.5cm by 8.5cm area of swelling w/redness around the edge & a blackening center;tx w/applications of ice & motrin;pt recovered;
pt exp weakness &  (a depersonalization rxn), diff w/inspiration airway constriction;devel bacterial bronchitis;spur on a vertebra found on MRI & swelling in spinal column noted;loss of balance, vertigo;suspect post vax encephalopathy
pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt date: 30-MAR-2023. The reporter was the patient.  She mentioned she received Shingrix and had pain at the injection site that lasted a few days. Nothing else was reported. The reporter did not consent to follow-up. The case was linked with case US2023048019, reported by same reporter.; Sender's Comments:  US-GSK-US2023048019:same reporter
Student developed blotchy, flat areas on upper chest, between clavicles and nipple line, as well as one area on the back of neck. No complaints of itching; no other redness/blotching noted on rest of body (examined in mother's presence). No other symptoms noted.
Death; Heart attack; Shortness of breath; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 72 years, at single dose on 23Mar2021 at 10:00 (Lot number was not reported) for COVID-19 immunisation. Medical history included asthma, penicillin allergy and she was diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient experienced death, shortness of breath and heart attack on 23Mar2021 at 20:30. And it was reported that the adverse event result in "Emergency room/department or urgent care" and patient was treatment with CPR. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not been tested for COVID-19 since the vaccination. Event outcome of events shortness of breath and heart attack was not recovered. The patient died on 23Mar2021 at 20:30. It was unknown if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death
Migraine, severe body ache, painful and swollen injection site, general weakness, pain in lower back.
Terrible case of vertigo that lasted for a week.  This happened after my first Moderna booster also (on 10/30/2021 at pharmacy) but I didn't make the correlation until it happened again this time.
My mother received the quad 4 flu shot in October.  In November she was put into the hospital with low sodium.
her sister received the pfizer covid-19 vaccine and began to experience palpitations; This is a spontaneous report from a contactable Other Health Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported her sister received the pfizer covid-19 vaccine and began to experience palpitations on an unspecified date. She declined to provide her sister's name and contact information. The outcome of event was outcome.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Pain at injection site, High Fever 101.5 lasting 24 hours, Whole body pain, Barely able to walk
Date: 3/23/2021  Problem: fainted Notes: Pt was being observed post Janssen COVID Vaccine when the nurse observed pt fall onto the floor from his chair. This nurse began to take VS- BP 144/77 P74  O2 100%  T  98.6 RR 18 BS 105. Pt did hit head when falling to floor but answered all questions appropriately. Pt states he is afraid of needles and this has happened to him previously as well. 911 called by head nurse. Pt able to move all extremities. This nurse stayed with pt until EMTs arrived. Pt alert and oriented x4. Redness noted to left cheek, no bleeding noted. EMT found no signs of distress and pt refused to be transported to hospital. This nurse notified pt that he would need someone to take him home. Wife arrived to take pt. Pt showed no signs of acute distress aand left with wife.
pt devel large (approx 4inch) red area on rt hip p/vax was given;red area was hard, painful & hot to touch;also had low grade fever x 24hr;
Vaccinated at 8 am,at about 7 pm  I had site and muscle pain 12/31/20,then 48 hours  I had loss of smell and taste,body aches,I was itchy all over,could not sleep that nite,I called did the Conversation at work and told me not to go to work,the next day 1/3 /21,employee health called me to get tested and tested positive on 1/4/21,I was place on quarantine for 10 days,I tried calling your office with 800 number and left my number nobody called me,I also experienced eye irritation,cough ,short of breath,low grade fever,nausea fatigue
Patient experienced a fever of 102.9-103 approximately 9 hours after receiving the Flu shot. Patient was not experiencing any illness symptoms prior to receiving the shot. Fever was controlled via alternating doses of childrens ibuprofen and Tylenol. Fever has not gone below 99 and is continuing to spike to 102 if dosage time is missed.
Urticarial rash developed the day after vaccination. He was examined 2 days after vaccination. By 5 days after, the rash had resolved
Pt. got the vaccine on Tuesday June 19, 2012. On Friday 6/22/12 the patient called to inform us that her arm had become red, hot and swollen surrounding the injection site in the days following her vaccination.
stomach ache; warm to touch; headache; fever; she was just sick,; injection site was very hard like rock; she was just scratching and scratching; soreness is pretty bad; its been terrible and scary.; Soreness; redness; swelling; could not lift her arm,; its itchy; she felt sleepy only.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling), HYPOKINESIA (could not lift her arm,) and PRURITUS (its itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (she felt sleepy only.). On 09-Apr-2021, the patient experienced PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling), HYPOKINESIA (could not lift her arm,), PRURITUS (its itchy), HEADACHE (headache), ILLNESS (she was just sick,), INJECTION SITE INDURATION (injection site was very hard like rock), SCRATCH (she was just scratching and scratching), PAIN (soreness is pretty bad), MALAISE (its been terrible and scary.) and PYREXIA (fever). On an unknown date, the patient experienced FEELING HOT (warm to touch) and ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling), HYPOKINESIA (could not lift her arm,), PRURITUS (its itchy), FEELING HOT (warm to touch), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), ILLNESS (she was just sick,), INJECTION SITE INDURATION (injection site was very hard like rock), SCRATCH (she was just scratching and scratching), PAIN (soreness is pretty bad), MALAISE (its been terrible and scary.), SOMNOLENCE (she felt sleepy only.) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication, diabetic medication, thyroid medication, cholesterol medication. Treatment medication was not provided.
no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 14-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002845 (expiration date: 23-JAN-2022) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010124: US-009507513-2008USA010123: US-009507513-2008USA010126: US-009507513-2008USA010125: US-009507513-2008USA010127: US-009507513-2008USA010135: US-009507513-2008USA010121: US-009507513-2008USA010136: US-009507513-2008USA010134: US-009507513-2008USA010122: US-009507513-2008USA010000: US-009507513-2008USA010128:
At first fever, chills, weakness, headache, aching, loss of appetite; Fever disappeared, weakness remained; fever returned within a week, with joint pains, swelling of hands and feet, weakness, appetite loss, headache, pinpoint rash on torso.
Left arm pain began approx 1 hour from time of vaccination to present, pain much greater than that of flu vaccine Sharp left shoulder pain from approx 5 hours after vaccination to present 5 hours after vaccination left side of neck swelling and pain. Subsided overnight and gone by morning.  Approx 24 hours after vaccination- left upper arm swelling approx 5" in diameter. Redness at injection site approx size of quarter.  Approx 15 hours after vaccination, experienced moments of heat flashes which subsided. Left arm swelling, left arm and shoulder pain still present with and without movement.
Information has been received from a registered nurse and Cancer Administrator and the patient's mother who works in Nuclear Medicine concerning a 13 year old female patient with a medical history of dermographism and grass or tree allergies and allergic to cephalosporins who in August 2008 and in October 2008 (also reported as in approximately 2009 ("about two years ago") ) was vaccinated with the first and second dose of GARDASIL (dose, route and lot # were not reported) respectively. The registered nurse reported that in approximately 2009 ("about two years ago") the patient experienced severe mental, emotional side effects from the vaccine. The patient had to go to see a psychiatrist. The registered nurse learned of this event while in conversation with the patient's mother. The patient's mother mentioned that in approximately October 2008 ("within a week or two of receiving the second dose") the patient experienced the severe mental, emotional side effects. The patient was referred to many specialists and performed much diagnostic testing. All physical workups were okay. The patient currently was on psychiatry medications and in a special learning program at school. It was unknown if there was any relationship to GARDASIL, but the third dose would not be given (a younger sister would also not be receiving the GARDASIL series). At the time of reporting, the patient's status was unknown. The severe mental, emotional side effects were considered to be disabling for a number of reasons including missed school. Additional information has been requested.
This spontaneous report has been received from a medical assistant referring to a 10 year old female patient. The patient's concomitant medication, pertinent medical History, drug reactions/allergies and concurrent condition were not reported. In October 2017 the patient was inadvertently administered with a dose of ZOSTAVAX (lot # reported as N008827; strength, route and expiration date were not reported) for prophylaxis (inappropriate schedule of vaccine administered). No adverse effects.
numbness all over, tingling, nausea, vomited x 1;tx w/epi;
Red, ringed, irregular lesion with fuictuane on tenderness left deltoid/posterior arm some itching, occurred today.
Mild muscle soreness, not as intense as the first shot started about 2 hours after the shot.  Then, intense migraine that started at 0400 in the morning, about 14 hours after the second dose of the Phizer COVID vaccine.  The pain woke me up from my sleep.  The pain was so intense that extra strength Tylenol and ibuprofen did not help at.  Pain ebbed and flowed throughout the day.  As of 1400 in the afternoon, 10 hours after the onset, pain has still not subsided despite taking Excedrin Migraine at about 1230.
Injection site pain - 11pm 08/26/21 - present Body ache - 10am 08/27/21 - present Tiredness - 10am 08/27/21 - present Intensified body ache - 2pm 08/27/21 Chills - 3pm 08/27/21 Fever (highest before taking Tylenol) 102,4 F 4:30pm 08/27/21 Lymphoadenopathy (left arm pit) 8am 08/28/21 Chills 12pm 08/28/21 - to present Fever 101F  1pm 08/28/21 (1h after Tylenol)
Pt received a flu vaccine, then went to xray and reported he had not gotten his flu vaccine in his appt, Pt came upstairs and got another flu shot in the opposite arm. Pt did not recall his 1st flu shot.
A report received on 25Oct02 concerning a 33 year old vaccinee and approx 15 clinic staff members who were administered a Fluvirin injection in error in Oct02. On an unk date in Oct02, the vaccinee and approx 15 staff members were administered Fluvirin with 1/2 inch needles. The reporter suspected that the staff members may have received the vaccine via a SC and not an IM route. The reporter has assessed the relationship of the vaccines to the event unclassifiable. A report  received from a health care professional on 13Dec02 concerning a 54 year old female vaccine who was administered Fluvirin SC on 08Oct02. On 08Oct02, the vaccinee was inadvertently administered Fluvirin SC. The outcome of the event was unk. Ref: PJP200200657, PJP200200883, PJP2002008884, PJP200200885, PJP200200889, PJP200200890.
following Td shot, lt arm inc painful, swollen, erythema for 5 days; 6th day exp fever of 101, pain in every joint like a toothache, malaise & problem w/equilibrium; seen by MD on 6MAY who dx toxic poisoning & prescribed APAP;
I developed a left "Frozen Shoulder" in August 2008. This development was not temporily linked to an injury event. The pathophysiology of Frozen Shoulder is related to wound healing.  The only physical trauma I've experience to the local anatomical site is annual flu vaccines. Is it possible that vaccination is triggering the induction of uncontrolled fibrogenesis that is characteristic of the Frozen Shoulder and Dupuytren's contracture pathophysiology? Perhaps there exists a susceptible subpopulation? Frozen Shoulder is 8 times more likely to occur in individuals that have Dupuytren's Contracture. I was diagnosed with bilateral Dupuytren's in 2006.
J96.00 ACUTE RESPIRATORY FAILURE 10/29/2022 CEREBRAL EMBOLISM
Information has been received from an 85 year old female consumer with codeine, penicillin and "vioxin" allergy and a history of "on steroids about fourteen years ago" who on 18-AUG-2010 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot# not reported) in her upper arm. Concomitant therapy included alendronate sodium (MSD), ENAPRIL and lovastatin. On 18-AUG-2010 she began to feel soreness at the injection site. On 20-AUG-2010 she began to feel itchiness. No medical attention was sought. On 10-AUG-2010, ultrasound on thyroid was performed with no results reported. At the time of this report, the patient had not recovered. No further information is available.
Felt dizzy and lightheaded immediately after vaccine. Verbalized  had not eaten today. Provided water snd crackers. Denied any additional sx  Vitals: 98% 66 110/60 repeat 90/66.   Had pt lay down in seat of car. Feet up. Drink water. Eat crackers.   Repeat BP 110/66   Pt reported feeling better. Thinks it was anxiety
Pain when breathing and difficulty breathing. Nausea. Started 12 hours after the 2nd dose and has yet to go away 1 week later. It's hard to breathe without coughing and pain. And the nausea came I had body aches too. But everything else went away except for the nausea which has been haunting me and the difficulty breathing which has limited the amount of work i do at work and has had an impact on my sleeping as well.
Pt had a 2nd dose Pfizer order 0.3 mL for June 16, 2021 prior to discharge.  Pharmacy inadvertently used Janssen COVID Vaccine in lieu of Pfizer, and gave 0.3 mL of Janssen (Wrong Drug/Wrong Dose).   Pt monitored for reaction.  Pt informed of the wrong medication/wrong dose.  MD aware.  ID contacted.  Pt discharged home.
pt recvd vax 29JAN93 & on 2FEB93 exp warm numbness-dec temp sensation, difficulties w/balance, lt arm & leg weakness, band-like tight sensation from mid-chest to lower abdo; dec strength, felt unsteady, poss MS, dysesthesias, pos oligoclona
Moderna Dose 1 2/10/21 (038K20A) Moderna Dose 2 3/10/21 (038A21A) Moderna Dose 3 11/6/21 (012F21A) COVID Positive 1/23/22  1/23/22: Patient is an 88-year-old male who presents to the emergency room due to some increasing confusion.  Patient was recently admitted to a care facility and was also recently diagnosed with a urinary tract infection but the patient has been refusing to take all of his medications.  There have been no complaints of abdominal pain with no reported fever, chills or night sweats.  No chest pain or shortness of breath.  A full history of present illness is significantly limited due to the patient's severe dementia.  Patient's medical history, current medications, previous imaging studies, vital signs, laboratory studies along with previous hospitalization notes have been personally reviewed.  1/29/22: 88 yo male with demential , seizure disorder and progressive decline in memory and functional status transferred from outside hospital for complicated UTI and delirium. Patient completed course of antibiotics, has impulsive behavior and was not taking enough po. Slept well with start of Haldol. Head CT showed left parietooccipital infarct with encephalomalacia. Discussed goals of care with patient's wife and grand daughter, family would like to purse hospice. Patient discharged to LTC facility with hospice.