chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in arm; pain in arm ever since; sensitive to touch; Arm hurts to move; "causes discomfort"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm ever since), SENSITIVE SKIN (sensitive to touch), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm hurts to move), VACCINATION SITE DISCOMFORT ("causes discomfort") and PAIN IN EXTREMITY (pain in arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm ever since), SENSITIVE SKIN (sensitive to touch), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm hurts to move) and VACCINATION SITE DISCOMFORT ("causes discomfort"). On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). At the time of the report, PAIN IN EXTREMITY (pain in arm ever since), SENSITIVE SKIN (sensitive to touch), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm hurts to move), VACCINATION SITE DISCOMFORT ("causes discomfort") and PAIN IN EXTREMITY (pain in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.
COVID positive on 11/11/2021. Admission dx: Weakness and Ankylosing spondylitis. 72-year-old male who comes into the hospital with increasing weakness over the last several days. The patient unable to get out of his chair so his wife called EMS. The patient had received a new infusion for his medical condition of ankylosing spondylitis. None of his other medications haven't changed. Patient evaluated in the emergency department. The patient's studies were essentially unremarkable. He was checked to make sure his shunt was functioning correctly. Patient placed in the hospital since he was unable to ambulate. Patient was seen the following day he did have a low potassium which was replaced. His appetite was good. The patient was seen by physical therapy. Physical therapy recommended rehabilitation. Patient was evaluated by physical medicine rehabilitation. It was felt the patient would be a good candidate for inpatient rehabilitation. A COVID test was done for transfer to rehabilitation and came back positive. Patient only symptom is a slight cough and no shortness of breath. Transferred to Rehab.
This spontaneous report as received from a nurse practitioner refers to a 13 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 07-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
I received my flu shot at work through a contracted company. At the time of administration, the technician/nurse was behind schedule and I felt very rushed. When I couldn't immediately remove my arm from my long sleeve shirt, he suggested I pull my collar over my shoulder and he administered the shot from above me. I clearly remember him mentioning that he would go above a tattoo on my upper shoulder, leaving the placement very high on my shoulder. I began experiencing significant and persistent pain in my left shoulder in the following weeks. This progressed and included weakness and limited range of motion. I first took a round of oral steroids 1-2 months following the injection, which only gave me temporary relief. I also attended physical therapy for several months. In June of 2018, I was still struggling with pain/discomfort in the same location. At that time I received an MRI and a steroid injection. I currently am still experiencing pain daily.
about 12 hrs p/vax pt spiked temp to 106 R & was shakey & lethargic; given APAP & tepid bath; recovered quickly & was fine when mom called the next morning;
pt recvd vax 26AUG93 & exp intense itching around eyes; On 30AUg had severe h/a w/ n/v; next AM noticed a dark red rash around both eyes;
woke the next day with what appeared to be hives on lips and chin, spread to neck under chin and left arm.  very uncomfortable and itchy.. taking benedryl for itch and calamine lotion to relieve itching.
Got vaccine on Tues - Friday roof of mouth felt weird. Sat had white spot on roof - Sunday same. Looked on internet and took lemon juice and yogurt. Monday all better. No evidence of problem.
Patient is 12yo but received the pediatric Pfizer dose for 5-11yo.
headache; This case was reported by a consumer via media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. After receiving the Shingrix the patient experienced headache. The patient asked Advil ok for treatment.
Patient was taken to ER 10/27/21 due to increased drooling, ataxia.  He was admitted for cerebellar ataxia on 10/27/21 and discharged 10/30/21. He had a follow up with PCP (our office) 11/05/21 and patient had returned to baseline at that time.
Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat.  Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes.  At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest.  Is still able to drink water.  Blood pressure 140/90 HR 120 Oxygen 100.  Called 911.  Patient had many questions about receiving Epi Pen.  Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh.  BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.
Extreme soreness in the upper arm that didn't go away after the first few days after the vaccine.  Pain has continued in the upper arm and there has been a loss of motion in the shoulder.  Will also be following up with my Dr. to ensure this isn't a side effect or issue in how the vaccine was administered.
Thighs became red and slight edematous around injection sites. Also facial cheeks became bright red for about 20 minutes. No respiratory distress. Patient alert. Exam by Dr. Monitored. When patient left with mother, cheeks no longer red, thighs less reddened.
SHORTNESS OF BREATH, PAPLITATIONS, PREMATURE VENTRICULAR CONTRACTIONS
Patient experienced rapid heart rate, increased respiratory rate and dizziness. The patient was given oral water to treat shock, and was monitored for worsening condition or anaphylaxis. After 5 minutes the patient had completely recovered and was observed for another 15 minutes.
Within 5 to 10 minutes of giving her the vaccine, patient complained of extreme nausea and she was also sweating more than normal.  She was able to communicate the entire time and I had an associate monitor her and be with her the entire time. She had a few sips of water and felt better. After about 20 minutes she felt better.  The associate was with her for 30 minutes and she felt better and continued to shop on and stopped by before she left the premises.
Pt. c/o total(LLE) weakess; LUE weakness on 2nd day post vaccine when she got out of bed. c/o decreased ROM/Strenth/myalgia. Had LLE dragging when walking, gait disturbance walking from side to side.
This spontaneous report as received from a pharmacist refers to a patient (id# 839) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 15-AUG-2012. Lot# was reported as 0217AE, expiration date: 22-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. Additional information has been requested.
2 days after getting 2nd dose of vaccine I became dizzy and queasy and my breathing changed. I spoke with pulmonologist on 3/1/21 and he advised me to start a 5 day regimen of 40 mg. prednisone. I am on day 3 and breathing has been better, not back to normal.
administered / shingrix on 6/21/2021 / was left outside at room temperature for a week; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number NR55Z, expiry date 22nd October 2022) for prophylaxis.   On 21st June 2021, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The reporter stated that, patient was administered a first dose of shingrix that was left outside at room temperature for a week, which led to incorrect storage of drug. The reporter consented to follow up. The batch number of Shingrix was updated from NR55V to NR55Z as per sales data sheet.
Patient states she had intense joint pain throughout her body 12 hours after the vaccine was administered. She also complained of malaise, light headedness, and feeling dizzy.
patinet  has red warm area at injectio site. reports tenderness. began the day following administration. Administration date is 09/27/2023
That evening after the injection I hot very sick...flu like symptoms w/ temperature of 102 - 104 degrees. Symptoms started to fade after a few days. About a day or two after the injection I experienced extreme fatigue, Severe Sinus infection along with Tinnitus. Worst I have ever experienced. I have been put on anibiotics starting the evening of 06/01/2021 and am scheduled to see an E.N.T. doctor at the end of June 2021.
Information has been received from a physician via a field representative referring to her/his 13 year old male son. Information about medical history, concurrent condition and concomitant medication was not reported. On an unspecified date in 2003 (reported as "about 12 years ago") the patient was vaccinated with VARIVAX (Merck) (subcutaneous injection; strength, dosage and frequency unspecified). The patient was immunized with the appropriate doses as indicated on the prescribing information. On an unspecified date in 2015 (reported as "within the past two weeks") the patient had developed chicken pox. The patient sought medical attention as he was the physician's son. The outcome of the event was reported as recovered/resolved on an unspecified date in 2015. Therapy with VARIVAX (Merck) was also reported as continued. Additional information has been requested.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 years old female patient who experienced redness of left forearm injection site, irritation of left forearm injection site while she received vaccine IPOL instead of TUBERSOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (VERO) lot N1A461M; expiry date: 09-Feb-2019. On an unknown date, the patient developed a non-serious redness of left forearm injection site following the administration of IPV (VERO). On an unknown date, the patient developed a non-serious irritation of left forearm injection site following the administration of IPV (VERO). Final diagnosis was irritation of left forearm injection site and redness of left forearm injection site. It was also a case of actual medication error due to wrong vaccine administered. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for redness of left forearm injection site, as Not Recovered / Not Resolved on an unknown date for irritation of left forearm injection site. 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. List of documents held by sender: none.
Temp 101 degrees 5 hours after shot > temp x 30 hours. (L) arm swollen 2-3 hours after shot/pain/aches/nausea/HA x 40 hours. Aches, nausea/pain. 10/23/15 temp today 99.2 only s/s nausea, pain (L) arm.
Onset of Shingles rash after having received the Shingles vaccine in Jan 2006. Treatment: Valtrex 500mg, #2 tid for 7 days
started out with a 3x2 red spot with a hard center on 16 may, 17 may expanded into a 5x4 red spot with a hard center. no treatment at this time/
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown ages. On unknown dates in 2013, the patients might have received unspecified doses of VARIVAX (Merck) (lot # 670184/0412AA, expiration date 16-MAR-2013) (strength and total daily dose not reported). No adverse effects were reported. It was unspecified whether the patients sought for medical attention. The outcome was unknown. Additional information has been requested.
1) Extremely sore arm after injection which is still moderately sore on day 3. 2) Fever, fatigue, headache evening of shot continuing through entire  day 2. Treated with Tylenol. Feel fine today, day 3.
31-year-old female presents with left shoulder pain getting her flu shot October 10 of this year.  Patient states she had immediate left shoulder pain with the injection. She tried to let this resolve naturally with rest and gentle range of motion however it has not improved.  Patient states that she has significant pain with raising her arm overhead, taking off her shirt, brushing or fixing her hair, and especially with throwing a ball. The pain is described as sharp and located deep to her AC joint and slightly posterior.
I DON'T KNOW THE EXACT EVENTS FOR THE CASE, BUT WAS ASKED TO FILL IN THE INFORMATION THE BEST I COULD WITH THE INFORMATION I HAD ON HAND. THIS YOUNG LADY, RECEIVED A COVID-19 VACCINE ON 3/6/2021 AND EXPIRED ON MARCH 13, 2021. THIS IS MOST OF THE INFORMATION THAT I HAVE. YOU WOULD NEED TO CONTACT THE MEDICAL EXAMINER'S OFFICE, THAT WILL BE ABEL TO PROVIDE YOU WITH MOST DETAIL FOR THIS CASE.
Rash, red, trunk and neck Prednisone Rx Developed rash four days ago (itchy) No hx of new product/food etc..
turned into a skeleton, all pants got loose; became very week/feeble; acute shortness of breath; Cannot perform daily activities smoothly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (became very week/feeble), DYSPNOEA (acute shortness of breath) and WEIGHT DECREASED (turned into a skeleton, all pants got loose) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (became very week/feeble) (seriousness criterion hospitalization), DYSPNOEA (acute shortness of breath) (seriousness criterion hospitalization), WEIGHT DECREASED (turned into a skeleton, all pants got loose) (seriousness criterion hospitalization) and PERFORMANCE STATUS DECREASED (Cannot perform daily activities smoothly). The patient was hospitalized from 13-Apr-2021 to 17-Apr-2021 due to ASTHENIA and DYSPNOEA. At the time of the report, ASTHENIA (became very week/feeble), DYSPNOEA (acute shortness of breath), WEIGHT DECREASED (turned into a skeleton, all pants got loose) and PERFORMANCE STATUS DECREASED (Cannot perform daily activities smoothly) had not resolved.            No concomitant medications were provided by the reporter.   Patient condition got worst by 12 Apr 2021. Patient discharged from the hospital with no improvement in health condition. Patient was suffering badly and could not perform daily activities smoothly. Treatment medications were not reported.  Very limited information regarding this events has been provided at this time. However, this patient's advanced age remains a confounder. Further information can't be  requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, this patient's advanced age remains a confounder. Further information can't be  requested.
Information has been received from a nurse referring to a patient of unknown gender and aged around 6 to 12 years old. The patient's relevant medical history and past drug history were unknown. On 28-JUL-2105 the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAS (lot # K026386, expiration date: 15-DEC-2016, dose, route, frequency and dose number unknown). This vial of (Oka/Merck) VARIVAX underwent temperature excursions as follows: On 07-JUL-2015, 8.9 degrees Celsius for 1 hour and 28 minutes; on 28-JUL-2015, 0.4 degrees Celsius for 1 hour and 25 minutes. Concomitant medications were unknown. The nurse reported the patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. As of 05-AUG-2015, it was unknown if the patient continued on (Oka/Merck) VARIVAX and the patient had not experienced any adverse events. This is one of several reports that received from the same reporter. Additional information has been requested.
Malaise, body/joint aches, lymphadenopathy of the left axilla and bilateral cervical lymph nodes (level 1 a/b), mild headache. Onset one day after injection. All symptoms resolved by the next day, with exception of the axillary lymphadenopathy.
Pt received flu shot at her work were I did a clinic in sept 2018. Pt called me on 01/23/19 states her arm has been hurting her since I gave her the flu vaccine also states saw her md and received a cortisone shot and has been going to therapy. She still states her arm is still hurting.
Patient collapsed within 15 minutes of receiving the vaccine. Emergency services was called and emergency services came.
felt a little dizzy / If she moves too quick she is light headed; Her equilibrium is off; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9263, first dose) solution for injection intramuscular in the right arm on 26Jan2021 (at the age of 77-years-old) as a single dose for COVID-19 vaccination. There was no medical history. Concomitant medication included lisinopril for blood pressure. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient felt a little dizzy if she bends down / if she moves too quick she is lightheaded and her equilibrium was off on 27Jan2021. There was no emergency room or physician office. The outcome of the events dizziness and equilibrium loss was not recovered.
Case number PHEH2012US006804, is an initial spontaneous report received from a nurse on 06 Mar 2012. This report refers to a patient of unknown age and gender. No medical history and concomitant medications were provided. The patient received only MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: 10005 and expiry date 31 Aug 2011) intramuscularly on an unspecified date. The nurse reported that she did not know which patient received a partial dose of MENVEO or date of vaccine administration. However, she was sure that vaccine was administered sometime prior to the expiration date provided as 31 Aug 2011. No adverse reaction was reported following this administration error.
We did not discard the extra volume in the vial during our initial clinics.  I came to realize this was not authorized under the EUA after the fact and ceased the practice after the first four clinics on 3/10, 3/11, 3/12 and 3/13/21. When we reported the extra doses, we were advised by DHE to cease pooling doses and report to VAERS, citing EUA guidelines. We gave 25 extras doses on 3/11/21 but no adverse reactions have been reported related to this issue.
Flu shot given on 10/25/07.  On 10/29/07 developed shingles.  Treated with antiviral, made full recovery.  I don't think the flu shot "caused" the shingles, but may have resulted in a weakened immune system that would allow shingles to develop.
pain after injection continued to get worse, patient reached out to the pharmacy after 6 hours and pain was extending all the way down the arm and it was recommended to seek medical care.
Severe armpit pain, feel life a baseball sized mass developed under arm (same side as injection), really painful to touch and to lift arm
Vaccine error - vaccine was administered past its beyond use date. The vaccine had been stored in the freezer beyond the time frame recommended by the manufacturer.
Information has been received from a healthcare worker concerning an 8 year old male with no pertinent medical history or allergies who in 1996 was vaccinated with a dose of hepatitis B virus vaccine live. There was no concomitant medication. In 1998 or four years ago (in 2001) the patient was diagnosed with autism. Unspecified medical attention was sought. It was reported that the patient had not recovered. No product quality complaint was involved. Upon internal review, autism was determined to be an other important medical event (OMIC). No further information is available.
Pt complained of a rash on the body. Treated with Soap - oillum creams and medication. Pt was out of work for one week.
On April 8, 2021, a violent case of diarrhea, followed for the next 110 days by others (including today), almost daily, of very soft  bowel movements, large amounts, sometimes entirely liquid coming on very suddenly.  A colonoscopy June 18, 2021,  with biopsies identified the culprit as lymphocytic colitis.  Treatment so far is a careful diet, smaller meals, a Pepto Bismol capsule once daily in the morning with breakfast.  Follow up appointment with Consultants in Gastroenterology on August 6, 2021, to determine if there is any other help to reduce inflammation.