chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right foot warts (plantar warts) resolved; HPV vaccine for right foot warts (plantar warts); This literature marketed report has been received from the authors of the published article, concerning a 56 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, salicylic acid and curettage. The patient's current conditions and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for right foot warts (plantar warts) (product use in unapproved indication) (strength, dose, frequency, route of administration, lot number and expiration date were not reported).   On an unspecified date, the patient's right foot warts (plantar warts) resolved (drug effective for unapproved indication).   The outcome of drug effective for unapproved indication was unknown.   The causal relationship between the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and drug effective for unapproved indication was considered as related, as the authors hypothesize that effectiveness of the vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) in extragenital warts was due to the cross-protection of extragenital strains.  A copy of the published article is attached as further documentation of the patient's experience.   This is one of several reports received from the same literature.
Information has been received from a 58 year old female consumer with drug reactions/allergies of sulfa who on 03-OCT-2011 was vaccinated with a dose of ZOSTAVAX (lot #, dose and frequency were not provided). Concomitant medication included "Anti-depressant and sleeping pill". The consumer reported that she experienced "unusual side effect" after receiving ZOSTAVAX. She reported that on 11-OCT-2011, she experienced post herpetic neuralgia (PHN) coming back and stated that "Neuralgia came back to the exact same location where she had it, on the right side of crown of her head to the hair line". She had a recent episode of shingles in June 2011 (also reported as no pertinent medical history) but she stated she had gotten over shingles completely with no PHN at the time of the ZOSTAVAX administration. She reported that the PHN was not as severe as before and she had been managing it with over the counter (OTC) medications (unspecified). The patient had sought medical attention by calling health department where she received ZOSTAVAX. No lab diagnostics study was performed. Her physician stated her on LYRICA 50 mg twice daily for 4 weeks. At the time of report, the outcome of the adverse event was unknown. Follow up information has been received from the consumer. On 17-SEP-2012 the patient developed a red rash in the area around her right eye. On 18-SEP-2013 she had a scratchy feeling in the right eye. On 19-SEP-2013 she was diagnosed with shingles and started taking acyclovir tablets. The outcome of shingles was not provided. Additional information is not expected.
UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, total 1 dose administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified side effects. He was hospitalized on an unspecified date for 1 week.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210740887-Covid-19 vaccine ad26.cov2.S Unspecified side effects. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
"COVID Arm" Just below injection site it got Red and swollen like a huge hive. It was very hot, itchy, and had pain that would come and go. 1st and 2nd day it came about were the worst. Then it slowly got better each day thereafter.
Developed hive like itchy rash that started on back.  Expanded to buttocks and front of trunk.  Has small patches on upper arms. Itching is intense and keeps him from sleeping at night.
I had vaccination on 02/10/2022. In that month I started to experience fever, fatigue and joint pain. The fever lasted 24 hours, the fatigue for 48 hours and achiness in joints was ongoing. It got worse 04/2022 with the joint pain. I do have a lot of chronic problems. I was seeing specialists during this time. I fell in 05/26/2022 fracturing my left shoulder. I had leg pain continuously and was seen through the medical system. I had had a fullness sensation in my thighs from the joint ache which is still present today 02/14/2023 bilaterally. I went to a private doctor 12/2022. I do have a follow up in 03/2023. Possible hip replacement on the right side.
Patient arrived at clinic for 2nd Moderna Covid19 vaccine. The nurse took a syringe from the Pfizer container that was sitting on the desk and administered Pfizer vaccine. The patient was observed for 25 minutes after the injection and had no adverse reaction. The patient was educated on signs and symptoms of severe allergic reactions to the vaccine.
After 9 days, developed redness, itch, swelling, hot to touch, sore big area on arm where injection given.
Immediate discomfort in arm, unable to lift arm. 48 hrs following injection became very lightheaded and dizzy, heart racing, palpitations, nausea, weakness, temp was 99.8. Symptoms continued for another day. Today is 1 week out, patient still dizzy and lightheaded with weakness and not able to mentally focus, trouble reading text.
This spontaneous report was received from a medical assistant (clinical coordinator) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005837: US-009507513-1708USA003358: US-009507513-1708USA005839: US-009507513-1708USA005840: US-009507513-1708USA005836: US-009507513-1708USA005838.
Headache; Fatigue; Fogginess; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 16:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and women's daily multivitamin (MANUFACTURER UNKNOWN); both taken for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 17:15, the patient experienced headache, fatigue and fogginess. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events headache, fatigue and fogginess was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Resident was given the vaccine on 4/8/21.  She had a stroke/heart attack when she was being taken to the bathroom on 4/13/21 around 8:30pm.  She was admitted to the hospital and at this time I believe she is still hospitalized.  We were unsure if this was related to the vaccine or her general health condition as she is recently started dialysis and they discovered a pituitary cancer when doing a scan for the stroke on 4/13/21 or 4/14/21.  We talked with our Medical Director and thought it would be best to report this since it happened shortly after her first vaccine dose.
I received my shot around 11:00am and by 4:30pm I had fever, chills, body aches and the lymph node under my left arm was swollen to the size of 2 golf balls
Myalgia, SkinRash, UrticariaPruritus,  1/7 body aches (back and hip), injection site itchiness, swelling, hard, warm to touch 1/8 injection site swelling/hard, warm to touch, neck and shoulder pain.  1/10 rash  Narrative: 1/7 body aches (back and hip), afternoon injection site itching, swelling/hard, warm to touch. 1/8 injection site swelling/hard and warm to touch, back and hip body aches resolved, but new unusual pain in neck and shoulders.  1/10 rash
Had Pfizer #1 on 12/17/20 but patient told nurse he was returning for Moderna #2. Nurse completed documentation and injection for Moderna then when completing the CDC vaccine card for patient the nurse noticed he had Pfizer for his first dose.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult patient who received FLUARIX TETRA. On an unknown date, the patient received FLURARIX TETRA. On an unknown date, unknown after receiving FLUARIX TETRA, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. The reporter considered the injection site erythema and injection site swelling to be probably related to FLUARIX TETRA.  Additional information received on 22 OCT 2014: A handful of employees receiving the FLUARIX Quadrivalent vaccine experienced increase site reaction described as redness and swelling. There were no informations about the concomitant medications and the relevant medical history. It was also unknown if the patients received other vaccines on the same date, if they had previously received flu shots and if they had adverse events following previous vaccinations.
Redness on upper body (Front & Back) and face a few days after the 2nd shot; Rash on upper body (Front & Back) and face a few days after the 2nd shot; Rarely Itching Rash on upper body (Front & Back) and face a few days after the 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Redness on upper body (Front & Back) and face a few days after the 2nd shot), RASH (Rash on upper body (Front & Back) and face a few days after the 2nd shot) and RASH PRURITIC (Rarely Itching Rash on upper body (Front & Back) and face a few days after the 2nd shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism (since 5 years ago). Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced ERYTHEMA (Redness on upper body (Front & Back) and face a few days after the 2nd shot), RASH (Rash on upper body (Front & Back) and face a few days after the 2nd shot) and RASH PRURITIC (Rarely Itching Rash on upper body (Front & Back) and face a few days after the 2nd shot). At the time of the report, ERYTHEMA (Redness on upper body (Front & Back) and face a few days after the 2nd shot), RASH (Rash on upper body (Front & Back) and face a few days after the 2nd shot) and RASH PRURITIC (Rarely Itching Rash on upper body (Front & Back) and face a few days after the 2nd shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, Blood test: Apparently it is an immune response..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that A few days after the 2nd shot, patient had a rash on upper body (Front and Back) and face. The rash area rarely itched. The rash area was not  itching all the time.   It was also reported that Initially the doctor prescribed oral antibiotics. patient did not remember the name of the antibiotic.patient did not recall anything else being prescribed for rash.  It was also reported that the reaction had not resolved more than a year after the 2nd shot also patient redness still there today
Vaccine given at 1110 Am, at approx 4PM pt. began experiencing swelling of the lips and then the eyes with reddness and watering of eyes.  Took cetirizine at 10 PM with some relief but lips remain swollen and eyes red.
Arm pain - difficult to raise, lift  & move arm, began at 12:30pm on 3/23/21 & is more intense now at 7:02am on 3/24/21; headache - 5:30am on 3/24/21; neck pain & stiffness, 5:30am on 3/24/21
Sore arm on first day, but woke up with very dark and/or blood-tinged urine 36 hours later (today).  Back pain and some aches, not sure if related to kidneys.   Has persisted all day.
Pt received vaccination at approximately 3:30pm. Immediately after, the injection site began to swell and became hard and hot to the touch. Pt was monitored for about an hour. She was given no meds. Pt left with minor swelling about 1 hours after shot.
Patient was here for well woman exam, she reported LMP as 8/15/19.  She received the injection & waited the 15 minutes post injection to monitor for side effects. Patient was then taken to lab for the additional testing that was ordered.  While there patient requested a pregnancy test from the lab staff, a BHCG was completed at that time.  It was resulted on 9/27/19 at a level of 32. Patient was notified and instructed to recheck levels on Monday 9/30/19. Patient was unable to verify date of her last menstrual period stating " I don't know it's always somewhere in the middle like the 15th."  Patient was transferred to make her appointment.  She completed another BHCG on 10/3/19 it was resulted on 10/4/19 with a level of 1,943.  Patient was notified and advised we were ordering an OB ultrasound < 14 weeks as patient  unsure of dates and was recommended she follow up with OB.
I started with a cough, body aches and a slight fever of 100 degrees. I had little to no energy and fatigue. I was prescribed the antiviral PAXLOVID. I took that for 5 days and started feeling much better rapidly. I have not felt any symptoms after the third day of testing positive.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for himself via a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) via an unspecified route of administration on 21Dec2020 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID-19 on 28Dec2020 and he was wondering if he was still able to receive the second dose of the vaccine. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: The reported tested positive for COVID-19 after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
He had heart problems for the first time in his life after the vaccine  , including atrial fibrillation and several  "heart events" . I don't know  the specifics about the heart events. He had to use a catheter something he never had to do before the vaccination. He became very weak and was hospitalized several times whereas he used to take long walks , not needing a cane despite being 96 and he lifted heavy objects . Over a several moth time he got a second shot and a booster. A few weeks before he died he was diagnosed as having acute leukemia, a a side effect of the vaccines perhaps?
delayed cutaneous hypersensitivity reaction Narrative: Patient did not have an adverse reaction to the first dose. From the second dose, he had the symptoms of fever, chills, fatigue, headache, for two days after the 2nd dose vaccination. On or about March 26, he started to develop a rash on his legs, torso and arms. It was very similar to what he had before as shingles. He thought it was unusual since he was vaccinated against shingles over a year ago with the new shingles vaccine. As of April 14, 2021, he still has the rash but he reports it seems to be at the "tail end".  Other Relevant History:
Left arm hurts, at the spot of the shot when arm is used a certain way. Since shot was given this has been a problem. Went to doctor's on 08/12/02. He did not know what problem was. He prescribed medication. Go back on 09/02/02
Information has been received from a physician concerning a 68 yr old male who in 1995 and on 23Nov04 was vaccinated with a first and 0.5 milliliter second dose of pneumococcal 23v polysaccharide vaccine, respectively (second dose lot number 647681/0986N). On the day of immunization, the pt experienced a local injection site reaction of swelling and redness accompanied by body aches, chills and a fever. Unspecified medical attention was sought. It was reported that the pt's adverse events lasted one day or so. No product quality complaint was involved. The physician requested an investigation into the lot number. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. It was also reported that a female pt was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also experienced adverse events (WAES0412USA00928).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2021 as dose 1, single (Lot number: EL3284), on 29Jan2021 as dose 2, single (Lot number: EL3248) and on 08Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Smoldering multiple myeloma" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "post menopausal" (unspecified if ongoing); "fatigue and immunosuppression from treatment for myeloma" (unspecified if ongoing), notes: fatigue and immunosuppression from treatment for myeloma.; "fatigue and immunosuppression from treatment for myeloma" (unspecified if ongoing), notes: fatigue and immunosuppression from treatment for myeloma.; "shingles prophylaxis" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR], 400mg Q12 hrs for shingles prophylaxis (herpes zoster), start date: 22Sep2021; ASPIRIN [ACETYLSALICYLIC ACID], 324 mg QD (everyday), brand: Bayer enteric coated 81 mg tabs, lot number: NAA9Ek3, start date: 22Sep2021; ACETYL L CARNITINE [ACETYLCARNITINE], 500 mg Q12 hrs, brand: Protocol for life balance, lot number: 3252002, start date: 01Dec2021; ALPHA LIPOIC ACID, 600 mg QD (everyday), brand: Doctors Best, lot number: 222195A, start date: 01Dec2021; ZINC, 50 mg QD (everyday), lot number: 22CPF0047, start date: 01Sep2022; OMEGA 3 ACID ETHYL ESTERS, 1 gm, start date: 22Sep2021; VITAMIN E, 400 IU, lot number: 511021, start date: 22Sep2021; TOP CARE, Docusate sodium 100 mg Q12 hrs, lot number: WJ37854, start date: 01Oct2021; CHELATED MAGNESIUM [MAGNESIUM CHELATE], (True chelate magnesium) 150 mg QD (everyday), brand: Professional health products, lot number: Lot 110010, start date: 22Sep2021; CITRACAL + D3 (Calcium citrate plus d3), 650 mg/ 1000IU, lot number: 22A007, start date: 22Sep2021; VITAMIN C, 1000mg. QD (everyday), start date: 01Sep2022; B-COMPLEX WITH VITAMIN C, lot number: 2447307, start date: 22Sep2021 received in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: indication: COVID 19 Treatment; (10Sep2022) Positive, notes: initial symptoms of covid and did rapid test and quickly showed positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies. Patients gender: Male (as reported). The patient received COVID 19 Treatment with Paxlovid from 01Sep2022 to 06Sep2022.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Continuous lumbar pain. Xrays show inflammation. Treatment is physical therapy and anti inflammatory meds for 2 weeks.
Patient was gone out for a run on 28th May. While running, he collapsed suddenly. Onlookers called 911 and they tried to revive him but he died on the spot. his autopsy result is still pending. He had no history of any illness and had been a healthy individual.  He used to exercise regularly. He had received his second dose of vaccine that month on 13th May and had faced expected symptoms like fever and chills that only lasted for 2 days.
Patient began to have heart palpitations, sweating and headache - arm at injection site was painful.  Took BENADRYL - onset approximately 1 hour after injection.
pt recv vax 17MAY95 & w/in 24hr pt devel an inj site rxn of erythema & swelling approx 3inches in diameter & fever;fever resolved w/in 24hr;22MAY pt began devel a pruritic rash on neck;seen by MD;tx included ATB;rash resolved in 1mo;