chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given Hep A vaccine too soon. Date of Hep A vaccine should have been 11/12/2023 or after.
12 year old child, new to area, no vaccination records. Parent - non language speaking but Pt is fluent. Pt reports that about 1 hour after receiving vaccines. She broke out in itchy rash all over body. Hives unresolved 3 days after vaccines. Sent to clinic for MD eval.
Arm hurt badly immediately after shot, around 12:30pm today I started to feel aches, chills and headache, and fever of 101.7 around 7:30pm
Extended vaccination interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a dose on 6th December 2021 of batch number 4C493).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Extended vaccination interval). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 24-May-2023 A pharmacist wanted to know if the second dose could be given or if the series needed to be restarted.  Information about vaccine, patient and event was collected. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Day nine after receiving first vaccination, a raised bump appeared on my arm with rash present. This went away after a few days and then reappeared as a rash outlining the edges of injection. I received my second vaccination yesterday and have both a raised goofball sized bump with rash, itching, burning at injection site.
Pain, Induration, Fevers, ultimately diagnosed as cellulitis, required ER visit and IV antibiotics
Patient was given an expired vaccine. The vaccine was punctured on 11/4/22 at 1500 and expired 11/5/22 at 0300. Patient was given a dose from this same vial at 12:35pm on 11/6/22.
Red rash swollen, pain, weakness, mild fever, only redness-mild pain at injection site remains, cold shivers evening of.
Initial (1 week), soreness, swelling; two weeks post vaccine tingling, transverse (L) ring finger, decreased power of left shoulder and arm. (L) shoulder/arm weakness onset 3-30-17. Improving. No numbness.
Náusea, vomiting, fever chills with onset 30 hours after injection. Still existing though not as severe. Was prescribed over phone Phenergan and Zofran.
I had a cough, extreme sore throat, and lethargy. The sore throat was the worst. I took at COVID-19 on 01/08/2023 at home which came positive. Then, I went to urgent care and was prescribed Paxlovid. By the fourth day, I felt much improved. I tested positive for even two weeks after recovering.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 13-FEB-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # N023024 with expiration date 23-AUG-2019 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Approximately 10-15 minutes after receiving COVID-19 vaccine, patient reported itching, tingly feeling, face appeared more flushed.  Seemed anxious due to history of allergic reactions and reported slight shortness of breath.  Treated with diphenhydramine 50 mg po and epinephrine 0.5 mg IM and transported to Emergency Department.  Observed in that area and released a few hours later as symptoms resolved.
Red raised skin, 6 1/2 in. in length, 12/2/09 6pm pain when raising left arm. 12/3/09 hot around area of shot, length the same, red, inflamed. 12/4/09 skin warm around area, decrease in size.
Day 3 after receiving vaccine, patient reports red, swollen arm. Redness extended about 3-4 inches and oval in shape. Area was warm to the touch. Patient reported some itching as well. No pain per patient.
patient had hives on upper body starting at 3:30pm and then around 8:00pm started with hives on lower body
This is a 33 year old female with a past medical history significant for Raynaud's Phenomenon (RP), erythromelalgia, Chronic Fatigue Syndrome (CFS), and dysautonomia, classic migraine, lumbar pain with radiculopathy, attention deficit hyperactivity disorder (ADHD), Post Traumatic Stress Disorder (PTSD) and mood disorders. She presented to clinic for evaluation of possible reaction to IIV or LAIV vaccine received during her service, most specifically doses received 10/2010 and 10/2011 as causality of her RP, erythromelalgia, CFS and/or dysautonomia, (which has subsequently more specifically diagnosed as Postural Tachycardia Syndrome [POTS]). The patient recalled developing purple discoloration with decreased sensation to feet and knees starting in late December 2010. She had performed a 17 hour sustained drive. She noted discoloration and numbness to her thighs extending distally below her knees, right more pronounced than left, and her feet were also discolored. She was seen in ER 28 Dec 2010 and was diagnosed with paresthesia and given instruction to follow up with her primary care provider. At subsequent visits with PCP and vascular surgery visit she reported symptoms spontaneously resolved until 5 January 2011, when they returned after exercising. She also stated symptoms were exacerbated by dependent position and resolve with elevation. She continued symptoms with discolored skin, swelling, itching and nail changes with concave ridges and dryness. She reported symptoms resolved spontaneously after cold weather ended. She denies any other acute symptoms post receipt of IIV. She has had extensive evaluation and consultation. She did not respond to usual treatment of Raynaud's disease. Consultation did not think she had Raynaud's but gave her a diagnosis of erythromelalgia. Over time she developed increasing fatigue, activity and postural intolerance. She was also given a diagnosis of Chronic fatigue syndrome, although she did not meet strict CDC criteria. She was evaluated for and demonstrated dysautonomia via tilt table testing but initially did not meet criteria for POTS; however on subsequent testing she did meet threshold criteria.
8/16/2021: admitted. presents to ED with complaints of generalized weakness, slurred speech, mild confusion, nagging non productive cough and feels run down since last week.  Wife (at bedside) thought his weakness and slurred speech were related to high ammonia level so patient has been taking lactulose daily. COVID 19 PCR was positive.  Note: patient previously vaccinated with Pfizer COVID-19 vaccine: First dose: 05/29/21 Lot Number;EW0180; Second dose: 06/18/21 Lot Number EW0196 Diagnosed with: toxic metabolic encephalopathy, COVID-19 infection Discharged 8/22/21.
12/23/21 presents to ED for "shortness of breath". PMHx of "atrial fibrillation on Coumadin, aortic stenosis"
STROKE; This spontaneous report received from a patient via a company representative concerned a 52 or 53 year old male. 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) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 25-APR-2021, the patient experienced stroke and another stroke was on 28-APR-2021. Patient was hospitalized on unspecified date and discharge date was not provided.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210505957-Covid-19 Vaccine.Ad 26.Cov2.S-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This is in follow-up to report(s) previously submitted on 6/12/2007.  Information has been received from a nurse concerning an 18 year old female who on 21-FEB-2007 was vaccinated with Gardasil (lot no 654535/0960F). That same day, she was vaccinated with Menactra. The nurse reported that the patient lied about her last menstrual period because her mother was in the room and she was 3 1/2 pregnant when she was vaccinated. A pregnancy test was positive. Her LMP was 06-NOV-2006 and EDD 13-AUG-2007. She had not yet chosen an OB/GYN physician. Information received on 25-MAR-2007 contained the following adverse experience: The patient was treated with AMOXIL 875 mg twice daily from 07-MAR-2007 to 17-MAR-2007 for tonsillitis. Additional information has been requested.
Patient has several visible red spots on (L) arm where influenza and pneumococcal vaccine were administered. These appeared about 48 hours after administration red spots are warm to the touch, patient denied fever or muscle pain but reports increased confusion.
Received 1st Pfizer dose 3/2/2021,  on 3/4 pm he started not feeling well.   On 3/5 he slept through the day and was not feeling well.  He reported his legs and back were hurting, and he had difficulty walking due to problems with his balance.    He got up at 9pm and fell in the bathroom.   He was dizzy.   His wife assisted him back to bed.   He was not able to sit, he would fall over.   On 3/6 his balance was still off.   His wife assisted him to the car and took him to the Hospital.    They treated him for dehydration and discharged him.  On 3/7 he developed a rash over his body, "big red spots".  3/8 his wife called the physician , who saw him the following day, on 3/9.   He was advised not to take the 2nd Pfizer vaccine.  The rash lasted 5-6 days.  At the time of this report, his symptoms have resolved.  His wife reports she completed a VAERS.  His report number is 346254
Information has been received from a registered nurse referring to a boy patient of unknown age. The patient's medical history, concurrent condition and other concomitant medication were not reported.  On 28-FEB-2018, the patient was vaccinated with improperly stored VARIVAX (dose, route unknown, lot # N017396 with expiration date 07-JUN-2019) for prophylaxis. The sterile diluent (manufacturer unknown) (unknown lot number and expiration date) used for reconstitution was properly stored. The vaccine was exposed to temperature excursion of -14 degree Celsius to -10 degree Celsius for a time frame of 2 hours. There were no previous temperature excursions. Data logger was involved. No product quality complaint (PQC) was involved in this case. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA011818: US-009507513-1805USA011819: US-009507513-1805USA011820: US-009507513-1805USA011821: US-009507513-1710USA004084:
Shingrix given to patient outside the age guidelines; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     Additional Information: GSK receipt date: 15-AUG-2022 Reporter's comments: The reporter was the pharmacist called to report a dose of Shingrix was given to a patient outside the age guidelines by accident. (Inappropriate Age).  The caller reported the patient was not immunocompromised. The reporter reported she did not have the injection date or arm used.  The reporter asked should she wait until age 50 to give the second dose or stay with the 2 -6 month schedule. Transferred to medical information (MI) for assistance.  The consent to follow up was granted. Additional Supportive Information:  As patient received Shingrix not as per the recommended age, which led to inappropriate age at vaccine administration.
6 out of 8 pts who recvd 3 doses of Engerix B did not seroconvert; all titers done w/in 1 yr;
PROQUAD and MMRII were administered on the same day; This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2017 (reported as at 1-year-old), the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (exact dose, route of administration, anatomical location, lot #, albumin status and expiration date were not reported). On 14-SEP-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), dose 0.5 milliliters, lot # S030211, expiry date 25-MAR-2021, albumin status rHA (route of administration and anatomical location were not reported) and the second dose of measles, mumps and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), dose 0.5 milliliters, lot # S020962, expiry date 07-JUL-2021, albumin status rHA (route of administration and anatomical location were not reported) both for prophylaxis. The reporter inquired if a patient should expect any untoward reactions if the vaccines were administered on the same day.
First the injection site swelled big and red and itches and hurts like no other. Then a body rash that hurts and itches appeared on Friday the day after getting the shot and today is Monday and its still spreading slowing and its just itches more than my shingles did
Mom did not want him to receive pertussis vaccine. Pentacel was given in error. Vaers is being filled out due to administration error. Patient had no side effects of pentacel while at our office.
WEIRD COUGH WITH A LITTLE BIT OF MUCUS, AND MUCUS SETTLED DEEP IN LUNGS WHICH CAN EXPEL IF COUGH A LOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced weird cough with a little bit of mucus, and mucus settled deep in lungs which can expel if cough a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weird cough with a little bit of mucus, and mucus settled deep in lungs which can expel if cough a lot. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Fatigue, joint pain, sore throat, slight cough, diarrhea, muscle pain.
Patient reports symptoms at 1514 of parensthesias to posterior neck and right arm followed by dizziness and shortness of breath. Denies tightness to throat or dysphagia. VS bp 125/80 pulse 83 oxygen 99%. At 1520 patient reports complete resolution of symptoms including shortness of breath. Oxygenation continues 99%  patient accompanied by significant other home.
Fully COVID vaccinated patient admitted to the hospital through ED for shortness of breath.  Hypoxic in ED with O2 at 75% with ambulation.  Wears O2 2L/NC at home - returned with home 2 L.
no additional adverse symptom were reported; a patient received a dose of ROTATEQ following a temperature excursion; This spontaneous report has been received from a medical assistant regarding an unknown age and gender patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On 13-JAN-2020, the patient was vaccinated with improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial orally (dose and frequency were not reported) lot # S010566 expiration date 19-JAN-2021 as prophylaxis following a temperature excursion. The lowest temperature was below 36°F/2°C (34F) in a time frame of 48 hours. There was no previous temperature excursion. Call was because of a data logger. No additional adverse symptoms were reported.
c/o pain, pruritus & swelling lt upper arm p/vax 10JUL98;response inc daily;tx initiated 13JUL98 med, ice, Ibuprofen & DPH PRN;
Patient experienced some lip swelling following Moderna booster dose. Staff/patient noted lip swelling, patient was responsive. No complaints of itching, or any other symptoms. No rash/hives noted on chest, back, arms, or legs. Blood pressure and pulse ox were taken and within normal limits. Patient was given dose of diphenhydramine 25mg liquid at 11:48 AM. Followed up at 12:10 PM, patient responded well to dose of diphenhydramine. Lip swelling had gone down and vitals were still within normal limits. Patient feeling well and was counseled on signs and symptoms to continue monitoring.
paralyzed from my neck down; five blood dialysis to replace my plasma with fresh; Initial information was received on 26-Nov-2022 regarding an unsolicited valid serious case received from a consumer/non-health-care professional.  This case involves an unknown age and gender patient who experienced paralyzed from my neck down, five blood dialysis to replace my plasma with fresh and two months in a rehabilitation facility after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date and month in 1999, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (unknown formulation) (lot number, expiry date, strength, frequency was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient reported that after being totally paralyzed from my neck down (paralysis) ,five blood dialysis to replace my plasma with fresh(Hemodialysis)(Latency unknown) ,8 days in the hospital ,two months in a rehabilitation facility ,I have decided not to get another one.  Action taken: not applicable.  Corrective treatment: Two months in a rehabilitation facility for paralysis  At time of reporting, the outcome was Unknown for the events.  Seriousness Criteria: Medically significant and hospitalization for event paralysis. Hospitalization for event Hemodialysis; Sender's Comments: Sanofi Company Comment dated 30-Nov-2022: This case involves an unknown age and gender patient who experienced paralyzed from my neck down and five blood dialysis to replace my plasma with fresh after receiving influenza vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information of onset latency, past and concomitant medication, hospitalization details, any family history and any relevant medical history of patient precludes comprehensive case assessment.
Febrile convulsion x 3mins. 10 hours after getting 4 immunizations at 15 months. Exam normal afterward. T 104 at ER. Afebrile by next day.
chills / hot / extreme fatigue  happened 5 times in 6 weeks following second vaccination
suffered on atypical feveral sz lasting 30-40min;had a fever of 102;taken by amb to hosp;white mark @ injs site;
Information has been received from a consumer concerning his 15 month old son with no pertinent medical history and no pertinent medical history and no known drug allergies/drug reactions who on an unspecified date was vaccinated with a dose of MERUVAX II. There was no concomitant medication reported. It was reported that "same day of the vaccination" the patient developed slight fever and some rash. There were no laboratory diagnostic tests performed. The patient did not seek medical attention. It was reported that the patient recovered 2 or 3 days after the vaccination. The reporter indicated that the patient also experienced an adverse experience following another vaccination. WAES # 0905USA01274. Additional information has been requested.
Pt recv flu vax 10/27/98. 10/29/98 pain & redness in rt eye.11/2/98-md visit,dx. episcleritis.10/27/98 sore throat w/ inflamed uvula that resolved in few hours. Feels & looks better, to see MD 12/9/98. Pt recv previous doses flu vax
brief (non-life threatening) generalized sz x 4 over period of 48 hrs; pt hospitalized; loaded w/phenobarbital; no futher sz;