chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick in bed; flu symptoms; immediately felt on fire while receiving the moderna vaccine/entire right side started to burn throughout my body while the needle was still in arm/felt like patient on fire from right ear, to right foot; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sick in bed), INFLUENZA (flu symptoms) and BURNING SENSATION (immediately felt on fire while receiving the moderna vaccine/entire right side started to burn throughout my body while the needle was still in arm/felt like patient on fire from right ear, to right foot) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (sick in bed), INFLUENZA (flu symptoms) and BURNING SENSATION (immediately felt on fire while receiving the moderna vaccine/entire right side started to burn throughout my body while the needle was still in arm/felt like patient on fire from right ear, to right foot). At the time of the report, MALAISE (sick in bed), INFLUENZA (flu symptoms) and BURNING SENSATION (immediately felt on fire while receiving the moderna vaccine/entire right side started to burn throughout my body while the needle was still in arm/felt like patient on fire from right ear, to right foot) had not resolved.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient had 2 covid vaccines, both moderna. The first one patient was sick in bed for 7 days with flu symptoms. The second was worse, patient was sick with flu symptoms for 7 to 10 days, and also had this happen, patient immediately felt on fire while receiving the moderna vaccine. Patient entire right side started to burn throughout patient body while the needle was still in patient arm. They kept patient there at the clinic for over an hour. The 2 years later and multiple visits to any doctor that would not throw patient out of their office for mentioning the vaccine, and patient still having issues and felt like patient on fire from my right ear, to my right foot. Treatment medications were not reported.
Nausea and light headedness that began around 1:00 PM on 3/17/2021, gradually got worse through 3:45 PM 3/17/2021, and went away by 7:00 PM 3/17/2021.
Extreme pain in left arm and across shoulders, into neck and head; after three weeks, loss of mobility in arm and still have a lot of pain; injection given higher up on the arm than I've ever had done before - almost to shoulder; can't raise arm, reach across body, wash hair, etc.  Planning to see doctor soon.
After  first dose of Vaccine she is having hives every morning but later in the morning if  I give her cetirizine 10mg the hives go away but it is happing every day. I am not sure the sudden allergies in her body. Also not sure why this thing happen not sure what is the cause. Certainly, this issue comes after vaccination. I am consulting with her allergy specialist and her PCP as well.
Leg became red & swollen @ inject site & entire thigh became red; below knee parents noted blotchy red spots over leg;
Swelling moderate, redness moderate 5 inch diameter, radiating heat, pain moderate.
pt came down w/a low grade temp; 4 days later sounded like was getting a cold; 2 days later started gasping for air; pt was given oxygen treatments in ER & adm for croup;
Became extremely tired.  Went to bed at 2:00 pm day after shot.  This subsided a little the next day but at the end of the second day, I experienced sharp pain in both shoulder joint.  This kept me awake until I took some ibuprofen which did ease the pain.  I woke up on the 3rd day feely normal again.
Around 11pm, a pain began in my left arm around the injection site that extended down to my elbow. The pain steadily increased throughout the night until I was no longer able to move my arm above the elbow joint. The pain stopped increasing by morning but has been holding steady for all of today (the day after the injection) and I am still mostly unable to move my arm. A fever of 100.0 - 100.5 developed around 10:00am on 1/5/21 and still remains.
One year old pt received Varivax and PCV7 on 11/15/01. Mother reported coming down with shingles on right ear and face on 11/26/01. This condition advanced to paralysis on right side of face on 11/28/01. Mother saw ENT physician and he prescribed Prednisone and Famvir (anti-viral). The Dr suggested to mother that shingles were probably due to her baby receiving the Varivax vaccine. Mother reported this to out clinic. Checked with mother on 12/20/01 and reported she was doing better and was back to work.
Headache; This is a spontaneous report from a contactable other hcp. A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 77-year-old) for COVID-19 immunization. Medical history included pulmonary fibrosis. The patient's concomitant medications were not reported. The patient previously took Xeljanz XR and experienced cough with pale greenish/yellowish phlegm, occasional wheezing and shortness of breath, sore throat. The patient experienced headache on an unknown date in 2021. Denied any fever. Per patient, he stopped the Xeljanz 4 days ago due to symptoms. The outcome of the event headache was recovered on an unknown date in 2021.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 2, single (Lot number: El9262), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: 845p21) at the age of 59 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Bees and mold" (unspecified if ongoing), notes: allergy to Bees and mold.; "allergy to Bees and mold" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2)". The patient underwent the following laboratory tests and procedures: COVID-19: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication in 2 weeks. Rebound infection after taking Paxlovid for 5 days. Tested negative and felt well then 6 days later worsened cough and malaise and tested positive again. Worse symptoms than original Illness. Device timestamp: 06May2022.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
The injection site as sore soon after the shot and through the second day.  I ran a fever of 99.3, was quite tried; had aches and slight chills for the next day.  The fever and aches went away after one day.  I also notice red blotches and about 18 hives.  The blotch was about 1 inch on my abdomen; hives were about 3/4 to 1/2 inch on various parts of my body.   They have not gone away yet.  I took Tylenol 1000 MG twice for the fever and aches.
Fever developed on 6/10/2020.  responded to Ibuprofen and Tylenol.  Rash developed on 6/15/2020 after no fever for 24 hours.
Tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sclerosis multiple.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced TREMOR (Tremors). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. At the time of the report, TREMOR (Tremors) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include vitamins. The treatment included Steroid (did not know name).   This case was linked to MOD-2021-089481 (Patient Link).
Initial unsolicited report received from a nurse on 10-Jan-2018. This case involves a six-month-old patient (gender not reported), who was vaccinated with first dose of 0.25 ml FLUZONE QIV via intramuscular route (batch number: UT5949KA; expiry date, route and site of administration not reported) and PEDIARIX (manufacturer: GSK) (batch number, expiry date, dose, route and site of administration not reported) and ROTAVIRUS VACCINE (batch number, expiry date, dose, route and site of administration not reported) and PNEUMOCOCCAL CONJUGATE VACCINE (PCV12) (manufacturer: Pfizer) (batch number, expiry date, dose, route and site of administration not reported) on 20-Dec-2017. Patient had a mild cough at time of vaccination. No fever. Concomitant medications were not reported. On 26-Dec-2017 in morning, six days following the vaccination, patient was found dead. Patient was previously vaccinated with all vaccines other than FLUZONE QIV twice. Lab test and corrective treatment was not reported. Reporter stated an autopsy was being performed to determine cause of death and rule out SIDS (sudden infant death syndrome). Patient's mother felt it was the flu shot (Fluzone QIV) that caused her child's demise. Documents held by sender: none.; Sender's Comments: Time to onset is compatible. The patient already had mild cough at the time of vaccination. No other medical history was reported. The patient also received Pediarix and Rotavirus vaccine on the same day as Fluzone QIV. Autopsy was being performed at the time of reporting to determine the cause of death and rule out SIDS. Considering that several different vaccines had been co-administered at the same time it is difficult to elicit role of each vaccine in reported event. Result of autopsy, patient medical history, past surgical history, and state of health at the time of vaccination would be helpful with identifying role of each vaccine in reported event.; Reported Cause(s) of Death: found dead the morning; Autopsy-determined Cause(s) of Death: found dead the morning
He received his second dose after 4 days he got hives and he was very itchy.
She reports having broken a tooth.; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an (Age: 71, Unit: Unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported Pfizer), via an unspecified route of administration on 02Feb2021 as 1st dose, single and received second via an unspecified route of administration on 23Feb2021 dose as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported having broken a tooth on Mar2021. Reporter would like to know if it is okay to go to the dentist appointment after received both doses of the Pfizer covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
little bump/ arm began to turn red and raised around the area; red circle/ arm began to turn red and raised around the area; Arm was tender; 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 TENDERNESS (Arm was tender), VACCINATION SITE ERYTHEMA (red circle/ arm began to turn red and raised around the area) and VACCINATION SITE SWELLING (little bump/ arm began to turn red and raised around the area) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced TENDERNESS (Arm was tender). On 14-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle/ arm began to turn red and raised around the area). On 21-May-2021, the patient experienced VACCINATION SITE SWELLING (little bump/ arm began to turn red and raised around the area). On 18-May-2021, VACCINATION SITE ERYTHEMA (red circle/ arm began to turn red and raised around the area) had resolved. At the time of the report, TENDERNESS (Arm was tender) and VACCINATION SITE SWELLING (little bump/ arm began to turn red and raised around the area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
The vaccine was injected in the left arm, however, my right arm started hurting the day after receiving the shot.  Finally, I checked my blood pressure on Sunday, January 9th and recorded a BP of 170/107, ahead of going to find an Urgent Care facility.
About 24 hours after vaccine pt developed erythema, induratino at left deltoid.
After the vaccine I did not feel anything until the next day; my arm hurts for a week, on 4/14 I felt a rapid heart bit, I monitored myself. the reading was over 200; I called my doctor, went to the hospital on 4/21; at that time, they did not let me go home, I stayed for observation. I had the stress test, and they gave me a mobile device. I stayed at the hospital for 2 days. Right now, I still have the monitor until until the 5/27.
a lot of chills after my booster shot from yesterday/on and off chills; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (a lot of chills after my booster shot from yesterday/on and off chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022 at 3:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2022, the patient experienced CHILLS (a lot of chills after my booster shot from yesterday/on and off chills). At the time of the report, CHILLS (a lot of chills after my booster shot from yesterday/on and off chills) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported  No treatment information was reported
Vial expire on 25-Mar-2022 and refrigerated on 05-Apr-2022; Dose was administered after 30-day use by date or after manufacturer date of expiry/Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date or after manufacturer date of expiry/Expired vaccine administered) and PRODUCT STORAGE ERROR (Vial expire on 25-Mar-2022 and refrigerated on 05-Apr-2022) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 076C21A, 027B21A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy and Allergy to antibiotic (Clyndamycin). Concomitant products included PREDNISONE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date or after manufacturer date of expiry/Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expire on 25-Mar-2022 and refrigerated on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered after 30-day use by date or after manufacturer date of expiry/Expired vaccine administered) and PRODUCT STORAGE ERROR (Vial expire on 25-Mar-2022 and refrigerated on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No other vaccine was taken by the patient within 1 month prior to Moderna.  Vial was initially stored in refrigerator on 05-Apr-2022. Vial did not undergo any temperature excursion.  No treatment medication was reported by reporter.  The patient was not experiencing any symptoms after receiving the vaccine or any acute or chronic illness after vaccination.  Patient had never had COVID positive test or diagnosis.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up was received and included no significant information
Moderate Facial Pain at R inner eye to R nose, following line across cheek; lessening toward R ear.
No additional adverse event reported; Expire dose of PEDVAXHIB was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old female patient with none concurrent conditions, none allergies and none illness at the time of vaccination.   On 05-NOV-2021, the patient was vaccinated with an expired dose (expired product administered) of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), intramuscularly, 0.5 milliliter, lot # R036178 expiration date 09-OCT-2021 for prophylaxis.    Concomitant therapies included measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) and pneumococcal vaccine conj 13v (crm197)(PREVNAR 13).     This error to administer expired vaccine occurred during storage in clinical practice, dispensing, preparation for administration and this was noticed after administration. The manufacturer was contacted, relayed in house data support potency but could not recommended re-administration dose. Also, this error was discussed with attending physician who advised re-administration not needed. Patient's mother was aware, and she did not want to pursue re-administration.  The nurse also reported, that no temperature excursions had occurred of the administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB). No additional adverse event and product quality complain were reported.
Red splotchy rash appeared at injection site about 10 min after injection. Given BENADRYL 50mg orally - pt also c/o headache & given acetaminophen 1000mg orally - w/in 5 more minutes observed red splotchy rash on chest and generalized itching. Pt. stated itching in throat. RR: 18, BP: 120/80; with no improvement after 20 min. Pt. escorted to ED adjacent to peds office. Tx'd with IV DECADRON, hydroxyzine and PREVACID. Sx resolved, released to home. Mild hives reported on 8/23, which resolved with oral BENADRYL.
Patient immunized in am, a few hours later, patient presented with rash all over body, mom called concerned patient has no problems breathing, gave mom phone number for shot line and instructed to give patient BENADRYL.
After I got the vaccine, I developed a slight headache. After going to bed that evening, I woke up shivering, was cold, and had serious abdominal pain.  I couldn't sleep because of fever (101) and the abdominal pain. The next day I had a migraine and the fatigue. Almost went to ER but decided to postpone, in hopes of getting better. Checked my blood glucose: it was 300 . It took me 2 days to normalize my blood sugar. After 3 days,  my left arm began to hurt at the injection area, and still hurts periodically.
Rash over face, trunk, back and legs, rash off & on for 3 days.
12/26/2020 developed rash on back of neck and behind ears. She took cetirizine twice that day.  12/31/2020 developed hives on abdomen, back and thighs. She started diphenhydramine 1/2/2020 and rash still seemed to be worse
pt recv vax 21JAN97 & pt called yesterday AM saying arm very sore, red & w/some swelling;pt advised to come in pt was given amoxil & DPH;pt told to apply heat to area;
Narrative: 73 year old male admitted on August 1 2022 with DKA and hypoxia. He had received Moderna vaccine x 2 on February 26 2021, March 26 2021. He was treated with remdesivir 200 mg x 1 then 100 mg IV daily x 2 days and dexamethasone 6 mg daily x 3 days.. He symptomatically improved and was discharged home on August 5 2022.
States she had immediate tingling in fingers when shot was given. Now has pain in the arm and unable to move it.