chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/30/21- Pt is a 56yo White male who presented to the Clinic for 1st Moderna vaccine via MyTurn registration. Patient answered No to all of the vaccination screening questions on MyTurn. At 1000, patient was checked in by staff. Immunization was administered approximately at 1002. Around 1007, the clinic providers were called for emergency response by CORE team member who was stationed at the observation area because this patient lost consciousness, fell down, and hit his head.  NP arrived to the scene with Emergency Epinephrine pen and benadryl tablets. RN was already at scene and assessed for patient's consciousness. EMS was called by Google volunteer. Patient was seated in the chair, being monitored by the clinic and CORE team member. Pt was unresponsive and actively undergoing tonic seizure-like activity with sustained posturing of bilateral hands in decorticate "cup" position. Patient's eyes were open during entire seizure-like activity, but unresponsive to stimuli. Inflamed abrasions were noted on patient's right temporal lobe, right cheek, and bilateral lower extremities near the knees. No active bleeding was seen.  At 1008, Pt regained consciousness after 10 seconds of seizure activity and began to answer RN's questions. Patient stated that he was "fine" and answered that he knew his current location "at the vaccination site." Pt was unaware that he lost consciousness, fell to the ground, and hit his head. Pt denied any active medical illnesses, hx of seizures, or reactions to prior vaccinations. Pt stated that he drove here to the appointment. Patient was given bottle of water, which he started drinking. NP measured pt with pulse oximeter, reading 98% O2 Saturation and 61bpm for heart rate.  NP arrived to the scene. The medical staff RN, NP, and NP advised for patient to stay and wait for EMS out of concern for his own safety and the safety of others because he will be driving home. We informed pt that EMS has already been called and for him to stay hydrated while waiting. Pt stated "I do not want to go to the hospital" and refused EMS evaluation. I informed pt that due to sustained head injury, LOC, and seizure activity, we highly advise for patient to seek further medical evaluation. Pt refused and walked away from the observation area to his car.  Adverse Reaction was reported to VAERS and CMO of the clinic.
first tested positive for COVID-19 on August 6th. He received monoclonal antibodies at an outside facility on 8/12, and felt generally well until two days before admission. The morning of admission he began experiencing body aches, HA, sweats, fevers, and cough, and vomiting
Information has been received from a registered nurse concerning a patient of unknown age and gender. The nurse reported than an expired dose of PROQUAD (lot # M002053, expiration date 11-JUL-2017) was administered to the patient on 13-JUL-2017 (route of administration not provided). The vaccine was reconstituted with sterile diluent (MSD) (unknown lot number and expiration date). No information was provided regarding the patient's past medical history, concurrent conditions, or other concomitant medication. No adverse effects. No further information to report. Lot number M002053 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. Additional information has been requested.
The ringing in ears still today. Other symptoms after 2nd dose: fever, headache, body ache, chills, fatigue, sore throat that lasted 2-4 days for all symptoms besides ear ringing to go away.
Febrile seizure (atypical) approx 2 wks later. Required intubation for prolonged seizure. Transferred to PICU.
Fever, chills and back pain starting from 2:00am and all throughout the next day. Very tired with headache from noon 4/6/2021 til approx 6am  on 4/7/2021. To summarize adverse events included fever, chills, headache, and tiredness. The side effects lasted approximately 28 hours.
Patient began feeling dizzy, and warm; patient's eyes appeared to roll back into her head and EMT was called.
Patient stated that she had a fever within the first 24 hours after receiving the shot, she said that she was okay with that but a few days later she broke out into a rash.
seizures after receiving a dose of Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of seizure in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-OCT-2023, the patient received Shingrix. On 06-OCT-2023, less than a day after receiving Shingrix, the patient experienced seizure (Verbatim: seizures after receiving a dose of Shingrix) (serious criteria GSK medically significant).  The outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Shingrix.     It was unknown if the company considered the seizure to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-OCT-2023 A member of the public called in to request information about the incidence of seizures after receiving a dose of Shingrix. The reporter accepted to receive follow up and were transferred to the agency. The reporter consented to follow up.
Age 17 1/2; A spontaneous report was received from a consumer, concerning a 17-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) at age 17 1/2 (product administered to patient of inappropriate age).  The patient's medical history includes ulcerative colitis. Concomitant product use was not provided by reporter.  On 19 Mar 2021, patient received herr first of the two planned vaccine doses of mRNA-1273 (lot number: 045A1A) intramuscularly for COVID-19 infection prophylaxis.  On 19 Mar 2021, the patient received vaccine at the age of 171/2.  Action taken with mRNA-1273 in response to the event was not provided.  The event, at age 17 ½, was considered resolved.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot #: 045A1A, with no associated AEs.
pt recvd vax & became unresponsive (difficult to arouse) & pale (and cyanotic);pt was adm to hosp x 3days;it is noted the pt had an apneic episode;pt discharged from hosp on 15NOV95 w/apnea monitor;woke up w/diff cry;was pale, not response
Pain and swelling at injection site, body aches, headache, low fever (100 F), fatigue, chills, rash on both arms and on chest and on both sides of neck, swollen lymph nodes under arms and on sides of neck, itching all over body, sore throat, and mild chest pains directly over heart.  Also, patch of 'blood freckles' appeared on right shoulder--perhaps it is small rupture of blood vessels showing on the skin?  Not sure of medical term for 'blood freckles'. Received the vaccine approximately 8 hours ago.
Patients states she had excessive dry mouth (couldn't get enough to drink), fever of about 100.5 F, headache, and she reports "feeling like her head was going to blow off like she was having a stroke"
Provider ordered Pediarix, HIB, PCV13 and Rota virus. The caregiver gave pentacel, pediarix, PCV13 and Rota virus. The patients mother was contacted and stated that the baby was fussy for 36 hours but had no redness or swelling at the injection site and is acting normal now.
Had the shot, still got Shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient had got the shingle shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
PHN gave Prevnar inappropriately regarding age.  No symtoms/rx observed.
This spontaneous report was received from a medical assistant, refers to unspecified patiens of unkonwn age and gender. No pertinent medical history was reported. On an unknown date, unspecified patients were administered GARDASIL (strength, dose, route, lot# were not reported) which were exposed to temperatures of 10 degrees Celsius for 7 hours and 45 minutes. No adverse events were reported. This is one of the several reports from the same source. Additional information has been requested.
elevated ALk Phos; elevated ALT; elevated AST; feel bad; feverish/ 102+ degree fever; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 30Mar2021 17:00 (at the age of 21 years) as dose number unknown, single for covid-19 immunization. Medical history included known allergies from Tree Pollen from an unknown date and unknown if ongoing (known allergies: Tree Pollen). Concomitant medication(s) included ibuprofen and vitamin d nos taken for an unspecified indication, start and stop date were not reported taken within 2 weeks of vaccination.  The patient previously took trumenba and experienced adverse event. Prior to vaccination, was the patient was not diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19. On 03Apr2021 the patient experienced feel bad, feverish after 4 days after the vaccination then 2 days after that he had a 102+ degree fever continued for at least 10 days and Blood test 13 days after vaccination patient had elevated ALK PHOS, ALT, AST on an unspecified date of 2021. Adverse Events were considered as nonserious. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. On unspecified date the patient underwent lab tests and procedures which included blood test included elevated alk phos, alt and ast, body temperature found to be 102+ degree, tested for flu found to be negative, tested for mono and tested for strep found to be negative. On 05Apr2021 patient was tested for PCR Test and Rapid Test found to be negative. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After waiting 15 minutes after the administration of the Pfizer vaccine, the patient and his mom left the pharmacy. According to the mother, the patient told her in the parking lot that he was having dizziness and a little bit of shortness of breath. So they came back to the pharmacy. The mother also stated that he had asthma when he was younger but that she suspected he grew out of it. He had no other symptoms of a possible allergic reaction. I gave him 10ml of Benadryl (25mg) as a precaution. They stayed 25 more minutes after Benadryl as a precaution, as the mother also contacted his physician for further directions. After that 25 minutes, the patient said he was feeling fine, and that they will be going to get something to eat.
FELT LOUSY; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced felt lousy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt lousy was not reported. This report was non-serious. This case, from the same reporter is linked to 20211057399.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 21-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated).    No concomitant medication information was reported.  On 20-Feb-2023, patient received dose of 25 microgram of monovalent Moderna vaccine as first dose having batch no.: AS1417B.  No adverse effects were noted. Appropriate vaccine was scheduled or given as indicated by the CDC.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
22 year old male developed red, warm, swollen left upper arm, which progressed to mid forearm 2 days after administering 3rd anthrax vaccination. Treated with arm elevation, Motrin and Claritin x 7 days.
Patient incorrectly received pediatric Pfizer formulation for her booster dose on 1/8/2022. Parent was notified and CDC guidance was shared. Guardian was referred to patients pediatrician if any additional questions.
the patient was given VARIVAX after a TE event; no additional AE; This solicited report was received from nurse and refers to an 18-month-old female patient. The patient's medical history and concurrent conditions, as well as concomitant therapies, were not reported.  On 07-MAR-2023, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W020525, expiration date: 14-DEC-2023, administered intramuscularly, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #W001519, expiration date: 13-JAN-2024, varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, (lot # reported W121740) and  diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), (lot# W3678444) administered intramuscularly, all for prophylaxis (Strength, dose and frequency were not provided for all vaccines). The vaccines had a temperature excursion which was detected by a data logger. No adverse event was reported.  Lot # W121740 is an invalid lot# for varicella virus vaccine live (oka/merck).  This is one of several reports from the same reporter. ; Sender Comments: Keywords : US-009507513-2303USA006990:MSD US-009507513-2303USA007002:MSD US-009507513-2303USA006967:MSD
This spontaneous report prospective report as received from a physician refers to an approximately 16 years old female patient. The patient's concurrent conditions and medical history was not reported. On 14-JAN-2015 the patient was vaccinated with the third dose of GARDASIL (Lot no. # K005881 and expiry date: 14-JAN-2017) (Dosing regimen and frequency unknown) before the patient discovered that she was pregnant (Vaccine exposure during pregnancy). Concomitant medications were not reported. On 11-OCT-2010 the patient was vaccinated with first dose of GARDASIL (lot # and expiration dates were not reported). On 12-SEP-2014 the patient was vaccinated with second dose of GARDASIL (lot # and expiration dates were not reported) and on 14-JAN-2015 was vaccinated with third dose of GARDASIL (Inappropriate schedule of vaccine administered). It was reported that the performed by the patient's unspecified obstetrician. No adverse event was reported. The patient estimated date of delivery was 12-SEP-2015. No product quality complaint (PQC) was reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. Additional information has been requested.
Since 3 December he has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on his body, especially at sites of pressure or where his skin is scraped or scratched. Lesions last less than 24 hours, affects his palms and soles, and resolve without post-inflammatory changes. Symptoms led him to present to the ER on 4 December where he was treated with oral corticosteroids; he subsequently received three additional courses of IM and oral corticosteroids with only limited benefit. He denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. He received his Moderna COVID-19 vaccine booster dose on 19 November, 14 days prior to onset of symptoms. He has used oral antihistamines with minimal benefit. He denies constitutional symptoms. UCT score today is 5 (1, 1, 0, 1, 1, 1, 0, 0). No history of adverse reactions to prior vaccines.
COVID 19 Treatment: Paxlovid, start date: 25Jan2023; COVID 19 Treatment: Paxlovid, start date: 25Jan2023; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment: Paxlovid, start date: 25Jan2023". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
26 hours post I took a hot shower.  While drying off, I noticed my legs itching. I applied Vaseline Intensive Care lotion like I usually to after shower and noticed my legs and feet were pretty red. I called my husband in to look at my back, nothing on back, chest or arms. Considered taking a Benadryl due to itch and redness but afraid it would make me sleepy at 4:00 pm. Then over a period of about 15 minutes total after stepping out of the shower, it was fading quickly along with the itching and completely gone within  20 minutes. The lotion helped the itching about 75% initially.
Loss of taste; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), AGEUSIA (Loss of taste) and FATIGUE (Fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included WARFARIN, METOPROLOL, OXYBUTYNIN and LEVOTHYROXINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (Fatigue). On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Feb-2021, the patient experienced AGEUSIA (Loss of taste). At the time of the report, PAIN IN EXTREMITY (Sore arm), AGEUSIA (Loss of taste) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Heart palpitations, fluttering, and racing. Symptoms began 24-48 hours after vaccination dose, tapering off over time. Also noticed similar symptoms following COVID-19 infection approximately a year after vaccinations. Palpitations occurred 10-15 times per day and slowly dissipated over time. Now occurring 3-5 times per week (4 Oct 2022).
Within 30-40 minutes of the booster shot, small hives started breaking out on my arms and hands - then spread to other parts of the body and face over several days.  Some were more flat-like (small raised bump) and red spots - which itched and caused irritability.  Others were blistery and scaly and painful. Some large, some very small.  They slowly faded or healed over 3 weeks or so.  I tried Allegra, but didn't do much.  I then took Benadryl at night to get some sleep.  I have a few scars.  No fever.  I've never reacted this way to any other vaccine before.   I called the Pharmacy RX and reported the reaction to the tech.  A nurse then called and asked several question for her report. She then asked me to fill out this form.  I also reported the reaction on my CDC weekly checkin texts.   This reaction was notable ODD because with all the other Covid vaccines/boosters I had a sore arm, more flu like symptoms or headaches for a day or two and then all better.  This time, NO other symptoms, not even a sore arm -  Just hives.
After the vaccine I was feeling really tired and couldn't stay awake. I went in to urgent care center, where I was transferred to the Hospital I was admitted for 7 days. I ended up getting a pacemaker and defibrillator. Still under doctors care.
Arm swelled, turned red and swollen. Had a hard knot.  Got cellulitis and spent 2 days in hospital.
Difficulty breathing, found to be hypoxic with pulse oximetry reading 60% Patient was sent to hospice for DNR status as well as comfort care Continue with antibiotics
Patient received Prevnar 20 vaccination in left deltoid. Reported to pharmacy staff on 12/14/22 that on 12/13/22 he began experience a "red welt" on skin under arm near the axillary area that was tender, swollen and warm to the touch. Patients states that he has not taken anything or sought medical care for the adverse event,  and that is has been stable over the last 24 hours.