chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Noted no reaction at time of vaccination.  8-10 days later, developed red, flat, itchy, dry, scaly rash beginning on thorax - upper chest.  2-3 nickel-sized spots on each arm.  Not responding to OTC hydrocortisone or Benadryl cream.
Extreme dizziness during the night, weakness and headache (took Tylenol 650 MG  for headache). Around 6 AM got out of bed to use toilet.  Wife heard a loud crash and found me in bathtub.  I don't recall falling but shower curtain fell down and have minor neck and back discomfort at this time.  Wife assisted me to crawl out of tub and she reported I "passed out" two more times for short durations as I crawled back into bed. Had profuse cold sweating episode for about 15 minutes.  Much less weakness now at 10 am, no dizziness but still a mild headache.
>42 days between the first and second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days between the first and second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days between the first and second dose). On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days between the first and second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not provided.
Right after the shot, pt feels dizzy and went passing out for a few seconds, turn pale,  then came back within seconds, start sweating and was laid on floor. Paramedics came and checked on her, she is alert and responding  to questions. She went home with Mom after being checked by paramedics.
deep tender pain that extended down the arm for four days,   diarrhea for three days and  The next day post vaccine I began to have muscle spasms-twitching and  in r arm and in various body locations, such as R rib muscles and bilateral buttocks, lower back muscles  and r arm bicep and Forearm intermittently  for up to 5 days and also had moderate to severe cramping  intermittent of leg muscles R /L buttocks hamstrings and calves, charlie-horse like at times, and overall body aches these symptoms lasted for 5 days. The  mild sore throat and moderate headache for two days. *** Missed several days of work.
1PM 1MAY97 mom noticed pt was warm & checked temp 105;was not quite as active;ate decent breakfast & lung;woke up middle of noc;mom gave APAP;2MAY97 did not feel warm & did not check temp;no sites swollen;
Woke up the next morning with chest pain and palpitations and chest tightness Came to office, normal exam and vitals. EKG ordered and abnormal. recommend going to ER
A few days after receiving the first dose of the Moderna vaccine in my left arm, a large red mark appeared on my arm. It looks like a rash and is warm to the touch compared to skin elsewhere on my body. I do not experience any discomfort such as itching or pain when touching this rash, it is just pretty bright red and inflamed.  The rash appeared on 4/19 and has not gone away at all, if anything it has gotten larger, and it is now 4/27.
This case was reported by a nurse and described the occurrence of chest tightness in a 37 year old female subject who was accidentally exposed to influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the subject. Medical history included a "severe" egg allergy. The nurse also reported that she is "not latex sensitive." On 03 October 2005 the subject was removing a label from a used Fluarix viral. She reported that she "did not use gloves when handling the vaccine." "Within minutes" on 03 October 2005, the subject "noticed that her mouth and lips were itching and she was coughing." "Later that day," on 03 October 2005, the subject administered a Fluarix dose to a patient and she "noticed the same symptoms." On 03 October 2005, the subject "took a desloratadine (Clarinex) and within 30 minutes, the events resolved." On 04 October 2005, the subject was again accidentally exposed to Fluarix when a small drop of the vaccine was expelled from a syringe. "Shortly" after the accidental exposure to Fluarix, on 04 October 2005, the subject again experienced itching of the mouth and lips, coughing and "slight chest tightness." The subject state that, "these symptoms never happened when she administered Fluzone (influenza virus vaccine)."
Extreme itching that started on chest & went up neck " dry throat and itchy", increased heart rate.  Was given BENADRYL and steroids at local ER.
MOTHER REFERS THAT PATIENT STARTED TWO DAYS AFTER VACCINATION WITH RASH ON FACE (1/03/2017). THE NEXT DAY SHE HAD RASH ALL OVER BODY AND MOTHER GAVE HER ZYRTEC. MOTHER REFERS THAT ON SUNDAY (1/8/2017) THE RASH WAS TOO MUCH FOR PATIENT AND TOOK HER TO A NEARBY HEALTH CLINIC, THE ATTENDING DOCTOR TOOK A CBC AND EXPLAINS TO MOTHER THAT THEY UNDERSTAND SHE HAD A REACTION TO THE VACCINES ADMINISTERED.
STARTED WITH FEVER, CHILLS, MYALGIAS. TAKEN UNRESPONSIVE TO LHC (PROBABLE ADRENAL CRISIS) FOUND WITH LEUKOCYTOSIS (30,000 WBC) RHABDOMYOLISIS AND ACUTE KIDNEY INJURY.   HOSPITALIZED AND IMPROVED.
I woke with extreme chills. I had a low grade temp of 99.6, when I got up for work. I went to work. When I got there I started to sweat intensely. This cycle happened throughout the day. I went to bed at 8:30pm and woke up the next day at 9, feeling back to normal.
pt recv vax; devel flu like sx w/ high fever & extreme muscle aches & "felt horrible";w/in 48 hr, sx resolved;
6pm I had chills and malaise associated with a pounding temporal, occipital, and frontal lobe headache. Also had a sour stomach ache and felt nauseous intermittently. Felt intermittent periods of dizziness. Took Tylenol, felt as if i was burning up in bed and checked temperature at 99.1. May have had a true fever if I hadn't taken Tylenol. Prior to Tylenol my temperature was 97.7.
Injection site reaction. Red, sore, shaped like an egg, but not swollen. Appeared 2 days after injection, redness is subsiding.
Initial and follow up information has been received through the Merck pregnancy registry for GARDASIL from a registered nurse concerning a 16 year old female with depression and anxiety with no prior pregnancies who on 02-JUL-2007 was vaccinated IM with the first dose (0.5 ml) of GARDASIL (Lot# 0212U). Concomitant therapy included ZOLOFT and EFFEXOR. Subsequently, the patient became pregnant. Last menstrual period was 18-JUN-2007 and estimated date of delivery was 24-AR-2008. On 24-OCT-2007 the patient had a routine ultrasound which was within normal limits. On an unspecified, the patient developed nausea and was placed on therapy with PHENEGRAN and ZOFRAN. On 08-MAR-2008 at 37 weeks/4 days the patient had a 7 lb. 2 oz. live born infant with an Apgar score of 8/9. It was reported that the baby was adopted out. Additional information is not expected.
flu-like symptoms- nausea, ache, dizziness, sleepiness for 30 hours after injection
left sided facial droop, consistent with bells palsy  (hx of right sided bells palsy 17 years ago age 19.
I have worsening tinnitus in both ears; mental health; depression worse; This is a spontaneous report from a contactable consumer (patient).  A 53-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18May2021 11:00 (Lot Number: ewc177) as single dose for covid-19 immunisation at Pharmacy or Drug Store.  Medical history included Major depressive disorder (ongoing), tinnitus (ongoing) insomnia, arthritis and menopause. Concomitant medication included venlafaxine (VENLAFAXINE 75 mg) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took nickel sulfate, morphine and benzoyl peroxide and experienced drug hypersensitivity. The patient previous received the first dose of bnt162b2 for covid-19 immunisation on 27Apr2021 14:00, in left arm (lot number EWO171) when 53 years old. The patient experienced worsening tinnitus in both ears (tinnitus) (medically significant), mental health (mental disability) (non-serious), depression worse (depression) (non-serious) on 30May2021 with outcome of not recovered. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient was not treated due to the events. Prior to vaccination, the patient was not diagnosed was not with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient reported she had worsening tinnitus in both ears.  What was once a low hum for several years, was now a remarkedly high pitched hiss in both ears since getting the 2nd dose of the vaccine. Loud enough to be heard over normal conversation and her television set. It was negatively impacting her mental health and making her depression worse.
Pt. reported back to ED on 03/10/2021 to show staff his local reaction after recieving his 2nd dose of covid-19 vaccine. Upper left arm was covered in purpura/ ecchymosis type bruising. Pt. also still has a spot high on the upper right arm that is scabbed over approximately 4mm in size with little redness. Pt. reports only slight soreness on the left arm and no soreness on the right arm. Bruising noted on the lower half of both arms as well. Pt. has not and does not plan to seek medial attention for this local reaction and just wanted to show the ED staff how his arm looked. Pt. states that this local reaction does not limit his ADLs.  pt. reports taking blood thinners and aspirin for 3 years.
Approx. 5 min. after Td injection client experienced strange tightness in left jaw for about 20 min.  Not painful some some radiation left side of face.
Severe vomiting & diarrhea 12 stools 6 vomit. Excessive crying & irritability, inconsolable. No fever. No blood in stools. No WBC in stool last 24h. hospitalized.
Started with heaviness on shoulder with pain and fever which normally expected but by noon severe body aches and severe pain on right lateral side of the body from waist up, by night I felt severe pain as if needles needles pricking. Make an appointment with primary care to find out I had developed Cellulitis and started pain medication and antibiotics. On 01/27/2018 I had my regular eye dilation check for Diabetic Retinopathy where the optometrist saw some swelling on the optic nerve. Has a stat MRI and an ophthalmologist appointment on 01/31/2018 where Dr and 2 other Ophthalmologist came to a conclusion that I have developed Optic neuropathy and papilledema. After that had a series of test and specialist appointments for next 2-3 months. The test conducted and MRI as well as spinal tap results were concluded normal. The tests are mentioned below.
Diarrhea; Diagnosed with Urinary Tract Infection; Nausea; Dizziness; Cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), COLD SWEAT (Cold sweat), URINARY TRACT INFECTION (Diagnosed with Urinary Tract Infection), DIARRHEA (Diarrhea) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Allergic reaction to antibiotics (Clindamycin) and Penicillin allergy. Concomitant products included METOPROLOL, MULTIVITAMINS [VITAMINS NOS], LUTEIN [XANTOFYL] and POTASSIUM for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DIZZINESS (Dizziness), COLD SWEAT (Cold sweat) and NAUSEA (Nausea). On 23-Apr-2021, the patient experienced URINARY TRACT INFECTION (Diagnosed with Urinary Tract Infection). On 25-Apr-2021, the patient experienced DIARRHEA (Diarrhea). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) on 23-Apr-2021 for Urinary tract infection, at a dose of 1 dosage form for 10 days. At the time of the report, DIZZINESS (Dizziness), COLD SWEAT (Cold sweat) and NAUSEA (Nausea) outcome was unknown and URINARY TRACT INFECTION (Diagnosed with Urinary Tract Infection) and DIARRHEA (Diarrhea) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Complex B with C is the other concomitant medication reported by reporter.  Patient stated that on 27-28Apr2021 that she Feeling better, urinary tract infection/diarrhea resolving.
This should of been administered into the deltoid muscle, however this was administered into the triceps muscle. The patient complained of pain, soreness, redness, swelling at the injection site beyond normal. It seemed that it was possible that capillaries may have been broken during administration that caused this.
Patient received Td after dogbite.  Rash all over her body with itching.  Redness and tendernesss to injection site.  No shortness of breath.  Sought MD's advice:  Elidel to face Bid; Elocon cream to rest of body daily until clear; Atarax 25 mg q6 hours prn itching; Levoquin 750 mg daily x 5 days
Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a seven-months old patient who received PENTACEL injection, without the HIB. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 20-Jul-2018, the patient received a 0.5 ml third dose of suspect PENTACEL via unknown route in unknown administration site. Lot number and expiry date was reported as Lot C5420AA exp. date 02-September-2018, NDC Not available per provider; Lot C5230AA exp 02-September-2018 NDC Not available per provider. It was a case of actual medication error due to inappropriate reconstitution technique. It was reported that MA staff member gave a PENTACEL injection without the HIB (missed dose of HIB) as the diluent was not available to administer the HIB portion. HCP notified the consumer and MA administrator was counseled. Plan is to administer ACTHIB for missed dose at future date. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
No additional AE/PQC; PROQUAD administered post temperature excursion; This spontaneous report was received from a Licensed practical nurse and  refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and historical drugs was not provided. Concomitant therapies included sterile diluent.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella  (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) lot # S031881, expiration date 07-APR-2021, 0.5 milliliter for prophylaxis (strength, frequency and route of administration were not reported).    The improperly stored suspect vaccine experienced a temperature of -9 degree Celsius (°C) to 8°C with an average of -2.8 °C  for 5 hours and  2 minutes. There was no previous temperature excursion.  The call was made due to a digital data logger. No adverse symptoms were reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA001249: US-009507513-2009USA001227:
COVID 19 Treatment; COVID 19 Treatment; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 18Jul2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Feb2021 as dose 1, single (Lot number: 030M20A), on 08Mar2021 as dose 2, single (Lot number: 026A21A) and on 12Nov2021 as dose 3 (booster), single (Lot number: 067F21A) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CITALOPRAM, start date: Jan2000, stop date: 13Sep2022; OMEPRAZOLE, start date: 01May2022, stop date: 13Sep2022; ATORVASTATIN, start date: Jan2007, stop date: 31Aug2022; VIT D [COLECALCIFEROL], start date: Jan2007, stop date: 13Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was received from 01Sep2022 to 05Sep2022 (lot number:00069-0345-30) for the treatment of COVID-19. And experienced Headache, sore throat, body aches and fever resolved during treatment but recurred on 09Sep2022 (day 9).; Sender's Comments: The reported COVID-19 positive after BNT162b2 COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.Based on the information, the causal association between the event interchange of vaccine products and the use of suspect product BNT162b2 cannot be fully excluded.
Patient attended a clinic at the Health Department on 10/26/2022 accompanied by son in law, who requested that she receive a flu shot.  Flublok was administered.  Daughter called HD on 10/27/22 to advise that patient had received a flu shot at her assisted living facility the previous week and request had been made in error.  Staff with the Assisted Living Facility on 10/27/22 and confirmed that patient had received Fluzone High dose on 10/21/2022.  To date, there have been no reports of an adverse reaction.
Expired Ipol was administered to patient with no ae; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Global Medical Information (GMI) (Reference number- 00567366) and transmitted to Sanofi on 19-Apr-2021.  This case involves a 4 years old female patient who an expired 0.5 mL dose of IPV (VERO) [IPOL] (lot R1B251M and expiry date: 13-Mar-2021) via intramuscular route in the left arm (expired product administered) for prophylactic vaccination on 06-Apr-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  No other vaccines received by patient.   It was an actual medication error case due to expired vaccine used (latency: same day).   The reporter wanted to know how soon they can revaccinate and wanted to reverify the information.   At the time of reporting, the patient experienced no specific adverse 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 Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My daughter recently got the Gardasil 9 vaccine and boke out in rash after getting vaccine; This spontaneous report was received from a company representative referring to her daughter a patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. The reporter stated that the patient broke out in a rash after getting the vaccine. The outcome of rash was unknown.        The causality assessment between rash and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
on 4/26/08 patient was admitted to the Pediatric ICU for bright red blood per rectum. found to have intussuception and taken to the OR. At surgery found to have Meckles diverticulum by pathologic examination. 8/15/08-vaccination record received-documents that Rotateq was refused. 8/25/08-records received for DOS 4/26-4/30/08-DC DX: Intussusception. Lethargic on morning of 4/26/08, bright red blood per rectum. Mass down to rectum with bright red blood. Exploratory laparotomy revealed intussusception Meckel's diverticulum. Small bowel resection with primary anastomosis and appendectomy.
He started a fever on the 9th of 100.6. Every day following he ran a low grade temperature between 99 and 100.1 for 22 days.
patient arrived at drive through flu clinic and presented her insurance card. it was assumed the patient was 65+, however she was only 64 years of age. no adverse side effects were reported.
1st dose of Gardasil received on 5/31/07. Patient experienced syncope after 10-15 minutes.
This spontaneous report as received from a nurse refers to patients of unknown demographics. The patients' medical history was not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX (Strength, dose, frequency, route and anatomical location were not reported) of lot # M038859 with an expiry date of 14-SEP-2018, for prophylaxis. Co-suspect therapy included sterile diluent (Strength, dose, frequency and route were not reported) of lot # N006324 with an expiry date of 19-JUL-2024. There were no concomitant therapies reported. The vaccines were exposed to - 2.4 degree Celsius (C) for 1 hour and 7 minutes. There was previous temperature excursion which involved exposure to - 6 degree Celsius (C) for 2 hours. Digital data logger was involved. There were no adverse effects reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Lot number N006324 has been verified to be a valid lot number for sterile diluent. Sender's Comments: US-009507513-1709USA000772.
2 weeks following her first Moderna covid 19 vaccine, pt woke up early Saturday morning on 4/10/21 with pain in left arm. The pain is described as throbbing, deep pain as well as superficial pain to skin from left shoulder to elbow on same arm as vaccination. No redness, no rash, no obvious signs of swelling. Pt feels what could be described as tightness inside. Pt has applied heat to arm and this has not helped. Ibuprofen has not helped either. Advised pt to report this to her PCP and notify health dept after follow up.