chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager and refers to a 14 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 17-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
It was reported, that a female pt received vaccines on 8/3/99. Reportedly, 4 hours, post vax, the pt experienced swelling of left thigh from knee to thigh, redness and tenderness to touch. Reportedly, the pt was seen in the ER. From additional information received on 8/19/99, additional pt and doctor information was provided.
Rash all over body-blotchy raised patches. Generalized urticaria, 12 hours later.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 23-FEB-2015 the patient was vaccinated with GARDASIL lot # K007264 (expiration date, dose, route, frequency and indication were not reported) that experienced a temperature excursion, which was later supported as well. There was no concomitant medication reported. At the time of the report, the patient's status was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
brought in by husband due to cough, shortness of breath and supratherapeutic INR.; dx with Covid PTA; CXR - left suprahilar pneumonia; Labs: D-dimer 1.38; CRP- 8.42; Ferritin: 8087; TX: Mazipime, remdesivir, Vit C, Zithromax, Decadron, Vanc, Zinc, Supplemental O2 via NC; back to room air at d/c
severe chest pain; This is a spontaneous report from a contactable physician. A 57-year-old female patient (Not pregnant) received bnt162b2 (Batch/Lot number was not reported), intramuscular on 07Mar2021 at the age of 57-year-old as dose 2, single for covid-19 immunization. Medical history included hypothyroidism, mixed hyperlipidemia from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, vitamins taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (Batch/Lot number was not reported) Intramuscular on 14Feb2021 at the age of 56-year-old for covid-19 immunization and experienced tolerated shot #1, previous took chloramphenicol;polymyxin b sulfate (MYCIN) and experienced allergies. The patient experienced severe chest pain on 10Mar2021. 3 days later and severe chest pain that lasted for a couple of days. No treatment received. The case was reported as non-serious. The outcome of event was resolved in 2021. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101559247 same reporter/patient, different  dose/AE.
Raised red rash with itching upon awakening 8/17/10. Progressively moving from fingertips to wrists/both hands. Has not yet treated the symptoms with OTC meds.
Aching. Significant pain in legs and lower body. Tachycardia. Trouble breathing. Numbness. Hard to stand or walk. Burning nerve pain. Headache severe
My arm has been sore since my second covid vaccination a month ago. I'm pleased to have been able to receive it, but can't find anything online about persistent pain at the injection site so I figured I'd report it. It basically feels as if there's a bruise where I received my shot. Sometimes it hurts worse,  sometimes it hurts less. If I brush my hand against it or press on it lightly, it's very sore/stinging. Sometimes it itches as well.
pt recvd vax; exp fever of 103 4 hrs after vax; given apap; listless 24 hrs later x 2 days; saw MD at 48 hrs, no rxn; resolved in 4 days;
erythema and swelling of affected arm. Tx for cellulitis with KEFLEX x 1 wk. Mimimal resolution after 1 day no F/S/C. Continue also BENADRYL, pm
Information has been received from an 85 year old female with hay fever and allergies to rofecoxib (MSD) (WAES # 0707USA02086), ibuprofen and penicillin who on 06-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 08-JUL-2007, the patient experienced redness and itching at the injection site.  Unspecified medical attention was sought.  No diagnostic laboratory tests were performed.  At the time of the report, the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
dose after 12 hours after puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose after 12 hours after puncture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose after 12 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose after 12 hours after puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Headache following immunization associated symptoms stiff neck, fever, body aches, nausea.
This is a spontaneous report from a contactable consumer or other non hcp. A 23-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:30 (Batch/Lot Number: EN 6202) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included known allergies Pollen from an unknown date and unknown if ongoing. Concomitant medications included escitalopram oxalate (LEXAPRO); ethinylestradiol/ferrous fumarate/norethisterone acetate (JUNEL FE) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EL 9264), administered in right arm on 08Feb2021 09:30AM, as a SINGLE DOSE for COVID-19 immunization. Patient did not take other vaccine in four weeks. Patient did not diagnose with covid prior to vaccination. No covid tested post vaccination. Several hours after the vaccine, on 01Mar2021 22:00 patient took tylenol to relieve symptoms associated with a slight fever (99.6 F). Fifteen minutes after taking tylenol, the interior and exterior of my throat became very itchy. patient began to cough and feel restrictions in her throat. Symptoms did not subside until after taking benadryl. The outcome of all the events was recovering. No follow-up attempts are possible. No further information is expected.
Shingles onset 5/24/10: Diagnosis made 2 JUN 10.
Had DTaP, IPV and MMR on 4/24/03. Swollen right arm where DTA and IPV had been administered. Noticed on Friday, site was size of quarter. Saturday morning size was size of half dollar, red, and hot to the touch. Saturday afternoon, site was size of pear, red, and hot to touch. Parents took her to hospital; she was admitted at 9PM Saturday until 5PM Sunday. IV antibiotics given and Benadryl at hospital. Patient saw doctor 4/28; gave antibiotics for 10 days. Patient went to school 4/29/03.
SORENESS AT THE SITE OF INJECTION; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included parkinson's disease, and alzheimer disease.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced soreness at the site of injection. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at the site of injection, and fever on 02-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210410164.
About 20 minutes afterwards my face kind of went numb a little bit, like around my cheeks and my lips they felt numb; Pretty significant ear pain in my left or jaw pain in left joint of my jaw; Pretty significant ear pain in my left or jaw pain in left joint of my jaw; Little bit of a rash on my face; Rapid heart rate for about a minute, a minute and a half of like around 200 beats per minutes I think; Exhaustion; Nausea; Different things, it kind of make sense for like as if I was experiencing COVID; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced about 20 minutes afterwards my face kind of went numb a little bit, like around my cheeks and my lips they felt numb, pretty significant ear pain in my left or jaw pain in left joint of my jaw, little bit of a rash on my face, rapid heart rate for about a minute, a minute and a half of like around 200 beats per minutes I think, exhaustion, nausea, different things, it kind of make sense for like as if was experiencing COVID. Consumer stated that when had first dose of vaccine, experienced about 20 minutes afterwards her face kind of went numb a little bit, like around her cheeks and lips felt numb and had a little bit of a rash on her face and had like some pretty significant ear pain in left or jaw pain in left joint of jaw. And then 2 days later, had a very rapid heart rate for about a minute, a minute and a half of like around 200 beats per minutes as per patient thought, based on her watch. Then after that like exhaustion and nausea and you know different things, it kind of make sense for like as if was experiencing COVID but wanted to see with those symptoms does it make sense." Consumer further stated that received her first dose and had some interesting responses and was trying to decide whether it was safe for her. Consumer wanted to know was it still okay for her to get the second dose. On an unspecified date, the patient underwent lab tests and procedures which included heart rate: increased (like around 200 beats per minutes). The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
eyelids became swollen; Eyelid inflammation; system was rejecting her eyes; Graves Disease; This serious case was reported by a consumer via interactive digital media and described the occurrence of graves' disease in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. In OCT-2021, an unknown time after receiving Shingles vaccine, the patient experienced graves' disease (Verbatim: Graves Disease) (serious criteria GSK medically significant). On an unknown date, the patient experienced swelling of eyelid (Verbatim: eyelids became swollen), inflammation of eyelids (Verbatim: Eyelid inflammation) and eye disorder (Verbatim: system was rejecting her eyes).  The outcome of the graves' disease, swelling of eyelid, inflammation of eyelids and eye disorder were not reported.   It was unknown if the reporter considered the graves' disease, swelling of eyelid, inflammation of eyelids and eye disorder to be related to Shingles vaccine.     It was unknown if the company considered the graves' disease, swelling of eyelid, inflammation of eyelids and eye disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-SEP-2022 The case was received from the patient's sister interactive digital media. The patient had a reaction to the vaccine.  Two days after the second dose, her eyelids became swollen (eyelid inflammation).  After that, she was diagnosed with an autoimmune disease.  Her system was rejecting her eyes and she was diagnosed with Graves Disease.  This was in October 2021.  The problem persists on the day 10th September 2023. It was all unfortunate.  The follow-up could not be possible as no contact details were available.
Approximately 10 days after the vaccination, the left side of my face became numb and swollen. It felt like Novocaine wearing off. The swelling has gone down, however, the tingling and numbness continues to this day.
pt recvd vax & w/in 12hrs post vax pt exp pain behind rt eye,h/a,lightheadedness,facial erythema,swelling of rt side of face & neck & itching;sx cont
Had 'reactions'; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had 'reactions') in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had 'reactions'). At the time of the report, VACCINATION COMPLICATION (Had 'reactions') outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2021-399673 (Patient Link).
No harm to patient. Patient was administered a monovalent dose on 9/5/22 as a booster versus the bivalent booster. Of note: Bivalent was not available in the department at the time and no communication had been sent that we were not to administer monovalent as a booster dose any longer.
Lazy pinkish red rash over site and extending down thigh apprx. 2 cm on right leg
On 4/14/21 experienced increased ringing in left ear & a hard hit of dizziness. Slowly improved over days. On 4/20, had right ear (my good ear) sudden loss of hearing along with a feeling of pressure & fullness. Thought it was a cold, treated w/some improvement w/decongestant. Hearing dropped out one more time before recovering. About 6 days later had a short course of antibiotics for a slight sinus infection (ears looked fine) . On 5/10/21 - had constipation & was pushing on the toilet & got another (worst one yet) hit of dizziness. I have had my PPPD for 9 years including tinnitus in left ear & occasional sinus infections and I have NEVER had anywhere near the amount of issues that I experienced after my 2nd shot including the increase in tinnitus.   Since 5/10 I have had an unprecedented amount of near dizziness and off balance issues & am embarking on a course of supplements to improve gut/mucosal health; immune support.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2524), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "in remission from MG (diagnosed 2010), not on any immunosupressive drugs", start date: 2010 (unspecified if ongoing), notes: in remission from MG (diagnosed 2010), not on any immunosuppressive drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2023) Negative, notes: paxlovid rebound tested negative 1 day; (06May2023) Positive, notes: after finished paxlovid tested positive 3 days after finished paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
contracted covid August 28, 2023; contracted covid August 28, 2023; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 at 13:15 as dose 5 (booster), single (Lot number: GJ6665) at the age of 22 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 25Apr2022 at 13:15 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Lot number: ER8737), in left arm, on 22Apr2021 at 13:15 as dose 2, single (Lot number: EW0162), in left arm and on 10Nov2021 at 13:15 as dose 3 (booster), single (Lot number: FH8028), in right arm for covid-19 immunisation. The patient's relevant medical history included: "MDD" (unspecified if ongoing); "unspecified anxiety" (unspecified if ongoing); "Nuts allergy" (unspecified if ongoing); "pollen allergy" (unspecified if ongoing); "covid", start date: Oct2020 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Aug2023 at 08:00, outcome "not recovered" and all described as "contracted covid August 28, 2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2023) Unknown results. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.
My upper arm was immediately sore following the administering of the shot, by the next day from my shoulder to my elbow was very sore and swollen. After 48 hours it began to get irritated and I noticed a small red areas in the middle of my upper arm (a few inches below where the shot was administered at the very top of my arm. This red spot grew and by Saturday morning was about 2 inches, lumpy and hot. It was also quite painful, over the next two days the spot grew considerably encompassing the outside half of my upper arm. It burned and hurt quite a lot, even more if I moved my arm to carry something, walk or drive. It was visibly swollen as well. On Monday I went to the doctor who gave ne a shot to counteract the effects.
she ended up testing positive for HPV, but was unsure about the HPV type she was positive for.; was given GARDASIL as the first dose. She was given GARDASIL as the first dose.; This spontaneous report was received from a physician and refers to a 28-year-old female patient. No information on patient's medical history, current conditions, and concomitant medications. On unknown date patient had colposcopy and the result was not provided.   On an unknown date the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (exact dose, route of administration, lot # and expiration date were not provided).  On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (exact dose, route of administration, lot # and expiration date were not provided) (interchange of vaccine products).      On an unknown date the patient experienced human papilloma virus test positive. The outcome of papilloma viral infection was unknown. Action taken with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.   The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event was not provided.
Booster dose instead of third dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Booster dose instead of third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included USTEKINUMAB (STELERA) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Booster dose instead of third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Booster dose instead of third dose) had resolved.            No treatment information was reported by the reporter. Patient had been on a drug Stelera which impairs immune system.  Patient had already had 3 shots and believed the third one was a booster.