chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her arm was pink about 4 inches round below the injection site; She felt weird (she felt like her body was getting sick); Throat was scratchy; fatigued; Little swollen at the injection site; Her arm hurt like after getting the flu shot; Bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm hurt like after getting the flu shot), INJECTION SITE NODULE (Bump at the injection site), FEELING ABNORMAL (She felt weird (she felt like her body was getting sick)), THROAT IRRITATION (Throat was scratchy) and FATIGUE (fatigued) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Her arm hurt like after getting the flu shot), INJECTION SITE NODULE (Bump at the injection site) and VACCINATION SITE SWELLING (Little swollen at the injection site). On 07-Apr-2021, the patient experienced FEELING ABNORMAL (She felt weird (she felt like her body was getting sick)), THROAT IRRITATION (Throat was scratchy) and FATIGUE (fatigued). On 11-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Her arm was pink about 4 inches round below the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 04-Apr-2021, PAIN IN EXTREMITY (Her arm hurt like after getting the flu shot), INJECTION SITE NODULE (Bump at the injection site) and VACCINATION SITE SWELLING (Little swollen at the injection site) had resolved. On 10-Apr-2021, FEELING ABNORMAL (She felt weird (she felt like her body was getting sick)), THROAT IRRITATION (Throat was scratchy) and FATIGUE (fatigued) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Her arm was pink about 4 inches round below the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Temp @ 10:30AM - 97.3; 4:30 PM - Rt. arm red, hot , muscle hard and sore @ inj. site; temp 99.8, took 10 gr ASA; 10:30 PM, temp 101.3, N&V, fever and chills, terrible body aching; took 15 gr ASA, applied cold cloth to head and neck. This lasted with fever, aching and flu like symptoms for 3 days and  general fatigue and malaise with temp running 99, taking ASA.  Did not return to normal until 5th day, but arm was still slightly wqrm, sore and itching.  No problems after day 6.  Only able to hold down soup and gingerale for first 3 days.
Patient developed strabismus. We gave him glasses for treatment.  On 03/22/14 he started having seizures, went into status elipticus, was hospitalized for two weeks. Released with medication without diagnosis. Still continues to have seizures and has been immune compromised since the vaccination.
Rash - improved with BENADRYL per mother - reappeared 2 days later - Rx for CLARITIN, BENADRYL, and Prednisone.
A day after having the vaccine, I experienced eye soreness in my right eye. The next morning both my eyes were blood shot. I administered eye drops and went on about my day. Late that evening they were really red and watery and my vision was blurred. I went to the optometrist on Monday morning and was diagnosed with Primary iridocyclitis, bilateral. My iris had been attached to my lens from the inflammation, but had detached it self. I was put on steroid drops and made to keep my eyes dilated until my follow up appointment. Went to my follow up appointment today December 28, 2020. My eyes are looking better, but not back to normal yet. Advised to keep administering my steroids drops and only use the dilation drops every other day. I will follow up on Thursday.
Within just a few minutes,  had chest tightness, racing heartbeat, difficulty breathing, tight throat, and getting flushed.  The nurses at the clinic monitored his O2 which dropped to 95%, and these symptoms lasted for a couple of days.  Also went to the ER the following day as it had evened out for a bit, then seemed to get bad again.  Very scary.  Got a fever too.
On 1/16 I had tachycardia, 1/18 I started feeling dizzy, nauseous, fatigue and episodes of tachycardia. My pulse reached 180-200bpm. That went on for about a week.  I felt like I had to take a couple deep breaths with my mask off. I could be sitting and my heart rate was all over the place. Each episode would last for about 10-15 minutes then go away. The nausea and dizziness went away but the tachycardia stayed. I went in to see someone after about 2 weeks, my primary doctor. I was referred for a heart monitor. I did the heart monitor, it showed supraventricular tachycardia and PVC's. The cardiologist recommended a stress test and echo and put me on a beta blocker. I have never had heart issues. The cardiologist recommended not taking the second dose of the vaccine.  I wore the heart monitor for 48 hours.  I still take the beta blocker metoprolol.
After going to bed, I began to feel tingling in my face. Over the course of an hour the swelling in my right side of my face became so pronounced that my gums were hard affecting the shape of my lips. I got out of bed and brushed my teeth, flossed, mouthwashed and salt water rinsed wondering if I'd maybe gotten something stuck in my teeth and went back to bed. By 1 am I was awoken by feeling like my teeth were going to fall out of my head it kept me up most of the night. I could feel my heart beating in my teeth. By morning, I had a small tear in my gums and the fluid had drained from the gums but there was an excess of tissue kind of hanging off my gums. I had typical mild fever and fatigue on Saturday, I took one dose of motrin. By Sunday the swelling was gone and my mouth felt better but I do continue to have some numbness on my upper right lip.
Small raised, red bump that appeared immediately after injection at injection site. Patient also experienced itching and small red dots that started to appear around injection site seconds after injection. Administered 50mg po Diphenhydramine following injection. Itching subsided and no additional redness or swelling occurred.
Patient received vaccination at 0730, around 1830 that evening while at work, patient experienced muscle pain, headache, not feeling well, and low grad temp of 100.4
rash on legs and back; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and experienced rash on legs and back.
2nd day started a fever, cold sweats, hot flashes, body aches 3rd day to 1 week later: loss of taste and smell, runny nose, foggy brain,  1 to 2 weeks later: nausea and diarrhea during ovulation cycle, spotting between cycles
ADMITTED FROM HOSPITAL 11/8, COUGH IS BASELINE, 11/9-NEG, 11/11-POS ROUTINE TESTING
weak; nauseated; dizziness; near syncope; n/v; tiredness, feeling very drained/tired; arm pain; ran low grade fever; headache; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 at 10:00 as dose 3 (booster), single (Lot number: GH9694) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "chronic bronchitis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; DARIFENACIN; LOSARTAN; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS. Past drug history included: Phenergan for known allergies: phenergan. Vaccination history included: BNT162b2 (Dose 2, lot number: ER8732, Route: Intramuscular, vaccine location Left arm), administration date: 20Apr2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "No adverse event"; BNT162b2 (Dose 1, lot number: EP6955, Route: Intramuscular, vaccine location: Right Arm), administration date: 28Mar2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "No adverse event". The following information was reported: HEADACHE (non-serious) with onset 13Jan2023 at 22:00, outcome "unknown"; PYREXIA (non-serious) with onset 13Jan2023 at 22:00, outcome "unknown", described as "ran low grade fever"; PAIN IN EXTREMITY (non-serious) with onset 14Jan2023, outcome "unknown", described as "arm pain"; DIZZINESS (non-serious) with onset 15Jan2023, outcome "unknown"; VOMITING (non-serious) with onset 15Jan2023, outcome "unknown", described as "n/v"; NAUSEA (non-serious) with onset 15Jan2023, outcome "unknown", described as "nauseated"; PRESYNCOPE (non-serious) with onset 15Jan2023, outcome "unknown", described as "near syncope"; FATIGUE (non-serious) with onset 15Jan2023, outcome "unknown", described as "tiredness, feeling very drained/tired"; ASTHENIA (non-serious) with onset 16Jan2023, outcome "unknown", described as "weak". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, fatigue, headache, dizziness, presyncope, vomiting, asthenia, nausea.  Additional information: Facility type vaccine workplace clinic. Patient did not received any other vaccine in four weeks. With the 3rd dose had severe arm pain 12 hrs after administration and ran low grade fever, headache. 2 days post administration (54 hours later) tiredness, headache, n/v, dizziness, near syncope. 3rd day after administration feeling very drained tired, nauseated, weak, headache. Patient did not have COVID prior vaccination and not tested COVID post vaccination.
The second shot of shingles was a bad "trip". I got the shot Saturday at noon time. By 7pm, I was not well, but I blame myself and my pushing myself with skiing. Two hours after, I realized that the book had fallen on the floor, so I decided to go to bed. By Sunday 2 a.m., I woke with my left arm hurting and heavy, my neck was very stiff, my jaw was not really opening. The right side felt better. I went to the bathroom, thinking get dress, call 911 I am having a heart attack. Curios, my heart was functioning as always. Finally, I observed the bandage on my right arm, and I told myself "No, no heart attack, shingles vaccine". I couldn't sleep, not I was awake. I walked my house back and for. I tried to drink coffee and my body rejected it. I drank seltzer water with orange or cranberry juice. Eating was an issue because my body rejected any solid food and my jaw was not chewing. I had to cut a phone conversation because my left jaw started to act out painfully. I was not able to read or watch TV. I cancelled a dinner appointment. Finally, I laid down on my bed about 8 pm, and woke up Monday at 7 a.m. As you know, I never sleep so many hours. I feel better today. I venture out to do driving errands. Last note: CDC requested to pass this information to my physician for her/him to send it to CDC. It there is a next time, I will do this shot with someone at my house. Really, my brain was functioning poorly  Another consequence of the shingles vaccine, my INR 4.5 today. I absolutely believe that it is the shingles vaccine not my diet. Please, pass this info to Dr. Warfarin is a tough medicine to deal with it.
7-20-10 Ax temp 100.2 degrees F child lethargic, lack of appetite, drowsy Health Center ref. family to child's regular physician who ref. them to outpatient. No Rx-outpatient Dr. thought vaccine related. Babysitters on 7-20-10 temp 103.8 Ax.
Pt states initially area pain/symptom free then 3-4 days after administration site itched, then 3/31/2006 came to clinic for rash, dependent erythema. Pt denies further symptoms.
10:45 that night, Tuesday the 30th, had teeth chattering chills for a couple of hours.  Couldn?t sleep, restless,  Next morning, Wednesday the 31st,  lethargic, felt like I?d been hit by a truck.. body ached, shoulder arm area, lower back were the hardest hit.  Felt better Thursday morning, April 1st, still a bit foggy headed, but was able to be active.
large red slightly swollen circle about 2.5 inches round appeared on arm.  A bit tender to the touch.  Not itchy at time of this report.
12/23/20 MOTION SICKESS, 12/30 - HEADACHE, MYALGIA 1/20/21 - MINOR REDNESS ROUND SITE Narrative:
Fatigue, fever, chills, body aches, headache, joint pain in elbows, wrists, hands, and fingers, cold sweats.
No adverse event; HCP called to report T/E for PROQUAD. PROQUAD was administered during a T/E(case#02492293). PROQUAD outcome was supported. No Additional AE reported. No PQC reported.  PROQUAD:  Outcome is supported: Temperature : 12.5F  Time frame: 0 hours 25 minute; This spontaneous report was received from a nurse, referring to a patient of unknown gender and age.  The patient's medical history, concurrent conditions were not reported, allergies, drug reactions and concomitant therapies were not reported.  On 16-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, administered for prophylaxis (lot #X000792, has been confirmed as valid, and expiration date was reported and validated on 07-JUL-2024, therapy type rHA, frequency, scheme, strength, and route of administration were not provided). The vaccine underwent temperature excursion, with a maximum temperature of 12.5 Fahrenheit (F) in a time frame of 25 minutes (Product storage error) (on 13-OCT-2023). No additional side effects were reported.
This case was reported by a physician, via GSK representative, and described the occurrence of lump injection site in a 4-year-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). The subject had not experienced similar reaction with individual DTaP or IPV vaccinations. On an unspecified date the subject received unspecified dose of KINRIX (unknown route, unknown thigh). At an unspecified time after vaccination with KINRIX, the subject experienced lump injection site and injection site pruritus. The lump was described as "like a baseball with itching". There were no systemic adverse events. At the time of reporting the outcome of the events was unspecified.
My Eczema is very mild, I haven't had a big flare up in over 10 years. I had a big flare up about 3-4 hours after getting the vaccine. My Eczema flared up in places where I didn't know that I had Eczema. It was not painful, it's just itchy, dry, and uncomfortable in spots that are covered with clothes.
issues with the lips/ chronic crusting on lips; This spontaneous case was reported by a pharmacist and describes the occurrence of CHAPPED LIPS (issues with the lips/ chronic crusting on lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHAPPED LIPS (issues with the lips/ chronic crusting on lips). At the time of the report, CHAPPED LIPS (issues with the lips/ chronic crusting on lips) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Treatment included oral steroids and topical antifungals.  Patient experienced the reaction some months after the second dose
This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patient received an unspecified number doses of GARDASIL 9 injection (exact doses, lot #, expiration date, route of administration and intervals were not reported) outside of recommended dosing schedule. There were no adverse symptoms reported. Additional information has been requested.
Nausea and dropped to the floor. Nurse Alert called. Upon UC RN arrival, patient awake and alert. Advised she was pregnant and having morning sickness.  Tolerated juice and crackers and discharged.
Soreness at the injection site and elsewhere in the body, Fever of 101.4, headache, breast tenderness
101-102 Temp- eyes matted - clear nasal discharge - cough - Sx lasted 2 days - to ER Fri, Amoxicillin, and cough med- Dr said ok to proceed with next series
Local edema of the shoulder, dizziness, near fainting, headache, vomiting.
Moderna COVID-19 Vaccine EUA Arm soreness began about 2-3 hours post-injection and steadily increased in intensity/pain throughout the day.  Following day, arm soreness extremely painful with some shoulder joint pain and pain any time upper arm muscle used. Slightly sore by second day post-injection without much discomfort.  Soreness completely subsided by third day post-injection. First day post-injection developed heavy fatigue at the beginning of the day (~8AM) followed by chills and then a fever a few hours after waking up. Thermometer was not used to detect fever.  Had slightly more energy and minimal chills by evening (~7PM).  Fever was subsiding (didn't feel as warm) but was still sweating pretty easily.  All fatigue, chills, & fever gone by following day (second day post-injection).
Extreme joint pain; This is a spontaneous report from a contactable consumer (patient) from the Pfizer sponsored program. An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20May2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced extreme joint on an unspecified date. The patient was scheduled to receive her second dose on 10Jun2021; however, the physician of the patient had advised the patient not to take her second dose for three weeks until she was okay. The patient was now feeling better and wanted to know if she could take her second dose on 30Jun2021. The outcome of event was recovering.  Information about lot/batch number has been requested.
Subsequently post vax, the pt's arm swelled up and became hard and sore. She also went pale as a ghost and got weak-kneed. She described her experience as a powerful reaction which forced her to be sent home from work.
Rash develop on body; Skin blotchy/Face blotchy/Ankles blotchy/Chest blotchy/Abdomen blotchy; Red wheal all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash develop on body), RASH MACULAR (Skin blotchy/Face blotchy/Ankles blotchy/Chest blotchy/Abdomen blotchy) and URTICARIA (Red wheal all over body) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 665K21A, 019F21A, 007M2019 and 032L20A) for COVID-19 vaccination.     Patient not tested positive for Covid and never undergone test or diagnosis for Covid.  Patient did not had known medical history. Patient did not receive other vaccine prior to the Moderna Covid-19 Vaccine.  Concurrent medical conditions included Drug allergy (it started 20 years ago) and Allergic to dogs.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash develop on body), RASH MACULAR (Skin blotchy/Face blotchy/Ankles blotchy/Chest blotchy/Abdomen blotchy) and URTICARIA (Red wheal all over body). The patient was treated with PREDNISONE for Rash, at a dose of UNK, qd. At the time of the report, RASH (Rash develop on body), RASH MACULAR (Skin blotchy/Face blotchy/Ankles blotchy/Chest blotchy/Abdomen blotchy) and URTICARIA (Red wheal all over body) had not resolved.        No concomitant medication was reported.  It was reported that the patient was not checked by doctor yet. Patient visited a primary care center and was asked to take prednisone daily for the rashes. Patient did not have the information of the primary health clinic.
Very achy all over the body severe headache and body pain and nausea. I contacted the doctor and they gave me steroids and a couple of other medicines and they said i might have had shingles but the headaches and the body pain. I made another appointment with my doctor for my mouth and went to the dentist and she said that it could've been herpes. My gums were super sensitive and the same day after cleaning my teeth's i passed out while driving and the next day i went to the primary doctor and they did a couple of the tests and the before the tests i passed out and i had to go to the ER and they sad i has having seizures an di had heart inflammation and white spot on my mri and they said they would just watch my test and body yearly.
Mother states that four days post imm, child's L arm in deltoid area became red and inflamed looking and two days later, still had swollen area that looked like a large whelp. Mother adm. tow doses of Benadryl which had no effect. Mother had given child two doses of Tylenol on the day of vaccination child did not run fever of c/o itching or soreness at site. On 7/30/02 (7 days post vac) the area was still slightly swollen.
This spontaneous report as received from a medical assistant refers to 18 month old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609.