chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant via a Company representative, referring to a female patient of unknown age. The patient was vaccinated with the first dose of GARDASIL in July 2015, then, in September 2015, was vaccinated with the second dose of GARDASIL. On 13-APR-2016, the patient was vaccinated with a dose of GARDASIL 9, and on 04-AUG-2016, she received a second dose of GARDASIL 9, all of them for prophylaxis (lot#, expiration date and route of administration was unspecified for all vaccinations). No adverse effect was reported.
Pt. presented at office afebrile, fussy at 0923 2/9/13. Per father, pt. had been fussy/gassy x24 hours. Decreased sleep, inconsolable, crying. Father reported a rectal temp of 103.6 degrees.
Severe flu like symptoms: running nose, sore throat, headaches, body aches. Chills, very  weak. Dizzy.
PATIENT STATES THAT HE WOKE UP THE NEXT DAY AFTER RECEIVING THE VACCINE ON 8/2 WITH HIS ARM HURTING  AND REDNESS, SWELLING AT THE SITE
pt recv vax; noticed large rash on back ; by 20aug95 had also covered front torso; *very large area of herpes zoster;
On 02/23/2001 the patient developed more than 50 varicella lesions on his trunk and extremities. The patient sought unspecified medical attention and recovered. Additional information has been requested.
reports she received the 2nd dose  of Covid vaccine on 1/27 at 1430 and started having fever 100.8-100.9 and HA, swollen tongue, around 1/27 2100.
FEVER, HARD BUMP ON SITE, COULD NOT LIFT OR MOVE LEFT ARM
Painful swelling of my ankles, joint pain in my toes, elbow and fingers on both hands. Taking ibuprofen.
Gave DTAP, Hep A #2, and 1st CPOX. Approx 4 hrs later mother returned to clinic and pt had hives over face, neck, and abdomen. BENADRYL given.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown demographics (captured in MARRS# 1409USA002329). Pertinent medical history, drug reactions or allergies were not reported. On unspecified dates, those patients were inadvertently administrated PROQUAD (Merck), that had been improperly stored (strength, dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effects reported. Follow up information received on 19-AUG-2014. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a registered nurse refers to a 6 year old male patient. On 07-AUG-2014, the patient was vaccinated with the second dose of PROQUAD (Merck) injection (lot # K004860 with expiry date: 04-OCT-2015) given subcutaneously in the left arm, and with a dose of KINRIX intramuscularly in the right arm (lot# EP2A3). This is one of several reports from the same source. Additional information is not expected as all required correspondence was scheduled.
a patient under 65 year of age received Fluzone High-Dose/No AE; a patient under 65 year of age received Fluzone High-Dose/No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient of an unknown age (under 65 years) who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Lung disorder and Autoimmune disorder.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  It was reported that patient under 65 year of age stated that she has been given the Fluzone HD previously due to her lung disease and autoimmune disease. Patient was wanting to have Fluzone HD administered again, Pharmacist stated that the patient called her HCP while standing in line and was told to get Fluzone Quadrivalent. Pharmacist stated that she was unsure if the patient really received Fluzone High-Dose in the past but she received Quadrivalent from her.  At the time of report, no adverse event was reported.  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 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.  Information on the batch number was requested.
Left arm sore, red and swollen at injection site. Went to Urgent Care twice and Dr. once for pain. Antibiotics and Benadryl.
made me tired for a day; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female patient in her 60's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "recovered" (2021), described as "made me tired for a day". Additional information: Patient experienced fatigue after COVID vaccine. Second shot just made her tired for a day. She was just tired the next day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Softball size swelling, harding, red. Very painful. Swollen lymph node in groin on that side.
C/o rash under arm where flu vaccine was given-occured 4-5 hr past vaccine was given. Several bumps underarm and none at injection site-looked normal. M.D. told patient he had the shingles.
CDC reports: 2 mo infant developed fever 103 & screaming episode following DTP/OPV immunization. duration of illness 3 days.
Sore and swollen at injection site. Sensitive to the touch. Fever of 101.7 F (rectal) at 5:30AM. administered 3.75 mL acetaminophen oral suspension at 5:30 AM. Fever reduced to 100.7 F (rectal) by 8:30AM. Administered 3.75 mL acetaminophen oral suspension 9:45AM.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share. Follow-up information from the registered nurse who provided patients details. This report refers to a 9 months old infant patient. On 09-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J016188, expiration date 02-OCT-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Child received a Td based on incorrect hx card provided. Td should not be given before age 7 yrs and client is only 5 yrs 11 mo.
Severe pain and infection; urinary tract infection/Infection; Fever; patient became septic; This serious case was reported by a consumer and described the occurrence of sepsis in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JUL-2023, the patient received the 1st dose of Shingrix. On 14-JUL-2023, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: Severe pain and infection) (serious criteria hospitalization) and urinary tract infection (Verbatim: urinary tract infection/Infection) (serious criteria hospitalization). In JUL-2023, the patient experienced sepsis (Verbatim: patient became septic) (serious criteria hospitalization and GSK medically significant) and fever (Verbatim: Fever) (serious criteria hospitalization). The patient was treated with ceftriaxone sodium (Rocephin) and vancomycin. The outcome of the sepsis, pain, urinary tract infection and fever were not reported.   The reporter considered the sepsis, pain, urinary tract infection and fever to be related to Shingrix.     The company considered the sepsis, pain, urinary tract infection and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUL-2023 The reported stated, after the first dose of Shingrix patient complaint about the severe pain and fever. The patient was admitted to the hospital due to severe pain and fever. The patient was also hospitalized due to urinary tract infection. She was treated with a course of antibiotics included Rocephin and vancomycin. Because of a subsequent urinary tract infection the patient became septic. Expiry date of Shingrix was unknown. The reporter consented to follow up.
Patient woke up the following morning after receiving his 2nd  Men B on 7/29/21 , on 7/30/21 with dizziness, headache, body aches,  weakness, nausea and vomiting. Was taken to the ED and given Zofran.  Went home, slept given Tylenol alternating with Advil and drank  fluids.  7/31/21 felt weak and tired and went to work that afternoon. 8/1/21 he work up with neck and chest soreness and went to work. On 8/2/21 he felt fine.
5hours after vaccine site itched. 17hrs after big red circle, arm sore, low grade fever
Pt received vaccines 02/13/19. On 02/27/19 pt had episodes of abdominal cramps with inability to rest. Parents took to ER for evaluation. Diagnosed with Intussusception.
CHARLEY HORSES/MUSCLE SPASMS ON HER LEGS, NECK AND SHOULDER; MILD TO SEVERE HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 55 year old female. 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) dose was not reported, administered on 14-MAR-2021 in right arm (deltoid) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAR-2021, the patient experienced charley horses/muscle spasms on her legs, neck and shoulder, mild to severe headache, nausea, fever. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild to severe headache, charley horses/muscle spasms on her legs, neck and shoulder, nausea, and fever. This report was non-serious.
Parent c/o "high" fever 4 hours post vaccination that continued for several days followed by a rash.  Parent brought child to Urgent Care lab work drawn and subsequently hospitalized and diagnosed with Kawasaki Disease.
[Covid-19 vaccine] treatment under Emergency Use Authorization(EUA): drew 9 doses out of 1 vial
Diaphoresis, tachycardia, nausea, vomiting, syncope.
Patient received the Tdap immunization; however was to receive the Hep A instead. Patient was not due for the Tdap according to Registry until 2024. Both orders were in the patient's chart, however the Tdap was only given and should have been canceled prior to reconciling. As a result the Hep A was not given to the patient. The provider, PAC was notified and stated that the patient would not be harmed as an outcome. The father of the patient was also notified and verbalized understanding that there would be no harm to the patient; but he should not receive a bill for the vaccine. He may bring his son back at any time to receive the Hep A.  Report on the Company Intranet is also completed.
Felt weak around 5pm, around 6pm I was pale and very weak, had to sit/lie down, tingling in hands. Slight wheezing, but not serious. Wanted to seek Urgen Care, but SO told me to just deal with it. At 7pm a fever with shivers came on, 101.3°F, which went down around 11pm. Now, the next day, I'm still feeling under the weather, but not completely knocked out any more.
3-7-2021 woke up with double vision.  Possible stroke 3-13-21 headache, nausea, left side numbness and tingling. 3-17-2021 ER visit to Hospital ER. Bloodwork, ekg, chest xray, ct scan, MRI w/contrast. All test negative.  Saw Dr. at Eye Center 3-17-2021.  After examination determined estropia in both eyes w/ mild CNVI of left eye.  No specialty send to Dr. Neuro-Opth 4-7-21.  After examination determine stroke in CNVI (crainal nerve 6 attaching to the brain in region 8 on left side) Possible 3 months improvement and hopefully gone in 6 months and if not will not go away and further testing at that time.
pt recvd vax 6SEP95 & 10SEP95 pt devel a mild gen varicella-like rash w/no other complaints;13SEP95 devel subconjunctival scleral hemorrhagic lesions in both eyes, fever;pt exp no problems w/vision;tx APAP & showed response;
After first injection, 2/22/2021 ran a temperature and broke out in hives. Treated with steroids. Four days after second injection, 3/22/2021 began running 100-101 temp in evenings, broke out in hives. Had pneumonia three times over the period through June including one hospitalization. Lost weight from 190 lbs to a low of 149. Referred to numerous specialists including Rheumatologist, allergist for testing, oncologist and pulmonogist. Found no cause for issue.  Did not start regaining weight till December.
A report has been received from a Health Professional concerning an adult, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. It was reported that a nurse, who was over 49 years old, was administered FLUMIST. The outcome of the event of ADMINISTERED TO 49 YEAR OLD was unknown. The report was considered to be non-serious. Summary of insignificant follow-up information received by AstraZeneca/MedImmune on 25-Apr-2014 from Health Professional: Reporter information updated.
pt saw MD 7OCT96 c/o rt arm pain & paresthesias even since vax 21SEP96;it was done @ another clinic;
feeling ill; just not feeling well; Chills; Fever; Nausea; overall lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 at 18:00 as dose number unknown (booster), single (Lot number: GJ5342) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Mild Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; manufacturer unknown), for Covid-19 immunization.  The following information was reported: CHILLS (non-serious) with onset 11Oct2022, outcome "unknown"; PYREXIA (non-serious) with onset 11Oct2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset 11Oct2022, outcome "unknown"; MALAISE (non-serious) with onset 11Oct2022, outcome "unknown", described as "feeling ill; just not feeling well"; LETHARGY (non-serious) with onset 11Oct2022, outcome "unknown", described as "overall lethargy". Therapeutic measures were taken as a result of malaise, chills, pyrexia, nausea, lethargy.  Additional information: The patient and his wife both took the Bivalent Pfizer COVID-19 Vaccine Booster on October 3rd at approximate 6 PM and starting this morning (at the time of reporting) both of them started feeling ill. By the afternoon they both had chills, fever, nausea, just overall lethargy and just not feeling well. The patient's wife took a test and it was negative but they were just finding it odd that the side effect took a one whole week to took effect. So patient asked if it was normal.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201221570 Same product and event, different patient;
pt recv vax 28MAR97 & 29MAR97 @ bedtime pt exp inguinal itching;30MAR97 pt devel papular, erythematous, pruritic dermatitis consisting of erythematous, fine papular, pruritic eruptions which spread over the trunk sparing the face & limbs;
48 hours post vax, the pt noticed a hardened area on leg and low grade fever of 99.7. Eased with Tylenol. Hardened area persisted until time of this report.
61-year-old white male received his second Moderna COVID-19 vaccine at 0910 and at 0945 he became slightly vertiginous and noticed poor balance and on both sides of his face and both sides of his upper neck became.  He felt like there was some swelling of his lips and tongue and he notes some trouble swallowing and states his throat feels "tight".  He denies lateralizing neurological signs, specifically denying tingling or numbness or weakness of extremities.  He had no trouble with his vision or cognition.  He had no trouble with the previous vaccine.  Presently the symptoms are resolving.  Feeling better with less sensation of neck and facial swelling and numbness as well as decreased vertigo after 1 dose of Benadryl. Time: 11:23
Did not sleep very well overnight; Achy; Headache; Nausea; Fatigue; Chills; Soreness at injection site; Flu-like symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIDDLE INSOMNIA (Did not sleep very well overnight), PAIN (Achy), HEADACHE (Headache) and NAUSEA (Nausea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  The patient's past medical history included No adverse event.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Achy), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness at injection site). On 05-Feb-2021, the patient experienced MIDDLE INSOMNIA (Did not sleep very well overnight). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIDDLE INSOMNIA (Did not sleep very well overnight), PAIN (Achy), NAUSEA (Nausea), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown and HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at injection site) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product use was reported.  No treatment details were provided.
Patient states flu shot given in incorrect area and showed staff bruise from injection which was about 8 inches lower than the deltoid area.
pt recvd vax;rash on waist w/ some spots on face & under breasts;some dizziness;started on Atarax;3 previous doses pre exposures series 10 yrs ago;MD does not want more doses;HD said to take 3rd;will follow MD's advice;titer chcks in future
10/1/13 AM Slight asthma attack within 10 minutes of receipt of vaccine. 10-17-13 PM feet started aching and cramping 10:20 PM lower legs starting aching and cramping. 10-25-13 AM woke up hurting all over, brain fog, headache, nausea, fatigue, constipation.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report was received from literature. This report concerned multiple (2) patients of unknown race and ethnicity. The objective of this study was to describe predominance of antibody-resistant SARS-CoV-2 variants in vaccine breakthrough cases. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced confirmed covid-19 infection, and confirmed clinical vaccination failure. Laboratory data (dates unspecified) included COVID-19 virus test (NR not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number: 90000191350. This case, from the same reporter is linked to 20210855269.; Sender's Comments: V0- 20210855307- covid-19 vaccine ad26.cov2.s - Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt experienced arthritis pain, MD noted unable to walk, ataxic,6 cont unsteady on her feet w/no sense of balance, but appeared to be in no pain; eating poorly unless fed; PE showed ext rigid & slow moving; T96F(R) @ 6AM by 630PM 91F;
Patient was given HPV #2 (LA) IM at approx. 11:00am. VARIVAX was given at approx. 11:10 am on (RA) SobQ. After VARIVAX was given pt. felt dizzy and faint. Patient then fainted and began to convulse for approx. 2-3 seconds. Pt. awake approx. 5 seconds later EPINEPHRINE was administered approx. 11:16 am 1 ml was given on (Rt) sub Q. at approx. 11:20 paramedic arrived. 11:35 am BENADRYL 1ml/50mg was administered. Taken to ER for observation
Patient did not have any reaction at all.But I did Give her to strong of a dose of  COVID it was the correct med,site,patient,and Medication I didn't dilute the medication so she got 3x the amount she should have. I gave her 0.3 ML of the 3 dose vile that should have been deluted with 1.1 ml of Sailine.
Patient received Hep A without incident. Immediately after he received his 3rd HPV immunization, the patient began to slump over. He was caught while leaning forward and assisted to supine position. The patient began to have a brief 20 second grand mal seizure. His mother noticed he was posturing with his right arm. BP 107/54 | Pulse 54 | Resp 12 | SpO2 100%. After the seizure, he was pale and pulse was noted to be low at 45. Pulse oximeter was placed and his pulse gradually came back to baseline. He was alert and seemed oriented. Heart showed regular rate and rhythm.  Patient was transported via ambulance to the hospital for further evaulation.