chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took third dose a day late; Spontaneous report received on 30JAN2020.  A nurse reported that a consumer "took third dose a day late" (PT: Inappropriate schedule of product administration) while being on Vivotif for immunisation. The consumer forgot to take third dose of Vivotif which was due on 29JAN2020 and instead took it on 30JAN2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took third dose of Vivotif a day late (Inappropriate schedule of product administration) as the consumer forgot to take the third dose on the scheduled date. Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took third dose of Vivotif a day late (Inappropriate schedule of product administration) as the consumer forgot to take the third dose on the scheduled date. Considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.
This spontaneous report as received from the patient's mother who is also a dentist, refers to a 21 year old female patient. Medical history and concurrent conditions were not reported. On an unknown date the patient received complete series of RECOMBIVAX HB injection (strength, dosage route and lot# were not reported). Concomitant therapy was not reported. The patient's mother informed that on an unknown date the patient had low titer levels (below 5), subsequently the patient received a booster of RECOMBIVAX HB injection (strength, dosage route and lot# were not reported), and again did not seroconvert. In 2014 the patient began RECOMBIVAX HB injection (strength, dosage route and lot# were not reported) series again, the patient's mother reported that the second dose was administered 10 weeks and 2 days later. The outcome of the low titer level was unknown. The is one of several reports received from the same reporter. Additional information has been requested.
chest pain; typical side effects; lethargic; doesn't want to eat; cough; fever; administered to a 7-year-old; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), VACCINATION COMPLICATION (typical side effects), LETHARGY (lethargic), DECREASED APPETITE (doesn't want to eat) and COUGH (cough) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a 7-year-old). On an unknown date, the patient experienced CHEST PAIN (chest pain), VACCINATION COMPLICATION (typical side effects), LETHARGY (lethargic), DECREASED APPETITE (doesn't want to eat), COUGH (cough) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 01-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a 7-year-old) outcome was unknown. At the time of the report, CHEST PAIN (chest pain), VACCINATION COMPLICATION (typical side effects), LETHARGY (lethargic), DECREASED APPETITE (doesn't want to eat), COUGH (cough) and PYREXIA (fever) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Reporter reported that, patient received the Moderna vaccine full dose for adults and was younger than 12 years old and experienced almost right away chest pain which diminished the next day and then it came back. After 2-3 hours daughter experienced typical side effects. This has been on and off. Doctors didn't run any tests, they only listened to her heart with a stethoscope. Doctor said the heart sounded fine.
no adverse effect; The patient received dose of PROQUAD and dose of VARIVAX on the same day; The patient received dose of PROQUAD and dose of VARIVAX on the same day; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided.    On 27-DEC-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S011952, expiration date 16-APR-2021 (dose and route of administration were not reported) for prophylaxis and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S021732, expiration date 10-JAN-2021, albumin status recombinant Human albumin (rHA) not provided but established upon internal validation (dose and route of administration were not reported) for prophylaxis. No adverse effects reported.
4/8  4:35-4:50pm: Immediate pain in arm and slight dizziness within the 15-minute observation window.  11:30pm: Onset of uncontrollable full-body tremors (rigors) and body chills with nausea. 101 degree fever.  4/9  1:30am: Nausea worsenes, uncontrollable vomiting. Headache and body aches. Fever persists.  Symptoms continue into the morning hours.   4:00pm: At this point the fever subsides but headache and joint pain remain. Major fatigue sets in. This continues into the night.  4/10: Headache and body aches for most of the day. Fatigue persists.  4/11 (today): Feeling better but still fatigued.
Feeling tired and unwell most of the day and then late in the day, around 4 pm, I had a slight fever and chills which lasted approximately 2 hours.
Patient suffered acute ischemic stroke on 7/26/22.   The symptoms were mild at onset and involved intermittent paresthesias in R face.   Went to ED and was admitted overnight.  Brain MRI showed ischemic infarcts in the deep white matter.  Embolic workup with echo and carotids clear.   Symptoms resolved quickly.   He is absolutely convinced the Moderna vaccine given in Nov 2021 caused this and demanded that an event report be filed with VAERS.
A non-serious report of inadvertently administered two doses of vaccine was received from a healthcare professional concerning a 30-year-old female.  No medical history and concomitant medications were reported.  The patient received two doses of FLUMIST vaccine on 26-Dec-2007.  The inadvertent administration of two doses of FLUMIST vaccine was realized and reported by a physician's office.  On 01-Feb-2008 the reporter and the patient both confirmed that the patient did not experience any adverse events after receiving two doses of FLUMIST on 26-Dec-2007.  Rechallenge is not applicable.  The reporter did not provide a statement of causality.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Additional info received on 01-Feb-2008: patient did not experience any adverse events.
High fever 101.7, severe muscle aches,for 3  fatigue for 4 days. Lymph tenderness lateral chest wall for over 1 week.
ZOSTAVAX was given on 10/10/13. She came back to the pharmacy today 10/18/13 complaining of bruising. I remember when I gave it to her, she claims to be painful. I advised her to take MOTRIN and apply cold compress.
On 11/19 I noticed onset of Right flank pain. On 11/21 I sought treatment at an urgent care clinic and was placed on Cipro for possible UTI and flexoril for poss lumbar sprain. On 11/23 the pain was worsening and radiating to my groin. New onset of a rash was noted on right hip and right abdomen. I sought treament by my PCP and was diagnosed with Shingles. I was placed on Valtrex and Vicodin for treatment.
This spontaneous report as received from a registered pharmacist who reported that on an unknown date an unspecified patient was administered a dose of ZOSTAVAX (dose, route, lot No were not reported). The vaccine went through a temperature excursion. The registered pharmacist reported that through in her house stability data did not support the ZOSTAVAX through the temperature excursion. No adverse effects were reported. Additional information has been requested.
Patient is a 29 year old female patient who went to County Health ER on 3-1-2021 at 02:52AM with possible complex migraine, vision blurring, and transient aphasia. CT was (-), she needs an MRI and referral to neurology. 1) paresthesia of skin,  2) other migraine not intractable, without status migrainosus, 3) (receptive) aphasia Saturday night(2-27-21) laying in bed looking at her phone and all of a sudden experienced a headache, vision went blurry, thought her eyes were tired and she tried to go to sleep. Headache was in the front of her head. Went to sleep then woke up at midnight, 2 hours later, breathing was off, head was hurting and felt anxious, felt like she needed to pace. Her husband was asking her what she was doing but she could not understand what he was asking. Couldn't figure out what to tell him or how to tell him, she could only say "what?" She then lay down, shaking, hand and tongue went numb. Went to ER, by that point the numbness was gone and she could understand what they were saying. The ER doctor Gave her Cogentin that helped to calm her down. Her head was not hurting all of the time. Gets headaches but not usually migraines. Patient has not had COVID that she knows of, son was negative for COVID in November 2020, but he had COVID-like symptoms. No recent sickness, travelled the first week of February 2020. Denies any weight loss, night sweats, no falls, no rashes, no tripping over her feet, no urinary retention. Yesterday felt light headed and dizzy, felt that she had to focus her eyes a little longer. PE abnormalities on office exam 3-2-2020: Right side smile is more droopy than left. Right side, pt is unable to  puff cheeks due to right facial muscles with decreased strength/tone. Right foot has decreased vibratory sense compared to left foot. Left foot slightly decreased vibratory sense, but very slight, right is much worse. Monofilament testing is good/normal in the hands and feet bilaterally. Point to point discrimination testing:  2 mm left hand 3 mm right hand Right foot 11 mm on bottom, 10 mm on top (abnormal) Left foot 12 mm on bottom, 11 mm on top(abnormal) strength 5/5 and reflexes normal 2+ in bilateral UEs and LEs. Mental status is normal. MRI and MRA of brain is advised. EEG study with Dr., neurology, referral made. Check tick borne illness panel, vitamin B, folate, thiamine. (ER labs were unrevealing.)
Diagnosed 17 week pregnant. Has received TYPHOID 7/9/08, AVA #1 9/4/08, and SMPX 9/24/08 before pregnancy diagnosed.
a week after vaccination I have been itching like crazy taking allegra, zyrtec and beneadryl  its like im itching in the inside, no outward rash had to go to ER itching so bad have an appointment with allergist(0even private itching
Information has been received from a consumer (a pharmacy technician) concerning her son who in 2005 was vaccinated with a dose of MMR II (dose, route, and lot# not reported). In the past summer of 2009, the patient was diagnosed with autism. At the time of the report, the patient's outcome was unknown. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Sudden onset of numb toes in right foot which did not go away. Tingling in toes in left foot and eventual numbness within a few days after the first onset of symptoms on the right foot. By week three, I had additional nerve tingling in other parts of body - fingers, face and my back near the spine which currently comes and goes. I am occasionally now feeling burning pain in the tips of my toes which is a new symptom which could be related to nerve damage.
On 7/28/2023 at approximately 1:00 PM, client requested Pfizer Bivalent COVID-19 vaccine from the team nurses. The team nurse, PHN, RN asked client for demographic information and confirmed client's immunization record and vaccine eligibility in the electronic database. Upon assessment by the PHN, RN, client denied having any cardiac issues and reported allergies to penicillin, reaction unknown. Client reported a history Anxiety and he receives an intramuscular injection every month for Schizophrenia. Client reported he sees a Dr. at a local clinic for primary care. Client denied experiencing signs and symptoms of illness or dizziness today. PHN, RN completed the screening checklist for COVID 19 vaccine per CDC interim guidelines. At 1:00 PM, a second PHN, administered Pfizer Bivalent Vaccine lot # GM1767 intramuscularly in the left deltoid. At 1:02 PM client quickly stood up from his chair and stated he "feels dizzy." The second PHN, assisted client to sit down in the chair. Client stated he "felt better" after returning to a sitting position. Client took sips of water from his own water bottle. Client denied having blurry vision and denied nausea. Client did not appear diaphoretic and skin appeared dry and appropriate to ethnicity. Client alert and oriented to person, time, place, and situation. The second PHN, asked and received client's consent to take his vital signs at 1:05 PM while sitting: BP 130/88, Sp02 95%, HR 103 bpm, RR 18. The second PHN, gave client juice to drink. At 1:07 PM client denied feeling itchy, denied pain, and no redness or rash was observed by both PHNs. Client verbalized his dizziness was gone and had not returned. At 1:10 PM the second PHN, asked and received client's consent to take his vital signs: BP 124/90, SpO2 95%, HR 95 bpm, RR 20. Client denied any history of high blood pressure. At 1:15 PM the second PHN, assisted client to stand up. Client denied any dizziness or blurry vision or nausea. Client consented to the second PHN, taking vital signs again at this time: BP 126/88 SPO2 96% HR 95 bpm, RR 20. Client returned to sitting position and completed the rest of his observation time. Client walked away with stead gait and balance at 1:30 PM.
anaphylactic shock/numb throat; high heart rate; light headed; anaphylactic shock/numb throat; This is a spontaneous report from a contactable consumer (patient himself).  A male patient of an unspecified age (reported as 39: unknown unit) received bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 22Dec2020 at single dose, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylactic shock, numb throat, high heart rate and light headed on an on 22Dec2020. The outcome of events was unknown.    Information on the lot/batch number has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (-14 degrees Celsius for 15 hours) doses of PROQUAD (albumin status rHA, lot # M007964, expiration date 15-AUG-2017; dose and route of administration were not reported) for prophylaxis. No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA001209.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/24/2021, 3/30/2021, and 11/11/2021. Patient tested COVID positive 1/5/2022 and started cefuroxime and molnupiravir x 2 days from primary care provider. Presented to Emergency Department in respiratory distress on 1/7/2022. Admitted for acute hypoxemic respiratory failure due to COVID-19. Received supplemental oxygen, antibiotics, dexamethasone, and remdesivir. Respiratory status continued to decline, transitioned to comfort care. Patient expired 1/10/2022 at 0908.
Pt's right arm and R side of neck where numb and pt. was dizzy, lasted 10min then went away, O2 @2lt was given and vitals where normal, Pt was monitored for 30 min and pt was allowed to leave . Pt was fine when he left
Information has been received from a physician via medical records concerning an approximately 15 day old male with bruising of nose and scalp and a history of respiratory distress, bilirubin increased and circumcision (WAES #0906USA02122) who on 18-MAR-2009 was vaccinated with a first dose of RECOMBIVAX HB. On 31-MAR-2009 the patient was seen by the physician. Physical examination showed scant oral thrush and a rash in the groin. The physician suggested that he use DESOTIN ointment for his rash in groin and do not use perfume wipes. It was noted that patient had used oral thrush medication and it was relieved. The outcome of the rash was no provided. Additional information is not expected.
Information has been received from a registered nurse concerning a female who on 14-JAN-2008 was vaccinated SC with her first 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On approximately 15-JAN-2008 within a day or two after vaccination, the patient developed an area of redness and induration at the injection site. The patient contacted the physician by phone for medical attention. The patient was treated with Zyrtec. The outcome was unknown. There was no product quality complaint. Follow-up information has been received from the reporting registered nurse concerning a 22 year old white female who on 14-JAN-2008 was vaccinated SC with her first dose of varicella virus vaccine live (Oka/Merck) (lot# 658411/1023U). There was no illness at the time of vaccination. On 15-JAN-2008 the patient experienced redness, induration and heat at the injection site. The patient sought medical attention through a doctor visit. No labs or diagnostic studies were performed. On approximately 19-JAN-2008 about 5 days after injection, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Vaccine was administered at approximately 5:57 P.M.  At approximately 6:00 P.M., patient's companion alerted pharmacist that patient appeared to be unresponsive. Patient was slumped forward and momentarily unresponsive to verbal queues. Patient quickly (within seconds) became oriented and stated he felt hot and sweaty. Pharmacist called 911. Patient denied difficulty breathing and reported no swelling or difficulty swallowing. EMTs arrived within 10 minutes. EMTs determined that patient most likely experienced vasovagal syncopal episode. Patient was allowed to leave on his own accord by EMTs with instructions to seek medical attention if difficulty breathing developed. Duration of entire case was approximately 25 minutes.
Post vax, the pt developed redness, swelling, itching, and a large hard area expanding out under vaccination site for several days to size of 4 inches. Lasted 4 weeks.
HORRIBLE HEART PROBLEMS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient never had any problems with his heart or health. 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced horrible heart problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of horrible heart problems was not reported. This report was non-serious.
Patient had immunization (MMR) on 4-13-05.  Child DEveloped a rash on Friday (4-22-05) Had fever on Friday 22 and Saturday the 23rd, also had diarrhea on these days.  Was seen in the office on the 26th, still has rash, but no fever or diarrhea.  Physician determined to be a Blueberry muffin rash
Patient has complained of itchiness all over her body starting within 24 hours of the vaccine. With in 3 days, a large majority of her body was covered in a rash that started on her trunk and spread to her extremities. Symptoms persisted for 2 weeks. Dr. prescribed clotrimazole/betamethasone cream. The topical eliminated the symptoms in 7 days. Patieint described the rash resembled measles.
High blood pressure; Face was blood red/Went up to 150 or 160; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unspecified age (reported as age: 71, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), dose 1 via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunization. Medical history included arthritis and fibromyalgia. The patient concomitant medications were not reported. It was reported that the patient received first dose of the Pfizer vaccine last Wednesday. The patient was fine the day of, but for the two days afterwards (on unspecified date in Mar2021), she believed she had high blood pressure. Patient said her face was blood red for two days and did not have a cuff to measure. The patient thought it went up to 150 or 160. The outcome of the events was recovered on an unknown date in Mar2021.  No follow-up attempts were possible, information about lot/batch number could not be obtained.
May 10 I woke up with a rash located on both upper arms. It is hot to the touch, swollen, super itchy.  Over the next few days the skin got more swollen, and little blisters began to form.  May 14 The rash begins to spread to lower arms, and chest.  My husband encouraged me to go to Urgent Care.  They prescribed me steroid cream.  Not much they could do.  May 15 Rash begins to spread towards stomach and my entire chest is covered. It has reached my neck.  Blisters for on my lower arms.  Mqy 16 Rash begins to spread to my thighs and buttocks.  May 17 Rash is all over my back qnd creeping towards my private areas. It is painful and still spreading.
sold red ring around the injection site/ red ring at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu unspecified (Influenza vaccine).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Influenza vaccine, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient developed a sold red ring around the injection site after receiving the 1st dose of shingrix. She also received a flu shot at the same time but did not develop any reactions to the flu shot.  The reporter consented to follow up. The case is linked with case  US2020AMR163478 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR163478:same reporter
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. Approximately in 2015 (reported as "in June or July"), unspecified number of patients received unspecified doses of GARDASIL (dose, route of administration, lot # and expiry date were not provided) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.