chrisvoncsefalvay/vaers-outcomes huggingface dataset:
painful rash outbreak on her head and eyes, consisting of scalp lesions, clusters of tender knots across her head; stabbing pain behind her eyes; painful rash outbreak on her head and eyes, consisting of scalp lesions, clusters of tender knots across her head; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient of unknown age. Her concurrent conditions, medical history and concomitant medications were not provided. On or around 30-SEP-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (strength, lot #, expiration date, dosage, anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, she suffered a painful rash outbreak on her head and eyes, consisting of scalp lesions, clusters of tender knots across her head (rash/skin mass), and stabbing pain behind her eyes (eye pain). Those injuries were caused by zoster vaccine live (ZOSTAVAX). As a result, her husband had suffered loss of services and society and asserts a loss of consortium claim. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the pt's symptoms had resulted in physical limitations no present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, she 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, she had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered.   The reporter considered all of the events to be disabling.
Patient reports having "covid arm" consisting of swelling, heat and rash. Patient is taking an antihistamine and will inform use if problems persist..
headache, fatigue, myalgia, chills, muscle weakness (legs gave out while walking)
suspected vaccination failure; My friend got the vaccine and still got shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's friend. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received the vaccine and still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
This case was reported by a nurse via sales rep and described the occurrence of erythema in unspecified number of patients who received FLUARIX QUADRIVALENT (batch number 345AX, expiry date 30th June 2018). On an unknown date, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown. The reporter considered the erythema and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination of the patients was not reported. The nurse reported that several patients had experienced significant redness and swelling after receiving FLUARIX QUADRIVALENT in the reporting year. The office had submitted a VAERS report. The reporter's office sees patients so possibility of private and public funds used for purchase of vaccines. This case was linked with case US2017GSK169703, reported by the same reporter.
High fever for 3 days (103 F after Tylenol)  Severe headache Severe fatigue and body aches Swollen, red, painful shoulder.
Dizziness, Diarrhea, HYPERtension, Tachycardia, weakness Narrative:  Patient sent to ER for further evaluation.
Patient felt like throat was closing in. She went to Nurse Practitioner and got an injection of Benadryl and was fine after that also went to urgent care and but was fine after couple hours.
sore throat; headache; fever; nausea; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache), PYREXIA (fever), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had vaccine in March and had symptoms of headache, fever, sore throat, nausea, fatigue.   No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
The ER stated I had a severe T-cell reaction. My arm, neck, face blow up four times the size. And I had fever and a lot of pain.
Had pain at left upper arm site of injection immediately, and noticed redness one week later (had not inspected it prior).
BIT THE VIVOTIF CAPSULE AND SWALLOWED SOME OF IT AND SPIT SOME OF IT OUT; This spontaneous case report (PVX2019-2935) was received from consumer on 27-Nov-2019. It described a 7-year-old female consumer who "bit the Vivotif capsule and swallowed some of it and spit some of it out" (PT: Wrong technique in product usage process), while being on oral Vivotif capsule for typhoid fever.  Case report: The consumer took the first dose of Vivotif on 26-Nov-2019 and bit the Vivotif capsule and swallowed some of it and spit some of it out. It was reported that she did not have any swallowing problem.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer bit the Vivotif capsule and swallowed some of it and spit some of it out (Wrong technique in product usage process). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A consumer bit the Vivotif capsule and swallowed some of it and spit some of it out (Wrong technique in product usage process). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.
Patient received second dose 1 month following first dose. Should have been 2 months after first dose. Patient did not have any ADRs
PATIENT PRESENTED WITH VOMITING AND DIARRHEA ON 8 FEB. AAS SHOWED PULM INFILTRATE. PT STARTED ON PO ABX. PT STARTED FEELING FEVERISH ON THE EVENING OF 8 FEB.  9 FEB WOKE UP FEELING LIGHTHEADED AND DIZZY. TAKEN BY AMBULANCE TO ED, WHERE SHE SUFFERED RESP ARREST.  CODED 3 TIMES.  ADMITTED TO ICU ON VENT.  DEVELOPED MULTI-ORGAN SYSTEM FAILURE. DIED ON 10 FEB.
Mom alerted RN of welt forming after the administration of MMR vaccine on right thigh. 15 mm x 15 mm in size, red, raised. Patient under no distress.
patient received the pentacel injection but only received the liquid portion, no AE; Initial information was received on 24-Jun-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 month old male patient who received first 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U65408A and expiry date 06-Apr-2021) via an intramuscular route in the right thigh for prophylactic vaccination on 22-Jun-2020, but received only the liquid portion (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) HEPATITIS A VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Burning in left eye; Pressure in left eye; Constant cigarette smoke smell all the time; This is a spontaneous report from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 09:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The Patient had no Medical history reported. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) 100mg once a day, vitamin b12 (MANUFACTURER UNKNOWN), and vitamin d (MANUFACTURER UNKNOWN); all from unknown date for unspecified indication. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Mar2021 at 20:30 the patient experienced burning in left eye when sleeping at night, pressure in left eye during the day and constant cigarette smoke smell all the time. The clinical outcomes of the events burning in left eye, pressure in left eye and constant cigarette smoke smell all the time was not recovered.    No follow-up attempts are needed. No further information is expected.
Temperature of 99.1; Not feeling well; Headaches; Muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 99.1), VACCINATION COMPLICATION (Not feeling well), HEADACHE (Headaches), MYALGIA (Muscle pain) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature of 99.1), VACCINATION COMPLICATION (Not feeling well), HEADACHE (Headaches), MYALGIA (Muscle pain) and CHILLS (Chills). At the time of the report, PYREXIA (Temperature of 99.1), VACCINATION COMPLICATION (Not feeling well), HEADACHE (Headaches), MYALGIA (Muscle pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment medication was reported.
excruciating pain upon injection; injection site and left arm; excruciating pain upon injection; injection site and left arm; Limited Use/Mobility of Left Arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 10:00 (Batch/Lot number: unknown) at the age of 80 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 25Feb2021, outcome "recovering" and all described as "excruciating pain upon injection; injection site and left arm"; MOBILITY DECREASED (non-serious) with onset 25Feb2021, outcome "recovering", described as "Limited Use/Mobility of Left Arm".  Additional Information: caller states that it is better than it was after 2 weeks but still there slightly. Caller states his second vaccine is on the 18MAR, a few days from now. The patient did not visit Emergency Room and Physician Office. Caller states he hopes that call handler might be permitted to give information as to since he had an acute local reaction if it would be better to choose a different arm for second dose in three days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site itching/rash at the injection site with itching; injection site bumps; soreness in her armpit on the left side/tenderness in her armpit on the left side; injection site redness; injection site with itching; injection site became immediately sore/tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection site bumps), PAIN IN EXTREMITY (soreness in her armpit on the left side/tenderness in her armpit on the left side), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE RASH (injection site itching/rash at the injection site with itching) and VACCINATION SITE PAIN (injection site became immediately sore/tenderness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site became immediately sore/tenderness). On 17-Mar-2021, the patient experienced VACCINATION SITE MASS (injection site bumps), PAIN IN EXTREMITY (soreness in her armpit on the left side/tenderness in her armpit on the left side), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE PRURITUS (injection site with itching). On an unknown date, the patient experienced VACCINATION SITE RASH (injection site itching/rash at the injection site with itching). At the time of the report, VACCINATION SITE MASS (injection site bumps), PAIN IN EXTREMITY (soreness in her armpit on the left side/tenderness in her armpit on the left side), VACCINATION SITE ERYTHEMA (injection site redness), VACCINATION SITE RASH (injection site itching/rash at the injection site with itching), VACCINATION SITE PAIN (injection site became immediately sore/tenderness) and VACCINATION SITE PRURITUS (injection site with itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication provided. No treatment drugs were provided.
Developed rash that itches on trunk, bilateral arms and bilateral legs 2 days after received Pfizer Covid vaccine #1.
Felt faint and body shaking  immediately,  after that sat during 15 min observation period. Had some more body shaking  and  feeling faint. Thought it was a normal vaccine reaction. Went to the car  w/daughter after observation period. As she was leaving the parking garage  she  started having palpitations, was holding her chest, starting "doing breathing  techniques." Throat then "dried out," drank water, then after a while it was  hard to drink the water. Daughter told her that her face was swollen. Pulled  the  car over, had daughter call family to come and help, daughter drove her to a  pharmacy where they purchased Benadryl. Patient took the Benadryl. Family  arrived, then swelling subsided. Then when they got home she had vomiting and  diarrhea. All symptoms lasted about 5 hrs. Vomiting and diarrhea continued  into  2nd day, then after that everything completely resolved. Next day she called  the  VA to report what happened, she was advised to have come back in.  Symptoms: palpitations, throat and face swelling vaccine administration time: 11:00am symptoms started: 11:01am symptoms ended: next day at 6pm
Information has been received from a pharmacist concerning a 79 year old female patient with allergic reaction to neomycin who on 03-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663894/0129Y) SQ. On 05-MAR-2009 or 06-MAR-2009, 2 to 3 days after administration of ZOSTAVAX (Merck), the patient experienced injection site reactions. The patient developed a knot, swelling, soreness, erythema, pruritus, bruising and redness by the site of injection. The pharmacist stated that most patients reported the redness and itchiness immediately after administration. The patient had sought unspecified medical attention via telephone. At the time of reporting the patient's adverse events persisted. This is one of several reports from the same source. Additional information has been requested.
Patient was given her first dose of the Moderna vaccine 3/24/21. Patient was directed to the observation room for monitoring and asked to wait 30min due to anaphylaxis allergy to peanuts and angioedema reaction to shellfish. Pt explained her throat was "scratchy" and "feeling funny, like I ate something I wasn't supposed to." Pt was alert and oriented. Denied SOB/chest pain. Reports slight wheezing. Vitals WNL-see below. ED rapid response was called.   Vitals @ 0900 BP 110/80 HR 96 O2 sat 96% on room air  Patient declined receiving epinephrine pens and requested diphenhydramine which she received when she was taken to ED for observation. Patient was discharged an hour later
I woke that night with achy bones and muscle pain. I was exhausted and took off work, slept off and on all day. Went to bed at 8:30 and woke for work at 7. I was still exhausted the entire next day. That night I started having heart palpitations and I still have them today 04/17/23. Off and on all day but worse at night. Hard heartbeats radiating through my neck, very uncomfortable with slight pain. I got an EKG which was normal. I have an ultrasound scheduled for tomorrow, 04/18/23. I have an Echo cardiogram scheduled for May 31st.  I do not know for certain it is a side effect of the vaccine, but it seems so to me as I have never had this problem before.
Received vaccine on afternoon of 10-25-05. By  8:00 PM that night, developed baseball-sized knot at site of injection. Over the next three days, the swelling increased in size and gradually migrated down my arm, accompanied by area of intense redness -- from the acromium process down to the antecubital space. Entire upper arm was very swollen, red, hot-to-touch,  and very tender -- preventing restful sleep for two nights.
This spontaneous report was received from a healthcare professional refers to a patient of unknown demographics. On an unknown date the patient was vaccinated with M-M-R II injection (dose, route, frequency and lot # unspecified). No medical history and concomitant medications were provided. It was reported that the dose administered on an unknown date was an improperly stored vaccine. But was unsure which ones, may have been M-M-R II, LIQUID PEDVAXHIB or GARDASIL. No adverse effects reported at this time. No further details provided. There was no Product Quality Complaint involved. The outcome of incorrect product storage and no adverse event was unknown. This case is linked to 1505USA014703 and 1505USA014702 (same patient link). Additional information has been requested.
My arm wasn't even really sore. I felt tired for about 24 hours. I have developed high blood pressure which I have never had problems within the past. I went in for cataract surgery and my blood pressure was extremely high. They said it was stroke level. I have been placed on some medicine for high blood pressure.
It wiped me out physically so I stayed home and slept. My shoulder hurt really bad the next day and my range of motion drastically reduced. I started physical therapy around March 2nd week. I started out with PT with 1 day a week in March then increased it to 2 days in April and 3 days from June- Nov, and then 2 days a week through January. My range of motion was completely impeded and has been ongoing. It started with the 1st dose, then got worse after the 2nd dose and then 3rd dose had another reaction.
Approximately 10-15 minutes after receiving vaccine patient reported the following symptoms: dizzy, nausea, sweating, blurry vision
headache; chills; fever/temperature of 103.2; body aches; big huge red knot; about the size of a golf ball that stuck up about 2 cm; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (big huge red knot), SWELLING (about the size of a golf ball that stuck up about 2 cm), CHILLS (chills), PYREXIA (fever/temperature of 103.2) and MYALGIA (body aches) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 076L21D and 045L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 12-Mar-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2022, the patient experienced ERYTHEMA (big huge red knot) and SWELLING (about the size of a golf ball that stuck up about 2 cm). On 13-Mar-2022, the patient experienced CHILLS (chills), PYREXIA (fever/temperature of 103.2) and MYALGIA (body aches). On 14-Mar-2022, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of Tylenol about every 2 hours and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of Motrin about every 2 hours. At the time of the report, ERYTHEMA (big huge red knot) and SWELLING (about the size of a golf ball that stuck up about 2 cm) outcome was unknown, CHILLS (chills) and PYREXIA (fever/temperature of 103.2) had resolved with sequelae and MYALGIA (body aches) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2022, Body temperature: 103.2 (High) fever/temperature of 103.2.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient experienced symptoms saturday evening after receiving the second dose of the vaccine. Patient asked her HCP for Decadron or steroids, who denied her request.