chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; pink around the injection site; warm at the injection site; itchy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (pink around the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and RASH (rash) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (pink around the injection site), VACCINATION SITE WARMTH (warm at the injection site) and VACCINATION SITE PRURITUS (itchy at the injection site). On an unknown date, the patient experienced RASH (rash). At the time of the report, VACCINATION SITE DISCOLOURATION (pink around the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she received the second dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Updated the outcome of all events.Added new event rash.
I got my 1st covid vaccine Wednesday. I went to donate blood the following Sunaday and my blood pressure was low (88/58) and my pulse was high (93 bpm). Later that night, it was normal (124/83) and 67 bpm. It continues to be normal now.
Pt developed a rash/blisters on arms, face and legs. Pt also ran a temperature.
first shot given a migraine began. Every day since I battle the same migraine. Was worsened with second shot; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for Covid-19 immunization (vaccinated at the age of 38-years). Medical history included food allergy (Apples, Bananas, Penicillin, kiwi, latex, adhesives, Niacin, all antibiotics), rubber sensitivity, dermatitis, polycystic ovaries, endometriosis, adenomyosis, fibrocystic breast disease, Heart attack. Concomitant medication(s) included rosuvastatin calcium (CRESTOR), fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), ibuprofen (MOTRIN [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. The patient previously took bnt162b2 for covid-19 immunization and experienced migraine, niacin and experienced drug hypersensitivity. On an unspecified date the patient reported first shot given a migraine began. every day since she battle the same migraine was worsened with second shot. The outcome of event was not resolved.  Information on the lot/batch number has been requested.
GUILLAIN BARRE SYNDROME ACUTE RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE
This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On 25-MAR-2013 the patient was vaccinated with GARDASIL (lot # and expiration date unspecified) injection 120 DF, (dose, route and anatomical location unspecified). The Registered Nurse reported that on 25-MAR-2013, the patient experienced pain and burning at the injection site where GARDASIL was administered. At the time of the report the outcome of pain and burning at the injection site where GARDASIL was administered, was unknown. Additional information is not expected.
Guillain Barre Syndrome.  11/3/09 PCP and neurological consult records received service dates 10/6/09 to 10/29/09. Assessment: Guillain-Barre syndrome. Patient presents with 4 hx of worsening achiness, myalgias. Tympanic membrane effusion. Uvula deviated to side. Sore throat. Viral syndrome. Finely papular erythematous rash on neck. Congestion. Sinus pressure and frontal headaches. Discomfort hamstring muscles. Neurological symptoms worsen. Fell, balance is off. Numbness in hands/feet, does not feel steady, proximal muscle weakness. Weakened grip and biceps strength. Reflexes trace to absent in upper extremities. Reflexes 2+ at knees and ankles. Vibration sense diminished. Joint position sense minimally impaired.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild
After having expected side effects for the first 36 hours,  I experienced gross hematuria, increasing body aches, fatigue, fever of 100 degrees.  Symptoms were consistent with an IGA Nephropathy flare up.  I also experienced a more mild flare up after my second dose.
Chills and fever lasted for 7 hours, rapid racing heart for 5 hours. Started 12 hours after the vaccine was administered. Took tylenol for fever. Went to er for rapid heart rate after I could t lower it for 2 hours.
Admitted to hospital for fall/weakness and COVID was found to be positive. Pt did not require oxygen. Was treated with steroids and albuterol inhaler during stay. Needed PT/OT and placement at discharge. Was inpatient at a local hospital from 8/25/21 until 9/2/21
Blood pressure spiked to 188/103 and remained at high levels for two to three days Felt a bit of psychosis mentally Heart Palpitations and slight chest pain
Six days after receiving the vaccine, a red rash circling the injection site appeared followed by the return of arm pain. Rash is itchy. I have read that this sometimes happens (and that it will go away in 24 hours to 1 week but wanted to report it for the record.
Horrific burning upper Left shoulder/back area. Electrical shock sensations. Went to Clinic received steroid pk. Then primary 1 wk later. Another steroid Pk Dr. then Chiropractor making sure not spine related, pinch nerve. No.. Continuing Chiro. Recently sent me to Orth. Now on Neurotin. Anticonvalsent
Pt developed shingles like rash. Clinic NP thinks it is shingles > 72 hours No antiviral tx necessary lesions are healing.
Mensuration has stopped since second vaccine. Normally it is very regular but now it hasn?t started again.
After 2 days I began to see circular abrasion that looked like calluses on my hands. Days later they began to spread and open up.  Then I more severe circular abrasions on my chest breast and stomach area. Then uncontrollable peeling of my hands and feet.  Extreme itching all over my whole body.
Syncope 10 min after vaccine for past 7 days short of breath, palpitations (with PVS on EKG that were not a prior known condition), weakness,  fatigue
Patient experienced vasovagal reaction but did not faint. EMS evaluated and gave patient water.
Back of left arm where varicella was given was swollen, red, hard, itchy.
Individual tested Covid positive on 8/11 and 8/13/21 and was in isolation .  Developed pink-eye and has been followed by her PCP.  She completed her treatment of antibiotics and steriods.  Her last follow up with her PCP was on 9/20/21 and cleared from pink-eye.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 47-year-old, adult, male patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case: 201804681 was cross-linked to the case 201804657 reported by the same reporter.
kidney issue; This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (patient's daughter) reported on behalf of patient. A male patient of unspecified age received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration from an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter called on behalf of her father who was scheduled to get the second shot tomorrow (08Mar2021). Patient won't be able to make it because he was in the hospital due to a kidney issue. Outcome of the event was unknown. Reporter wanted to know how to reschedule vaccination.  Information on the lot/batch number has been requested.
Pain - running down my arm - left/don't have strength restless at time. Pain killer will not take the pain away.
Patient administered a pediatric Pfizer vaccine intended for his daughter. After the error, the pharmacist administered 80% of the Moderna booster dose (0.2cc = 40mcg).
This spontaneous report was received from Licensed Practical Nurse refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot # were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
patient had soreness in neck and couldn't lift arm above head, pt went to er and was told to take Tylenol and ice, re=-checked with patioen on 10-3 and she is doing some better, also some pain in armpit area but no redness or pain at site of injection
Noticed a slight headache the evening 8:30 pm - of the injection (Friday night ) 07/06/18. Injection site was slightly sore- just like when I get the flu vaccine. Went to bed around 11 pm. Work up at 2 am with a myriad of reactions. Splitting headache/ migraine / sensitive to light, fever, chills, body aches over entire body, swollen arm at injection site, rock hard and extremely painful and hot to the touch, nauseous, dizzy, weak, fatigue. Could not get out of bed. Felt worse than any flu I have ever had. Finally feeling better after day 6, on 7/12/18.
This spontaneous report as received from a healthcare worker (Medical Assistant) refers to an unspecified number of patients (age and gender unknown). The healthcare worker stated that improperly stored VARIVAX (Merck) (administration/dosage details unspecified) had been possibly administered to these patients between 17-DEC-2014 and 05-JAN-2015. Concomitant medications were not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Headache; Sore arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142) via an unspecified route of administration on 30Dec2020 10:00 at single dose for covid-19 immunisation. Medical history included hypertension, high cholesterol and asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC), hctz (HCTZ), metoprolol succinate (TOPROL XL), omeprazole (OMEPRAZOLE) and pravastatin (PRAVASTATIN). The patient previously took diphenhydramine (BENADRYL) and experienced drug allergy. The patient experienced headache and sore arm on 30Dec2020 13:00. Outcome of events was recovering.
pt recvd vax;numbness from waist up;aching w/ sharp pains across top lt arm & lower part of ribs & chest;fever on & off;n,chest pain;some diff breathing;all muscles hurt;duration 40 hrs;tx w/ ibuprofen q/ 4 hrs;
Pt was found in severe distress in the bathroom by his wife.  He couldn't walk or stand, complained of being dizzy with slurred speech and was throwing up a lot. 911 was immediately called. The EMTs during their assessment said his BP was normal but when he was asked his name, he started saying the alphabet"ABC... XYZ".  He was transported by ambulance to ER. Cat scan showed he had a bleed on the brain.  The doctors told us it was because he had very high blood pressure, however where the bleed was, they said he wouldn't need surgery and that the body would reabsorb it over time.  He was admitted to the ICU and has been there ever since.  Several days later, he started having difficulty breathing and they discovered several blood clots in his right leg that had broken off into his heart and lungs.  He had emergency surgery to remove the clots in his heart (approximately 10) and was given heparin in small doses over an 8 hour period so that it wouldn't cause the bleed in his brain to increase.  The doctor should fill in the rest.
"moderna covid-19 vaccine EUA"  1st covid 19 shot received 2/20/21. One week later on 2/27/21 my arm at the injection site became very pink and extremely itchy.  The area is about 3 " long and 2" wide more oval shaped than rectangular.  Still appears the same on 2/28/21  I have not received any medical treatment for the reaction.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 10:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:28 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 66.69 for dose administered on 03-Mar-2021 and 66.77 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Batch number 014M20A underwent temperature excursion on 03-Mar-2021 with temperature 51 degrees Fahrenheit at 9 AM, 34 degrees Fahrenheit at 10 AM and 35 degrees Fahrenheit at 1 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Patient presented with blister below right arm near deltoid muscle. Blisters have ruptured and left hyper pigmentation and redness around the entire arm. The patient said it was easily irritated and couldn't wear any clothes that could rub against the skin.  Patient can now wear clothing without feeling irritated. Blisters have popped.
Came down with Shingles  about 5 weeks after 2nd shot of Pfizer vaccine
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 19-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Her arm was swollen and she had a rash on her arm that eventually spread to her chest. The rash has gone away but her arm is still swollen
Patient noticed a rash/redness that formed that had defined borders one week after vaccination.  Patient stated it was itchy.  Patient stated they have no done anything differently; no new detergents, etc.  Patient was told to take diphenhydramine and was told to seek medical treatment if the redness grew, started to throb, emitted heat or if the developed a fever.
Client started developing symptoms of fever, facial swelling, hives and rash. She was seen in an express care clinic on 1/13/16 and was given Benadryl and a shot if steroids. Symptoms continued to worsen and she returned to express care on 1/15 and received same rx. She continued to worsen and ultimately went to ED on 1/21/16 and was admitted for 2 days.
1 of 2 pts who exp a fever of 105 following immun both pts were immunized from the same HIBTITER vial; This pt exp a fever of 105.5 which lasted 2 days; pt recvd HIBTITER (4th dose); No sx of cold or ear infect; MD visit required;
A red area on arm, beginning on Feb. 21, slightly swollen, warm to touch, itching, about the size of a silver dollar.  Symptoms are same today, Feb. 22, as yesterday.
no additionalAE's reported; temperature excursion/ vaccine given to patient; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date between 29-AUG-2021 and 30-AUG-2021, the temperature excursion of the stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U007506, expiration date 04-SEP-2022) was 8.7 Fahrenheit degree (F) for a time frame of 19 hours and 12 minutes. There was no previous temperature excursion. On 23-SEP-2021, the patient was vaccinated with an improperly stored 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, lot # U007506, expiration date 04-SEP-2022 (route of administration were not reported) for prophylaxis. The patient did not report symptoms after the administration of the vaccine. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA000390:
My daughter was having trouble breathing at about 745 pm and after 15 minutes on a nebulizer it was not helping her breathe better.  She panicked and began to point to her neck repeating "it's not working,  something is wrong". 911 was called at 807pm and before they arrived she stopped breathing . After arrival at about 815 pm, they carted her into the ambulance where they injected her with an epi pen where then she gained consciousness. She was rushed to the ER for further treatment at about 9Pm.
Fever (99.9) Severe muscle and joint pain all over Exhaustion Moderate by 4 hours post injection Much more severe the first day after Moderate the second day after Gone by third day after
This spontaneous report as received from a pharmacist refers to a 64 year old male patient. No medical history and concurrent conditions were reported. On 22-JUN-2015, the patient was vaccinated with ZOSTAVAX (lot number: L006379 and expiry date: 25-MAY-2016) vial dose 0.65 milliliter (ml) once subcutaneous. No concomitant medications were reported. On 22-JUN-2015, the patient experienced redness and warmth at the injection site. No laboratory details were provided. The patient was not treated for the reported events and the patient sought for the medical attention and visited the pharmacist. The outcome of injection site erythema and injection site warmth was reported as not recovered. No further information available. No product quality complaint (PQC) was filed. The reported events were not considered as hospitalisation, cancer, life-threatening, disability or overdose. Additional information has been requested.
Dose administered at 12:30, pt.complained at 12:40 of "itchy mouth and tongue". MD on site administered Benadryl 25 mg p.o. and instructed pt. to wait an additional 15 minutes. 1:00, pt stated "no worsening of symptoms", no changes observed. Pt. was dismissed and verbalized understanding of emergency instructions.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 28-DEC-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), he suffered shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he 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, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome for shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).  The shingles was assessed as a disabling event by the reporter.
t102 w/APAP, unconsolable crying, piercing screams if inject site touched; didn't sleep @ all-all noc; inject site reddened;