chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of hives in a 4-year-old female patient who received KINRIX (batch number 99A7M, expiry date 3rd September 2016). Previously administered products included INFANRIX with an associated reaction of no adverse event (Series) and PEDIARIX with an associated reaction of no adverse event (Series). Concomitant products included PROQUAD. On 27th March 2015, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On 28th March 2015, 1 days after receiving KINRIX, the patient experienced hives and allergic reaction. The patient was treated with BENADRYL ALLERGY. On an unknown date, the outcome of the hives and allergic reaction were recovering/resolving. The reporter considered the hives and allergic reaction to be possibly related to KINRIX. Additional information was provided as follow: The patient had KINRIX along with PROQUAD in her left leg. Next day, she had hives on left leg from thigh down to knee and corresponding hives right thigh where there was no injection. PROQUAD given SQ back of left thigh and KINRIX given IM left AL thigh. Mother finally took child to ED on 2 April 2015 because hives were not resolving. No other local injection site reactions or systemic reactions. ED said it was an allergic reaction and she should not receive KINRIX again.
Information has been received from a pharmacist concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient developed a rash.  There were no laboratory or diagnostic tests performed.  Unspecified medical attention was sought.  At the time of the report the patient had recovered.
Rapid heart beat running 90-100 per minute.  Numerous pvc's during.  Difficulty  breathing.
Patient is experiencing issues with numbness in fingers that started about 2 weeks after the vaccine was administered. It is affecting the same arm the vaccine was administered in.
missed second dose of Moderna COVID-19 vaccine / to get it rescheduled; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose of Moderna COVID-19 vaccine / to get it rescheduled) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose of Moderna COVID-19 vaccine / to get it rescheduled). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose of Moderna COVID-19 vaccine / to get it rescheduled) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment details were not provided.
Information has been received from a registered nurse concerning a 10-year-old male with a milk allergy and a history of reactive airways disease who on 26-OCT-1996 was vaccinated SC in the left arm with a first 0.5mL dose of Varivax (Lot # 617695/0776D). There was no illness at the time of vaccination. Concomitant therapy that day included a first dose of MMR (Lot # 618613/0469D) administered SC> There were no other concomitant medication. On 05-SEP-2006 the patient presented to the physician's office with an itchy rash all over his body (face, back, and groin area). He was treated with BENADRYL and CALAMINE LOTION. The patient's itchy rash persisted. There were no lab diagnostic studies performed. There was no product quality complaint. Follow up information received from a registered nurse indicated that on 05-SEP-2006 the patient developed 100-200 lesions on his face, back, chest, and groin. He was given symptomatic treatment. The outcome was recovered. No additional information is expected.
Patient received vaccination on 1/19/2011. Parents report no fever. Patient developed redness, swelling at vaccination site. Redness and swelling continued to maximum measuring 11cm x 9cm (R) thigh  around vaccination site no groin adenopathy. KEFLEX 5 ml QID x 7 days prescribed. Parents did not follow up to appointment 2 days later to evaluate.
Endoscopy indicates ulcer with a perplexing virus probably auto immune. Getting blood tests today
Information has been received on 27-DEC-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. In or around 15-NOV-2014, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered a "brain attack" and became aphasic. He was diagnosed with a left carotid thrombus and cervical internal carotid artery which was either severe stenosis or near occlusion and a stroke with NIH score of a 4. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: the patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. Left carotid thrombus, cervical internal carotid artery which was either severe stenosis or near occlusion, cervical internal carotid artery which was either severe stenosis or near occlusion and a stroke with NIH score of a 4 were considered to be disabling. Upon internal review, left carotid thrombus, cervical internal carotid artery which was either severe stenosis or near occlusion, cervical internal carotid artery which was either severe stenosis or near occlusion and a stroke with NIH score of a 4 were considered to be medically significant. Additional information has been requested.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-01-11.
I'VE NEVER HAD A REACTION BEFORE, BUT LATER IN THE NIGHT I WOKE UP NOT FEELING WELL AND WARM. I WENT TO THE COUCH, LATER LAID ON THE BATHROOM FLOOR, VERY HOT AND SWEATY. MY PJS WERE WET ALL OVER. A LITTLE LATER I FELT BETTER, GOT UP AND WENT BACK TO BED.  ALL LASTED ABOUT AN HOUR I BELIEVE. I  KNEW I DIDN'T NEED THE HOSPITAL, MY PARTNER WAS UP WITH ME.    BEEN FINE SINCE.
Information has been received from a physician concerning a 2 month old female patient with no known allergies or pertinent medical history who on 12-AUG-2008 was vaccinated orally with a first 2 ml dose of ROTATEQ vaccine live (human-bovine). There was no concomitant medication. On 14-AUG-2008 the patient experienced watery stools. Medical attention was sought in the office. There were no lab studies performed or treatments reported. At the time of the report, the patient was recovering. It was noted that the patient's stools became more solid on 15-AUG-2008. There were no other symptoms reported. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 09/15/2008. Follow-up information has been received from the physician's office. It was noted that the diarrhea was only for one day after vaccination. It was also noted that the mother did not think the diarrhea was related to the vaccine. Additional information is not expected.
Shingles like rash, more maculopapular than vesicular rash starting on the back of the L arm. Lesions spread to torso, abdomen and R arm. Pt reports the other lesions are healing but the original ones remain. Pt reports all over body pain that is burning/tingling/throbbing and not helped by medication.
Twitching muscles at collar bone for aprox. 10 min followed by onset of fever of 102.  Arthralgias, headache, nausea, pain radiating from injection site that grew worse as day went on with most severe pain at ~26-30 hours after injection.
This spontaneous report was received from a nurse practitioner and refers to a female patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient accidentally splashed an unknown amount of VARIVAX into an unspecified eye (exposure via eye contact). The patient reports that her "eye was burning" (eye irritation), and she was instructed to flush her eyes with an eye wash. The patient sought medical attention with the nurse practitioner. At the time of the report, the patient had not recovered from the eye irritation. The causality between the event eye irritation and VARIVAX was unknown.
Itching in the palms and the bottom of the feet on and off itching throughout the body ever since she got the shot.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 12:00 as dose 1, single (Lot number: PAA156051), in right arm, on 20Jun2021 at 12:00 as dose 2, single (Lot number: EL9261), in left arm and on 06Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid cancer", start date: 2012 (unspecified if ongoing); "thyroidectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Known Allergies: Sulfur". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jul2022) Negative; (05Jul2022) Positive; (17Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: She was taking any other medications/products within 2 weeks of starting COVID-19 treatment-Yes. She previously receive a COVID-19 Vaccine- Yes. She tested positive with PCR test 05Jul2022. she started Paxlovid 08Jul2022, finished med. Wed 13Jul2022. she took another PCR test 17Jul2022 the test results came back positive, the antigen test she took that day was negative. Still not feeling 100%, tired with dry cough.  No follow up attempt are possible no further information expected.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Drug Ineffective and COVID 19  and the suspect drug BNT162b2 .
pt recvd vax & exp t104, convuls, was white & clammy & lethargic; taken to ER slept several hrs afterwards;
Sore left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left arm injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm injection site). At the time of the report, VACCINATION SITE PAIN (Sore left arm injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-410457 (Patient Link).
Resident presented coughing  copious amounts of clear frothy sputum. Continuous after suctioned.
Tingling in tongue, comes and goes. Seen doctor he he thought was anxiety but still have sensation.
Pt began having SOB, wheezing, N/V, CP, dizziness, diaphoresis, and dizziness within 25 mins of receiving FLULAVAL injection.
It was reported that a pt received a Fluzone SV 2000-2001 vaccination on 10/23/2000. Reportedly that same day the pt experienced redness and swelling at the injection site, dizziness, nausea and fainting. She was sent to the ER. No specifics were provided. Further information is being requested. From additional correspondence received on 02/07/2001 additional pt, vaccine administrator and responsible physician information was provided. No further information is expected for this case. Case is closed.
Red splotchy  large rash at site.  Raised bumps.  Itchy
Two days after receipt of 2nd dose, patient noted new heart palpitations. Went to ED for assessment and was given Holter monitor to wear x 24 hours.  Also reported increased asthma symptoms after 1st dose of vaccine, went from needing no inhaler to twice daily inhaler use.
Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX subcutaneous injection (lot # M012990, expiration date 14-MAR-2018, 0.5 ml, once, subcutaneously) for prophylaxis. On 25-SEP-2016, the vaccine was exposed to 28 Fahrenheit degree for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. On 06-DEC-2016, the registered nurse provided contact details to contact other registered nurse who could provide additional information about the patient. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA009079: US-009507513-1610USA009080: US-009507513-1610USA009085: US-009507513-1610USA009082: US-009507513-1610USA009083: US-009507513-1610USA009084: US-009507513-1610USA009078: US-009507513-1610USA001984:, MERCK 1610USA009081:Mfr number.
9 days after first COVID vaccination on 1/1/2021 the injection site became warm, red blotchy, and swollen from shoulder down to elbow. Worsened on day 10 with the full area being red, then started resolving on day12. Did not completely resolve for a week.
Information has been received from a health professional concerning a 6 year old female who on 08Jun1999 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot 626409/0666H). There was no concomitant medication. On 14Apr04 the pt presented to the office with scattered lesions on the trunk area. Medical attention was sought, but no treatment was required for the event. No product quality complaint was involved. Additional information has been requested.
My hand began to swell, then began throbbing. Continued throughout the night. Pain was so unbearable my daughter took me to Emergency Room 10/08/16 at 9:00 am. Was checked by ER doctor adverse effect to flu shot. Given wrist splint for left arm, prescribed hydrocodone 5-325 mg, ibuprofen 800 mg oral tablets for pain.
Pt received immunization on 8/27/18 (1st dose). Pt admitted 10/17/18 for critical illness statin-induced myopathy (atorvastatin). The concerning thing is that the patient had been on atorvastatin for a long time (years) without problem. He was discharged in a wheelchair 10/31/18. Able to walk now (12/31/18). He never received the 2nd dose of Shingrix due to they myopathy admission and concern for the drug's involvement with it.
Case number PHEH2013US025056 is an initial spontaneous report received from a pharmacist on 27 Nov 2013. This case refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUCELVAX (batch number: 0092031A and expiry date: Jun 2014) at dose of 0.5 ml intramuscularly on 26 Nov 2013. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Nov 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
This spontaneous report has been received from a registered nurse referring to a 12 year old female patient. The patient's medical history included eczema. Information regarding the patient's drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 08-AUG-2017, the patient was vaccinated with the first dose GARDASIL 9 0.5 ml, by intramuscular route (strength, anatomical location, lot number and expiration date were not provided) for prophylaxis. On 07-JUN-2018, the patient received the second dose GARDASIL 9 lot # N022583 with expiration date of 20-JUN-2020 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis (inappropriate schedule of drug administration). On an unknown date, the patient developed "vaginal lesion", "a fever, a sore arm, and blisters and lesions in the vaginal area" (vaginal lesion, genital blister, pain in extremity, pyrexia and vaginal lesion). On 11-JUN-2018, a "urine dipstick" was performed which identified "2+ protein", and a "genital swab for HSV (herpes simplex virus)" (results were not provided) (genital disorder female and protein urine present). The outcome of vaginal lesion, genital blister, pain in extremity, pyrexia, protein urine present and genital disorder female was reported as not resolved. The causality assessment between therapy with GARDASIL 9 and the events was not reported.
Taken to directly to the ER from the site SOB Headache Chills Chest pain Dry hives Faintness  Aching legs Heavy feeling in chest Vertigo following day Increase HR-as though heart was pounding in my chest
Initial report received from a healthcare professional on 20 March 2013. A 28-year-old female patient had received first dose of ADACEL vaccine (Lot number: U4586AA, site of vaccination was not reported) intramuscularly on 20 March 2013. At the time of vaccination the patient was pregnant. The patient's last menstrual period was on 18 June 2012. The patient's estimated date of delivery was reported as 09 April 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were reported as "not applicable". As of 21 March 2013, the patient had not experience any adverse events. As of 21 March 2013, the patient's outcome was unknown. Documents held by sender: none.
From initial information received on 5/13/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 35 year old female patient received her first dose of a pre-exposure IMOVAX RABIES series, lot number X0581, administered IM in the deltoid on 5/6/04 at 9:30 AM. Two hours later, at 11:30 AM, the patient experienced dizziness, muscle twitching and rapid heartbeat. She was not evaluated by a physician. The patient recovered from these events.
Pt had syncope episode while waiting in observation area. Pt fell out of his chair and hit face on outer corner of right eye causing a skin abrasion. Suffered a small abrasion to outer aspect of his right wrist.
This spontaneous report as received from a pharmacist refers to a 55 year old female patient of unknown age with drug allergies to codeine and penicillin. On 04-FEB-2016 the patient was vaccinated with a 0.65 mo dose of ZOSTAVAX (lot # L035283, expiration date 15-DEC-201) by subcutaneous. Concomitant therapies included morphine, acetaminophen, NORCO, lidocaine, EMLA cream, meloxicam, gabapentin, levetiracetam and amlodipine. In February 2016 the patient developed numbness starting at the injection site (unspecified arm) down to her elbow, and continuing to spread, which started an unspecified amount of time after administration of ZOSTAVAX. The patient sought medical attention by calling pharmacist. No treatment was given for the event. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (656609/0015U) ZOSTAVAX on 01-APR-2008. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
One week after shots started feeling tired. A week later feeling fatigue and tired. On October 30 started tingling on tongue, fingertips, toes Nov 8th at Roller Derby had lack of coordination and falling. Nov 12 numbness in leg to groin. Nov 14 went to Local ER. Nov 17 admitted to Hospital.
Pt reported flushing/sweating, dizziness and stiffness of neck/neck pain. Vitals: 136/71, 82, 18, 100%, 98.1F Pt transported to ED.  In ED:  Received 3rd COVID vaccine today, immediately started feeling like her head is "heavy" with mild neck pain and posterior headache. Feels flushed,. Denies fever, n/v/d, cough, sob, swelling, sore throat, vision changes, numbness/weakness.  Steady Gait A&Ox4.   Vitals: 140/84, 70,20, 100%, 97.7F, Pain Score = 8 Pt discharged 18:53
Received shot on my left arm. Immediately felt medication run down to fingers. Whole upper left side got swollen. Major pain of the entire left arm including neck. Severe abdominal cramps, and all over body sensitivity. Day 3 from receiving shot and still have arm and abdominal pain.
Given influenza vaccine in left arm. Vaccine was painful. 1 week later had increased pain in deltoid. 2 weeks later had large bump and bruise on deltoid. Still have residual pain in shoulder and decreased range of motion.
She received the first dose of the Pfizer Covid Vaccine in the left deltoid.  She has reported allergies to oxycodone, codeine sulfate, and penicillins which she reports as experiencing hives.  1220 she reported itching at the injection site.  1224 she reported that her throat felt like it was itching, and she was assessed, O2 100%, BP 115/83 in the left arm.  126 she reported that she felt as though her throat was closing up ans she was given Benadryl IM 25mg in the right deltoid.  1228 she utilized her personal albuterol inhaler.  1233 EMS called to the building.  1235 she received EpiPen injection in left thigh. 1250 she was transported off the property by EMS.