chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced an achy sore arm with decreased range of motion. Patient reported this 10 days post vaccination and states pain has not improved and is still achy. unable to verify exact time of onset with patient.
no evaluation , treatment or outcome done by health Center. pt reported shortness of breath and asthma exacerbation 2 weeks post vaccine   pt was evaluated by his own primary care provider office, please contact this provider for treatment and outcomes.
Body was sore to the touch, hurting all over, high fever. It was like flu like symptoms. These symptoms recurred after the 2nd dose. My lungs tighten and I continue to get sinus infections.
Child c/o itching at site to mother 3 days after Tdap given in right arm. Area was 2 to 3 inches in diameter. When seen by her Pediatrician the area was hard, erythematous and hot to touch. Diagnosis of cellulitis was made by child's physician. Child was started on antibiotic oral therapy of Amoxicillin and Bactrim on 4/15/ or 4/16. Area less swollen today according to school nurse & mom. Injection site becoming darker in color of skin.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Pt. received vaccine around 1930. She stated on 5/12/21 that she did not sit down for the full 15 minutes and left after approximately 5 to 10 minutes. She stated she began to have chest tightness and difficulty breathing. She was brought to an ambulatory care room by pharmacy technician and laid down. I observed her for approximately 10 minutes and took her blood pressure (124/83, pulse 90). She stated that she was able to breathe okay, but her chest was still tight. No known harm.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 12-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# N013863 and expiration date 31-OCT-2018) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
Patient received vaccine after beyond use date of  07/29/2022 (30 day freezer to fridge dating). Patient contacted and experienced chills, fever, sweating, nausea, and no appetite. Patient will contact PCP due to error.
Started having severe chills on saturday Jan 2, 2021 resolved with acetaminophen and rest. The next day it kept coming back and more symptoms became present.   Symptoms: chills, fever (100.7F), diarrhea, shortness of breath, cough, fatigue, muscle and body aches all over and loss of appetite. OTC meds have helped, but does not resolve. Still unable to get out of bed or function due to severity of cough and shortness of breath as of today Thursday Jan 7th, 2021. This has been going on for 6 days now.
Blood pressure went up. Right side of face was covered with blisters. Went to the ER dx with Shingles
This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 1st December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), weakness of arms, strength loss of and sensitive skin. The patient was treated with gabapentin, naproxen and corticosteroid nos (Corticosteroids Nos). On an unknown date, the outcome of the peripheral neuropathy, weakness of arms, strength loss of and sensitive skin were not recovered/not resolved. It was unknown if the reporter considered the peripheral neuropathy, weakness of arms, strength loss of and sensitive skin to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After vaccination, the patient experienced neuropathy, weakness, loss of strength, and sensitivity to touch in the anterior part of the left forearm. The patient was given a course of corticosteroids, naproxen and gabapentin to help alleviate the symptoms but with no relief at the time of reporting.
within 2 weeks of the vaccine- I started to get terrible pain in my right elbow.  I even had to call into work for this (which I never do).  I wasn't sure what was going on at first.  I have not been using my right arm any differently or more frequently.  I am right-hand dominant though and this was very painful and disruptive to my daily activities.   I have since been using a "tennis elbow strap" which only helps slightly.  The pain has lessened over the past 2 months but continues to be bothersome.  I have been speaking to my co-workers and I also work as a nurse - so I hear a lot of comments from the public.  There have been MULTIPLE instances of people complaining of elbow pain after taking the Covid vaccine.  On the chance this may not just be a coincidence - I decided to complete this form.    It's way too difficult to find any information other than serious adverse events online so I'm not sure if there is something to this or not. If you have any data on if this is a side effect or when I can expect this to go away/ subside... that would be great.  I understand you are just collecting data at this point but I thought this important to report.
pt recv vax 3NOV95 & 1hr following vax pt exp dizziness, shaking, nausea, vomiting;pt reported sx to the MD;
Fever or Chills  Fatigue  Muscle or body aches  Sore throat  Congestion or running nose  Nausea or vomiting
Fever body aches shakes chills muscle cramping and pain headache nausea, awoken from sleep with symptoms.
Patient talking to, LVN  prior to vaccine administration stated her daughter had Covid and it was rough on the family as she had been on the vent. After administering the vaccine client became non-responsive, clammy and pale immediately. Client moved to obervation via chair. Client asked what was wrong she stated she just didn't feel well. V/S taken B?P 120/78 P-78 R-28. Asked client if she had eaten anything she stated no , snack given with water. Client begins to shake upper and lower extremeties uncontrollably advised we need to lay you on floor she refused. V/S 139/98 P-84 R-28 she states she is hot, cold compress applied to back of neck and fan turned directly facing her. Her color begins to return and she is drinking water and eating snack. V/S 124/98 78 24 states she is beginning to feel better. she is no longer shaking extremeties and no longer clammy. V/S 124/98 74 24 states I feel so much better. Advised we will keep her a while longer to make sure she does not have any other reactions. V/ 124/98 74  24 no complaints voiced states her husband is sitting outside waiting on her. Advised her of postcare if she should have SOB, heart palpitations or rash over entire body she should contact EMS. V/S 120/9472 20 continues to observe and monitor no complaints voiced. V/S 110/78 72 20 advised to stand slowly states no dizziness advised to rest today and if she should have any distress or any of the reactions previously reviewed to go to emergency room. Escorted to car without complaints or problems
PATIENT PRESENTS WITH ALTERED MENTAL STATE, SOMNOLENCE, CONFUSION. DR. DIAGNOSED HER WITH ACUTE DISSEMINATED ENCEPHALOMYELITIS (ADEM) SECONDARY TO VACCINATION. FOR ANY QUESTIONS OR PATIENT'S HX PLEASE CONTACT DR.
9/6/07 Saw pt today, has had fine rash over cheeks, neck, arms, and legs x 1 wk. Had fever x 2 days. Prior to rash, back of head itches occ, but not rash. Rash is fading, except on face, cheeks are bright pink.
I was administering the dose and the syringe did not allow me to finish the dose. It was a retractable needle and it would not allow me to finish administering or retract. So the patient received a partial dose and then was given another full dose.
Redness and swelling on the left upper arm area that extended to the bend of her elbow and started the night of 9/4/21. Patient stated she was taking Aleve 1x in the morning and applying cold packs to the area though out the day.  Discussed with patient to take Aleve 2x a day and to apply cold pack for 10-15 minutes and then remove it for at least 30 minutes and repeat if needed. Patient stated she was feeling better when contacted on 9/7/21. Instructed patient to contact  Health Department if she was not feeling better by Friday 9/10/21.
Starting on the day of vaccination, patient's both arm on the vaccine sites  swelled and hot to touch. She felt dizziness and also had high fever and was not able to move both arms. She was at work so she asked her supervisor to allow her to check the blood sugar and it turned out to be decreased down to 50. She left work early and  skipped work until 8/19/2019. She is planning to go work starting 8/20/2019
have shingles at 8yo. He had been vaccinated / suspected vaccination failure; shingles; have shingles at 8yo. He had been vaccinated; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 8-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's parent.. The age at vaccination was not reported. The patient was tied for the youngest person to have shingles at 8 years old. He had been vaccinated and reporter never knew he actually had chickenpox, until he got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has bene linked with US2021AMR205252 repored by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205252:same reporter
This spontaneous report was received on 20-FEB-2017 from the medical assistant who reported an unspecified patient (age and gender not reported) was administered the first dose of GARDASIL 9 on 09-FEB-2015 for the indication of prophylaxis.  The patient was administered the second dose of GARDASIL 9 on 15-APR-2016 for the indication of prophylaxis and administered the third dose of GARDASIL 9 on 13-FEB-2017 for the indication of prophylaxis. The strength, dose, route of administration, Lot number, and expiration date were not reported for any of the three vaccinations. No adverse effects were reported. No further information was provided. Additional information has been requested.
I became achy, nausea with a headache about 8 hours after the injection. I did not vomit and the symptoms lasted about 36 hours.
08/12/09 Pt returned with reddened nodes all over the body. Seen at ER. Please. see accompanying ER records. Per Dad, Pt is getting better nodes are going away.
chills; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (muscle soreness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A20A and 031L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LISINOPRIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced CHILLS (chills) and MYALGIA (muscle soreness). At the time of the report, CHILLS (chills) and MYALGIA (muscle soreness) outcome was unknown.            No treatment medications were provided by the reporter.
Chills, body aches so bad I couldn?t move,  restring heart rate of 120-130, felt like my heart was going to beat out of my chest, nausea, headache. All these symptoms lasted 24 hours. I still feel a tightening in my chest once and a while and extremely fatigued.
On May 10th symptoms of diarrhea, abdominal pain, loss of appetite, shortness of breath, vomiting nearly every hour on the night of 18th prompted me to go to the ER next morning. I went to local Hospital ER on 05/19/2021. I had a variety of tests I could not recall all them but did have an echocardiogram. Ejection fraction was 15%, Liver and Kidney function were severely decreased. My heart was 240 SPT. I had to have my heart shocked to get my HR back to normal. You are seeing a cardiologist and follow-up middle of March.
Sleep for 3 days /neice found her and put her in the hosp; Got the shot and still got the shingles; Had to have dialysis possibly for the rest of her life; Suspected vaccination failure; This case was reported and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), sleep excessive (serious criteria hospitalization), shingles and dialysis nos. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the sleep excessive was recovered/resolved and the outcome of the dialysis nos was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, sleep excessive, shingles and dialysis nos to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient's sister. The age at vaccination was not reported. The patient got the shot and got shingles. The patient was given medicines which put her to sleep for 3 days. The patient's daughter found her and put her in the hospital and later was informed that the patient had to have dialysis possibly for the rest of her life. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and lab test confirmation was unknown at the time of reporting.
Pruritic, red, petechial rash over face, trunk and extremities - turning to purpura. Also causing ankle edema.
Patient broke out in hives and hands and feet swollen night after shot. Went to doctor said not to give 2nd H1N1 shot. Parent did not report rcn to school nurse right away. Reported to Health Dept. Attempted to reach parents phone # disconnected. 3/23/10 New # provided by patient school. Again unable to reach patient parents. Left message will try later. Parent returned call 3/22/10 1:15pm states child doing fine. Symptoms resolved in less than 48 hr. no c/o, parents to call if questions.
Sudden-onset, Severe stabbing chest pain, left side of chest only.  Pain/numbness in left arm and shoulder/back also.  Pain subsided about 3 hours later and shortness of breath and "bruising" sensation in left chest persisted 24 hrs.  I had the same incident exactly 5 weeks after having COVID also - same time period.  I am a very healthy person with a very clean diet and competitive athlete.
high fever, chills and sweats throughout the night; extreme fatigue and weakness the next day in addition to sore injection site
Patient stated that she has extreme diarrhea. Has been having body aches, lot taste, had a bad taste in mouth, fever, headaches, chills, lightheaded, skewed thinking, sweating, has to change clothes at least three times a night due to sweating. Patient couldn't move out of bed for at least a day and a half. Every time she eats, she has to go to the bathroom. She stated that she's unable to eat things that used to like.
Change of vision, blurry, double vision. BP readings 133/108 (pulse 99), 147/103; 96% O2 sat.
Breakthrough case admission after 4 vaccines Pfizer 1/27/21 Lot# EL9265;  Pfizer 2/17/21 Lot#EL9267;  Pfizer 11/23/21 Lot# 30155BA;  Pfizer 5/26/22 Lot# FK9894
PATIENT HAD PFIZER COVID VACCINE ON 01/13/2021 and 02/03/2021, AND TESTED POSITIVE TO COVID.
Sporadic episodes of vertigo. It started 3-4 days after vaccine. I went to ENT and they prescribed steroids for about a week or two. It is now 2 months after the shot and the vertigo has returned. I have been dizzy for the past 3 days. Am going to schedule another appt with ENT.
Consumer continues to have injection site pain from second Shingrix dose shot; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 31st December 2019) for prophylaxis.   On 4th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than 3 weeks after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had injection site pain.
Client reported rash on evening of 06-13-08 (received vaccines 06-13-08 afternoon) rash presented on right and left shoulder and back-Feels stingy and somewhat itchy per client. Rash remains present on 06-16-08. Client reported she did not apply any treatment. Advised client to go to see M.D. for evaluation.
Approx. 5 minutes after receiving vaccines became dizzy.  Passed out.  Mom states it looked like he was having a seizure.  C/o weakness & being tired.
Arm swelled next morning and arm was immobilized for 1 day.  Swelling just started to go down on 9th day.  Puncture mark not closed and site very itchy on and off since 1/16/21.  Going to Dr. on 1/25/21
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-NOV-2015 00:12, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. NO adverse effects were reported. The high temperature and low temperature were 10.8 (1 hour 31 mins) and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I95.9 HYPOTENSION 4/4/2023 LUNG CANCER, RIGHT UPPER LOBE
First dose was on 01 Feb 2021 and second dose was on 12 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 01 Feb 2021 and second dose was on 12 Mar 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A12A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (17 years ago was reported.) in 2004. Concurrent medical conditions included Hypertension. Concomitant products included WARFARIN for Anticoagulant therapy, LOSARTAN for Heart rate abnormal, METOPROLOL for Hypertension, ATORVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 01 Feb 2021 and second dose was on 12 Mar 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 01 Feb 2021 and second dose was on 12 Mar 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antibody test: 4.9 4.9.         No treatment medication was reported.  Initial titer was 4.9 in September which was exponentially lower than anyone the patient knew after having the first two doses.Patient did not got the antibody level he was expecting, was reported.Concerned about the efficacy, was reported.   This case was linked to MOD-2022-477578 (Patient Link).
Fever given Tylenol,  later had emesis then temp went up to 102. Eyes got wide open, legs, eyes and shoulder  was twitching. Call EMS transported to Hospital . Was observed at hospital temp at 99.5 discharged home.
Developed a headache the following morning. By two days after was experiencing extreme joint and muscle pain (especially in lower body).  Continued feeling foggy headed, had consistent headaches during the day, and pain leading to sleeplessness for four days.
This spontaneous report as received from an other health professional via a field representative refers to a male patient of unknown age. The patient's medical history was not reported. On 24-OCT-2013 the patient was vaccinated intramuscularly with a dose of GARDASIL (dose, frequency, lot number and expiration date were not reported). No concomitant medications were reported. It was reported that on 24-OCT-2013, the patient stood up after waiting 10 minutes after the administration of GARDASIL and then fainted. No other vaccines were administered other than GARDASIL. The outcome of the event was unknown. The patient sought medical attention during doctor's visit. The relatedness between the event and GARDASIL was not reported. Additional information is not expected.
This spontaneous report was received from a doctor of pharmacy concerning an approximately 73 year old female patient with no pertinent medical history and no drug reactions or allergies. On 03-JUN-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000494 and 14-APR-2014 respectively, dose unspecified), subcutaneously. No concomitant medications were reported. On 04-JUN-2013 (the day after vaccination), the patient experienced an injection site reaction. The injection site was swollen, red, sore and had blisters. The patient sought medical attention (called pharmacist). No treatment was given. The patient had not recovered from the events at the time of report. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
On 11/09/02 developed abdominal and leg cramps, sore throat and L arm pain. Noticed L arm redness, hot to touch. Had limited range of motion of L arm. Symptoms persisted. Began with nausea and vomiting on 11/11/02 and sought treatment at medical center. Hospitalized one day. 11/14/02, L arm remains reddened, warm to touch from mid-upper arm to elbows. Normal range of motion.