chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful blistering rash on face and torso; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On unknwon date, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as "shortly after receiving zoster vaccine live(ZOSTAVAX)"), the patient suffered a painful blistering rash on her face and torso. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), 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 zoster vaccine live(ZOSTAVAX), patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event to be disability.
Chills, headache, body aches, nausea, soreness at injection site, heat at injection site, redness at injection site
Pain in the Left deltoid with irregular macular erythematous rash 20cm in length and variably 6.5 to 4 cm wide longitudinally up and down arm
1 day after injection pt had rash, warm extremities, nausea, generalized itching.
Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 15 year old female patient, with anemia and no drug reactions or allergies, who on 24-AUG-2011 was vaccinated subcutaneously with one dose of 0.5 ml of VARIVAX (Merck) (lot # 670177/0419AA). Concomitant therapy included hormonal contraceptives (manufacturer unspecified). The registered nurse reported that on 24-AUG-2011 the patient received the vaccine while she was pregnant. A unspecified pregnancy test was performed. The patients last menstrual period was on 28-JUL-2011 her estimated delivery date was on 03-May-2012. She did not seek medical attention. No adverse effect was reported. Follow up information has been received from the registered nurse for VARIVAX (Merck), a Pregnancy Registry product concerning the 15 year old female patient with no history of previous pregnancies, birth defects or stillbirth or miscarriage. It was reported that the patient was not tested for varicella antibodies before vaccination with varicella zoster virus (VZV) containing vaccine. The patient did not have a local reaction at vaccination site and no varicella symptoms post vaccination. On 25-NOV-2011, the patient delivered a premature male liveborn infant at 17 weeks (also reported at 32 weeks) from her last menstrual period with no congenital anomalies with a weight of 3 pounds 12 ounces due to pre-eclampsia (also reported as no complications during pregnancy and labor) no infections or illness during pregnancy. Diagnostic tests during pregnancy included an ultrasound and urinalysis (results not reported). There was no other medication used during this pregnancy. The infant did not experience any adverse event. At the time of the report the outcome of pre-eclampsia and premature baby was unknown. The nurse reported that this information was obtained from the patient and her mother. Upon internal review, premature baby was considered to be other important medical event. Additional information has been requested.
3 DAYS AFTER VACCINE, PT PRESENTED TO THE EMERGENCY ROOM WITH A HEADACHE AND ELEVATED BLOOD PRESSURE ( 220/95) W/ NO PREVIOUS HISTORY OF HTN.  PT WAS TREATED FOR MIGRAINE AND RELEASED SAME DAY. THE FOLLOING DAY, PT WENT TO THE ER AGAIN FOR UNCONTROLLED HIGH BLOOD PRESSURE, PT WAS ADMITTED 1/30/22 AND DISCHARGED ON 2/1/22 TO FOLLOW UP W/ CARDIOLOGIST. PT STATES THAT THE ER DOCTOR, NEUROLOGIST AND CARDIOLOGIST AT THE HOSPITAL SUGGESTED TO THE PATIENT THAT HER SUDDEN HTN COULD BE DUE TO THE VACCINE.
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 25-JUN-2019,  the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT#R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000862: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000937: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: 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-009507513-1907USA000925: US-009507513-1907USA000924:
Symptoms began the following morning (12/2/21): splitting headache, severe body aches, slight fever, fatigue. Symptoms abated slightly with Tylenol 500 mg. As of this evening, symptoms still persist.
I may have noticed small bumps on neck within 30 minutes of the first injection.  Day 2  I experienced all day dull headache and muscle pain in the right arm.  Approaching Day 6  roving hives(over the entire body), fever, tingling in the fingers, nausea, weakness,  a feeling of about to pass out, and slight itching occurred.
This is worse than second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (This is worse than second dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 007M204) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac valve disease.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (This is worse than second dose). At the time of the report, VACCINATION COMPLICATION (This is worse than second dose) outcome was unknown.            No Concomitant  informations were reported.  No Treatment informations were reported.   This case was linked to MOD-2021-365408 (Patient Link).
covid vaccine reaction J&J. c/o temporal h/a, generalized body aches, n/v, rhinorrhea, chills, and dizziness after getting J&J single dose COVID vaccine at 0830 this AM. Pt began feeling ill around 1000. History:  Pt had COVID-19 J&J vaccine this morning and then felt lousy and started heaving some headache, non-thunderclap, behind eyes, with shakes, chills, nausea, and then vomiting, here for eval.  Feels better now after ibuprofen/Tylenol and has bad headache at this time.  No recent illness/injury, COVID-19 hotspot visit, sick contact, recent international travel, diarrhea, rash, photophobia, ear pain, cough, SOB, abdominal pain, dysuria, vaginal bleed/discharge, recent surgery/procedure/abx use, prior co-morbid
Swollen lymph nodes under left armpit. Back pain and muscle soreness. Insomnia and fatigue.
Information has been received from a nurse and office manager for the pregnancy registry for GARDASIL a 27 year old Caucasian female who on 28-SEP-2006 was vaccinated with the first dose of GARDASIL. On 31-OCT-2006, the patient was vaccinated with a second dose of GARDASIL. On 06-MAR-2008, she was vaccinated with a third dose of GARDASIL. Concomitant therapy included a first influenza virus vaccine (unspecified) on 23-JAN-2006 and a second dose on 17-OCT-2007 and vitamins (prenatal vitamins). In September 2007, approximately 6 months after the third dose the patient became pregnant. When she was 15 weeks pregnant she experienced headaches and in the 18th week of pregnancy she was diagnosed with venous sinus thrombosis. The patient's family history and genetic relation of blood disorder that out after delivery. Since then, the patient has had a live birth female who was healthy and was born at 39 weeks from the LMP on 26-APR-2008 with a weight of 7 pounds and 1 oz and the length was 21.5 inches (LMP = approximately 26_JUL-2007, EDD - approximately 03-MAY-2008). Additional information is not expected. 3/10/09-records received for DOS 12/7-12/8/07-DC DX: Venous sinus thrombosis. Presented with C/O headaches at time 18 weeks pregnant.  Office note 11/19/07 seen for evaluation of worsening headaches. During course of first trimester of pregnancy had increasing and severity of chronic headaches which began at age 8 or 9. Throbbing pain and sensationof nasal congestion. Assessment:mirgraine headaches. Office visit 2/14/08-follow up visit after hospitalization. Assessment:right cerebral transverse sinus thrombosis. 3/12/09-office records received office visit 6/20/07-annual exam WNL- 7/30/06-C?o fatigue and discharge, vagninitis. 9/28/06-1st Gardasil vaccine Lot #0955F, left deltoid. 10/31/06-2nd Gardasil vaccine received. 1/19/07-C/O feelings of anxiety, chest pain, shaking. 3/6/07-3rd Gardasil vaccine given Lot #0146U.
Eyes-itching, scratching, hands burning & pinching; wrist weak. Top of hands freezing cold. Continually still burning gone to rheumatologist - under (Eyes itching - drs appt for eye drops) done nerve tests. - given gabapentin 3 x day. Some relief. Rheumatologist made appointment with neurologist in March 2012. Need help relief.
pulmonary embolism; Also developed flare of viral myelitis symptoms; dyspnea; This is a spontaneous report. A 37-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 17Apr2021 at 12:00 PM as single dose for COVID-19 immunisation. Medical history included hypothyroid, migraines, viral myelitis from Nov2019, allergies to bee stings. Concomitant medications included levothyroxine sodium (SYNTHROID); magnesium glycinate; ascorbic acid, calcium pantothenate, calcium phosphate dibasic, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous fumarate, magnesium oxide, manganese sulfate, nicotinamide, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, zinc oxide (MULTIVITAMIN AND MINERAL) . The patient previously took prochlorperazine (COMPAZINE SPANSULE) and experienced allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient developed dyspnea 4 days after vaccine (on 21Apr2021 at 12:00 PM) and diagnosed with pulmonary embolism 2 wks later. Also developed flare of viral myelitis symptoms which had been improving and almost resolved for 2mos prior. The adverse event result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (with one day hospitalization), life threatening illness (immediate risk of death from the event). Lab data included covid tested post vaccination, SARS-CoV-2 test (Nasal Swab) on 06May2021 was negative. Treatment received for the adverse event including blood thinners. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Patient was given influenza vaccination using 5/8 inch needle instead of correct 1 inch needle.
This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored dose of GARDASIL which had lot # K011325, expiry date: 08-APR-2017 (route and dose not reported). No adverse effects were reported. No product quality complaint (PQC) involved. No further information provided. Additional information has been requested.
numbness that started at the injection site; numbness from  the shoulder area to the fingers.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site numbness in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2021, the patient received the 2nd dose of Shingrix. On 14th October 2021, 2 days after receiving Shingrix, the patient experienced injection site numbness and numbness. On an unknown date, the outcome of the injection site numbness and numbness were not recovered/not resolved.   It was unknown if the reporter considered the injection site numbness and numbness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the immunocompetent patient presented 2 days after the 2nd dose of Shingrix vaccine, numbness that started at the injection site and goes now from the shoulder area to the fingers. The patient got in contact with a neurologist and suggested to report the adverse event. The reporter consented to follow up.
c/o dizzy 5/19, 20    c/o pain lt side of chest & shoulder back c/o bad H/A 5/19 LT deltoid upper arm swollen (9 cm 10 cm) warm to touch.   c/o could not move arm high 5/19 AM
Initial misuse report received from a healthcare professional on 16 April 2013. A 4-year-old patient had received ADACEL vaccine instead of PENTACEL vaccine. No adverse event was reported. List of documents held by sender: none.
pt in nursing home; was tested for COVID on 9/13/2021 and found to be positive; placed on isolation x 10days and monitored; per death certificate, pt died in the facility; cases of death:  Pneumonia, COVID, physical debility, metastatic prostate CA
pt recv vax 8AM was gine when left peds office, approx 2hr later fell asleep babysitter on mom could not arouse @ 4:30-5PM;therefore went to ER dec resp not responsive;
covid vaccine breakthrough case   dose 1 Pfizer 12/23/20 EK5730 dose 2 Pfizer 1/13/21 EL0142  admitted for induction of labor at 40.2
no additional AE details available; have been stored outside of recommended range; This spontaneous report was received from an office manager in charge of vaccine storage and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The concomitant therapies included sterile diluent used for vaccine reconstitution.   On an unknown date in2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U039722, expiration date 15-DEC-2023 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine underwent temperature excursion of 6 Fahrenheit degrees up tp 14 Fahrenheit degrees for 50 minutes and 14 Fahrenheit degrees up to 46 Fahrenheit degrees  (15 Fahrenheit degrees) for 30 minutes on 28-JUN-2022. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680:Merck US-009507513-2207USA000470:Merck US-009507513-2207USA000544:Merck US-009507513-2207USA000552:Merck US-009507513-2207USA000563:Merck
Pt recvd pedvaxHIB on 7FEB92 & 20FEB92 pt presented to MD w/1 cm sterile abscess @ inject site; no further details were provided;
Pfizer-COVID 19-EUA: The patient began complaining of nausea and being lightheaded about 5 minutes after receiving vaccine. Pt was sitting down and had a syncopal episode while in observation area. Pt was assisted to the ground. Pt was hypotensive and treated by staff with and IV and fluids. Pt improved with treatment and was transported to Hospital. Incident #. PCR was completed by staff.
Throat tightness - tightness gone by 1300. BP 150/85, HR 56, SpO2 98% (1230) -- > BP 147/85; HR 56, SpO2 97% (1255)
MODERNA COVID #3 GIVEN 11/2/21, LOT #076C21A; 2/2/22 pt to ED from a SNF with AMS and apnea; in PSVT, treated with medication; acute encephalopathy; admitted to ICU; positive for COVID; COVID pneumonia; ABX; BiPAP; status changed to DNR; pt expired the following day
pt presents to the ED for migraines and blurred vision that began last night which he is concerned is a side effect from the J&J vaccine, pt received the vaccine on 5/3/21.
Patient began w/ wheezing and hives about 5 min after receiving vaccine. Vital signs all stable. She received benadryl 50mg PO, epi 1mg IM and supplemental O2 while awaiting EMS. She was transported to Medical Center by EMS.
5/15/18 clinic note: Ptt has #1 of new shingles shot 21 days ago- 4/26. 7 days ago developed rash on right scrotum and groin, denies any preceding malaise, low grade fever, feeling ill. etc. Pt has lesions on right groin/upper medial thigh close to groin, states these aren't painful. Surrounding skin isn't painful he states some early cellulitis scrotal area- KEFLEX Rx given for 7 days.
No additional AE reported; during administration the patient moved and the needle came out of the skin/no medication leaked from the injection site, but there was still 0.1mL left in the syringe that the patient did not receive/patient only received 0.4mL of the MMR Il vaccin; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's medical history and concomitant medications were not provided.  On 07-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II), 0.4 milliliter (lot # T029550 and expiration date reported as 01-SEP-2022) for prophylaxis. During administration the patient moved, and the needle came out of the skin, nurse confirmed no medication leaked from the injection site, but there was still 0.1mL left in the syringe that the patient did not receive. Nurse stated the patient only received 0.4mL of the MMR Il vaccine (accidental underdose). No additional information provided. No additional AE reported. No PQC reported.
pt recvd vax;w/in 2 hrs exp flu like sx w/ T of 104;
5/1/08 (L) arm rash right after Varicella vaccine administered SQ. 5/2/08 TC to parent. Pt still has rash and slight redness and swelling. Pt told to apply cold compress and come back if worsens/does not improve.
raised, reddened area above site of inj immed p/vax;applied cold compress x 20min;reported to MD office 1041AM;
Vaccine reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.       Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: Nurse was unable to confirm if a patient was involved, she reported that there was a potential that Hiberix was reconstituted with sterile water from another manufacturer. Follow up request was not asked during conversation. Additional Supportive Information: Hiberix was reconstituted with sterile water from another manufacturer which led to wrong solution used in drug reconstitution.
4/29/22 pt admitted to hosp; positive for COVID; extensive comorbidities; given O2 supplementation, dexamethasone, remdesivir; pt experienced A Fib with RVR; pt decided to become DNR/DNI; requesting comfort care and hospice; pt passed away in the hospital
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: PATIENT WAS SITTING IN THE MINUTE CLINIC WAITING AREA, SYNCOPAL EPISODE, BP WAS 79/54, HR 71, TEMP 97.9, 02 98% LUNGS CLEAR, 15 MINUTES LATER PATIENTS BP 123/81 HR 74 100%