chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incorrect product storage; no adverse effect; This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patient's relevant medical history, concomitant medications, concurrent conditions or drug reactions/allergies were not reported.     On unknown dates, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R035221 expiration date 04-DEC-2020; lo# S005078 expiration date 19-FEB-2021; or lot# S002392 expiration date 23-JAN-2021 for prophylaxis (dose, strength, frequency, and route of administration were not reported).         The patients experienced no adverse events. It was reported that the vaccines had a temperature excursion of 6°F to 14°F (5.7F) during 25 minutes. No previous temperature excursions were reported. Digital data logger was involved.
I started with a red rash on my thigh then it went up to my buttocks and my back my doctor diagnosed me with plaque psoriasis.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (dose and route were not reported), lot # Joo6995, expiration date 14-JUN-23015; lot # J013315, expiration date 18-OCT-2015; lot # K002527, expiration date 18-FEB-2016; lot # K006396, expiration date 04-MAY-2016 and lot # reported as K002919, expiration date 26-FEB-2016. Total number of doses administered was 17. No adverse effects were reported. This is one of several reports received from he same reporter. Additional information has been requested.
Patient was 3 month when she got chickenpox. Have not receive varicella shot.
Headache, Myalgia, Fever, NauseaVomiting, Fatigue, chills, loose stool Narrative:
Patient is a 53-year-old female who presented to the emergency department with chief complaint of confusion, generalized weakness and shortness of breath.  In the emergency department, the patient was found to be COVID-19 positive and to have a pulmonary embolism.  She was found to be hypoxemic in the emergency department and placed on supplemental oxygen. She was started on a heparin drip, Decadron and remdesivir.  She was admitted to the with pulmonology consult. Pulmonology recommended completing remdesivir & decadron, anticoagulation for PE and obtaining echocardiogram. She was weaned to room air. Echocardiogram was obtained and revealed EF 60%, no regional wall motion abnormalities noted. She was started on Eliquis for pulmonary embolism.  Patient was significantly hyperglycemic and endocrinology was consulted. Her hyperglycemia was most likely secondary to steroids. Endocrinology recommended insulin basal bolus for hyperglycemia.   She was evaluated by PT/OT and acute inpatient rehab was recommended. PM&R was consulted.    On the day of discharge, the patient denied any chest pain or SOB. She stated that her cough have improved. She denied any fever or chills. No nausea, vomiting or abdominal pain. She was tolerating diet. Her vital signs have been stable. She was seen by endocrinology and they recommended that the patient should continue insulin therapy during decadron therapy (lantus 22 units daily, humalog 1 unit for every 5 g of carbs plus correction). Once decadron therapy is completed, metformin 500 mg bid should be started. The patient was discharged in stable medical condition.
Patient tolerated well no adverse reaction, dose given after moderna bivalent vial was in the fridge longer than 30 days.
Woke up on 7 June with a head cold like symptoms.  Took home COVID test which showed positive.  By the time filling out this form, 8 June (9:30 PM) feeling normal.
GAVE WRONG VACCINE TO PATIENT. PATIENT WAS HERE FOR SHINGLES VACCINE AND RECEIVED COVID19 PFIZER VACCINE. PATIENT WAITED IN CLINIC WAITING ROOM FOR 20 MINUTES BEFORE LEAVING STORE.
second dose was given late; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 26th July 2022, the patient received the 2nd dose of Twinrix. On 26th July 2022, the dose was an unknown dose. On 26th July 2022, the patient started Twinrix Pre-Filled Syringe Device. On 26th July 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Jul-2022 Reporter's Comments: The pharmacist reported the patient received first dose of Twinrix series on 25th May 2022 and second dose was given late on 26th July 2022.   Both doses were administered from lot number 4F3YY. The reporter consented to follow up Additional Supportive Information: The patient received 2nd dose of Twinrix on 26th July 2022, later than the recommended standard schedule, which led to lengthening of the vaccination schedule.
After the COVID-19 shot "I" haven't had a period at all; I've got brain fog; Ive got hot flashes; Ive got thinning hair; Early onset menopause/ I havent had a period at all / got full-blown menopause; Received the vaccine on the left leg; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left leg on 05Jun2021 at 16:15(at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN), multivitamin (unspecified) and probiotic (unspecified); all for an unknown indication from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 16:15(at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 11Aug2021, the patient experienced early onset menopause. The patient had absolutely no symptoms and her periods were absolutely regular and she reported she was mad about the age but still to go from zero symptoms to full on menopause (meta-paws) right after, seemed too much of a coincidence. The patient had been completely regular, no hot flashes but after the COVID-19 shot, she hasn't had a period at all. She had brain fog, hot flashes, thinning of hair, full-blown menopause and she did not have any warning or symptoms beforehand. The events resulted in doctor or other healthcare professional office/clinic visit. It was unclear if therapeutic measures were taken as a result of events. It was also reported that the patient had appointments coming up. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events early onset menopause, after the COVID-19 shot haven't had a period at all, got brain fog, hot flashes, thinning hair, full-blown menopause was not recovered at the time of this report.   The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Info has been received from a health care professional concerning a child who received an injection of Prevnar. W/in 4 hrs of administration, the child experienced a seizure. This event was considered medically important. No further info was available at the date of this report.
Pt developed lump in bilateral thighs.  Was not immediately reported by parents, unknown when lumps developed.  Pt seen in office 6/15/22 for deceleration in weight gain.  6/27/22 pt started on iron supplement for iron deficiency anemia.  Pt seen again 7/7/22 for mass of both thighs and congestion.  US ordered and to be done when family returns back from vacation over this next weekend.  Pt seen 7/20/22 for abscess.  Mother notes that the left side area opened up and began draining purulent material, and mother notes that it is now significantly decreased in size. Pt developed COVID 19 and subsequently ultrasound not completed until 7/28/22.
Red, swollen, painful from site of injection to elbow, fever. Reaction occurred within a few hours of vaccination. Recommended ice & Ibuprofen, ER if worsens, call in AM for follow-up. On follow-up - pt feeling better. Swelling decreasing - no ER needed.
SORENESS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, on the left arm, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced soreness, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness and headache was not reported. This report was non-serious.
pt recvd vax & w/in 24hrs pt exp bad cold,coughing & a thick mucous post-nasal drip;sx cont;addl pt exp sensitivity @ the lt arm inj site;pt recvd 1st dose of vax DEC94
2nd miscarriage. July 4th. (First miscarriage prior to first dose of moderna vaccine). Periods completely normal following vaccination.
Anger, big increase in talking, aggression, sleep issues  He received second vaccine dose on feb 23, symptoms were much worse after that, no more than 2 hours sleep, total personality change, wants to yell at everyone, bigger increase in talking, cannot interrupt him, cannot reason with him, thinks he no mores than doctors, starting discontinuing some of his meds.  He was taken to the hospital by ambulance.  He is now 68.  He was diagnosed with Manic (Mania) for the first time.  Has since been admitted to hospital (behavioral facility) and is not cooperating with treatment.  I've been told they have never seen onset of Mania at his age, and they cannot determine a reason.
Heart failure; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "Heart failure".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected..; Sender's Comments: Based on the information in the case report, a possible causal relationship between the event cardiac failure and suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Right thigh red, swollen, warm to touch area 8x5". right leg above knee 11 1/4", left leg above knee 10 1/2", no fever no pain.
Parent signed consent for H1N1 to be given at elementary school on 10-27-09. Parent did not notify nurse or school staff that student received H1N1 dose at Dr office on 11/20/09, so student received dose at school today 12-04-09.
Erythema and swelling to right deltoid to elbow with heat. Patient had difficulty with arm movement. Onset 10/4/05 at about 16:00.
Pt was given the vaccine incorrectly. Was given the powder of Menveo & a sterile Diluent out of a  separate box. No reaction. We need to make you aware & know what to do for patient.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. Since 10-NOV-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lots # L025598 exp date 13-JAN-2017, L004255 exp date 01-FEB-2017, M007125 exp date 06-OCT-2017 and M046919 exp date 17-FEB-2018) (dose and route not reported) orally. The vaccines were exposed to 33.8 °F for 1 hour 25 minutes. A data logger was reported. No adverse experiences were reported. This is one of several reports received from the same source. Lot number L004255 has been verified to be an invalid lot number for rotavirus vaccine, live, oral, pentavalent. Additional information has been requested.; Sender's Comments: US-009507513-1612USA001949: US-009507513-1612USA001950: US-009507513-1612USA001951: US-009507513-1612USA001952:
Some warm skin, red bumps and itching in the groin, on back, upper legs, and buttocks.
Patient reported having flu-like symptoms for 3 days. For one week, patient reported swelling, itching and redness around the site. Patient has reported using ice packs and anti-itch cream as treatment, but they've also reported that the redness has spread down her arm and has gotten bigger.
30 minutes after injection - muscle spasms in both arms from wrists to elbows 45 minutes after injection - itching, warmth, rash, hives on face, neck, chest, arms, and legs 1 hour after injection - eyes watering and inner ears itching and stinging; itching all over body 4 to 5 hours after injection - tongue swelling and tingling
Headache, dizziness, chills, chest pain, throat fullness -- all started at once appx 5 min after the vaccination
01/03/22 presents to Triage "for labor". PMHx of "COVID in pregnancy (12/28/21)" "Anemia, Aphthous ulcers, kidney stones"
Started with itching and rash at injection site. Went away in 2 days. Next day palm of hands and soles of feet became very itchy. Then progressed to whole body itching. Unable to sleep for two nights. Went to urgent care next morning. Was prescribed hydroxyzine 25mg. Itching went away that night and was able to sleep. Next day bilateral hands had numbness and tingling and general dizziness so stopped taking hydroxyzine. Went to family practitioner and was prescribed methylprednisolone dose pack. After starting steroids, by 2nd day (today - 1-21-21), hands continued n/t. Bilateral feet developed n/t. Dizziness continues when standing but goes away when sitting. Balance and gait are unsteady. Difficulty walking from weakness, balance issues, and dizziness.
She got her vaccine she felt a little bit like she had flu symptoms, they were mild so they did not stop her.  She woke up and she could not hear.  A couple of days later she felt liquid like swishing noise around teh right ear.  She went to the doctor who gave her Allegra to take.  She took it and it did not help.  The liquid stopped swishing around.  All of a sudden she started getting dizzy but before she took the Allegra and had Meclizine and took that up until yesterday 1/4/23.  She took the Allegra for 5 days and stopped taking it as it did not help.  She went back to see her doctor and saw an audiologist to see if she had hearing loss and she did and was pretty bad, and she went to an ENT yesterday.  He felt that her reaction was from the vaccine.  Today she is scheduled for an MRI.  The vertigo is very bad, but was given Prednisone dose pack yesterday and this has helped the vertigo but she still cannot hear.  She did not have any hearing problems prior to the vaccine.  She had seen an ENT in the past for nasal issues but that was 3 years ago.    She had a pneumococcal shot a few weeks before the COVID shot.  She did not have any reaction to that vaccine.
Pt had an episode of vasovagal syncope, fell to ground and was sitting up when mom got there but staring blankly and mumbled answers.  Pt was laid down and returned to normal after 3 minutes.
approximately 15 min post vaccine nausea and pain. VS WNL gave water and snack. Md in for assessment, Symptoms improved after observation for additional 15 minutes.
I developed an intense delayed-type hypersensitivity reaction in the injection arm.  My upper arm was swollen, turned an intense red color, was very hot to the touch, and associated with burning and pain.  The reaction is still evident, but has subsided substantially since April 16.  Although not completely resolved, I'm going to select "yes" below for "has the patient recovered .... "
Narrative:  Hospitalization in patient who was fully vaccinated: found to be COVID-positive upon admission. Hospitalized for atypical chest pain and discharged 2 days later.
underdose; underdose was giving due to a syringe malfuncion; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 73-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number e55xz, expiry date 24th May 2022) for prophylaxis.   On 27th October 2021, the patient received Boostrix. On 27th October 2021, unknown after receiving Boostrix, the patient experienced accidental underdose and syringe issue. On an unknown date, the outcome of the accidental underdose and syringe issue were unknown.  Additional details were provided as follows: The pharmacist reported the administration of less than the recommend dose to a patient, on the day of reporting and stated that an underdose was given due to a syringe malfunction, which led to accidental underdose and syringe issue. The dose of the vaccine came from a single dose vial according to the health care professional and into the syringe.  No further events were reported.  The reporter consented to follow up.
Employee stated she is feeling  dizzy, dehydrated, eye sensitivity with classroom lighting, having difficulty focusing.
chronic shoulder pain ever since first shot.  (Left arm). Pain in joint with movement and pain at injection site.
FOUR HRS AFTER VAX (IM RT DELTOID EXP MUSCLE SPASMS IN LOWER BACK,BOTH ARMS BOTH LEGS RESULTING IN CHARLEY HORSES IN LOW BACK. UNCOMFORTABLE FOR 2 DAYS. NO TREATMENT GIVEN.BACK DISCOMFORT CONT UNTIL 4-9-90. PT REFUSED TO CONT VACCINATIONS
RASH, HIVES BEGAN 2 DAYS AFTER, HAVE SPREAD TO ENTIRE BODY (BACK, ARMS, NECK, LEGS, CHEST, STOMACH)
On day 8, rash developed at injection site.  Erythema, warm, itchiness.  Started small and expanded to approximately 10 cm.  Currently day 12 after injection.  Rash seems to have stabilized in size and is lighter in color.
shortness of breath/difficulty breathing; a fast heart rate; chest pain; chills; vomiting; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), HEART RATE INCREASED (a fast heart rate), CHEST PAIN (chest pain), CHILLS (chills) and VOMITING (vomiting) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), HEART RATE INCREASED (a fast heart rate), CHEST PAIN (chest pain), CHILLS (chills), VOMITING (vomiting), FATIGUE (fatigue) and PYREXIA (fever). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), HEART RATE INCREASED (a fast heart rate), CHEST PAIN (chest pain), CHILLS (chills), VOMITING (vomiting), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: abnormal (Inconclusive) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Cardiac related signs and symptoms: shortness of breath, difficulty breathing, chest pain, fast heart rate, fatigue  No concomitant drug was reported.  No Treatment drug was not reported.   This case was linked to MOD-2021-360066 (Patient Link).
Vomiting; Intussusception; Rotavirus infection/diarrhea; This case was reported by a physician via sales rep and described the occurrence of intussusception in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 4TB5G, expiry date unknown) for prophylaxis.   On 22nd August 2019, the patient received the 1st dose of Rotarix lyophilized formulation (oral). In August 2019, less than a week after receiving Rotarix lyophilized formulation, the patient experienced vomiting (serious criteria hospitalization). On 30th August 2019, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant) and diarrhea rotavirus (serious criteria hospitalization and GSK medically significant). The patient was treated with enema preparations (nos) (Enema (Nos)). In August 2019, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the intussusception and diarrhea rotavirus were recovered/resolved.   The reporter considered the intussusception, diarrhea rotavirus and vomiting to be possibly related to Rotarix lyophilized formulation.  Additional details were provided as follows: On 27th August 2019, the patient came back and complaining of vomiting and diarrhea. On 29th August 2019, the patient's mother took the patient to hospital and performed the laboratory tests, but the all tests were negative. On 30th August 2019, the patient's mother went to another hospital and tested positive for rotavirus. The patient was given an enema for the diagnosis of intussusception. No surgery needed because the enema resolved the problem. The patient followed up with on 4th September 2019 and the patient was much improved. The patient had no symptoms after leaving the overnight stay in the hospital. The reporter consented to follow up.
The day following the 1st dose vaccination, my left arm was sore and the vaccination site was red, tender, swollen for about 3 days total then went away. Approximately 1 week following the 1st dose vaccination, my arm felt sore again and I noticed that the area was red again along with the tenderness and swelling. This lasted for about 2 1/2 days. I  found the description for 'COVID-19 Arm' which is the return of swelling, redness, tenderness and soreness and vaccination site up to a week or more after the initial 1st dose. My primary doctor advised (via email) that I contact her if the redness spread. It did not and went away after 2 1/2 days.
Patient is vaccinated with Moderna 2/16/2021, 3/16/21, 10/28/21. Patient presented to the ED with complaint of having a cough, pain in his chest and upper back with cough, body aches, chills, generalized weakness. Patient denied any shortness of breath. Patient stated symptoms started a few days after leaving the hospital from his previous hospitalization. Patient stated he has decreased appetite, but no nausea, vomiting or diarrhea. Assessment noted of Bilateral pneumonia with H/o of COVID-19 on 2/7/22 o CXR with moderate bilateral opacities o Only SIRS criteria met is leukocytosis of 15.23 o Antibiotic therapy with ceftriaxone, doxycycline. No further information. For further information, please contact provider.