chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Fatigue; Headache; Muscle pain; Joint pain; Chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eye injury (from a bad car accident several years ago and had to have a prosthetic lens in one eye) and COVID-19 (two years ago) on 21-Jan-2020. Concurrent medical conditions included Asthma and Trigeminal neuralgia (patient takes Botox).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced NAUSEA (nausea). On an unknown date, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2020, SARS-CoV-2 test: negative (Negative) Negative. On 21-Jan-2020, SARS-CoV-2 test: positive (Positive) Positive. On 26-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative. On 31-Dec-2020, SARS-CoV-2 test: negative (Negative) Negative. In April 2022, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was reported that the COVID shot (also) messed with her vision. This morning she woke up and cannot taste anything nor she can smell anything.   Patient is taking Botox for her trigeminal nerve damage.   This case was linked to MOD-2022-547079, MOD-2022-547083, MOD-2022-547056 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2022: Follow up  document contain no new information.
contracted COVID-19 confirmed by test around 18JUN2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted COVID-19 confirmed by test around 18JUN2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jun-2022, the patient experienced COVID-19 (contracted COVID-19 confirmed by test around 18JUN2022). In June 2022, COVID-19 (contracted COVID-19 confirmed by test around 18JUN2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Negative) Negative. On 18-Jun-2022, SARS-CoV-2 test: (Positive) positive.         No concomitant medications were reported. Patient had symptoms included fever, sore throat, a scratchy cough, body aches, hip pain, and back pain and diagnosed with Covid-19. It was reported that patient feeling better around the 24th or 25th of June 2022. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning  a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious AESI events of COVID-19. The events occurred on 18-Jun-2022 after the third dose of mRNA-1273 Vaccine was given on unrecalled day of in November 2021. Patient had symptoms included fever, sore throat, a scratchy cough, body aches, hip pain, and back pain and diagnosed with Covid-19. Patient tested positive for SARS-CoV-2 test. No treatment medications were reported. The event were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Event terms, seriousness criteria and product information were captured as provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-600557 (Linked Report).; Sender's Comments: This is a spontaneous case concerning  a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious AESI events of COVID-19. The events occurred on 18-Jun-2022 after the third dose of mRNA-1273 Vaccine was given on unrecalled day of in November 2021. Patient had symptoms included fever, sore throat, a scratchy cough, body aches, hip pain, and back pain and diagnosed with Covid-19. Patient tested positive for SARS-CoV-2 test. No treatment medications were reported. The event were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Event terms, seriousness criteria and product information were captured as provided. US-MODERNATX, INC.-MOD-2022-600557:MOD22-017744
2 months after shot got shingles\Suspected vaccination failure; Got shingles; Rash is gone; Pain is there on the tip of the nerves; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and nerve pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the rash was recovered/resolved and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash and nerve pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and about 2 months later a got shingles that was in 2020 rash was gone now pain was still there and very painful, physician said might be painful up to 5 years. It was on the tip of the nerves. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
On 2/27/2023 you passed out. I felt pain across my shoulders and my back hurt and I passed. I woke up. I called my doctor the next morning and I went to the ER Hospital at Medical Center. The doctor scheduled me for some test and I will call back when I get the results.
Patient received the SHINGRIX vaccine on 5-1-18. Pt. then presented to Medical Center to be evaluated due to dizziness and elevated blood pressure. Pt's. dizziness continued along with hearing loss.
HAD VACCINE ABOUT 9 AM. AT 12:30 PM, WHILE DRIVING, ALMOST PASSED OUT. VERY RAPID HEART BEAT. WHEN I GOT CHECKED INTO EMERGENCY ROOM AT 1:30 PM, MY PULSE WAS 250 BEATS PER MINUTE. MY BLOOD PRESSURE HAD DROPPED TO 64 OVER 25. BY 9 PM THAT NIGHT, TWO CHEMICALS APPEARED IN MY BLOOD INDICATING HEART CELLS HAD DIED. I SPENT 5 DAYS IN CARDIAC INTENSIVE CARE AND HAD TO HAVE A PACE MAKERS / DEBFIBRILLATOR IMPLANTED. Discharge summary states atrial flutter. msv
6 hrs p/vax, mom called to report pt had vomited 3x; pt became pale, limp, ?unresponsive for 10-15 mins; EMS came & reported pt OK approx 30 mins later;
1st dose of vaccine administered on 03/25/21 at 1:30 pm.  Side effects:  03/25/21-03/28/21 ? pain on the site of injection; nausea.  03/26/21-04/04/21 ? increased tone of facial muscles; tiredness.  04/05/21-04/07/21 ? stomach pain; slight increase in body temperature up to 37.2 C; nausea; vomiting; muscle and joint pain in the belt region.  04/08/21-04/12/21 ? increased maximum body temperatures up to 37.8 C; temperature declined overnight to 36.7-37.2 in the morning and then rising again; change of voice; all other side effects are gone.  04/13/21-04/14/21 ? maximum body temperature decreased to 37.4 C; change of voice.  04/15/21-04/20/21 ? maximum body temperature decreased to 37.2 C; change of voice.  04/20/21 blood test results - inflammation: Erythrocyte Sedimentation Rate (ESR) 56 mm/hr SARS-CoV-2 Antibodies, Spike Protein 15.10 U/mL C-Reactive Protein (CRP) 1.06 mg/dL  04/21/21-05/08/21 ? maximum body temperature decreased to 36.7-37.0 C; change of voice persists; chest pain.  Multiple rectal bleedings: 04/30/21, 05/01/21, 05/11/21, 05/12/21, 05/15/21, 05/16/21, 05/21/21, 05/22/21, 06/03/21, 06/04/21(small).  Temperature is in the normal range since 05/09/21.  06/01/21 blood test results ? inflammation gone: Erythrocyte Sedimentation Rate (ESR) 10 mm/hr SARS-CoV-2 Antibodies, Spike Protein 10.10 U/mL C-Reactive Protein (CRP) 0.44 mg/dL  Looking for suggestion to do or not to do second vaccine administration.
Systemic: Weakness-Severe, Additional Details: Patient reports neurological induced paralysis from date of injection until and through current date.  Has consulted with dr who thinks vaccine is likely cause to to current medical history.  Reports inability to walk and "needing to be carried".
Swelling in both arms; Numbness and tingling in arms and fingers; Unable to grasp things and dropping things for a period of time; Pins and needles sensation in feet/ numbness and tingling in arms and fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 08:30 (Lot number: FF8841) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hemachromatosis" (unspecified if ongoing); "known allergies: corn and corn products" (unspecified if ongoing); "known allergies: tomatoes, coconut" (unspecified if ongoing); "known allergies: pork" (unspecified if ongoing); "Known allergies: Sulpha" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, product: COVID 19, Brand: Pfizer, Lot number: EW0150, Administration time: 08:30 AM, Vaccine location: Left arm, Following first dose, swelling and numbness in right arm subsided within 12 hours.), administration date: 13Oct2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Swelling and numbness in right arm", "Swelling and numbness in right arm". The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 05Nov2021, outcome "recovering", described as "Swelling in both arms"; HYPOAESTHESIA (non-serious) with onset 05Nov2021, outcome "recovering", described as "Numbness and tingling in arms and fingers"; MOTOR DYSFUNCTION (non-serious) with onset 05Nov2021, outcome "recovering", described as "Unable to grasp things and dropping things for a period of time"; PARAESTHESIA (non-serious) with onset 05Nov2021, outcome "recovering", described as "Pins and needles sensation in feet/ numbness and tingling in arms and fingers".  Additional information: Other medications in two weeks include Multivitamin. No Covid prior vaccination. No Covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Patient received monovalent booster shot when they were  scheduled to receive Bivalent booster. Patient has no adverse reactions to vaccine.
A non-serious spontaneous report of administration to 19 month old was received from a registered nurse/healthcare professional concerning a 19-month-old female. The patient had no relevant medical history. The patient was not any concomitant medication. On 02-Dec-2009, the patient was administered a dose of H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved. Additional information was received on 17-Dec-2009 and incorporated into the narrative: Reporter's name and address and responsible physician address was changed. Additional information was received on 28-Dec-2009 and incorporated into the narrative: Patient's date of birth, gender, information on child's condition, medical history and concomitant medication.
This spontaneous report was received from a pharmacist refers to a 89 year old female patient of unknown age. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. None drug reactions/allergies. The past drug included PREVNAR 13. On 11-OCT-2016, the patient was vaccinated with PNEUMOVAX 23, injection (lot number/expiry date and dose not reported) intramuscularly in the left arm (as follow-up to PREVNAR 13). Approximately on unknown date in October-2016, the patient developed pain and redness in her left arm, which spread up to her shoulder "within hours" of being vaccinated. None lab diagnostics studies performed. The patient received an unspecified treatment. No Product Quality Complaint (PQC) was involved. The outcome of the events was recovering. The reporter did not provide any causality assessment between events and PNEUMOVAX 23. Additional information has been requested.
Mild headache, very sore arm, exhaustion - headache was day of injection, soreness of arm began day of and lasted one full day, exhaustion was day after injection
Very sore left arm, pain went away 2 days late  currently pregnant, 18 weeks, due 9/3/2021
10 minutes after vaccination felt lightheaded and dizzy,  pulse 64 resp 18 - given water and put feet up.   15 minutes later better but still woozy - pulse 80 resp 20. 15 minutes later walked around pulse 72 resp 18   20 minutes later - still feeling dizzy wishes to go to ER - transported via wheelchair.
Received flu vaccine from pharmacy pharmacist. Injection given wrong site, (R) mid upper arm.  Local reaction of erythema 7.5 cm x 8.5 cm - irregular shape, increased warm at site and painful.
Patient received 0.5mL primary series dose, instead of 0.25mL booster dose. Patient was notified of this; patient denied any complications as of a couple hours after receiving vaccine.
Initial information received on 03-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 24 years old male patient who received 1 ml dose of an expired vaccine IMOVAX RABIES (lot number: M1565, expiry date: 23-Oct-2018, dose in series and route not reported) in right deltoid on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. This was a case of actual medication error due to expired vaccine used and overdose because the patient was received 1 ml expired dose of IMOVAX. It was not reported if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Shortly after vaccine vasovagal response. Night of vaccine developed severe back pain. Woke up in the middle of the night with severe leg pain , severe head pain,and severe back pain. Sunday felt nausea, dizzy, lightheaded, severe body aches. All of the above mentioned symptoms lasted til Monday night.  Had to call out of work on Monday due to all above symptoms. Tuesday the severe pain and resolved although did not feel like myself.  I also experienced changes in my menstrual cycle which took a while to return back to normal. Also fatigue, unable to tolerate being out of bed for long periods of time.
Immediately following the shot my son complained of feeling weak, dizzy and woozy.  That evening he spent most of it lying down.  I gave him 300mg of motrin.  Two to three days following the vaccination I noticed a red rash about an inch in diameter at the injection site.  I then noticed a bumpy but colorless rash on both arms and across his chest.  That was the only place he had a rash. The rash was also slightly itchy.
Pt. received initial hep vac on 5/26/04 without any adverse effects. Afterwards,contracted 5th Disease and had to postpone 2nd vaccination until 7/14/04. Felt able to take the 2nd vaccination then. Given in R arm. One to two hours later felt pain going down R arm, then up arm, then into R chest. Was sent by supervisor to ER and was seen. ER does not know what caused the event but have requested that our institution titer pt now and see if 3rd shot can be avoided.
No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from other health care professional, regarding to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 13-JAN-2023, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number W008711 which has been verified to be valid, expiration date reported and validated as 14-MAR-2024) (strength, dose, vaccination scheme frequency, route of administration, and anatomical sites of injection were not reported) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  and diphtheria vaccine toxoid (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (QUADRACEL) (strengths, doses, vaccination scheme frequencies, routes of administration, anatomical sites of injection, lot numbers, and expiration dates were not reported). All of the vaccines were administered as prophylaxis.   Administered doses were stored at a temperature of -10.5 degrees Celsius (C) during a time frame of 1 hour and 34 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.  This is one of several reports received from the same reporter.
Client called and stated that she had to go see her PCP for an adverse reaction to the first dose Moderna and that she would not be taking the second dose. Aside from the expected side effects (redness at site, sore arm, and headache), she did have an adverse reaction. She stated that her entire upper arm was swollen along with the left arm lymph nodes. Her PCP gave her a steroid dose pack and instructed that she take OTC benadryl and excerdrin.
Five days after the second dose of the Pfizer vaccine I developed a extremely itchy rash on my torso and random blotches of exema on my arms and legs.  Saw a dermatologists and was treated with topical steroid.  It took two months to resolve completely.
Right upper arm, hot, ache, hard, swollen, within 2 hrs, next day upper and under side into arm pit all of the above symptoms. Painful to move arm, slight swelling, inside, down below elbow. Antihistamine and extra strength Tylenol.
This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date between 2007-2008 the patient was vaccinated with ZOSTAVAX (lot # not reported) dose and route not reported. No concomitant medications were reported. The reporter stated that the patient came down with Bell's Palsy sometime on an unknown date in 2007-2012. Patient stated on the advice line that she thought Bell's Palsy was caused by same organism that caused shingles and she thought she should've been protected from Bell's Palsy as well as from receiving ZOSTAVAX. The outcome of the event was unknown at the time of this report. It was unspecified if patient sought medical attention for the event. Additional information is not expected.
Side effects began at 11:30 at night on 12/27/2020. Began with slight chills. The chills began to get worse. My body was physically shaking. My thighs began to burn. My whole body ached. I had a headache. I had nausea. I could not get out of bed because my body hurt so bad. I had severe chills till 12/28/2020 6:00 am when I began to sweat the fever out. My temp that night was 102 and went down to 100.2 in the am. Then 98.2 by 10:00 am. My whole body ached until 12/29/2020.
08Jan98 Pt recv 1st dose vax. 5 days post vax, inject site inspection was neg. 21Jan98 Pt exp itchiness, redness & tenderness at inject site. No vesicles 29Jan98 Pt recovered.
PATIENT COMPLAINED OF EXCRUCIATING PAIN IN ARM/SHOULDER OF PNEUMOVAX INJECTION WHICH BEGAN 2 HOURS AFTER INECTION, PATIENT ACTUALLY SAYS SHE PASSED OUT AND FELL FROM THE PAIN. HAD DIFFICULTY SLEEPING OR GETTING COMFORTABLE. WENT TO EMERGENCY ROOM TWICE, ONCE THE DAY OF, AND ONCE ON 8/15/19. 1ST VISIT THEY GAVE HER NORCO, WHICH SHE DIDNT TOLERATE WELL, 2ND VISIT GAVE MEDROL DOSEPAK, WHICH SHE SAID HELPED, BAD PAIN HAD LASTED 5-6 DAYS, HAS RESOLVED WITH TIME AND MEDROL, BUT SHE IS STILL FEELING THE EFFECTS OF THE SHOT IN THAT ARM.
feel so bad for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had first case when patient was pregnant with second child).   In July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had her first case of shingles when she was pregnant with her second child. She got her first shingles shot a week ago and it made her feel so bad for a few days.  She will get the next one but she dread it. Follow up was not possible as no contact details were available.
After vaccine I felt fine waited fo r15 min monitoring. Then I started getting dizzy, felt cold go up spine up to my arm and my arms went numb (bilateral). One of the monitor personnel stated I look really pale gave me coffee and took me to ER. My blood pressure was elevated slightly and arms was still numb started IV fluids, Benadryl stayed there for observation. Upon me being discharged arms wasn't numb for about 5 days and  I was prescribed Prednisone. When i woke up on 1/23 face felt puffy took Benadryl
Had DPT & PRP-T in left thigh 01/23.  01/24 mother states thigh is swollen, warm and red about size of grapefruit.  Will treat with cold compresses and Tylenol for discomfort.  If unimproved or fever pt will come to clinic tomorrow.