chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VARICOSE VEIN RED AND HARD; UPPER RIGHT THIGH PAIN; SUPERFICIAL CLOTS; This spontaneous report received from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 09-APR-2021, the patient experienced varicose vein red and hard, and was hospitalized. She sought care at the Vein Institute in Voorhees, NJ, as she says she had been treated there in the past.  On 09-APR-2021, the patient experienced upper right thigh pain. On Apr-2021, the patient experienced superficial clots, and was hospitalized. Laboratory data  included: Diagnostic ultrasound (NR: not provided) confirmed Superficial clots. Treatment medications included Motrin and Heating pad for Varicose veins. She was told to return in 2 weeks for a follow up ultra sound.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the superficial clots, varicose vein red and hard and upper right thigh pain was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically important condition). This case, from the same reporter is linked to 20210501531.; Sender's Comments: V0 : 20210500162 - Covid-19 vaccine ad26.cov2.s - Superficial clots and Varicose vein red and hard . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Within hours of receiving shot I developed nausea, vomiting and headache that intensified as the day went on. These headaches then developed into migraines. These migraines lasted for several months with a constant headache; severity just changed. 3 months after the shot I started to develop a cool sensation in my left foot that then felt like pins and needles with intermittent sensation of my leg being on fire. This radiated up my left left then started in my right  foot with same progression. June 2022 I developed chronic muscle fatigue with muscle fasciculations, spasms and locking up. I continue with all of these symptoms with brain fog, forgetfulness, feeling like I am out of my body. I suffer from insomnia. I experience periods of chest pain, heart palpitations and heaviness of my lower extremities. The numbness and tingling has started in my left hand approximately 1 week ago. I also experience vaginal bleeding (full hysterectomy 4 years ago) and recurrent yeast infections.
hurt like heck; felt miserable; overcoming sensation with chills; overcoming sensation with shakes; This case was reported by a pharmacist via sales rep and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 18 hrs after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced pain, chills, tremor and feeling miserable. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain was unknown and the outcome of the chills, tremor and feeling miserable were recovered/resolved.   It was unknown if the reporter considered the pain, chills, tremor and feeling miserable to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced hurt like heck and had an overcoming sensation with shakes and chills. The patient also felt miserable. The patient will receive the 2nd dose in January. This case has been linked to US2019203750, reported by the same reporter.
Patient received Pfizer Covid vaccination at pharmacy on 7/20/21 at around 4:15pm.  Patient was told to wait in our waiting area for 15 minutes.  Around 10 minutes later, patient was throwing up.  He called his mom who works at bakery.  She bought him some donuts and gave him water.  We checked his blood pressure and it was 111/78.  He told us he was feeling dizzy, nauseous, sweating, and felt like his body was shutting down.  He gave him an ice pack and told him to lay down.  He continued to monitor him for 15 more minutes.  He told us he was not feeling any better.  His mother told us to go ahead and call 911.  We called 911 and the paramedics took him.
Ever since i got the shot. 3 times alreasy i have nose bleed. Never happen like that before
dizzy; can't eat; I got my 2nd shot 10 days ago and I'm still sick; headache; nauseous; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FEEDING DISORDER (can't eat), MALAISE (I got my 2nd shot 10 days ago and I'm still sick), HEADACHE (headache) and NAUSEA (nauseous) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy), FEEDING DISORDER (can't eat), MALAISE (I got my 2nd shot 10 days ago and I'm still sick), HEADACHE (headache), NAUSEA (nauseous) and CHILLS (chills). At the time of the report, DIZZINESS (dizzy), FEEDING DISORDER (can't eat), MALAISE (I got my 2nd shot 10 days ago and I'm still sick), HEADACHE (headache), NAUSEA (nauseous) and CHILLS (chills) outcome was unknown.            No concomitant product information is provided  No treatment product information is provided   Reporter did not allow further contact
Information has been received from a physician concerning a 7 year old healthy female who on 9/22/97 was vaccinated with a dose of varicella virus vaccine live (lot # 622851/0539E). The physician reported that on 3/29/04, the patient experienced breakthrough. Unspecified medical attention was sought, but no treatment was required. At the time of this report, the outcome was unknown. The physician also reported that another patient developed breakthrough after being vaccinated with varicella virus vaccine live (WAES0405USA00764). Additional information has been requested.
High blood pressure; high heart rate; chills; fever; site pain; body pain; tired; not feeling well; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 27Mar2021 at 10:15 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, sleep apnea, hashimotos, Ehlers-Danlos syndrome (EDS). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the left arm on 06Mar2021 at 11:15 (at the age of 43-years-old), as a single dose for COVID-19 immunisation and mushroom and experience food allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 28Mar2021 at 00:00, the patient experienced high blood pressure, high heart rate, chills, fever, site pain (vaccination site pain), body pain, tired, and not feeling well. The patient did not receive treatment for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events high blood pressure, high heart rate, chills, fever, vaccination site pain, general body pain, tiredness, and feeling unwell was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arm wound, left, IRRIGATION AND DEBRIDEMENT UPPER EXTREMITY. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Got really sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patients experienced sickness (Verbatim: Got really sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 The case was received from the consumer via interactive digital media.  The reporter asked if anyone got sick from the Shingles vaccine. The reporter was scared to get Shingles vaccine because his or her several friends got really sick. The follow-up could not be possible as no contact details were available.
Patient complains of pain in the arm and she has hard time lifting her arm up. MD said the needle might have hit a nerve to cause the pain and it will eventually go away over time
In January 2022 I had a breakthrough while vaccinated, I had a itchy throat, fever and a bad cough. I took my inhaler the same day and I felt like I couldn't breathe then I immediately called my doctor and did a telehealth visit. My doctor prescribed me antibiotics and it has helped me a lot so I am still taking it currently because I am still having troubles breathing.
Patient looked light headed and face got flushed and was not sure if he was breathing.  His partner put some candy in his mouth and he quickly jerked up and initially looked like he was having a seizure, but started breathing calmly right away.  Patient was feeling light headed but was conscious and breathing. Paramedics arrived, and upon evaluation, paramedics reported patient had very low blood pressure, and it was continuing to drop.  The paramedics provided IV fluids.  Per paramedics, patient has no lymph or facial swelling, and no obstruction of to airway.   Per paramedics, it seems like patient had fluid problems. Patient was being transported to ER for further stabilization.
Red circlular raised area about 2 inches across in the middle of the upper arm below the deltoid muscle. Itchy areas extend around it and lateral to it 8 inches which worsened at 24 hours. Swollen 3 inches at 48 hours but less itchy.
No adverse event; Moderna Lot number 021H22A was accidentally administered yesterday 07-Jun-23 to patient after the expiry date of 01-Jun-2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday 07-Jun-23 to patient after the expiry date of 01-Jun-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     Patient did not report any relevant medical history, conditions, allergy, concomitant diseases, and risk factor. It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 07-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday 07-Jun-23 to patient after the expiry date of 01-Jun-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday 07-Jun-23 to patient after the expiry date of 01-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday 07-Jun-23 to patient after the expiry date of 01-Jun-2023).    Concomitant drugs were not reported. It was reported that the patients either received the expired vaccine as 4th or 5th dose.  It was also reported that one of the patient had COVID-19. Treatment medications were not provided.  This case was reported for elderly patient of total 3 patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-728519 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728519. Case(Patient 1)
Shaking chills; body aches; nausea; vomiting; vertigo; This is a spontaneous report from a contactable Other-healthcare professional (patient). A 57-year-old female (not pregnant) patient received BNT162B2 (lot number: EH9899) first dose on 17Dec2020 02:00 PM intramuscularly on left arm at single dose for COVID-19 immunization. Medical history included Colon Cancer, Hypothyroidism, Allergic Rhinitis, Weight Loss Surgery, GERD, BPPV. Concomitant medications in two weeks included Levothyroxine, cetirizine hydrochloride (ZYRTEC), Escitalopram, MVI, Calcium, colecalciferol (VIT D3), cyanocobalamin (VIT B12). No Known allergies to medications, food, or other products. Facility type vaccine was Other. No other vaccine in four weeks. Patient experienced Shaking chills, body aches, nausea, vomiting and vertigo on 18Dec2020 03:30 AM. Patient received Zofran, Meclizine, Phenerga as treatment. Patient did not have covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering. The seriousness was reported as no.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EH9899), on 19Jan2021 as dose 2, single (Lot number: EL1283) and on 21Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Bactria sensitivity" (unspecified if ongoing), notes: Known Allergies: Bactria sensitivity. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional Information: There was no medication in 2 weeks. The patient received COVID 19 Treatment drug (Lot number: FW4118) from 11Jul2022 to 25Jul2022 for treatment of COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Parent called on 12/5/18 to report child had developed fever on 11/30/18 in the evening. Child continued to run fever until 12/4/18, on morning of 12/5/18, child woke with rash on shoulder that traveled up neck to head. Child rubbing at ears on morning of 12/5/18 but no complaints of fever.
Pt did not have any adverse events. Wrong vaccine administered. Pt received PROQUAD vaccine and varicella vaccine.
dose from expired vial administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose from expired vial administered to patient) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose from expired vial administered to patient). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose from expired vial administered to patient) had resolved.        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.   A nurse reported that one of her facilities gave 10 doses between 8 am to 12 pm on 01-Sep-2021 from a vial that expired on 31-Aug-2021, lot 037A21B. It was a new vial that had never been opened. It had been moved into the refrigerator on 25-Aug-2021 (8 days prior). Upon follow up it was reported that the vaccine given at 9 am  on 01-Sep-2021. No adverse reaction noted.  It was reported that the patient had no known allergies (NKA) and not diagnosed or tested positive for COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before vaccination. It was unknown if prescriptions, over the counter medications, dietary supplements, or herbal remedies being taken by the patient at the time of vaccination.  No concomitant medication was provided. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Updated reporter information. Added ethnicity of patient, vaccination time, route of administration and location of vaccination. Added facility information.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2008 the patient was vaccinated with dose 1 GARDASIL (lot #, expiration date and route not reported). No concomitant medications were reported. On 12-DEC-2012 the patient was vaccinated with dose 2 GARDASIL (lot #, expiration date and route not reported). No adverse effect reported. Additional information has been requested.
It was reported that a 37 year old female pt received a TD Adult vaccination in the right deltoid and a Hep B vaccination in the left deltoid on 10/24/2000 at 2:30om. Reportedly the pt stated "didn't hurt but the last 3 weeks it is very painful. Initially red but never hard, compress did not provide relief." Evaluated on 11/14/2000. On 11/15/2000 continued with pain to site, range of motion affected; pain radiating into right shoulder, increased complaint of pain. Pt is presently taking prescribed catominophen with relief of symptoms. On 11/16/2000 appointment confirmed with physician first for medical evaluation. Emergency dept visit not warranted at this time per associate. The pt's recovery status is unknown. An appointment is scheduled in Dec. for the emergency dept. From additional correspondence received on 02/22/2001, it was reported that the pt recovered from this experience. No further info is anticipated; this case is closed.
blurry vision/ she looked at pictures and faces were blurry and she could not make them out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 at 01:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "she had no side effects from her first three doses of the vaccine"; Covid-19 vaccine (Dose:2, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "she had no side effects from her first three doses of the vaccine"; Covid-19 vaccine (Dose:3, Booster, Manufacturer Unknown), for Covid-19 Immunization, reaction(s): "she had no side effects from her first three doses of the vaccine". The following information was reported: VISION BLURRED (non-serious) with onset 10May2022, outcome "unknown", described as "blurry vision/ she looked at pictures and faces were blurry and she could not make them out". The events "blurry vision/ she looked at pictures and faces were blurry and she could not make them out" required physician office visit and emergency room visit.  Additional information: The patient had received dose and came home and everything seemed fine.  She did a few things and sat down for a while and dozed off for half an hour.  When she woke up, the pictures of her family in her living room were blurry.  She thought it was a temporary thing.  It continued, so she called her daughter at 4pm and said something was wrong.  She was having problems seeing a clear face.  She took her to the emergency room.  She went to the emergency room and sat there for approximately 6 hours because they did not have an eye doctor.  The doctor there checked her eye with something she was not familiar with.  They did not put anything in her eye, but made her look up, down, right and left.  He called her regular doctor and told symptoms and doctor's nurse answered.  She left the emergency room around 10:30 pm and the nurse said to come in today because that was when the retina doctor will be in her area.  She was seeing him at 2:40 today, but she wanted to know there were a myriad of symptoms with the different vaccines, not just Pfizer.  She would like to know if vision problems have been an issue with the Pfizer booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis . No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Headache (I rarely get) and then all my muscles, joints, arthritis flared up, bad. I have been to the chiropractor 5 times now, gotten a massage and have tingling in my fingers and my arm is numb. My neck is totally messed up from the trauma, couldn't sleep, and just totally exhausted from it for almost 2 weeks now.
I woke with stuffy nose,sinus pain, bad headache, ans fever, arm sore.  Pulse 120 Fever 102-100. ,  I checked my heart rate with Pulse Oxyimiter. My blood pressure around 2:30 was 140 over 90.   I took a cold shower, drank 70 ounces of water during day.  Took 2 Tylenol ,  3:00 and 10:30. Also allergy med which was Bromelain, stinging nettles, Quercia in. 10:30 am and midnight.  Also cup of ginger and cinnamon teas.  By midnight temp at 100.  Heart rate around 81-83.  Next day fever down,  slight lightheaded ness,  very faint head pain, little sinus irritation,  heart rate 78 - 68by 11:00pm.  No fever.
Soreness, Tired/sleepiness/Nausea/cramp-stomach.