chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; temperature excursion; This spontaneous report was received from a certified medical assistant and refers to 15-year-old male patient. There was no information about the patient's concurrent conditions, concomitant medications or medical history provided.  On 07-FEB-2022, the patient was vaccinated with the second dose (previous dose reported as 1) of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T030746, expiration date 16-MAR-2023, intramuscular, right deltoid  (dose and route of administration were not reported) for prophylaxis, which were involved in a temperature excursion of 0.39 degrees Celsius for 80 hours and 11.2 degrees Celsius for 80 hours (product storage error). This temperature excursion was from 17-JAN-2022 to 31-MAR-2022. The medication error occurred in the process of storage in clinical practice. The operator of vaccine/vaccine-device was healthcare professional who was trained. The vaccine/vaccine-device was used according to the instruction leaflet. The patient wanted to repeat dose in August 2022. There was no additional adverse event or product quality complaint reported. No information about previous excursions reported.  This is one of cases from same reporter. ; Sender's Comments:  US-009507513-2207USA000782: US-009507513-2207USA000783: US-009507513-2207USA000784: US-009507513-2204USA005218:
Upper respiratory symptoms developed about 18 hours after vaccine dose, including sneezing, runny nose, itchy face and eyes, as well as itching at injection site..  Fatigue onset at that time as well.   Treated with Benadryl, neti pot, Flonase, warm compress and rest.  Symptoms alleviated after 2 days.   Injection site is still slightly red and irritated 8 days after vaccine.
PT HAD COVID 11/02/2020; FULLY VACCINATED AFTER COVID INFECTION; PATIENT EXPIRED ON 03/23/2021; COVID RELATED DEATH REPORTED ON THE DEATH CERTIFICATE.
This spontaneous report received from a medical assistant referred to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients received VAQTA (Lot number: M002268, Expiry date: 20-SEP-2017) (dose, frequency were not reported) which was improperly stored. No adverse effects reported. Causality assessment was not reported for the events. This is one of the several reports received from the same reporter. Additional information has been requested.
I woke up with a sore throat that lasted a few days then moderate to severe cold symptoms no fever mild headache congestion and cough with no difficulty breathing the symptoms moderated over the next three weeks with some raspiness and  fatigue throughout this course.
21NOV95 unconsolable crying >5hrs;very irritable;APAP;22NOV95 AM unconsolable didn't want to be touched;afternoon elevated temp 106 a;taken to ER;23NOV95 pt seemed congested yet better, activity nl
Above employee received her second dose of the Pfizer today. During the follow up assessment she was asked if she had any reactions from the 1st vaccination she claims that she reported to her manager that time that she can't move the right side of face and right eye twitching. She also verbalized that the eye twitching was intermittent for 4-5 days. Never consulted a doctor or ER visit.  After vaccine administration she was required to sit for observation for 30 minutes. No reported reactions. Was advised to call the vaccine clinic or RN will call her for follow up. At 14:15 pm RN called above employee while still at work. She claims that the twitching started again on the right eye accompanied by slight throat tightness. Denies any c/o SOB, difficulty of swallowing. Instructed to go to ER but she verbalized she will go home and then go to urgent care if needed but still refused to go to the hospital ER.
Fever, Rubor, Dolor, Tumor 9x10c (L) U extremity.
Mother called on 04/21/2017 at 5:00PM to report that pt had a 3 inch area of redness and 2 inch area of swelling on L arm "at the site of the GARDASIL vaccine." He also had soreness and warmth at the site.  At the time of the call mother had already administered ibuprofen and pt had been applying an ice pack.  She was preparing to administered Benadryl but was calling to specifically ask if there was any other recommendation.  Mother was advised to mark the border of the redness with a pen, and if redness exceeded this marked area to take pt to urgent care that evening.  Pt came in 4/24/17 for an appt to rule out a "sinus infection."  The site was visualized at 3:30PM 04/24/2017 by RN.  There was still approximately 1.5 inches of swelling but redness and warmth had resolved.  Pt denied pain or itching at the site.  Mother reported 04/24/17 @ 3:30PM that pt had a similar reaction in the past to a vaccine but she can't recall which vaccine and when it occurred.
Client had chicken pox immunization on 7/11/01. Recently broke out with chicken pox at home, moderate to severe case.
Hives developed two hours after. Still getting hives 4 days later  Flu shit unknown which kind. Second shot. Did fine with first shot
After the second vaccine in May 2021 I developed very acute pain in my feet. I had horrible burning and pain,  The pain and burning was progressing and in November 2021 stared a series of steroid injections in my feet for pain. They didn?t help. I was diagnosed with nerve inflammation : bilateral neuromas. I started a series of alcohol injection ( ablation of the neuromas). They brought me a relief. January 2022 I got more pain and tingling in feet that spread out to ankles and hands and arms. January 2023- diagnosed with short fiber neuropathy.
The dose has been at room temperature over 24 hours and >12 hours post punctured and administered.; The dose has been at room temperature over 24 hours and greater than 12 hours post punctured and administered.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose has been at room temperature over 24 hours and greater than 12 hours post punctured and administered.) and PRODUCT STORAGE ERROR (The dose has been at room temperature over 24 hours and >12 hours post punctured and administered.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose has been at room temperature over 24 hours and greater than 12 hours post punctured and administered.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The dose has been at room temperature over 24 hours and >12 hours post punctured and administered.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose has been at room temperature over 24 hours and greater than 12 hours post punctured and administered.) and PRODUCT STORAGE ERROR (The dose has been at room temperature over 24 hours and >12 hours post punctured and administered.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter. HPC reported that the dose was at room temperature since Friday 18-Feb-2022.   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2022: Follow up contains No new information added.
2 missed periods so far. Negative for pregnancy. I take the pill so I am usually regular but I have not had a period since  taking the vaccine.
MODERNA COVID-19 vaccine  Sore arm Tiredness  Headache  Chills Fever 100.3 with Tylenol
1020 am Complaint of dizziness, increased heart rate and anxiety with sweaty palms. Patient stated that she did not take blood pressure medication this morning. BP 165/100, T 97.7, P 113, O2 98%. 1050 am T 97.9, P 67, O2 96%, BP 160/90. Patient states symptoms have subsided. Patient educated on taking blood pressure medication as directed by primary provider. Patient discharged from clinic.
03/16/15 Heart racing and anxiety starting about a week prior. Around 05/23/15 noticed warts on stomach; OBG and dermatologist diagnosed as (flat) warts (on 06/05/15). I have been treating them since then, yet they have persisted. They have spread to chest, neck, chin, arms, back, and genital area.
Youth has approx. 2 inch red area to (R) upper arm, c/o pain. Slight swelling to area. Recommended Ibuprofen, ice pack to site.
m ankles swollen; bones of right leg felt pain; Ankles red; muscle aches; stomach was tight and couldn't eat; chills; blood pressure went up 260/160; heart rate increased; trembling; right leg swelling; pain in arm; A spontaneous report  was received from a consumer concerning 69 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  some pain in arm/ pain in extremity, right leg swelling/peripheral swelling, chills,  trembling/ tremor, heart rate increased, blood pressure went up 260/160/ blood pressure high, stomach was tight and couldn't eat/ abdominal discomfort, muscle aches/ myalgia, bones of right leg felt pain/ bone pain, ankles also swollen/ swollen ankles and ankles red/ erythema.  The patient's medical history was reported by the reporter as he was a dialysis patient and had some heart problems. Concomitant medications taken by the patient were not provided.  On 22 Jan 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 013L20A) through unknown route at right arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, patient experienced some pain in arm. Patient also experienced right leg swelling but that had not bother him. On 25 Jan 2021, morning he experienced chills, trembling, heart rate increased, blood pressure went up 260/160. Patient took 2 Tylenol and after 3 hours everything had went down like normal. Later his stomach was tight and couldn't eat and next day stomach was better. On 26 Jan 2021, he experienced muscle aches and bones of right leg felt pain, ankles were also swollen and red.   Treatment activities for event was done with paracetamol.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event, experienced some pain in arm/ pain in extremity, right leg swelling, muscle aches and bones of right leg felt pain, ankles were also swollen and red were unknown. The outcome of event, experienced chills, trembling, heart rate increased, blood pressure, stomach was tight went up 260/160 were resolved on 26 Jan 2021.
11/27/2008 pt noticed red area at injection site size of a quarter warm to touch and swollen.  C/o rash all over.  Pt advised to put ice pack on area and take BENADRYL which did help when pt got hot and made worse over time 11/27/08 + 11/28/08 + 11/29/08 area went away.
4MAY98 seen in ER d/t urticaria p/vax;following day 5MAY98 had fade erythematous rash;15min later urticaria flare up;epi & DPH given;
On 9/23/03 pt's mother stopped in nurse's office and said that her son had immunizations done 8/18/03 and then developed a rash on 8/28/03 on his trunk. It has extended to his legs and arms the past few days. She said the rash on chest and back is less reddened now. I examined his rash and it was slightly raised, red, and scattered on arms, legs and chest and back (1-2 mm in size). Appears like text book picture of measles. Mother states child has not been sick or complained of pruritis. 9/24/03: Call to state Dept of Health Immunization Program staff and they recommended I call National Immunization hotline since the rash usually occurs in 7-10 days and this rash is still occurring over a month later. 9/24/03: Call to National Immunizations Hotline and was told a rash can occur up to one month after the immunization but that is rare. Recommended see physician. 9/23/03: Mother took pt to his pediatrician, and she did CBC, platelets, urinalysis. All tests were reported "normal." The doctor recommended child be seen by a dermatologist. On 9/24/03, the dermatologist said it looked like dry skin and recommended vaseline and triamcionolone ointment daily after bath times 5 days. 9/25/03: I called Merck to discuss above and they said such a reaction was unusual and requested I complete an adverse reaction sheet. 10/16/03: I called mother. She said the rash on pt's back and chest is gone but he still has it on his legs. It is fading. Has a few scabs on waist line and ankle. She did not follow-up with the dermatologist as she really did not believe the rash was due to dry skin. The vaseline and triamcinolone ointment "made no difference in the rash," stated the mother. I explained to her that I would complete an adverse reaction report for health dept and for manufacturer. She was receptive to that. She took pictures of Bobby's rash and will bring me a picture of it to send in with the report. (copy of photos attached)
Patient presented with pain, redness and warmth of left upper arm that started the evening after flu shot that was given in same arm. No evidence of wheezing, chest pain, shortness of breath or difficulty swallowing. Patient treated with supportive care including rest, cool compress and otc analgesics for comfort.
Hives; Didn't go back to the 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced hives (Verbatim: Hives) and incomplete course of vaccination (Verbatim: Didn't go back to the 2nd dose).  The outcome of the hives was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the hives to be unrelated to Shingles vaccine.   The company considered the hives to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-Mar-2023 This case was reported by a patient via interactive digital media. The patient reported that 2 weeks after he/she got the first shot he/she broke out in hives and have had them ever since. So annoying.  The physician said it was not related to the shot, and it just might be a coincidence.  However, the patient did not go back for the second shot. Till the time of reporting, the patient did not receive the second shot, which led to incomplete course of vaccination. The follow up could not be possible as no contact details were available.
SHOULDER INJECTION SITE BECAME VERY SWOLLEN ,BLOTCHY LOOKING, AND HOT TO THE TOUCH
Small red rash on chest , face, stomach, back, arms developed within 1 week of vaccine. Fever at night, hot flashing during day. Patient took clindamyacin for a tooth infection 2 days then discontinued after rash developed. Rash has continued for approximately 1 month. After 1 month, rash is still evident on chest, arms.
Reported initially experiencing right deltoid soreness and shoulder stiffness beginning Sunday, May 17 which progressively became worse and radiated to: neck stiffness, elbow and hand joint pain and swelling, and to pain radiating to the ankle joints. "I counted 17 joints that have been affected. My right shoulder hurt so much; it was as if I had a major shoulder injury I didn't have any arm involvement that appeared resemble an infection, but I think I have developed vaccine syndrome. Each year I have a worse reaction to the flu shot. I am a proponent of vaccinations, but if a patient came to me like this, I would not recommend vaccinations."
Constant vertigo and dizziness, paresthesia in arms and legs that comes and goes. Tinnitus, brain fog, anxiety. All continuous starting 4/16/21 and unrelieved by meclizine, methylprednisolone dose pack, benadryl, sudafed, and flonase.
Sore arm with it 2 hours of the vaccine administration second dose, fatigue onset 4 hours after vaccination second dose , lightheadedness and nausea onset 5 hours post administration  second dose.
After the vaccine, patient reported pain from the arm radiated to left neck area and left ear. EMS at bedside.
pt recvd vax & w/in a few hrs p/vax exp a warm,raised rash @ inj site;
I became wracked with full-body chills at around 1:00am the night I received the booster. I felt extremely cold and experienced uncontrollable shivers, but I didn't take my temperature, so I'm not sure if I had a true fever or what my body temperature was at. I woke up around two hours after dozing off again and woke up feeling hot.  The day after, my body temperature was back under control, but between 7/23/22 - 7/25/22 I've noticed a drastic loss of appetite. I'm not feeling nauseous, I just haven't noticed myself getting or feeling hungry, and I've been having to make myself eat food.
Right thigh swelling within 24 hours after shot had been given along with heat/warm to touch. Limping and refused to bear weight for 24 hours. Fever also present 3 days after immunizations.
Localized redness, pain, rash and swelling over a period of three to four days.  No treatment was required
Began feeling pain in arm about 3 hours after flu shot. Thought it was normal soreness from shot. As the evening progressed the pain worsened until I could hardly move the arm. At this time looked in the mirror and realized the shot was given in the shoulder. After 2 days of severe pain I contacted my brother who is a nurse and asked him if the injection site could be causing the pain. He suggested it may have hit a nerve. Waited one week before going to clinic where PA also stated it could have hit a nerve causing inflammation. Prescribed Medrol dose pack and muscle relaxers. Follow up with doctor 4 days later. Doctor agreed the injection could have hit a nerve or tendon and would probably be fine when meds were finished. Pain came back worse than before in shoulder and upper arm within 24 hours of finishing Medrol. Saw doctor again and was prescribed Naproxen 500 mg. No change in pain at follow up visit. Researched arm pain and flu shot to find the SIRVA website. Doctor agrees that this could be an injury cause by injecting into the shoulder. Currently awaiting approval for MRI. This is a Worker's comp case as the flu vaccine is required and given by my job.
This spontaneous report as received from a physician refers to a 3 month old (at the time of second vaccination) and currently 21 year old non-pregnant patient. On 09-JUL-1992 the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 0.5 ml, intramuscularly (lot number and expiration date not provided). The second dose was administered on 10-SEP-1992 and the third dose was administered on 08-MAR-1993. The reported stated that on an unknown date a titer for hepatitis B were drawn and the titer resulted negative. No treatment was given for adverse event. The outcome of hepatitis B titer negative was unknown. The is one of 10 reports from the same source. (1309USA005675, 1309USA007825, 1309USA007826, 1309USA007827, 1309USA007828, 1309USA007829, 1309USA00730, 1309USA007831, 1309USA007833). Additional information has been requested.
Symptoms are ongoing 8+ weeks post vaccine. I have had two doctors visits and numerous blood tests.  All normal.  I was perfectly healthy prior to this other than a vitamin D deficiency that is now within the normal range.  No known prior COVID exposure/infection.  Have been maintaining a small, strict family bubble since March 2020 - working from home, home schooling my son, no travel or even going into stores.  I had the normal/expected next day reaction to the 2nd shot - extreme fatigue, body aches, headache.  I rested for the full day on Saturday and felt better /normal by Sunday morning.  However, by late Sunday afternoon, new symptoms came on.  They started out on the left side of my body and then grew from there in the days that followed.  First it was pain behind my left knee that radiated down to my ankle and later upward through my left thigh, hip, entire arm, and shoulder.  From there, it progressed to all over pain in my joints on both side of my body and almost daily headaches - typically around the base of my skull.  I am also experiencing prolonged periods (days and sometime weeks at a time) of constant muscle tension/soreness in both arms and legs and intermittent tightness in my chest.  However, the pain has remained most intense/pronounced/persistent on my left side and a couple of different times in the last 8 weeks I've had bruising on my left foot and ankle.  As a result of all of this, I am fatigued most days and it is all inhibiting my ability to function normally.  I don't know whether it is related to the vaccine or not, but I know it isn't normal.  My quality of life and ability to function as I typically have has decreased dramatically in the last 8 weeks and I am very worried and I don't know what to do.  If someone can please contact me and advise whether they have received any similar reports and provided direction on some type of specialist or test that might be able to help, I would be forever grateful as I am scared and my primary care physician has basically just said I need to wait it out.
Pain started in left arm around to back - felt like bone pain in shoulder elbow and wrist and extended to fingertips. Pain in pit of arm lasted for 2 days and arm is still tingling 4 days after vaccination was administered.  On a scale of 1 to 10 I would give it an 8 during the first 2 days.  It is a disgrace that this vaccine is even on the market.  All that pain and stress and there is still over 100 types of pneumonia one can catch.  I can't believe they also give this to children over 2 years of age.  The next box says it all - Patient Died?????
Severe hives and itching all over body and head at 10 days post vaccine. Began as generalized itching 7 days post vaccine.
myocarditis; This is a spontaneous report from a contactable nurse reported for a patient via a Pfizer company representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration on an unspecified date (batch/lot number and expiry date unknown) as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse reported "Verbatim question: for the covid vaccine, 12 and up, they encountered myocarditis. Can you please send/call her about this. She's a pediatrician. She would like more info.". The outcome of the event was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information and known drug profile, a possible causal relationship cannot be excluded between the suspect product bnt162b2 and the reported event myocarditis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.