chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received from another manufacturer (ID# B0519583A), who received the report from an investigator participating in their clinical trial. Verbatim from the report: "This female subject was enrolled an a prophylactic open study. On 03 April 2007, the subject received the 1st dose of HPV (IM, left upper deltoid) and the dose of BOOSTRIX (IM, right upper deltoid). On 14 May 2007, the subject received the 2nd dose of HPV (IM, left upper deltoid) and the dose of MENACTRA (IM, right upper deltoid). On 12 September 2007, the subject received the 3rd dose of HPV (IM, left upper deltoid). On 19 February 2008, five months after the 3rd dose of HPV 16-18, nine months after the 1st dose of MENACTRA, 10 months after the 1st dose of BOOSTRIX, this 13-year-old subject developed bell's palsy. the event was disabling. The subject was treated with ACYCLOVIR and PREDNISOLONE. The event was unresolved at the time of reporting. The investigator considered that there was a reasonable possibility that the bell's palsy may have been caused by HPV 16-18, MENACTRA and BOOSTRIX. Investigator comments: On 19 February 2008, left eyelid started twitching. The eyelid felt numb + left side of face was numb. she could not close her eyes, mouth angle twists to right when smiling. Continues to worsen. On 20 February 2008, patient given ZOVIRAX and PREDNISOLONE. On 28 February 2008, patient returned to clinic for recheck - no improvement - referred for a neurology consult - patient did not get a neuro consult. On 09 April 2008, recheck in clinic - Bell's Palsy worsening. On 25 April 2008, patient had not improved, worsened. Patient is receiving physical therapy. On 01 May 2008, no improvement. On 08 May 2008, the Bell's Palsy is probably related to the study. On 20 February 2008: Exam in clinic - findings: left eyelid cannot be approximated, numbness left cheek. Exam reveals facial asymmetry left facial palsy. Patient never seen by neurologist - referral by neurologist office for physical therapy." No further information was provided.
Initial report was received from a health care professional on 03 November 2011. A 57-year-old female patient had received FLUZONE intramuscular injection in left deltoid, lot number UH477AD on 28 October 2011. On the same day, two to three hour after the vaccination the patient complaint of severe pain at the injection site and surrounding area, left shoulder pain that radiates down her arm and limited range of motion. The patient was seen in an urgent care center due to pain and was referred to a neurologist. No further information was available at the time of the report. The patient outcome was reported as not resolved/not recovered. Follow-up report was received from a healthcare professional on 30 January 2012. From new information received it was determined this case now meets seriousness criteria (other medically significant) and has been upgraded from non-serious to serious. The physician reported that the patient had no history of pain or injury prior to vaccination. The neurologist diagnosed the patient with cervical radiculopathy (C7), secondary to herniated disc. The patient received a complete blood count (CBC), erythrocyte sedimentation rate (ESR) and creatine kinase (CK) all satisfactory. The patient received corrective treatment, however it was not provided. The patient outcome was not reported. Documents held by sender: none.
Information has been received from a pharmacist concerning a patient who was vaccinated with a third dose of varicella virus vaccine live. Subsequently the patient experienced a lack of response. Additional information has been requested.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age and ethnicity. 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 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-MAY-2021, 8 weeks ago the patient got the test done through a blood draw it did not show up that patient has antibody. (confirmed immunological vaccine failure). Patient did not know what kind of test was done. Laboratory data included: On 19-MAY-2021, Blood test (NR: not provided) Did not show antibody. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210619586-covid 19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
Yellow Fever Vaccine Accidental Overdose: Five (5) dose vial was inadvertently reconstituted with 0.5 ml saline (instead of 3.0 ml saline)and 0.4 ml reconstituted vaccine adminstered to client.  Immediately after vaccine administration, supervising nurse discovered error.  Client interviewed and no immediate reaction reported. Department of Public Health, CDC, and vaccine manufacturer consulted for recommendations. Further client followup by phone conducted on 9/16/10 and 10/18/10 revealed that he felt "fine" and denied experiencing any high fever, behavioral changes, flu-like symptoms, or any signs and symptoms of allergic reaction.
pt recvd vax & w/in 24 hrs p/vax exp multiple hives sites on trunk & back; pt took DPH; sx has not subsided;
Developed redness, pain and swelling at site of anthrax vaccine within a few hours after receiving the shot.
Information has been received from a physician via an email concerning a female who was vaccinated with a dose of GARDASIL. The consumer reported that a ER nurse stated that the patient was admitted to the hospital with the same symptoms as the consumer's daughter down to constant fatigue, inability to walk, severe back pain, spine pain, symptoms of bladder infection, fainting spells, gasping for air, acid reflux, hallucination, headache, sleep deprivation, not feeling of her arms and legs, bouts of aches and pain, fever, blood clots in her legs, vomiting, dehydration and all over pain. It was reported by the nurse that this patient was finally diagnosed with a severe reaction to GARDASIL. Attempts are being made to verify the existence of an identifiable patient and reporter. Additional information will be provided if available. This is one of two reports from the same source. Additional information has been requested.
Several small "water blisters" on foot starting 1 day after the vaccine. MD treated with Mupirocin 2% oint., AUGMENTIN XR 1000 mg, BACTRIM DS & PERCOCET 5/325.
pt recv vax 19OCT98 & states passed out twice, was cold & clammy w/a tight feeling in chest;further exam revealed a localized erythematous & edematous area @ inj site on rt deltoid;
Pt healthy & tolerated well for 3 hrs after vaccination, then became very fussy, swelling, redness & tenderness at injection site of PREVNAR.
It was reported in a published article, that a healthy adult male patient's child was vaccinated with a dose of VARIVAX (Merck) (dose #, lot # and route of administration not reported). Subsequently, the father developed a rash caused by vaccine-strain VZV after exposure to his 12 month old child. It was also reported that the 12 month old child developed disseminated VARIVAX (Merck) (MARRS # 0803USA04453). The article also discussed the experiences of two other patients after vaccination with VARIVAX (Merck) (MARRS numbers 0803USA04454 and 0803USA04484). Follow up information has been received: Information has been received from a healthcare professional. the author of the published article. It stated that the most frequently reported adverse reaction to vaccination is a mild rash that appears several weeks later in about 5 percent of healthy children, particularly after a first vaccine dose. Extensive rashes, with occasional pneumonia or neurologic symptoms have been reported rarely in immunocompromised children who were inadvertently vaccinated, such as those with undiagnosed AIDS, natural killer (NK) cell deficiency, and other immunodeficiency diseases. The author states that there is a potential for transmission of the vaccine virus if vaccines develop rash from the Oka strain, but transmission is extremely rare from healthy individuals; fewer than 10 instances of transmission have been reported since 1995, during which time as many as 60 million children were vaccinated. Additional information is not expected.
10 minutes after injection, patient began to have redness/flushing of her face/neck. Symptoms partially resolved. She flushed approximately 3 times. Reported tingling in fingers bilaterally. Kept rubbing her fingers together and shaking hands. Pulse 107, BP 154/101. Patient states normal BP for her is 120/60. Hives and itching also reported. Patient states often flushes/gets hives when stressed/upset.  No issues prior to injection. Patient take to hospital ED for observation. Symptoms had resolved when she spoke to the ED doc but are lingering today 12/24 as of 1030 am.
11/1/99 pt started w/spots on abd & back;seen 11/2/99 scattered papules & vesicles;
Provider ordered Prevnar 20 from adult stock. Medical assistant gave Prevnar 13 from pediatric stock.
Telephone call from mom. Pt. was fine all day. Received GARDASIL #3 at 1 pm and started vomiting 1/2 h after vaccine every 1 h. Vomited last 10 am 5/21/14. Stared with diarrhea.
This spontaneous report as received from a nurse at doctor's office, via sales representative refers to an 18 month old patient of unknown gender. The patient's pertinent medical history or concurrent conditions were not provided. On an unknown dates the patient received the complete scheme of ROTATEQ, oral, (lot numbers and expiry dates were not provided). Co-suspect therapy and concomitant medications were not provided. The nurse informed that the patient had Rotavirus after receiving the complete dosing schedule of ROTATEQ. Unspecified laboratory tests were performed after the patient had received the complete dosing schedule of vaccine and revealed that the patient had Rotavirus (rotavirus test positive). At the time of the report, the patient had not recovered from rotavirus test positive. The relatedness between the event and suspect therapy was not provided. This is one of several reports received from the same source. Additional information has been requested.
Fever, malaise, muscle aches (onset 2 hours post vaccines); fever resolved 4 day and later cough developed with 24 hours of vaccines, w/dyspnea
Exhaustion. Dizzy that night and had to go to bed early, slept soundly for 8 hours. Had to take 2-hour nap the day after (day 2) and the day after that (day 3). Had diarrhea on day 2. Chest feels like I?ve been in a Smokey bar.
metallic or saltytaste; tenderness at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive in October 2020, Dyslipidemia and Hypothyroidism. Concurrent medical conditions included Loss of taste and Loss of smell. Concomitant products included PRAVASTATIN for Hyperlipidemia, LEVOTHYROXINE for Hypothyroidism, MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;SELENIUM;THIAMINE HYDROCHLORIDE;TOCOPHEROL;ZINC], VITAMIN D [VITAMIN D NOS] and PROBIOTICS NOS for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test positive: positive (Positive) Tested positive for COVID-19, specific date not provided..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Additional information added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded
This spontaneous report was received from a registered nurse via company representative regarding an unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with ZOSTAVAX, lot number-1709X, expiration date- May 2010. No concomitant medication was reported. On an unknown date the patient experienced a mild rash that they believe was shingles. The outcome of shingles was unknown. Additional information is not expected because physician does not want to get contacted.
had open sores in mouth and pain associated; had open sores in mouth and pain associated; This non-serious case was reported by a physician via sales rep and described the occurrence of sores mouth in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sores mouth (Verbatim: had open sores in mouth and pain associated) and oral pain (Verbatim: had open sores in mouth and pain associated). The patient was treated with valaciclovir (Valacyclovir) and mouthwash, nos (Mouth Rinse). The outcome of the sores mouth and oral pain were not resolved.   It was unknown if the reporter considered the sores mouth and oral pain to be related to Shingrix.     It was unknown if the company considered the sores mouth and oral pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JUL-2023 The doctor stated patient administered first dose of Shingrix in 2019. The patient had open sores in mouth and associated with pain. Apparently, since 2019 patient has been going through this. The patient has been treated with Valacyclovir and a mouth rinse. The reporter consented to follow up.
Patient was give a double dose of HiB. Pt mother as not reported any adverse events.
Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown gender and age. The patient's pertinent medical history and drug reactions/allergies were not provided. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX (lot # L035504, expiration date 16-DEC-2016) (strength, dose and route were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
to get a rash that weekend.; This is a spontaneous report from a Pfizer-sponsored program. A consumer (patient) reported for a male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, lot/batch number and expiry date were not reported), via an unspecified route of administration on 21Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a rash that weekend (Jan2021). The outcome of event was unknown.    Information on the lot/batch number has been requested.
The injection hurt. The arm continued to be painful, without redness or swelling. Have had some numbness ang tingling. Arm continues to have a dull pain making it hard to move and do things like getting dressed.  About a week and a half after the flu shot got a sore throat and laryngitis.  At that time the arm started to flare up and get painful again. Went to the doctor for the sore throat and mentioned the arm. He felt the shot had made her fibromyalgia flare and that it should be reported to VAERS.
Patient in for persistent hematuria.  Was discharged last week with hematuria that resolved with bedside irrigations.  Foley catheter was removed at the time of his last discharge as urine was clear.  Patient redeveloped clot retention.  He was treated in the emergency department with CBI and again his urine cleared.  CT scan shows no obvious source of bleeding such as large bladder mass.  No large quantity of clots within the bladder.  UA suggestive of persistent UTI.  At the time of discharge his urine is amber.  This is with CBI off for approximately 1 hour.  Patient will discharge back to memory care unit with the indwelling Foley catheter in place. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Swelling/redness to left deltoid measuring 13x8cm, warm to touch after receiving HPV vaccine.
Redness and swelling at injection site left thigh. Generalized hives per report. Benadryl was given in ED
Two day after receiving vaccinations, pt developed minor fever, vomiting, mustard or curry colored stools and what appeared to be stiffness and guarding at the IZ sites.
This spontaneous report was received from a Office Manager refers to a 04 year old male patient. The patient's relevant medical history and concurrent condition were not reported. On 09-APR-2018, the patient was vaccinated with a dose of expired PROQUAD injection lot # M041083 (expired date: 04-APR-2018), 0.5 ml once for prophylaxis (expired vaccine used). Concomitant therapy included sterile diluent (DILUENT MRK INJ) which was used to reconstitute. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1804USA004507:
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 04/13/2021. PATIENT FULLY VACCINATED ON 03/16/2021.
Arm soreness, chest pain, shoulder  and back pain, headache, cough, nasal congestion, sore throat, arm pit and neck lymph node swelling and moderate to severe pain began within 5hrs of taking vaccine. All other symptoms resolved  within 2 days except lymph node pain & swelling which is now constant. 6/10 pain rated scale which is persistent and she cannot work or sleep.  Taking 800-1000mg Tylenol without relief.
NIGHT OF FLU LIKE SYMPTOMS; This spontaneous report received from a parent via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 night of flu like symptoms. The action taken with covid-19 vaccine was not applicable. The patient recovered from night of flu like symptoms. This report was non-serious.
Onset reported to occur within a few hours. Fever dizziness lightheadedness and nausea.
6JAN97 2hr p/vax irritability, 4hr p/vax swelling of rt leg w/erythema;no fever;cont irritable
pt recv vax 22APR88 & JAN99 pt devel pneumococcal (type 3) pneumonia & sepsis & was hosp;
Had flu-like symptoms and sore arm for first 5 days. Felt somewhat better for a couple of days. Today red, swollen spot on arm and sore spot near shoulder. Spot is somewhat inflamed.
CONTINUOUS SWELLING AND PAIN IN THE RIGHT UPPER ARM WHERE THE VACCINATION WAS ADMINISTERED ON JANUARY 24, 2021
Information has been received from a nurse concerning a female in her 20's who in the past few months , in 2007, was vaccinated IM with 0.5 ml Gardasil. Subsequently the patient experienced syncope after the first and second doses of Gardasil. No treatment was required, and no lab diagnostic studies were performed. Subsequently, the patient recovered. Additional information has been requested.
A healthcare professional reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated on 4/24/00 and subsequently developed injection site swelling described as the "size of a half dollar". This is 1 of 2 pts from this facility who developed injection site swelling following this vaccine, lot 465319.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild, Additional Details: MILD HYPOTENSION FOR 15 MINUTES AFTER ADMINISTRATION AND NAUSEA. BP GO BACK TO NORMAL AFTER 30 MINS. OXYGEN LEVEL NORMAL. FOLLOWED UP WITH PATIENT AFTER 6 HOURS, PATIENT IS DOING FINE. JUST A SORENESS AT THE SITE OF INJECTION.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: Some forms of general anesthesia" (unspecified if ongoing), notes: known allergies: Some forms of general anesthesia. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 01Feb2023 to 06Feb2023  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.