chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OUT OF SPECIFICATION PRODUCT USE; TEMPERATURE EXCURSION (EXPOSED TO 27F DEGREES FOR 44 MIN); This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-AUG-2021, the patient experienced temperature excursion (exposed to 27f degrees for 44 min). On an unspecified date, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the temperature excursion (exposed to 27f degrees for 44 min) and out of specification product use was not reported. This report was non-serious.
October 27th started with extreme fatigue,  difficulty walking, unable to preform usual ADL's.  November 2nd had fall due to stroke, liver laceration, subarachnoid hemorrhage.  Continued L sided weakness, unable to walk on own, needs help with all ADLS-Tranferred to assisted living.
This spontaneous report has been received from a physician and refers to three unspecified patients of unspecified gender and age. The patient medical history and concurrent conditions were not reported. The physician stated that the three unspecified patients were delayed in receiving start of therapy with MMR II (dosage, frequency, lot number not reported) because the carton the office received was empty. A product quality complaint was filed. No adverse event symptoms were reported. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Unknown. In January 2022, the patient experienced ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Fever (highest was 101.5), aches, weakness, nausea, chills. Throbbing in injection site.
severe chills; severe soreness in shot area; lethargic; This is a spontaneous report from a contactable other HCP. A 60-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810), via an unspecified route of administration, administered in Left Arm on 10Feb2021 as single dose for (at the age of 60-year-old) covid-19 immunization. Medical history included arrhythmia neonatal, thyroid disorder, gout and umbilical hernia. Other medical history reported as tachy-Brady syndrome, thyroid, gout, umbilical hernis. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had tested with covid 19. No known allergies reported for the patient. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); allopurinol (ALLOPURINOL); and digoxin (DIGITEK). These Other medications are administered in two weeks. On an unspecified date the patient experienced severe chills, severe soreness in shot area and lethargic. No treatment received for the event. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2013US026140 is an initial spontaneous report from a nurse received on 18 DEC 2013. This report refers to a 10-year-old male patient. He was an inpatient psychiatric ward resident. No concomitant medication was reported. He was erroneously vaccinated with FLUVIRIN 2013/2014 (batch number:  1309101, expiry date: April 2014) at a dose of 0.1 ml intradermally instead of PPD for tuberculin skin test on 17 DEC 2013. On the same day immediately after vaccination, he experienced intense itching and stinging at the injection site. On 18 DEC 2013 the injection site was painful upon palpation, tender upon touch, slightly swollen and red. The outcome of the events was reported as condition unchanged. The seriousness and causality were not reported.
tightness in chest, like right side of the chest; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Jan2021 (reported as "maybe Saturday or maybe starting Friday"), the patient experienced tightness in chest, like right side of the chest and it still continues this morning. Patient was just wondering if it was just something or if it was a side effect or be anything else. The outcome of the event was not recovered.
PATIENT RECEIVED AN EXPIRE JANSSEN VACCINE DOSE ON 12/10/21.  THE VACCINE BOTTLE WAS OPEN THE DAY (12/09/21) BEFORE AT 9AM  (2 SHOTS WERE DREW FROM IT) THEN PUT BACK TO THE FRIGE.   THE NEXT MORNING (12/10/21), THE NURSE  TOOK THIS SAME BOTTLE AND  DREW 2 MORE DOSES AND GAVE THE PATIENT IN THE MORNING .  THE PHARMACY CALLED THE PATIENT THE NEXT DAY (SATURDAY 12/11/21)  AND THE PATIENT'S HUSBAND SAID SHE WAS FINE.  NO UNUSUAL SIDE EFFECT.  SAME EXPERIENCE AS THE FIRST DOSE.
Employee reported "racing heart and "feeling like passing out". Employee was transported to Emergency Department for evaluation.
Got the vaccine on 6/13. Developed fatigue, sore throat, runny nose within 24 hours on 6/14. Was stable, but on 6/17 developed high fevers up to 101-102, erythematous rash on his neck, bilateral conjunctivitis and runny nose.  Presented to the ED under my care on 6/18 due to ongoing fever, dehydration and neck pain.   Currently undergoing full evaluation: COVID19 PCR positive. ESR, CRP, procal elevated. ALT/AST elevated High sensitivity troponin elevated. BNP normal. CBC with neutrophilic predominance, platelets clumped - repeating. RVP pending.  Evaluating for MIS, COVID reinfection, post-vaccine reaction, different viral illness, post-covid reaction + development of a cellulitis.
Went to the dentist at 4:30 PM, received 1 carpule 1.7ml of Septocaine (articane HCI and epinephrine) Articaine hydrochloried 4% epinephine 1:100,000 Lot B)6649AA Expired 2014-07.  The cheek area near the tooth, at the injections site, got very hot.  Also broke out in a cold sweat on the forehead and upper lip.  Haven't previously received any reaction.  It may have been a combination of flu shot and the numbing shot.  After the numbing shot wore off, return to normal.
60 hours after FLUMIST administration, pt developed generalized hives all over face, pruritus of face, and headache. BENADRYL administered - helped.
Dizziness. Complained of 'racing heart' BP 110/74, HR 88.  Observed for 30 minutes. Symptoms resolved.   No issues with dose #2.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 17Aug2021 as dose 1, single (Lot number: FC3182), in left arm, on 07Sep2021 as dose 2, single (Lot number: FC3184), in left arm and on 01Apr2022 as dose 3 (booster), single (Lot number: FK9893) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "severe COPD", start date: 2008 (ongoing); "Prediabetes" (ongoing); "Borderline hypertension, fluid, and blood pressure" (ongoing); "Borderline hypertension, fluid, and blood pressure" (ongoing). Concomitant medication(s) included: GLUCOCIL taken for glucose tolerance impaired (ongoing); HYDROCHLOROTHIAZIDE oral taken for hypertension, blood pressure abnormal (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment with Paxlovid (30Jul2023 to 01Aug2023). Clinical course: She had covid once before and had 3 of the vaccinations. She went to the ER (Emergency Room) on Saturday and they said she had covid and gave her a prescription for Paxlovid. She had 2 shots and got covid. She had a booster in Apr2022. Had covid the first time in 2021. She was 56 years old the first time she had covid and had covid again at 58 years old. She had cancer in her family.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266686 Same patient, different drug, different event;
Given HPV #2 at 943am. Asked if had any problems with 1st HPV, denied. Sent to another clinic 10 min away to scoliosis series felt dizzy in xray room, fell and hit head. Unconscious, suffered skull fracture.
Patient reports hives started 48 hours after receiving the vaccine. Today they are starting to scab over.
Patient felt dizzy and "throat tightness" during post-vaccination monitoring period. Patient denied difficulty breathing. Patient was assessed by onsite EMTs, no other problems noted and throat appeared clear. Patient stated that she has anxiety. She denies any other medical concerns. Patient recovered and EMTs released her to go home of own volition due to her reports of feeling well again.
Received the injection in my left arm, same as the first two rounds. Arm felt like someone hit me with a bat (same as with first two injections) within a few hours. By Wednesday evening, I received bruising toward my upper inside arm near arm pit and my lymph nodes around the outside of my armpit near my left breast swelled significantly. Roughly the size of a softball. Swelling decreased to half by Thursday morning. I did not have this reaction to the first two shots.
I had a sore arm. Then, I had a sore throat, headache, fatigue, and swollen lymph nodes in my neck and arm. I also had weakness and light headiness. I had SOB. I had to got go urgent care about this. They did COVID-19 and a flu test, negative result. They did blood work and a CT scan of my lungs, normal results. These symptoms lasted for 3 and half weeks I am still having weakness, joint pain, fatigue and issue with sleeping.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose and route were not reported) lot # L037339, expiration date 09-FEB-2018. It was reported that the vaccine was exposed to 29 Fahrenheit degrees for 96 hours. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
dizziness ( 1 hour after vaccine); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness ( 1 hour after vaccine)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On 26-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced DIZZINESS (dizziness ( 1 hour after vaccine)). At the time of the report, DIZZINESS (dizziness ( 1 hour after vaccine)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.
On 1/25/21 (12 hours after vaccines was given), patient reports fever, chills, body aches, rash on arm On 1/28/21 (3 days after vaccine), patient reports cough, SOB, midsteral CP, N/V/D with dizziness
Pt previously received 1 dose of Moderna on 02/19/2021 at another facility
Right upper arm swelling and pain on 3/30/16. On 3/31/16 left arm began with redness and swelling and heat around shot site. Redness on upper back with mottling of the skin of the torso.
23 year old female 5 minutes post-vaccination developed sudden nausea and dizziness. Patient denied shortness of breath, pruritus, difficulty breathing, fatigue, diaphoresis, tongue or lip swelling. Patient experience two episodes of emesis, after which she reported an improvement in her symptoms of nausea and dizziness. Patient was fully assessed by medical staff and given PO fluids. She was monitored for an additional 20 minutes with no further progression of symptoms. Upon leaving the patient reported a full recovery of any adverse symptoms and was driven home by her significant other. Patient and significant other were educated to call for EMS if symptoms returned or worsened.
Inspection of injection site on left deltoid reveals approximately 2 in diameter of reddened area with 2 3 cm areas of light purple in the center. Patient denied any difficulty breathing or swallowing, she states that last night the site was itchy and slightly painful. She believes that the redness at the injection site has worsened since last night. She denies pain or itching at this time. Skin irritation. Diphenhydramine 50 mg once.
Within 4 hours of vaccine administration, I began to feel slight dizziness, moderate fatigue, and an increasing lack of concentration and focus on my work.  I left work early and experienced symptoms of car sickness, stomach nausea, on my way home.  The above symptoms continued to varying degrees for the next two days, enough so that I knew I would be unable to function normally at work.  I slept and/or rested in bed for a great portion of each of those days.  The symptoms passed by noon of the third day.
Developed erythema at injection with decreased ROM and pain, but no tenderness. Treated with NAPROSYN for 5 days with great improvement, then day 6, is c/o pain (L) supraspinatus. Referred to orthopedics.
Fever, chills, severe redness and swelling to elbow. Joint pain and limitation in movement fatigue and headache.
Mild shoulder pain.  Mild dizziness, not enough to cause staggering.  Drowsiness and causing many naps.  Unusual fatigue during ski training at 7200 ft.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 04-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a medical center (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-JUL-2016, the patient was treated (by an unspecified healthcare professional) at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Monday night started with Nausea and diarrhea Tuesday: chills,  nausea, diarrhea, fatigue, headache  Wed: chills,  max fever 100.8, headache, fatigue, diarrhea
48 hours after administration of PVC 13 mom called with sx of increased swelling, red hard bruised area at site of vaccination PVC 13 pt did not want to come in - was told s/sx to watch for. Called mom 8/20 in am and pt doing fine area/? better.
Patient is 11.5 years old and was given an adult dose (0.3 ml) when is should have been the 5-11 year old dose (0.2 ml).  Contacted by Dept of Health.  Advised to review immunization process/workflow and to complete a VAERS report.  His 2nd dose should be 5-11 age appropriate dose after 21 days interval.
Patient had a blank stare on her face and did not respond to stimulus. She went limp slumped back, she was pale, hypotensive, and unable to follow directions. We called 911 and the Medics took her to hospital where she was released around 5pm
Subjective fevers, body aches; started several hours after the vaccine was given. Treated with tylenol, motrin, rest and hydration
expired DT vaccine was administered with no reported adverse event; Initial information received on 30-Jun-2022 regarding an unsolicited valid non-serious case received from medical assistant. Number: 01170883  This case involves a 66-year-old female patient to whom expired (Diphtheria and Tetanus Toxoids) TENIVAC vaccine was administered with no reported adverse event.  The patient presented with a laceration on her right foot (Skin laceration). The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 20-Jun-2022, the patient received a dose of suspect TENIVAC vaccine at dose of 0.5ml once with (lot: U6265A, expiry date: 19-Apr-2021) via intramuscular route in unknown administration site for Immunization (expired product administered, latency same day).  It was reported that "HCP reports about a patient of the practice presented with a laceration on her right foot. She was administered a DT vaccine which was later noted to have expired 4/19/2021. No adverse events have been reported."    Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the guidelines. 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.
I was at the onset of symptoms I had a general feeling of being tired or having  a cold tired unwell I took a quick view tests and had a faint line followed up with a Flowflex test and had an immediate bright red result, I called my Doctors office and they gave a ne the Covid line I called the number that day or the next and was prescribed Paxlovid and I had a temperature of one hundred and two point five. I masked after my positive test and stayed masked including my family staying out of the house, I slept for days. On day nine I got COVID-19 rebound.  I called the Doctors office and they said the rebound rate was five percent my Doctor said fifteen to twenty percent. I asked for information n the virus as to impact on the mensuration cycle none was available but my period is off cycle and has not returned frequency is the same the volume is low. I was really fatigued for a month afterwards including my eyes feeling like they were swollen as well.
Patient stated that her reaction started about 2 hours after vaccination.  Patient stated she had redness, swelling, warmth at injection site.  Patient denied that swelling/redness was traveling down arm down to elbow.  Patient denied having a fever.  Symptoms began improving on 9/23 and continued improving through 9/24.
Within a couple of minutes of receiving vaccination, patient fainted and became stiff.  Episode lasted less than a minute.  No physical injury-patient remained in the chair.  CHC physician examined patient and her feet were elevated.  Patient was given juice and observed for 15 minutes.  Patient became alert and oriented.
I am 29 weeks pregnant and had ringing in my left ear. It lasted for at least a few hours before I went to bed. I woke up and it was gone. My due date is May 13.
No reaction or symptoms were noted at the time of the visit, nor were they reported by the parent when they were notified.
Red; whole bicep was puffy; Losing sleep; Itching whichworse at night; Rash; Small bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Losing sleep), VACCINATION SITE PRURITUS (Itching whichworse at night), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (whole bicep was puffy) and VACCINATION SITE RASH (Rash) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for Diabetes.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Small bump at the injection site). On 29-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching whichworse at night) and VACCINATION SITE RASH (Rash). On 12-May-2021, the patient experienced INSOMNIA (Losing sleep) and VACCINATION SITE SWELLING (whole bicep was puffy). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red). At the time of the report, INSOMNIA (Losing sleep), VACCINATION SITE SWELLING (whole bicep was puffy), VACCINATION SITE RASH (Rash) and VACCINATION SITE SWELLING (Small bump at the injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itching whichworse at night) and VACCINATION SITE ERYTHEMA (Red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was not reported.
Redness, swelling, painful to touch, swelling up into neck and down arm (R).
Pt came into the clinic, 4/2/2021, states that she received the Pfizer on 3/18/2021, she got a itchy red rash all over her body.  Pt states the redness has gone away but her body is still itchy.
Pt wife called and said that his shoulder was extremely sore and shot was given too high above deltoid, in the joint fluid.  He had soreness, inflammation and could not even touch.
2:03PM:  nausea, light headed and visual changes (light became brighter)  2:16PM: Zofran 4mg tab po given.  02:25PM: discharged:  pt no longer experiencing symptoms.   03:05 PM:  contacted pt to let pt know that we will report the adverse effect.  Pt states "am fine".   E. R if symptoms return.  Pt aware.
Apparently a few hours after FLUMIST was admin. pt developed fever, vomiting and abdominal pain. As of 11 AM on 10-16-12 symptoms continue.