chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; Information was received from a lawyer regarding a case in litigation and refers to a currently 68 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-NOV-2013 the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of her receipt of zoster vaccine live(ZOSTAVAX), in 2014, patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Initial information received on 12-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves a 63 years old male patient who accidentally received 0.5 mL suspect TUBERSOL via intramuscular route in left deltoid (lot - C5476AA, 16-Nov-2020) instead of 0.5 mL TENIVAC on 12-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to Wrong product administered. 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 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. Follow up information received on 13-Mar-2019 from a physician. No new information received. Documents held by sender: none.
Received vaccine on 4/11/21.  On 4/12/21 woke up with pounding headache. Took Tylenol and slept most of the day.  Felt better on 4/13/21 and returned to work.  On 4/15/21 in the morning, I noticed a small itchy spot on my lower left side of my back.  By the end of the day it was about the size of my fist and found another spot on my left side of my stomach.  Began taking 2 Benadryl every 2 hours and applying Cortisone 10 ointment to the areas.  By 4/16/21 both spots had become very sore and much larger.  More spots started on my upper left thigh and the back of my left leg.  Continued Benadryl and cortisone 10 and also tried an oatmeal bath.  Carried on thru the weekend.  Monday, 4/19/21 called doctor first thing in the morning.  Saw Dr. at Family Medicine and she said it was Shingles most likely activated by the Covid vaccine.  She prescribed prednisone and valtrex and instructed me to report this.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot # unknown) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The physician stated he had a patient who experienced an adverse event while taken GARDASIL on an unknown date. It was unknown that if the patient had sought medical attention. The outcome was unknown. Additional information has been requested.
Client vaccinated with Moderna vaccines for Covid x 2 in February 2021.  Boosted with Moderna vaccine on 12/9/2021.  Symptoms started 12/14/2021 - fever, myalgia, sore throat.  Admitted to Hospital on 12/18.  Not in ICU, no supplemental oxygen
shot hurt like hell, worse; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included covid vaccine with an associated reaction of pain (received 2 shots on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-NOV-2022 Reporter's Comments: The reporter reported the case via  interactive digital media. The reporter stated that he/ she got this done but let him/ her tell that the shots hurt like hell.  The reporter stated that worse than that stupid covid 2 shots. Additional Supportive Information:The follow-up would not possible as no contact details were available.
Hep A #1 given 6-26-2009 - Also given TDAP and Varicella Booster on 6.26.09. Mother states that evening he developed redness on R deltoid. Fever 6-26 and 6-27. Per mother difficulty breathing resolved after sitting up all sym. resolved.
My wife and I had gone to a place where they had converted railroad tracks into bike tracks. I was lifting our bikes off of the car and noticed some heart palpitations. Even though the bike path was pretty flat, I noticed that my heart palpitations were continuing and I felt more tired than usual. We rode for about an hour and when we stopped for lunch, I lied down on a bench to see if it would help my racing heart. As we were riding back, I had to get off of my bike about half way back to sit down. I walked the bike for a bit and got back to the car and drove home. I went to bed, but I didn't feel that the fibrillation ended until the next morning. So it lasted about 14 hours. I spoke to my doctor about it but felt it was an isolated event. It happened again though, about a week later when I was just sitting at home. My daughter advised that I go get it checked out. So I had a friend drive my wife and I to the hospital. My doctor recommended a specific hospital where I was admitted and given an I.V. which helped end the A-fib event after about a half hour. They kept me over night and I spoke with a cardiologist who prescribed two different medications which I am still taking.
Fatigue, Muscle Ache, Mild nausea and mild headaches persistent for 39 days after vaccine shot.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-SEP-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) injection (dose, route of administration, lot# and expiration date were not provided), for prevention of shingles. On an unknown date, a short time after receiving the vaccine, the patient developed shingles. The patient sought medical attention. She had the doctor's office appointment. On an unknown date, the patient recovered from the adverse event. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
1. Thurs, 3.17.22 (day after injection) - soreness at site (applied ice and exercised/stretched arm 2. Friday, 3.18 - fatigue and nausea all day, beginning in the morning; 6:00pm level 8 nausea set in (no vomiting), w/ extreme diarrhea, lasting from Friday night - Sunday, 3.20, mid-day 3. Sipped water and pedialyte, all of Saturday, 3.19. Was able to eat a small amount of noodle soup and drink chicken bone broth 4. Mon, 3.21 - nausea has reduced, but remains, light-headedness, and fatigue
This spontaneous report was received from a nurse concerning an unknown number of patients, unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, frequency, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse reported that in her facility got a new thermometer system on 13-MAY-2014, and according to the thermometer, (Oka/Merck) VARIVAX was exposed to temperatures above the recommended storage temperature on multiple occasions. At this time, it was not known whether or  not the excursions were supported because data was insufficient to evaluate. The nurse stated that she was certain that doses of (Oka/Merck) VARIVAX was administered to patients since there excursions were recorded. No adverse effects have been experienced. Additional information has been requested. These case is one (1) of two (2) reports from the same source.
Reddened area on the posterior and side of right arm with a quarter size blister. Pt c/o soreness and pain.
Red rash and itching on arms face and legs 3 weeks post vaccine, cramping in legs and unusual menstrual cycle
It was found that the above patient only received diluent instead of reconstituted freeze dried Shingrix vaccine.   No adverse reaction from this error.  Patient cannot receive a fully reconstituted dose for four weeks from 10/30/23.
This case was reported by a other health professional via sales rep and described the occurrence of headache in a 16-year-old female patient who received MENVEO. On an unknown date, the patient received MENVEO. On an unknown date, 1 day after receiving MENVEO, the patient experienced headache, joint pain and fever. On an unknown date, the outcome of the headache, joint pain and fever were recovered/resolved. It was unknown if the reporter considered the headache, joint pain and fever to be related to MENVEO. Additional details were reported as follows: No further information was available or reported regarding the event. The patient attended the Emergency room or doctor visit.
Patient's sister called approximately 4pm on 3/26/2022 to report that her brother had a seizure about 30 minutes after receiving the vaccination.
Left hand RA episode 3 days, Right leg RA episode 3 days, Right hand RA episode 3 days,  Left hand four finger RA episode 3 days, Right hand RA episode days (episodes started on March 17 - April 3, 2021 ended.   On April 4,2021 Notice a spot in left leg psoriasis almost completely gone 4/13/21.250
This spontaneous report has been received from a Medical Assistant, concerning to a 35 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not provided. On 21-MAR-2017,  the patient was vaccinated with an expired dose of M-M-R II lot # L009213 and expiration date of 17-MAR-2017, albumin status rHA (dose, frequency, route of administration were not provided) for prophylaxis.  No adverse effect were reported. Additional information has been requested.
PATIENT GIVE PNEUMOCOCCAL VACCINE POLYVALENT 23 0.5 ML IM X 1 DOSE IN ER. PRESENTED 24 HOURS LATER WITH REDNESS AND SELLING AT INJECTION SITE AND DOWN SHOULDER AREA.  GIVE BENADRYL 50 MG PO TID AND SOLU-MEDROL 125MG X 1 DOSE
Patient felt dizzy and almost fainted but regained consciousness pretty soon. She started feeling nauseous , threw up and improved after that. Patient reported needle phobia.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 18-OCT-2012 11:58, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Within 15 minutes of receiving the first dose of the Pfizer vaccine, my body began to go into shock. I started to lose vision and motor skills. I felt an intense burning sensation going through my entire body. There were no medical professionals present in the waiting area. Out of pure desperation, I got up to go alert someone. I made it to the door where the vaccine was being administered, but I fainted before I could alert a medical professional. I landed directly on my face, resulting in 4 fractured teeth. I required two surgeries to repair the damages, all of which I was forced to pay out of pocket for. One surgery was to remove the fractured teeth that were not salvageable, and the other was to put support posts into my gums for my new teeth (caps). Soon after the accident, I began to suffer from trauma induced panic attacks that I have never had in my life. I am now forced to take medication to ensure that I do not have these panic attacks anymore. I also have to go to therapy because of this incident. I was assured beforehand by the vaccine screeners that I would be safe, and that there would be professionals there to help me should I go into shock. There was no one to help me in the waiting area once I went into shock.
Two large knots developed on the child's Left arm.  The site was swollen, sore, hard and hot to touch.
Patient got COVID shot today at 4 pm. She stated that her arm started stinging at 4:05pm. She waited till 4:30pm and stated that her arm was not stinging anymore. She signed a paper saying she was ok and wanted to leave.
My arm swole from the injection site all the way down to my fingers . I couldn?t lift my arm without assistance from my right hand. It was very fevered I took ibproufen and placed an ice pack on the injection site on and off 10 hours. It wasn't until that afternoon that the swelling went down. For over a week it was very hard to move my arm.
One week after receiving Moderna booster he presented to ED with chest pain and had developed pulmonary emboli in the left lung as evidenced by CT Scan. Heparin was given. Already on Apixiban so treatment was not changed.
Alot of pressure headaches with numbness and heaviness on right side of face.  Pain in legs, shortness of breath followed by sudden cough.
developed full body chronic hives within 3 weeks of her 1st dose of the vaccine/full body chronic hives/Urticaria; dizzy; scarring due to the hives; doctor thinks she has histamine intolerance from the vaccine and says they called it urticaria; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed full body chronic hives within 3 weeks of her 1st dose of the vaccine/full body chronic hives/Urticaria), DIZZINESS (dizzy), SCAR (scarring due to the hives) and HISTAMINE INTOLERANCE (doctor thinks she has histamine intolerance from the vaccine and says they called it urticaria) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (developed full body chronic hives within 3 weeks of her 1st dose of the vaccine/full body chronic hives/Urticaria), DIZZINESS (dizzy), SCAR (scarring due to the hives) and HISTAMINE INTOLERANCE (doctor thinks she has histamine intolerance from the vaccine and says they called it urticaria). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (developed full body chronic hives within 3 weeks of her 1st dose of the vaccine/full body chronic hives/Urticaria), DIZZINESS (dizzy), SCAR (scarring due to the hives) and HISTAMINE INTOLERANCE (doctor thinks she has histamine intolerance from the vaccine and says they called it urticaria) 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.   Treatment drug included STEROIDS.   This case was linked to MOD-2021-255960 (Patient Link).
had APAP @ time of immun had a high pitched cry 4 hrs p/shot cont to be inconsolable till late in evening; didn't call MD seen by MD;
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.). Additional details: Patient had severe pain in shoulder for about 7 days after IM injection. Possible injection into shoulder joint.
Hives around neck, face (cheeks, and around eyes) about 2 hours after vaccine was administered. Reduced appearance of hives after 12 hrs. Cortisone (topical ointment) applied and hives seemed to subside.
flu symptoms; body aches; fever/low grade fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms), PAIN (body aches), PYREXIA (fever/low grade fever) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020. Concomitant products included ACETAMINOPHEN and IBUPROFEN for an unknown indication.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu symptoms), PAIN (body aches), PYREXIA (fever/low grade fever) and CHILLS (Chills). At the time of the report, INFLUENZA (flu symptoms), PAIN (body aches), PYREXIA (fever/low grade fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, COVID-19: positive (Positive) Patient had COVID-19 back in June..   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient is taking unspecified High Blood Pressure Medication and Supplements currently. No treatment information was provided.
In November 2022, I noticed after my period I began having spotting for an additional 10 days. My natural family planning instructor saw my charts and referred to a specialist doctor.  I had glucose testing.  I was diagnosed with PCOS - Polycystic ovary syndrome.  I had a Vitamin D deficiency and excessive mucus.  I am on a treatment plan now.
I had reaction to the first three doses of migraines and throwing up for about three days. I already had migraine medication and I took PHENERGAN and ADVIL for my symptoms. I started to have symptoms of a sore throat and a headache. I test for COVID-19 at a clinic, and it was positive on 10/18/2022. I was given a prescription for molnupiravir and it helped with my symptoms. I was feeling better after two days. I also was diagnosed with Strep with COVID-19.
unable to move; unable to communicate with my wife; severe back pain; still weak; got all the same reactions; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (unable to move) and COMMUNICATION DISORDER (unable to communicate with my wife) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Past medical history not provided).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HYPOKINESIA (unable to move) (seriousness criterion hospitalization) and COMMUNICATION DISORDER (unable to communicate with my wife) (seriousness criterion hospitalization). On an unknown date, the patient experienced BACK PAIN (severe back pain) and ASTHENIA (still weak). The patient was hospitalized from 13-Mar-2021 to 16-Mar-2021 due to COMMUNICATION DISORDER and HYPOKINESIA. On 16-Mar-2021, COMMUNICATION DISORDER (unable to communicate with my wife) had resolved. At the time of the report, HYPOKINESIA (unable to move) had resolved and BACK PAIN (severe back pain) and ASTHENIA (still weak) had not resolved.            Concomitant medications taken by the patient were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-082315 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
31MAR93 7AM client awoke mom noted hives on rt leg & lower abdo; also had t101; pt given APAP in AM; mom called MD & wanted to check client, but mom never went to appt;
Seen at our facility 12/8/09 for stool with blood in one diaper today.
COVID-19 infection.  Positive test 1/10/2022.  My back ache started and shifted into full body ache with cold symptoms.  Aches lasted about 24 hours and cold symptoms lasted about 4 days.
given a dose of Shingrix reconstituted with a sterile diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 6R5XF, expiry date 22-AUG-2025) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: given a dose of Shingrix reconstituted with a sterile diluent). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt date: 15-AUG-2023 A nurse reported that a patient was accidentally given a dose of Shingrix reconstituted with a sterile diluent 3 weeks ago from reporting and wanted to know how to proceed. The vaccine administration facility was the same as primary reporter. The patient received Shingrix reconstituted with a sterile diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Painful rash developed on trunk, arm, wrist and leg. Left side only. This was not at injection site. Lasted 2 weeks.
This spontaneous report as received from a physician (local reference #PHL/12/0048) refers to a patient of unknown age. On unknown date the patient was vaccinated with a dose of ROTATEQ (lot# and dose not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced intussusception and Kawasaki-related disease post administration of ROTATEQ. No treatment information was reported. The outcome of intussusception and Kawasaki-related disease were not reported. Additional information has been requested.