chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness and burning of the skin; Itchiness and burning of the skin; Chest tightness; Shortness of breath; This is a spontaneous report from a non-contactable Physician. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 01Apr2021 as dose number unknown, single for COVID-19 immunisation. (Reason for no Lot number: Not available/provided to reporter at the time of report completion). The patient medical history and concomitant medications were not reported. It was unknown if patient was pregnant at the time of vaccination. It was Unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient been tested for COVID-19 Since the vaccination and patient diagnosed with COVID-19 Prior to vaccination. The patient experienced itchiness and burning of the skin (pruritus and skin burning sensation), chest tightness, and shortness of breath on 04Apr2021. Patient received treatment for the adverse event, includes: Medrol Dosepak. It was unknown whether the patient had been tested for COVID-19 since the vaccination. The events were assessed as Non serious by reporter. The outcome of event was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
In area of deltoid and upper bicep, pt developed induration, erythema and vesicular rash, resembling poison oak dermatitis but non-pruritic.
He had severe swelling in arm at injection site. Red, hot to the touch. He became tired and run down within hours of vaccination. Doctor said if it got any worse then to come in but some swelling was normal. He had exczema appear on his inner elbows, and it comes and goes ever since.
Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional. This case involves a 5 years old patient who was vaccinated with 0.5 ml dose of PENTACEL (Batch number: C5464AA and expiry date: 26-Jul-2019) via intramuscular route in the left deltoid instead of DAPTACEL and IPV on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR for Immunisation; and VARICELLA VACCINE for Immunisation on an unknown date. It was a case of actual medication error due to wrong vaccine administered. No adverse events reported at this time. 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. List of documents held by the sender: none.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 20-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, lot # R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. Digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000928: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000929: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000862: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925:
Initial report received on 21 January 2010 and follow-up reports received on 26 January 2010 and 27 January 2010 from an investigator in the above mentioned local trial. A 70 year old female subject developed BELL PALSY right side on 18 January 2010 i.e. 115 days after receiving an intramuscular injection of INFLUENZA VIRUS VACC USP TRIVAL A AND B HIGH DOSE, SUBVIRION-U or FLUZONE SV 2009-2010, in right deltoid on 25 September 2009 (UD12307). The subject had medical history of upper respiratory illness and hypertension. (Details were not provided.) The subject was on concomitant medication hydrochlorothiazide, AUGMENTIN, ALLEGRA and received NOVEL H1N1 vaccination intramuscularly on 22 December 2009. On 14 January 2010, the subject developed upper respiratory infection symptoms (URI), fatigue, headache, muscle aches. She developed fever, cough, and shortness of breath, sore throat, post nasal drip and sneezing on 15 January 2010. The subject developed paralysis right side face on 18 January 2010. The symptoms worsened on 18 January 2010 and the subject was seen at urgent care center. The subject was diagnosed with BELLS PALSY on right side of face. The subject received corrective treatment with prednisone 50 mg once a day for 5 days. Details of lab were not provided. The events of fever, headache and sneezing resolved on 19 January 2010 and events of cough, shortness of breath resolved on 21 January 2010. The events of fatigue, muscle aches, sore throat, post nasal drip, paralysis right side face and BELL'S PALSY were ongoing at the time of this report. According to the investigator, the event was unrelated to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. List of the documents held by sender: None.
On 7/6/00, the pt was vaccinated with 1st dose of varicella. On 7/12/00, the pt resented to a physician with acute cerebellar ataxia and one varicella lesion on her soft palate. Upon internal review, the acute cerebellar ataxia was considered to an Other Medical Event. The physician noted that the ataxia is not severe, but that her walking is definitely affected. He indicated that the pt had previously been walking without any problems. On 7/12/00, at the time of the office visit, the pt struggled to walk. He stated that as of 7/13/00, the pt's symptoms remain unchanged and she has no problems with her arms, hands or eyes. Additionally, it was noted that she has no other signs or symptoms.  Additional information has been requested. Follow-up information from a physician reported that the ataxis primarily affected the pt's gait. As of 7/31/00, the ataxia had resolved entirely by exam, although the pt's "parents still report some ataxia first thing in the morning". It was noted that no tests were done and that the physician had a telephone consult with pediatric neurologist. No further information is expected.
This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported for the patient. On an unspecified date, the patient may have been vaccinated with an improperly stored dose of ROTATEQ (dose, frequency and route were not reported) lot # M025563 with expiration date of 06-NOV-2017, for prophylaxis.  No adverse effects were reported. The temperature excursion of the ROTATEQ was between 32 F and 36 F, for a time frame of 72 hours. No previous temperature incursion was reported and no data logger was involved. No product quality complaint was involved (PQC). This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA010330: US-009507513-1703USA000331:
This medically confirmed spontaneous report (initial receipt: 11-Jul-2012) concerns a male patient, who had penicillin and streptomycin allergies. The patient received an unspecified flu vaccine (brand name and manufacturer not reported) 'many years ago' and developed a rash. He stated that he had the same reaction of a rash two years in a row. The patient sought medical attention and was treated with epinephrine. The event outcome was recovered. Follow up (06-Aug-2012): patient had the same reaction of a rash two years in a row.
Covid positive after vaccines and boosters; Covid positive after vaccines and boosters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL9262), on 02Feb2021 as dose 2, single (Lot number: EL9269), on 18Oct2021 as dose 3 (booster) , single (Lot number: FE3590) and on 20Aug2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: COVID-19 Caller has had Covid 19 a total of three times. States that she cannot remember the dates or time frames for the first two times she had Covid 19. Concomitant medication(s) included: ARICEPT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Dec2022, outcome "not recovered" and all described as "Covid positive after vaccines and boosters". The patient underwent the following laboratory tests and procedures: Flu test: (unspecified date) Negative, notes: Doctor also tested her for the flu and another test that they swab for, but both of those were negative; Nasopharyngeal swab: (unspecified date) Negative, notes: Doctor also tested her for the flu and another test that they swab for, but both of those were negative; SARS-CoV-2 test: (05Dec2022) Positive; Scan brain: (05Dec2022) Unknown results, notes: The doctor did a brain scan. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 Caller has had Covid 19 a total of three times. States that she cannot remember the dates or time frames for the first two times she had Covid 19. Her most recent positive Covid 19 test, for her third time having it, was on 05Dec2022. Patient was received Paxlovid as treatment (Start: 05Dec2022 Stop: Ongoing). Paxlovid, the medication they gave her for Covid.
Mild allergic reaction. Immediately after injection I had itchiness at the site. I had arm soreness, redness, swelling at the injection site. There was a large, raised, red circle at the site. It resolved after about a week
Narrative: Day 1: 10-12 mins after shot, flushing neck & face-progressed to right cheek skin itch. No resp problems. Started talking to co-worker 20 mins still a bit warm bilateral face & neck though it might be red, dry mouth. Took ibu at bedtime Day 2 fatigued. Headache Day 3 Sunday back to normal x intermittent chill, but no fever
This spontaneous report was received from an immunization specialist regarding an unspecified patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified date, an unspecified patient received an improperly stored dose of either PROQUAD with lot# M026879, expiry date 27-NOV-2017 or VARIVAX with lot# M008171, expiry date: 16-FEB-2018 or VARIVAX with lot# M024683, expiry date: 18-MAY-2018 (dosing details not reported). It was unknown which of the three vaccines listed were administered to the unspecified patient. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Patient reports vaccine dates from pharmacy as 10/24/2019 and 7/22/2021.  He presented at office with what appears to be shingles on 7/15/2022.  Patient wanted this reported.
A few minutes after her injection, patient started feeling dizzy. She seat down on a chair but started complaining of feeling faint, very sweaty and hot. Made patient lay down on the floor and elevated her feet. Gave her an ice pack, water and some orange juice. She shortly started feeling better. Stayed in the store for another 45 minutes and then left saying that she is feeling fine.
Information has been received from a consumer concerning her sister, a 16-year-old female, who on 21-AUG-2008 received a first dose of GARDASIL in her left arm.  On 28-AUG-2008, a week later, the patient started to have pain in the back of her knee.  Then not to long after that she started to have a dull aching pain in her upper right arm, in the triceps area, but was not sure if it was coming from her elbow or shoulder, and at times she would have a sharp pain in triceps as well.  The patient has seen her primary care physician about the pain she was having and was treated with naproxen, which gave her stomach problems and so she stopped taking it.  The patient's primary care physician did blood work for her on 30-SEP-2008.  She will have an ultra sound check on 06-OCT-2008 on her arm and leg.  At the time of reporting, the results of her blood test were unknown and the patient's symptoms persisted.  Additional information has been requested.  12/15/08 Received PCP medical records. FINAL DX: bursitis/synovitis, gen arthrosis,  Records reveal patient expereienced GERD & left knee pain x 3 weeks on 9/16 visit.  Tx w/meds.  RTC 9/29 w/right arm/shoulder pain & decreased ROM, knee pain had improved.  Meds adjusted & labs ordered.  RTC 10/8 w/arm & knee pain.  Injected knee, changed meds & x-ray/MRI ordered.   2/25/09 Received GYN vaccine records & medical records of 10/19/06-2/12/2009. FINAL DX:none provided. Records reveal patient received only HPV #1 on 8/21/08.  RTC for annual exams w/o complaints.  On 2/12/09 c/o of muscle aches s/p HPV & no further shots given.
Immediately after HPV-9 inj. developed runny nose, went with family to lunch approx 20 min later developed dry cough/tickle to the back of throat lasting approx 45 min, no issues with breathing, sob, swelling of lips, nose, mouth, tongue, eyes, nose, throat.  Ate lunch and went home approx 1 1/2 hrs after vaccine told mom he just didn't feel well, felt 'shaky on the inside', HA, clingy, requesting mom to lay down with him/sitting on mom's lap-totally out of character for patient.  Mom phoned to report this concerns, discussed with Dr. requested pt be brought for evaluation.  Pt seen by Dr. currently stable with only c/o of HA, foggy headedness, sniffles, and some nausea.  Instructed to take Benadryl every 4-6 hrs X24 hrs, return in the am if still foggy headed or no improvement. If new/worse or further concerns bring to ER STAT.  Family voiced understanding. Stable at d/c 5:30pm.
I was fine until the following day felt some tingling in my fingertips and feet. Then the day after that, my face has some tingling. By Monday, the left side of my face was feeling numb when I went to work and as the week went on the tingling became worse and became more painful. The pain went from my jaw up the left side of my face, pain across and was traveling up my head pass my temple (up to my forehead). I was diagnosed at the hospital with Trigeminal Neuralgia. I started to get shooting pain across my back (happened the second week just out of nowhere and I'm the type of person that waits to see what would happen and then it slowly, after a few weeks, went to the lower right side of my back. So, I thought it was from the way I was sleeping and then on June 3rd, I went to my Doctor because the pain had started to radiate down the front/back of my leg and my hip on the right side of my body (leg and hip); therefore, I went to my PCP. He gave me what he though (complete physical) his clinical diagnosis was since I had nerve trouble (possibly related to nerve inflammation and he wanted to see because it was not a disc or anything else...nerves have become inflamed). He give me a steroid shot and give me oral steroids and if after I took them that if I didn't feel the pain anymore in my nerves it was because my nerves became inflamed. The pain has gone away and I am keeping my fingers crossed that it does not happen again. My Doctor and I do believe that before COVID came out that I was very ill and I had all the COVID symptoms. I went and at that time there was no testing available. The Doctor basically tested me and feels that I may have had COVID since he tested me for Strep Throat the last week of February 2020.
Blood clot in injection arm; This is a spontaneous report from a contactable Other-HCP.  A 39-years-old female patient received at hospital bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 27Jan2021 (Batch/Lot Number: El3249) as SINGLE DOSE for covid-19 immunisation  . No other vaccine in fours weeks. Other medications in two weeks: Multivitamin.The patient received the first dose on 06Jan2021 at 10:30 AM (lot number=El1284) on left arm via IM The patient medical history was not reported.     The patient experienced blood clot in injection arm (vaccination site thrombosis) (life threatening) on 02Apr2021 15:15 with outcome of not recovered.  The event was treated wth Xarelto. No Covid prior vaccination; No Covid tested post vaccination; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event "blood clot in injection arm" and BNT162B2 vaccine cannot be excluded. 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.
Pt was given SHINGRIX vaccine subcutaneously on 9/24/18, when it should have been given intramuscularly. Patient experience redness, swelling and pain few days after. Pt does not need medical treatment and did not deem in necessary.
I started getting really short of breath and when I go to sleep and lay down, I felt like I couldn't catch my breath. In the interim, I went to my internist, and they said to go see doctor who I saw on and off. I got the referral to go see him. I went there and did breathing tests. They made me stop walking after two passes in the hallway because my O2 went down to 89 when I was walking. I've had a corroded scan, and CT of lungs. And he said that I had fibrosis in my lower right lung. It was never there before when he checked before. He sent me home with a simple put on your arm pulse oximeter, and they gave me a bigger one that works much better. Still waiting on results from tracking. I also have had more drainage from my nose - it's like an allergy but not an allergy. No itching or anything like that, especially at night. I wake up and cough and have a deep feeling of congestion.
pt called on 10NOV92 saying had lt arm pain elbow to shoulder, not severe, intermittent, occurs w/light activity; claims it began approx 2 days p/MMR in SEP92; It was noted that pt recvd MMR in JUL92 not SEP 92;
Menstrual cycles are no longer regular after being regular for 17 years. I get 3 very heavy bleeding cycles in 24 days. I used to only get one every 28 days and it was very light and only lasted 3 days
Dr. ordered ZOSTAVAX, Pt took script to pharmacy, pharmacy filled Rx, brought back to Dr. office, injection given. No adverse reaction noted.
Initial and follow-up information has been received from a registered nurse and a physician concerning a 64 year old, male, patient, whose reported weight was 176 pounds and whose reported height was 66 inches who on 27-OCT-2006 was vaccinated into the left deltoid muscle with the second dose of Pneumovax 23 (lot # 651332/1049P). Subsequently on 27-OCT-2006, the patient developed redness and swelling at the injection site with warmth and tenderness, 8 centimeters (cm) area. At the time of the report, it was unknown if the patient recovered. A lot check of concern has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. Additional information has been requested.
Started out with irregular menstrual spotting last a  couple of months. Increased  weakness  . Frequent headaches. After a yr ended up in the ER due to blood loss and required first ever blood transfusion due to increased bleeding with menstrual periods. Eventually lead to fibroids . Now recommended for  surgery due to blood consistent bleeding. Now a chronic condition. Dx with Anemia
5-7 minutes into having the vaccine I felt a jittery heat rush all over my body and immediately my blood pressure went up, not sure if it was because I got nervous. Since then I?ve had a heat sensation across my chest like if I had icy hot. Middle of my chest is painful in the sternum area.
had the vaccine on the 6th and started the effects on the 7th. Had a bright red rash from top of head to toes, itchy red blotches, swollen shut and red left eye, vomiting, slept non stop could not get out of bed. Went to the doctor on the 9th, saw health care provider, got meds from her for the vomiting and the rash. This lasted for about until the 13th. of April. I still have a sore arm where the injection was. I still find myself being very tired.
Pneumovax administered on 7/3/13. By 7/4/13 am redness noted around injection site. By 7/5/13 cellulitis appeared around injection site, approx 10 cm x 25 cm. Antibiotic (cephalexin) started on 7/5/13. Cellulitis rash resolving by 7/7/13. vital signs normal.
The next day my hands got stiff 3 times and the next day 4 times. I had cramps in my legs for 3 days.
16days p/vax pt exp rash & fever & had a few papules. by 22nov98 papules had scabbed over & did itch
Myalgia left arm sore; then extended into left axilla; back of both shoulders; then right trapezius Narrative:
In evening t103, hives, cried "high pitched screaming", up all noc, miserable; Mom gave APAP supp as wouldn't take liquid; High pitched cry lasted through the noc, hives 2 days, & fever persisted x 3 days; mom phoned MD re:sx 2APR91;
Head was itching and noticed a loss of hair. By 12/12/2009, 3/4 of hair on my head was gone. Hair was just falling out and by 10:00PM 12/12/2009 I was bald.