chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vision significantly impacted; Both distance and reading vision affected.; Both distance and reading vision affected; Dose received 3/ dose number=3; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162b2), administered in left arm, administration date 20Nov2021 at 14:00 (Lot number: FG3527) at the age of 52 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Pre-diabetic" (unspecified if ongoing) and "Penicillin allergy" (unspecified if ongoing) notes: known allergies: Penicillin. Concomitant medications included: ADVIL; VIT E; VIT C, MULTI-VIT and MAGNESIUM. Vaccination history included: bnt162b2 (DOSE 1, SINGLE; Lot number: EW0153; Anatomical site: Right arm; Administration time: 16:00), administration date: 12Apr2021, when the patient was 52 years old, for COVID-19 immunisation and bnt162b2 (DOSE 2, SINGLE; Lot number: ER8735; Anatomical site: Left arm; Administration time: 14:00), administration date: 13May2021, when the patient was 52 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021 at 14:00, outcome "unknown", described as "Dose received 3/ dose number=3"; VISUAL IMPAIRMENT (non-serious) with onset 22Nov2021 at 09:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Vision significantly impacted"; VISUAL ACUITY REDUCED (non-serious) with onset 22Nov2021 at 09:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Both distance and reading vision affected"; MYOPIA (non-serious) with onset 22Nov2021 at 09:00, outcome "recovered with sequelae" (an unknown date in 2021), described as "Both distance and reading vision affected". The events "Vision significantly impacted" and "Both distance and reading vision affected'' were evaluated at the physician office visit. Therapeutic measures were not taken as a result of visual impairment, visual acuity reduced and myopia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient needed reading glasses now everyday glasses and stronger new glasses needed for reading.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of an unspecified age, reported as probably over 65, received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cellulitis at injection site. Clinical outcome of the event was unknown. Information on batch and lot numbers has been requested. Sender's Comments: Based on the information currently available, the vaccination with PREVNAR 13 might play a contributory role in triggering the occurrence of vaccination site cellulitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Itch: 2-21-09. Severe welts (red, puffy) 2-23-09 to 2-25-09 (peak discomfort) 1 tablet BENEDRYL 2/25.  Itch relief w/ AQUAFLOR topical area : Head (scalp) under eye, mouth chest area, elbows, arms, abdomen, butt, thighs, behind knee's, ankles, legs; ALL OVER.
ON LOWER LEFT ARM, PATIENT STARTED HAVING WELTS ALL OVER ARM. NO ITCHING, NO ISSUES BREATHING, NO PAIN. STARTED AFTER ABOUT AN HOUR AFTER ADMINISTRATION OF VACCINE. OFFERED TO CALL PARAMEDICS, AND OFFERED BENADRYL, PATIENT DECLINE. INFLAMMATION OF WELTS STARTED SUBSIDING, SO PATIENT DECIDED TO LEAVE WITH NO TREATMENT ACCEPTED.
Onset of fatigue, myalgias, fever and chills about 5 hours after dose.  Fever increased to a maximum of 102.8 2-3 hours later.  Fever and other symptoms gradually resolved with a few hours by 03:00 on 11/12/2019
36 hrs after Hib, PCV, and Dtap vaccinations the pt had a seizure of about 10 secs. She had had low fevers 99.5 for 24 hrs.
Headache TIREDNESS SAME DAY. NEXT DAY, BAD HEADACHE, BACK WAS HURTING. TODAY 01/05/21 JOINT PAIN WHEN I WOKE UP. LEFT ARM JOINT PAIN AT ELBOW AND AT WRIST AND MY HAND AND FINGERS Narrative:  2 DAYS OF SAFETY LEAVE
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE, start date: 01Mar2022, stop date: 03Apr2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19. Clinical Information: The patient received COVID 19 Treatment with Paxlovid from 05Apr2022. Patient received vaccine. The patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received Flucelvax Quad 2020-21 vaccine drawn up from multidose vial on 10/12/2020 by pharmacist around 4:20 pm. Patient had no immediate reaction to the flu vaccine while at the pharmacy. Patient was waiting for other friends to finish receiving vaccine for about 10 or 20 minutes with no reaction then either. Patient called pharmacy on 10/14/2020 at 11:20 AM to notify pharmacy of potential allergic reaction to flu vaccine. Patient states she woke up the morning of 10/14/2020 with hives all over her body, as well as swollen lips. Patient also states she did not receive any other vaccines since Monday 10/12/2020 and does not believe she had any exposure to any other allergen in that time. Patient did not have to use epinephrine, but she has been taking loratidine. In addition, MD prescribed a course of steroids to help with patient's symptoms.
This medically confirmed literature report (initial receipt 22-Jul-2014) concerns a 46-year-old female patient who had a medical history of human immunodeficiency virus (HIV) disease. Her concomitant medications included efavirenz, lamivudine and zidovudine. She noted no history of previous reaction to drugs or vaccinations of any kind. She had received annual influenza vaccines in the past without incident. On an unknown date, she received influenza vaccine (manufacturer and batch number not provided) for her annual influenza vaccination. On an unknown date, one day following the influenza vaccination, she developed a rash. On an unknown date, she presented at the clinic with seven weeks of onset of a diffuse, highly pruritic rash. On physical examination, she had a diffuse eruption of hyperpigmented, slightly violaceous polygonal papules and plaques with white, lacy reticulations that spared her face, palms, and soles. No changes were noted on the buccal mucosa. The CD4 count one month prior to vaccination was normal at 704 cells/mcL. The viral load was suppressed at 128 copies/nL. Histopathology revealed a lichenoid interface dermatitis with eosinophils, most consistent with lichenoid drug eruption. Immunohistochemical stain for Treponema pallidum was negative. She was treated with high potency topical corticosteroids, two oral prednisone tapes, and narrow band UVB therapy. While therapy was being initiated, the lesions progressed to include the face. Narrow band UVB therapy and clobetasol ointment were continued, and metronidazole 500mg PO BID and topical tacrolimus 0.1% ointment were added to the regimen. Approximately 6 months after initiating therapy, all active lesions had resolved with marked post-inflammatory hyperpigmentation. Outcome was reported as recovered for all active lesions, and unknown for other symptoms. Author's comments: Lichenoid drug reactions to vaccinations are rare but well-documented events, vast majority of these reported reactions have been triggered by Hepatitis B vaccination. This is only the fifth reported case of lichenoid drug reaction, and only the second generalized case, following influenza vaccination. The patient's underlying HIV disease, known to be a risk factor for both cutaneous drug reactions and more severe manifestations of lichen planus, likely predisposed her to this generalized hypersensitivity phenomenon.
pt recv vax 16SEP97 - SIDS on 21SEP97;parents requested VAERS on 22SEP98-1yr anniversary of pt death;
Itchy, red, hot, raised welt appeared on arm surrounding the injection site. The site was swollen, hard, and painful. The pain extended down the arm through the fingers and upwards to the left ear. Ice, ibuprofen, and cortisone cream were used with minimal symptom relief. The symptoms of the reaction continued to increase for several days and the welt was approximately 7 cm by 8 cm in size 10 days after injection. On the 10th day following the injection, medical care was sought. Antibiotics, cephalexin 500 mg b.i.d. were prescribed. Hives occurred three days after starting antibiotics. The welt resolved approximately 14 days post-vaccine date.
patient received booster dose at the 4.5 month mark as opposed to the 5 month mark. Patient is not immunocompromised therefore the spacing between doses should have been 5 months or more.
Started with join pain for a few days, started taking one Aleve a day. The muscles became extremely sore. Joint pain increased, involving shoulders, hands, legs, arms, knees and hips. Left hand began swelling on January 23rd and continued so I could no longer see my knuckles and it ballooned and it was hot and very painful. The knees were so bad it was almost impossible to stand from a sitting position and walking was stiff. Could not sleep laying down because pain in shoulders and knees would increase.   I went to the doctor on the 26th.   he prescribed Prednisolone for one week and I am scheduled to see him next Tuesday February 2nd.
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR051880   Additional Information: GSK Receipt date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient had both vaccines the first one didn't affect patient no other way but a sore arm. The second vaccine hit his/her with everything from sore arm to dizziness, and feeling so sick to my stomach.  But patient glad to have gotten them. The follow-up could not be possible as no contact details were available. This case had been linked with US2023AMR051880, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR051880:Same patient
Last month I went for an appointment with my gastroenterologist, Dr., for a colonoscopy. He performed a CT scan with contrast to see if he could notice any other possibilities causing the pain in my stomach. My colonoscopy came back normal with a polyp found and removed. My CT scan showed that I had a cyst, about 9cm in size, on one of my ovaries. I was ordered to see a GYN. I had my appointment with Dr. where she performed a pelvic exam and a pap smear. Both exams came back normal. I was ordered to have an ultrasound completed. When I did, they noticed 2 dark spots on the back of my uterus. Dr. took a biopsy of the spots and I'm still waiting for the results. Regardless of what the results are, I'm going to have a hysterectomy performed on me. If the biopsy shows cancer, I will have an oncologist perform the surgery, if it is not cancer, Dr. will perform the surgery.
Day 1: Received vaccine @ 2pm and about 15 minutes later lymph nodes in neck started to swell with right greater than left swelling. Notified nurse and told to wait another 15 minutes and contact if difficulty breathing. Took 25 mg benadryl orally, Symptoms remained the same. At 2:30 left vaccine site. At 2:35 took another Benadryl due to tightness in throat. No change in breathing, Swelling in Lymph nodes increased. No change in breathing. Went to bed for a few hours. Upon waking felt achy all over. Day 2: The next day about 20 hours after the receiving the vaccine felt chilled, increased body aches, feverish, temp 102.4. Treating with Tylenol and Benadryl, warm showers to try and decrease chills and fluids.  Day 3 increased body aches and now mild headache, temp continues 100.2 treating with Tylenol, additional fluids.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender (reported as "up to 20"), who between 01-SEP-2016 and 28-SEP-2016 were vaccinated with improperly stored doses of GARDASIL 9 (lot # reported as 040459, expiry date 06-APR-2017) and "Gardasil 4" (doses and routes were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA014070: US-009507513-1612USA011604: US-009507513-1612USA014071.
Case number PHEH2016US028828, is an initial spontaneous report received from a consumer on 04 Oct 2016. This report refers to an adult female patient. Past medical history included chronic fatigue syndrome, surgeries for the melanoma, needle biopsy, cold sores and LEEP (loop electrosurgical excision procedure). Current condition included melanoma on chest and legs. Concomitant medications included dexamethasone and VALTREX. The patient was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date, the patient experienced drug allergy/drug reaction. The outcome, seriousness and causality of the event was not reported.
The pt experienced nausea, vomiting and a seizure on 9/20/01.
Temp 103.8, malaise, myalgia, drowsiness, increased in appetite.
Received shot at 7:30am. Around 1pm, started experiencing tingling in hands and feet. Called an on call nurse through my insurance to see if this was anything concerning, and she recommended I go to the ER. My hands/feet tingled for  about 10 hours continuously, with some numbness in my feet as well. The ER did lab work but everything came back normal.  By the next morning, the tingling/numbness was gone.
pt admitted to hosp with SOB and cough; found to be positive for COVID; COVID pneumonia; given steroids, anticoagulants, remdesivir; pt's condition worsened and he was transferred to ICU; pt suffered a cardiac respiratory arrest requiring intubation with mechanical ventilation; pt's condition continued to deteriorate requiring dialysis, but family refused; pt passed away in the hospital
Sensation of throat closing, tightness in throat, panic attack. I was given 50 mg of Benadryl and a shot of Dexamethasone
pt immed started screaming;pt home & became stiff & would stop breathing & then sz, fever 103-104;would at times become listless & not respond to anything & start screaming for 3hr or more, bones became thin, Dx=osteogenesis imperfecta;  Follow up received on 10/17/00 states the pt still has osteogenisis, still breaks bones easily and still has a hard time breathing because of pleurisy.
Cold rush in arm , chills, fever, pain in arm where shot administrated , arm swollen and body pain.
sick; aching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of illness (On an unknown date, the patient received first dose and experienced pain, refer case US2023AMR086707).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick) and pain (Verbatim: aching). Rechallenge with Shingles vaccine was positive. The outcome of the sickness and pain were not reported.   It was unknown if the reporter considered the sickness and pain to be related to Shingles vaccine.     It was unknown if the company considered the sickness and pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR086707   Additional Information: GSK Receipt Date: 17-JUN-2023 The patient self-reported this case. This case was reported by a patient via interactive digital media. The patient received both the doses of Shingles vaccine, however they both made the patient sick and aching. The patient was glad after having both the doses.; Sender's Comments:  US-GSK-US2023AMR086707:same Reporter case for first dose
right thigh muscle and bicep/ tighten up; right arm and leg are cramping/diagnosed with muscle spasms; sore/ eerie-feeling; low grade temperature/running a temp; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (right thigh muscle and bicep/ tighten up), MUSCLE SPASMS (right arm and leg are cramping/diagnosed with muscle spasms), PAIN (sore/ eerie-feeling) and PYREXIA (low grade temperature/running a temp) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (right thigh muscle and bicep/ tighten up), MUSCLE SPASMS (right arm and leg are cramping/diagnosed with muscle spasms), PAIN (sore/ eerie-feeling) and PYREXIA (low grade temperature/running a temp). At the time of the report, MUSCLE TIGHTNESS (right thigh muscle and bicep/ tighten up), MUSCLE SPASMS (right arm and leg are cramping/diagnosed with muscle spasms), PAIN (sore/ eerie-feeling) and PYREXIA (low grade temperature/running a temp) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Lips felt a little numb and little swollen about 20 minutes after vaccine was given.  Still have numbness on bottom lip and still swollen even after taking Claritin or benedryl for past 11 days.
after the first vaccine is when I had my side effects; I had A-fib and is very controllable its minor caser of A-fib but after the first dose I was in A-fib for a total 48, little over 48 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Aug2021 (Lot number: FC3182) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing), notes: have A-fib but it's controlled A-fib but it's controlled by a medication. The patient took concomitant medications included 'water pill (unspecified)'. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "after the first vaccine is when I had my side effects; I had A-fib and is very controllable its minor caser of A-fib but after the first dose I was in A-fib for a total 48, little over 48 hours". The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: it was after I got the vaccination. It was about a month or so that I got blood work then (Not clarified). What's then? No. The patient received treatment with Metoprolol and Propafenone.  Clinical course: Consumer stated, "Someone told she that, she should report a side effects that she had when she received the Covid vaccine, the Pfizer Covid vaccine. "Paraphrased for Covid19 vaccine: Consumer stated, "That's correct. "After the first vaccine was when she had her side effects. Yes with the first dose was when she had her side effects. She didn't have any side effects with the second dose." Consumer stated, "she went into, she had A-fib and was very controllable its minor caser of A-fib but after the first dose she was in A-fib for a total 48, a little over 48 hours and medication (Further not clarified hence suspect captured as Unspecified medication) wasn't controlling it." Further probing: Consumer stated, "Yes, as it helps somebody, yes." Medical condition: Consumer stated, "No, she didn't have anything like that. She had, she did have A-fib but it's controlled A-fib but it's controlled by a medication. A-fib, it stands for atrial fibrillation which mean her heart flutters." Treatment: Consumer stated, "Yes she took all the medication that she was supposed to take.". Consumer stated, "It would help for may be better an hour and then it would come back (Further clarification unknown hence suspect not made). Sure, hold on, she took 2. She took Metoprolol 25mg, she took it twice and another medication Propafenone she took 300 mg and she took that twice for 2 days, twice a day for 2 days." Consumer further stated, " The second medication the Propafenone, she only took that once one day and once another day. She didn't take it twice in 1 day. She only took it once. The other 1, she took it twice."  No follow-up attempts are possible. No further information is expected.
Pt rec'd OPV/DTP/HIB became pale w/shallow respirations; 02 administered x 15mins; Pt alert, responsive w/improved color; Cried x 5 min a/leaving clinic mom to notify PMD;
Immediately subsequent to the shot, I had bad headache in the back of my head that didn't last more than 2 days. On August 24, I woke up with double vision. Neurologist diagnosed me with multiple sclerosis.
Patient given 0.25 mL instead of 0.5 mL. Patient came back same day to receive additional 0.25 mL.
hardly able to walk, crippled up, everything hurting, rheumatoid arthritis, vax caused flare up
1.5 in. x 1.25 in. raised, red, hot dorsal left upper arm accompanied by migraine-like headache without aura.  Patient out of school 12/1/09- 12/3/09.  Seen at walk-in clinic 12/3/09, as unable to see PHCP. No treatment given; symptoms resolved on own by 12/3/09.
This spontaneous report as received from a nurse refers to a 13 month old female patient. On 08-MAY-2014 the patient was vaccinated with VARIVAX (lot# and expiration date no provided) (dose not reported). It was reported that the patient was vaccinated with VARIVAX exposed to a maximum temperature of -7C for 27 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This patient received IPV #2, DTaP (Infanrix) #2, and Hib / Hep (Comvax) #2. The father relates elevated temp of 104 for 5 days to the doctor, blood work neg. Advised Motrin on 11/09/00. The patient has a "rash" on her trunk. reported to us on 11/08/00.