chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vision loss in the form of uveitis; Information has been received from a lawyer regarding a case in litigation concerning a  patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-JUN-2014, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage,  route of administration and expiration date were not provided) for routine adult health maintenance and for its intended propose; the prevention of shingles (herpes zoster).  Shortly after receiving the zoster vaccine live (ZOSTAVAX), the pt suffered vision loss in the form of Uveitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms have resulted in physical limitations not present prior to using the vaccine. The pt sustained severe and permanent personal injuries. The reporter considered uveitis to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the uveitis was considered as medically significant event.
Information has been received from a health professional concerning an adult patient who in approximately February 2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 649695/0512P). In approximately February 2005, the patient experienced injection site reactions describes as swelling, soreness, warmth, erythema and induration. Unspecified medical attention was sought. It was noted that the patient was treated with levofloxacin (LEVAQUIN). Subsequently, the patient recovered. A lot check will be performed. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Within 20 minutes of vaccine dose, patient developed a rapid heart rate, poor blood pressure, hot flashes/sweating, shortness of breath and was sent to the ER. Patient received fluids and monitoring; was discharged 3-4 hrs later.  30 minutes after discharge, patient returned to ER with throat swelling and shortness of breath -- > discharged 4 hrs later on Benedryl and steroids (with prescription to continue prednisone Dosepak, Pepcid, and Benadryl).
Maculopapular rash w/ hyperesthesia s/p Moderna COVID vacc.  Pt was given Prednisone and Triamcinolone by our office.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with a doses of RECOMBIVAX HB, that were improperly stored on unknown dates. No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
HEADACHE, NECK PAIN, RIGHT SIDED FACE PAIN, BODY ACHES, FEVER
Developed spots located on her scalp, forehead and face Lt is bilaterally. Spots itchy. no blistering -Treatment - acyclovir X 7 days
rash is sore; rash itches; developed a rash on her right arm/Feels like a Mosquito bite/The rash is in the one spot  on my right arm. next to where I got the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (rash is sore), RASH PRURITIC (rash itches) and VACCINATION SITE RASH (developed a rash on her right arm/Feels like a Mosquito bite/The rash is in the one spot  on my right arm. next to where I got the Moderna shot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced VACCINATION SITE RASH (developed a rash on her right arm/Feels like a Mosquito bite/The rash is in the one spot  on my right arm. next to where I got the Moderna shot). On an unknown date, the patient experienced PAIN (rash is sore) and RASH PRURITIC (rash itches). At the time of the report, PAIN (rash is sore), RASH PRURITIC (rash itches) and VACCINATION SITE RASH (developed a rash on her right arm/Feels like a Mosquito bite/The rash is in the one spot  on my right arm. next to where I got the Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by reporter. No treatment information was provided by reporter.
diarrhea; colon spasms; extreme headaches; Fever 104 F; chill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 13May2021 at 15:00 as dose 1, single (Lot number: FL0182), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "extreme pain" (unspecified if ongoing); "(headache) increase" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN oral taken for pain, headache. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; GASTROINTESTINAL PAIN (non-serious), outcome "unknown", described as "colon spasms"; HEADACHE (non-serious), outcome "unknown", described as "extreme headaches"; PYREXIA (non-serious), outcome "unknown", described as "Fever 104 F"; CHILLS (non-serious), outcome "unknown", described as "chill". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The vaccine was administered in the left shoulder. Patient age at time of vaccination was 27- 28 years (as reported). For 1st/2nd dose, both caused diarrhea, colon spasms, extreme headaches, fever 104 F, chills (some patient thought were standard). Patient's father thought this was all some big government conspiracy, which was obviously silly. Patient did think that may be it was rushed out, but it was necessary. This thing saved millions of lives. Patient just wish it didn't mess up theirs (more than it already was).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300132673 same reporter/patient/suspect drug, different dose number/event;US-PFIZER INC-202300085419 same reporter/patient/suspect drug, different dose number/event;
pt recv vax 28OCT95 & c/o wrist pain, numbness in little finger, fever, hot flashes, nausea, & h/a;sx lessened by the next day & pt recovered
Was given incorrect booster dose.  Was give 0.3ml dose of Janssen on 10/28/21.  Pt notified and was given 0.5ml does on 11/10/21.  No adverse reactions
A healthcare professional reported that a pt received an injection of Pnu-Imune 23. Approx. 4 hours to 1 day, post vax, the pt developed an injection site reaction characterized by swelling, redness and pain. The symptoms resolved in 2 days. The reporter indicated that 4 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Information has been received from a physician concerning a 58 yr old female who on 03Oct05 was vaccinated IM with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P). Concomitant vaccination on the same day in the other arm included a dose of influenza virus whole virion 3v vaccine inactivated (Fluzone). On 03Oct05, within 1.5 hrs of vaccination, the pt experienced a very sore arm. Unspecified medical attention was sought. No treatment was required. Additional information has been requested.
At least half of the dose was administered / small amount left in the syringe; few drops were on the patient's arm; few drops were on the patient's arm; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a patient who received Herpes zoster (Shingrix) (batch number 252JX, expiry date 14th September 2023) for prophylaxis.   On 18th July 2022, the patient received the 1st dose of Shingrix. On 18th July 2022, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: The patient inadvertently received less than a full dose of Shingrix because a few drops were fell on the patient's arm after administering the vaccine. There was also a small amount left in the syringe. The vaccine had leaked out of an unknown site (unknown if injection site or the syringe).  At least half of the vaccine dose was administered. The reporter consented to follow-up via phone. Additional Supportive Information: The patient received half of the vaccine dose, because a few drops were fell on the patient's arm and small amount left in the syringe, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 was not reported. There were no concomitant medications. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with PAXLOVID from 16Jun2023 to 19Jun2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect products cannot be fully excluded.
3/30/21 Extreme backache, knee pain; 3/31/21 headache, aching behind eyes, and temperature 100 deg., tiny bit of left arm soreness, tiredness; 4/1/21 RIGHT arm soreness (the LEFT arm had been injected), headache, aching behind eyes, tiredness; 4/2/21  BAD left jaw pain, headache, tiredness; 4/3/21 headache, tiredness, general muscle pain; 4/4/21 tiredness, general muscle pain, fever blister on lip, canker sore in mouth (both at same time and had not experienced in several years); 4/5/21  very sore throat, fever blister and canker sore; 4/6/21 headache, fever blister, canker sore, sore throat; 4/7/21 (tomorrow) I still expect to have a headache and pain from the mouth sores.  NOTE: only previous extreme backache and knee ache was experienced at age 16 before diagnosis with rheumatic fever;  have experienced fever blisters and canker sores most of my life, except for last 10 years, these have been an unusual occurrence, nothing I did precipitated it.; left jaw ache experienced 20 years ago before diagnosis of Temporo-Mandibular Joint Dysfunction, this was also an unusual occurrence;  I haven't had a sore throat in over 35 years.  I FEEL THESE REACTIONS MANIFESTED MOSTLY FROM OLD MEDICAL EXPERIENCES.  But the adverse effects just keep continuing.  I am still suffering side effects almost a week after the second shot.  It has been a VERY DEPRESSING experience.
heart irregularities; severe tightness in chest; chest pain; shortness of breath; could not move neck much, barely could get out of bed; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 20-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021, at 12:00 (at the age of 20-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Past drug included augmentin and had allergy to it. Patient was tested for covid prior and post vaccination. On 18Aug2021, Less than 48 hours after injection patient woke up Wednesday morning and experienced heart irregularities, severe tight-ness in chest, chest pain, shortness of breath, could not move neck much, barely could get out of bed. Adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. There they did electrocardiogram and asked the patient to go straight to ER for heart irregularities. The patient underwent lab tests and procedures which included electrocardiogram and results was unknown and sars-cov-2 Nasal Swab test which showed negative results on an unspecified date. Therapeutic measures were taken as a result of heart irregularities and received Medications for heart inflammation, severe tightness in chest, chest pain, shortness of breath, could not move neck much, barely could get out of bed. At the time of this report, the outcome of events was not recovered.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Severe Covid fog. Because patient is 93  she was not able to recognize that something was wrong until late in the day when things keep going wrong. Even then it didn't occur to her or her daughter that it was related to the vaccine. This was also the side effect patient suffered after her second Shingles shot in August.
immediate pain in my upper arm; pain in my upper arm it is accompanied by numbness on and off in my are to my fingers tips.; Initial information received on 28-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an adult patient who experienced immediate pain in my upper arm (pain in extremity) and pain in my upper arm it is accompanied by numbness on and off in my are to my fingers tips (hypoaesthesia), while he/she received vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient developed a non-serious immediate pain in my upper arm (pain in extremity) and pain in my upper arm it is accompanied by numbness on and off in my are to my fingers tips (hypoaesthesia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was not reported if the patient received a corrective treatment.  The outcome for both the events were unknown at the time of reporting.  Information on batch number will not be available.
Scheduling error. Patient was given Pfizer vaccine at 16 days after first dose instead of 17-21 days after first dose.
Information has been received from a nurse concerning a 20 year old female who was vaccinated with the third dose of GARDASIL (Lot # 658556/1060U).  The patient experienced pain at the injection site and in the arm after the third dose.  Patient outcome was unknown.  Unknown medical attention was sought in the office.  No product quality complaint was involved.  This is one of two cases from the same source (WAES # 0804USA03130).  Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of headache, chills, arthralgia (joint pain), ear pruritus (itch at the back of the ear) and hypertension (hypertension 1 140/90) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine), batch# 038B21A) for COVID-19 immunization. The occurrence of additional events detailed below. Concurrent medical conditions included hypertension (hypertension I 140/90) on Apr 14, 2021. On Apr 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 13, 2021, patient experienced headache, chills, arthralgia (joint pain), ear pruritus (itch at the back of the ear) and nausea. On Apr 14, 2021, patient experienced hypertension (hypertension 1 140/90) and increased heart rate (fast heart beat). The patient treated with Tylenol (paracetamol) for pain, 2 pills. At the time of the report, headache, chills, arthralgia (joint pain), ear pruritus (itch at the back of the ear), hypertension (hypertension 1 140/90), nausea and increased heart rate (fast heart beat) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication details reported. Reporter did not allow further contact.
Pt recvd booster dose of MMR vax on 19FEB92 & on 9MAR92 pt devel a swollen rt cheek & a low grade fever; presented to MD on 10MAR92 & w/ rt parotitis & hyperemic Stinson's duct orifice w/clear saliva expressed from the gland;
Pt's daughter arrived Monday (10/1/18) morning to alert the pharmacy of a possible ADR with the Influenza and/or SHINGRIX vaccine. The pt received the vaccines on Saturday morning (9/29/18) and began experiencing a fever and weakness later that day. The fever and weakness got worse on Sunday (9/30/18). The pt experienced a HA that involved both hemispheres, self-diagnosed as a migraine. Her blood pressure was reported as normal, around 114/60-70, throughout the day on Sunday. On Monday (10/1/18) the pt experienced light headedness, dizziness, blurry vision, and collapsed in her bed. The pt trialed ibuprofen for pain/fever. Pt went to hospital. BP was 160/74 at admission, when attached to monitors came down to 114/62. Blood glucose information was not known when reported to the pharmacy. Pt has a history of asthma and pt was slightly SOB in the hospital. Pt has a history of several allergens (environment, bees, among others) for which she receives weekly allergen shots. Pt had marked not allergic to any of the ingredients of the vaccines as far as she knew.
PAIN; DRY HEAVING CONTINUOUSLY; BACK DISCOMFORT; DISCOMFORT IN SCAR TISSUE FROM HIS PRIOR SURGERIES; CHILLS; FEVER; NAUSEA; VOMITING; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgeries. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced nausea. On an unspecified date, the subject experienced pain, dry heaving continuously, back discomfort, and discomfort in scar tissue from his prior surgeries. Treatment medications (dates unspecified) included: hydrocodone bitartrate/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea, had not recovered from dry heaving continuously, and the outcome of chills, fever, pain, back discomfort and discomfort in scar tissue from his prior surgeries was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
This medically confirmed report (initial receipt 27-Apr-2012) concerns a female patient. On 23-Apr-2012 the patient received AFLURIA (batch no. 1169AA) intramuscularly. On an unspecified date the patient experienced cellulitis. The patient was a hospital in-patient at the time of the event. The event did not result in the hospitalisation. Cultures and sensitivity tests were performed. The patient was treated with Vancomycin. The outcome for the event was recovering.
On 08/14/2002 at around 5pm she was found unresponsive when she was picked up from her swing. She was rushed to the ER and from there she was flown by helicopter to another hospital. She was admitted to the ER to be stabilized. After stabilization, she was taken to the pediatric intensive care unit. On that same day she was diagnosed with having massive bleeding on the right side of her brain, swelling on her brain, bleeding behind her right eye and (we found out about 2 weeks later) she had fractures in her arm and leg. The next day, 08/15/2002 around 4am she started having seizures. She was put on phosphenetoin, phenabarbetal and valium to control her seizures. She is still taking Dilantan to this day. After about 24 hours she stopped having seizures. She was also put on Manital for the swelling in her brain. She resided in the PICU until 08/20/2002. She was moved from the PICU to the rehab unit in the same hospital. Physical Therapists worked with her to do exercises to help her start moving her left side again. She had minimal movement to her left side and she wouldn't turn her head to the left. While she was still in PICU, she had a neck brace on and towels taped to both sides of her head to decrease movement of her head and neck. She also had been on a ventilator to help her breath. Later, they removed that and put a feeding tube down her nose. She had the feeding tube in until the day after she was discharged from the hospital. She was discharged from the hospital on 08/26/2002. The ER diagnosed her with shaken baby syndrome which I believe is a misdiagnose for the simple fact that she had no previous signs of abuse, no current (at the time) signs of abuse. Most cases of SBS, children have bruises to the ribs, fractured ribs, whiplash and neck and back injury and previous signs of abuse. My daughter had none of these. She received her 2 month vaccinations 5 days prior to the day she was admitted to the ER.
On 5/9/00, the pt's mother brought him in for the nurse to look at his arm. The nurse noted on the left deltoid at the injection site a 2 inch round rash. The rash is slightly raised, pink in color. The pt denies pain or itching. No other concerns were voiced and no treatment was given.
This spontaneous report as received from a nurse via company representative refers to certain less than 50 year old patients of unknown gender. No information regarding the patients' pertinent medical history, concomitant medication, drug reactions or allergies was reported. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX (strength, dose, route of administration, lot # and expiration date were not provided). The reporter stated that there had been times that, on unknown dates, rheumatologists ordered ZOSTAVAX for certain patients who were less than 50 years of age. On unknown dates, rheumatologists ordered ZOSTAVAX for these certain patients before they began therapy with ENBREL or HUMIRA. Additional information has been requested.