chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/6/21 at 12:00pm: sudden onset of chills, no fever at this time, joint pains, blood streaks in urine 2:00 pm: chills and uncontrolled shivering, fever (102.7-103.4), blood streaks in urine progressed to bloody urine; Tylenol taken, increased fluid intake, and slept 10:00 pm: Fever down to 100.8F; bloody urine continued 2/7/2021 at 8:00pm: Normal temp, no bloody urine but with urinary urgency, symptoms similar to UTI (note: I haven't had UTI since I was in my 20's which was a one-time incident, there are no conditions in my current situation that predispose me to developing UTI but since I was too uncomfortable, I sought online consult as urgent care was closed to get antibiotic prescription).
Lump in right side of neck (possibly a lymph node); Lump in right side of neck (possibly a lymph node); This is a spontaneous report from a contactable consumer (patient). A 48-year-old female (no pregnant) received the second dose of BNT162B2 via an unspecified rout of  administration on the left arm on 30Apr2021 at 10:00 (Lot Number: EW0179) as single dose for COVID-19 immunization. Medical history included migraines with auras, vertigo, arthritis in knee and eczema. The patient had not been tested for COVID-19 since the vaccination and was not diagnosed with COVID-19 prior to vaccination. The patient do not received any other vaccines 4 weeks prior to the COVID vaccine. The patient's known allergies was none. Concomitant medication included ibuprofen and erenumab aooe (AIMOVIG). The patient previously took the first dose of BNT162B2 on Apr2021 at 10:00 AM (Lot Number: EW0150) on left arm for COVID-19 immunization. On 14May2021 at 16:00, the patient experienced lump in right side of neck, possibly a lymph node. This was opposite the arm the injections were given. It was not noticed until 14May. It was visible when looking at the patient's neck. Treatment was not taken. The outcome of events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Developed redness, itchiness, and hive to thigh. Seemed to be mostly related to PROQUAD location.
Pain and redness at injection site, fever (101 F), headache, tired, nausea, muscle stiffness and soreness, light headed.
pre anaphylactic reaction; injection site was bruised; wheel" formed under the vaccine site / area felt raised; wheel" formed under the vaccine site / area felt raised; area felt raised and was little itchy; muscle fatigue; malaise; isn't sure it was given IM / unsure if the needle ever reached the muscle; used a  5/8 in 25 gauge needle; This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of muscle fatigue (received 1st dose on March 2020, refer Case ID:US2020AMR108337).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a day after receiving Shingrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site bruising, injection site wheal, injection site swelling, injection site itching, muscle fatigue, malaise, intramuscular formulation administered by other route and wrong technique in device usage process. The patient was treated with benadryl (nos) (Benadryl) and medication unknown (Inhaler (Nos)). On an unknown date, the outcome of the anaphylactic reaction, injection site bruising, injection site wheal, injection site swelling, injection site itching, muscle fatigue, malaise, intramuscular formulation administered by other route and wrong technique in device usage process were unknown.   It was unknown if the reporter considered the anaphylactic reaction, injection site bruising, injection site wheal, injection site swelling, injection site itching, muscle fatigue and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was received the first dose of Shingrix in March of 2020. The patient received the 2nd dose on 18th June 2020, in the left arm but was not sure it was given intramuscular.  The reporter said it was a quick injection without resistance. The pharmacist used a 5/8 in 25 gauge needle so she was unsure if the needle ever reached the muscle. Within four to five hours later on the same day, the patient noticed the injection site was bruised , and the wheel was formed under the vaccine site. It was more oblong in shape and began to spread until it was three to four inches vertical and two inches horizontally. The area felt raised and was little itchy. She also had a pre anaphylactic reaction so she took Benadryl and used an inhaler. The patient had some muscle fatigue as well as malaise. The reporter consented to follow up.
At the time of vaccination i was approximately 3-4weeks pregnant according to my last menstrual cycle test's showed positive 3 were taken and primary doctor appt was set. Started having fever,chills,throwing up and real bad rash around my belly button and on both inner arms inside elbow. Went to emergency room and informed nurses i just got vaccinated and this is happening and chose to ignore my symptoms. I informed doctor's i was pregnant was advise i was no longer pregnant miscarriage. i did get an infection and throat was sore.  I did bleed at the time of my shot once injected i was bleeding alot on my left arm.  I keep having symptoms
She got a cyst on her like a its a lymph node swollen; This is a spontaneous report from a contactable consumer or other non-health care professional. This consumer (patient's parent) reported for a female patient (reporter daughter) that a female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the patient received vaccine she got a cyst on her like a its a lymph node swollen and then they went to the emergency room and they told that they have to call that number to report this, so reporter calling just to report. The outcome of event was unknown.  Information on the lot/batch, further information has been requested.
approx. a week or more after the first shot i developed a ringing in my ears i told my doctor an she said it could be a side effect
developed sx and tested positive for covid on binax rapid antigen test 1/23/2022
Patient stated he broke out in hives 3-4 hours after received the shot and began to have trouble breathing.  He then administered an Epi-Pen, however he did not go to the hospital.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient. On an unknown date in 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Vaccine appeared to be administered IM below the deltoid. Area is very red inflamed and painful with a 3 inch diameter. Pt referred to physician.
Pt had a negative BHCG dated 1/27/03, prior to vaccination on 1/27/03. Pt received 3rd Anthrax vaccination on 2/25/03. On 2/28/03, pt had a positive BHCG.
SCRATCHY THROAT; SORE ARM; LIGHT HEADED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced light headed. On 06-APR-2021, the subject experienced scratchy throat. On 06-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the scratchy throat, sore arm and light headed was not reported. This report was non-serious.
2 days p/vax pt stated arm (immun site) was warm, swollen & itchy for days;felt poisoned for 2 days;
09/20/21 11:28AM RED RAISED AND SWELLING AT INJECTION SITE, BRUISE UNDER SITE BETWEEN SITE AND ELBOW DIAGONAL AND STRAIGHT DOWN FROM SHOT TWO BRUISES, BRUISE STILL SEEN 10/13/21 WHEN ARRIVED FOR SECOND DOSE
pt recvd vax & w/in several hrs post vax exp flu-like sx,fever,nausea & aches;sx resolved w/in 48hrs;
Pt recevd Rho(D) RhoGAM on 27JUL90 & MMR II vax on 07AUG90.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324608, 2018SA324603, 2018SA324605, 2018SA324604, 2018SA324607, 2018SA324609, 2018SA324606 and 2018SA324596 (same reporter). This case involves Elderly female patient received 0.5 ml dose of vaccine FLUZONE HIGH DOSE (lot number: UJ048AB, expiry date: 31-May-2019, dose in series was not reported) via intramuscular route in right deltoid. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. This was a case of actual medication error due to incorrect product storage because the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
vial was opened at 5:24 PM on 01Sep2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial was opened at 5:24 PM on 01Sep2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 007D21A) 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 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was opened at 5:24 PM on 01Sep2021). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vial was opened at 5:24 PM on 01Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported.   The treatment medication was not provided.   This case was linked to MOD-2021-311050, MOD-2021-311042 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up appended contains no new information
At 9:24AM MCV4 0.5 ml was given IM in Rt. deltoid. At 9:25AM a PPD 0.1 ml was placed intradermally into Rt. forearm. Almost immediately client c/o nausea; face became very pale; had client lie down and deep breathe. BP 100/60 P-64 R-20. Reclined for 15 minutes; ice pack to forehead. At 9:42AM color returned to cheeks. She stated she felt much better. BP-106/60 P-68 R-20.
Symptoms started as red dots on legs with spread to rest of body with raised red lesions, irregular borders and splotches in 24hrs with significant itch. Patient tried BENADRYL and topical cortisone without relief then was prescribed hydroxyzine and 3 day oral steroid burst (prednisone 20 mg PO BID x 3 days). Rash and itching waxed and waned for another 48hrs.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Patient's medical history, concurrent condition and drug reactions or allergies were not reported. On 10-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose: 0.65 ml, subcutaneous, frequency, indication and lot # were not provided), that underwent a supported temperature excursion (on an unknown date). Concomitant medication was not reported. No adverse experience was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Noticeable worsening shift (close and distance) in vision, two to three days after the vaccination.  Has not gone away.  Appointment to see optometrist due in October.  Some instances of long-term memory loss (names, places) and to a lesser degree, short-term memory loss (names).  This also occurred within days after the vaccination - not able to recall where I filled up gas in my car was the first sign.  Then introducing  friends and acquaintances to each other took abnormal amount of time to recall their names.
alergic to eggs; This case was reported by a consumer via media and described the occurrence of egg allergy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced egg allergy. On an unknown date, the outcome of the egg allergy was unknown.   The reporter considered the egg allergy to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient stated the shingles vaccine left the patient completely allergic to eggs. The follow-up would not possible as no contact details were available.
Patient had trouble breathing. He almost called 911 but took rescue inhalers for his asthma which has been stable since 1/25/2019. He was able to stay conscious and restore breathing and then followed up with his PCP here at  Medical Clinic.
The next morning after injection there was some discomfort at the injection site.  At 3:30 am CST I woke with a 100.8 fever, muscle and joint aches, chills, and headache.  I took acetaminophen and ibuprofen for the fever and pain throughout the day with rest.   The symptoms cleared around 9:30 pm CST that evening.
Resident had completed AM ADLs, ate breakfast, returned to room and was found unresponsive.  Resident was absent of vitals signs.  AED applied, no shock advised.
foot so swollen can barely walk; foot so swollen can barely walk; This is a spontaneous report from a contactable consumer (Patient) report from a Pfizer-sponsored program COVAX US SUPPORT. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included autoimmune disorder and arthritis: from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, the patient's foot was so swollen that can barely walk. The patient is scheduled to receive the second dose of the Pfizer COVID-19 vaccine on an unspecified date. She reported that she is also scheduled to receive a cortisone injection in her foot because it was so swollen that she can barely walk at this time. When the patient spoke with the doctor, doctor advised that it would be okay to receive the second dose of the Pfizer COVID-19 vaccine as scheduled along with the cortisone injection in her foot. The patient wanted to know if Pfizer has any information on whether this cortisone injection would interact with the vaccine. The patient reported that she has an autoimmune disorder and takes a biologic medication and understands that the vaccine may not work as well for her due to having an autoimmune disorder and taking immunosuppressants. It was reported that the reporter is not a Healthcare Professional (HCP). The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Subject in pneumococcal vaccine trial, with severe COPD, found dead in his room at home on 8/14/08. Cause of death listed as Sudden cardiac death due to cor pulmonale due to COPD due to cigarette smoking. Vaccination took place on 1/28/2008. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Reporting Form upon request.  9/19/08 Case notes received from reporter. Pt had recently been hospitalized for Community Acquired Pneumonia and COPD exacerbation. During admission noted to have signs of CHF. Tx with abx and steroids with return to baseline. Seen 8/6/08 for f/u. PE (+) for 2+ lower extremity edema. Pulse ox 91%. Encouraged to wear O2 supp 24/7. Pt found dead 8/14/08. Nasal cannula off. COD listed by PCP as sudden cardiac death due to cor pulmanale due to COPD due to cigarette smoking. 1/23/2009 Death Cert received from ME. COD: sudden cardiac death due to cor pulmanale due to COPD due to cigarette smoking.     .
Pale (White), weakness, LOW heart rate, Dizziness, Passed out, was out for about 90 sec. Put water on face, after came to gave her orange juice.  Patient was also given at the same time 3 other shots. Tetanus, Hepatitis A, Meningococcal Vaccine. I had asked before she was given all of the shots if it would be to much for her. They told me that it would be fine.
He developed plaque psoriasis within weeks of receiving the vaccine. The first area affected was on his right upper arm at the site of the vaccine injection and then additional sites developed on his right arm with the largest patch above his right elbow. To date he now has multiple sites of various sizes all over his body.
Sever bruising on back of both thighs and inside of right thigh not due to an injury. Extensive blood work done which rules out blood disorders. No treatment  to date and no change in condition after 1 week. Bruising is at the exact same spot on both thighs.  Does not stop normal routine but is sore to touch.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unkonwn date the patients were inadvertently administered with unknown number of doses of improperly stored GARDASIL (dose strength, route unspecified). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
high fever, whole body pain, chills, nausea, headache, treated with tylenol, lasting for 2+ days and counting
about 1 wk p/vax pt has pain @ the top of rt femur when walks; does not have pain when not walking;
This spontaneous report as received from a nurse refers to 3 unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history provided. On 06-SEP-2015, one unspecified patient was  vaccinated with a dose of improperly stored MMRII lot # L001336, expiry date 13-JAN-2017 (route and site of administration, dose were not reported). On 11-SEP-2015, two unspecified patients were vaccinated with doses of improperly stored MMRII lot # L001336, expiry date 13-JAN-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. Therapy type of MMRII was determined to be rHA (recombinant human albumin). Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 15 year old patient of unknown gender. On 11-SEP-2015, the patient was vaccinated with MMRII. This is one of several reports received from the same reporter. Additional information has been requested.
Raised red ring appeared approx 7 days after the injection.  It was itchy and very painful. The lump on my arm is still there and the are remains slight bruised looking.
Received Pfizer Covid vaccine 2nd dose on 13Apr2021 diagnosed positive COVID-19 on 15Jun2021; Received Pfizer Covid vaccine 2nd dose on 13Apr2021 diagnosed positive COVID-19 on 15Jun2021; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EP6955) via an unspecified route of administration on 13Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for covid-19 immunisation. The patient received Pfizer Covid vaccine 2nd dose on 13Apr2021 diagnosed positive COVID-19 on 15Jun2021. On15Jun2021, patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug.
Information has been received from a health professional concerning a 21 year old female who on 18-APR-2007 was vaccinated with Gardasil (Lot #653978/0955F). Concomitant therapy included ORTHO TRI-CYCLEN. On the evening of 20-APR-2007 the patient experienced hives which were generalized on her trunk. The patient was instructed to take BENADRYL but it did not help. She was examined by a physician in the emergency room on 22-APR-07. She was not admitted. She was given ATARAX and prednisone. After the first dose of Atarax her rash resolved. It was reported that the patient took "CORICIDIN" (therapy unspecified) for the first time the morning of 20-APR-2007. the patient's mother also stated that "her daughter often breaks out in hives". Additional information has been requested.