chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely swollen lymph nodes on left side.  Left armpit swollen Cannot let left arm relax fully (armpit too swollen and sore to let arm rest at side.  Cannot see left collarbone because of swollen area.  Left tonsil swollen/inflamed and sore.  Pain in left armpit.  Pain at injection site.
Patient had a fever on and off for 10 days, also had a rash after vaccine on cheeks and body that lasted for 3 days.
Information has been received from a health professional concerning a 14 month old male with no known drug allergies who on 7/9/01 was vaccinated with varicella virus vaccine live (lot 638243/0557L). A registered nurse reported that on 7/10/01, the pt developed a rash with pustules. The pt was seen by the physician on 7/14/01 with 50 scattered vesicles on his head, face, cheeks, upper extremities and he was afebrile. The pt was diagnosed with varicella. No treatment was ordered. Follow-up info received from the registered nurse indicated that the pt recovered without any problems and was seen in the office on 8/14/01 for a well child visit. Additional info is not expected.
Patient stated that his shoulder was sore and swollen for 3 days. He had a headache and felt puny for 3 days. Still seemed to have a little joint pain.
light achiness; Light headache; sensitive skin (all over); light fatigue; light soreness at injection site; Date of start of drug: 17Oct2023. Pfizer/BioNTech Bivalent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2023 at 14:15 as dose 1, single (Batch/Lot number: unknown) at the age of 30 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 17Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient didn't receive bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 17Oct2023, outcome "unknown", described as "Date of start of drug: 17Oct2023. Pfizer/BioNTech Bivalent"; HEADACHE (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "Light headache"; PAIN (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "light achiness"; FATIGUE (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "light fatigue"; VACCINATION SITE PAIN (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "light soreness at injection site"; SENSITIVE SKIN (non-serious) with onset 18Oct2023 at 08:00, outcome "not recovered", described as "sensitive skin (all over)". Therapeutic measures were taken as a result of headache.  Additional information: Ibuprofen used for headache.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 1:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 1:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 62.56. Concomitant products were not provided. On 22-Jun-2021, Excursion time was 08 AM, temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021. On 04-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 36, 9 AM: 36, 10 AM: 35, 11 AM: 38, 12 AM: 40, 1PM: 38, 2 PM: 38, 3 PM: 38, 4 PM: 39. On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, 4 PM: 43. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Peripheral neoropathy. Pins and needles, weakness in legs, shocking jolts. It started very subtle within a month of vaccine than continued to spread and mess up my legs. Now my legs are burning and aching.
Very red arm at the injection site noticed it last Friday 3/19/2021, arm not sore, not elevated, not warm to touch. Aquaphor was applied to the area
Patient: medical care provider calls to report that patient "can't move her right arm" this AM. He has diagnosed vaccine being injected into deltoid bursa-rather than muscle, states"given to low"
significant erythema, warmth, swelling at injection site upon examination; Pt received injection on a Friday afternoon 9/26/08. He called in on Monday morning 9/29/08 complaining that his arm was "still hot and red" and was advised to come in to the clinic. Pt was examined and given an injection of triamcinolone 60mg IM with further instructions to return if his symptoms did not resolve. As of this date he has not returned for further treatment.
This medically confirmed non-serious report (initial report 21-AUG-2014) concerns a female patient. The patient had a medical history of shingles in the past. On an unspecified date, the patient received ZOSTAVAX and subsequently was diagnosed with recurrence of shingles. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not reported). On an unspecified date, after receiving the influenza vaccination, the patient developed an unspecified reaction. Outcome was reported as recovered.  Reporter's comments: The reporter could not confirm if it was AFLURIA as the reporter did not administer influenza vaccine to the patient.
As reported by subject: Deployed in Feb 2003. Healthy before and during deployment. In 2004, within months of return from a foreign country, he experienced fatigue, general ill feeling and left sided face pain. Had Anthrax vaccine #4 21FEB04. Seen in clinic, diagnosis of nerve damage in face, possibly related to sinus problems, or dental problems, or dental problems or accidental injury during combat. Had x-ray of sinus which showed deviated septum. Had several office outpatient surgeries since 2004 for deviated septum and sinus problems. Also had significant dental work done. Treatments have not changed left sided face pain. Complained of back pain. MRI in 2008 showed degenerative arthritis. MRI also showed mass in back diagnosed as lipoma. Chest pain in 2008, blood work, EKG and stress test were WNL. Has difficulty sleeping at night and is tired all the time. Sleep study diagnosed sleep apnea. Treatment with CPAP machine has not corrected the tiredness. 2009 diagnosed with gout.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with dose 1 ZOSTAVAX in 2009. No other co-suspects were reported. No concomitant medications were reported. On 02-NOV-2012 the patient received a 2nd dose of ZOSTAVAX. The patient is not experiencing any known symptoms. Additional information has been requested.
Patient self-reported left arm pain traveling down her arm after second dose of covid vaccine (pfizer) administration. Patient has documented history of anaphylaxis with IV contrast. EMS on-site provided cardiac monitoring. Observed elevated BP.
Three days after receiving vaccination, patient started to experience swollen wrists and joints. She experienced severe joint pain. She also developed a rash red rash from her injection site to her elbow.
Onset chills, fever, cough, difficult breathing hives for 1 1/2 monts weakness. I tool Ibuprofen, cough medicine, BENADRYL.
PNEUMOVAX given 1-21-14 1630 Pneumo vaccine given rt arm. At 1900 pt c/o pain in arm, no redness, difficulty lifting arm took ibuprofen 800mg and BEN GAY. Woke us decreased soreness took VICODIN and ibuprofen. At 1420 1-22-14 c/o pain warm to touch, red, difficulty raising ar. Dr notified. Tx - ice, ibuprofen, elevate arm, re check tomorrow 1-23-14 0800 Arm is better. Able to lift decreased swelling. Still warm.
New Bloody nose discharge and nosebleeds since first vaccination on December 27. Never had a nose bleed until after the vaccination.
MUSCLE AND JOINT PAIN, FEVER,  RASH AND SWELLING AT AND DOWN ARM OF INJECTION SIGHT 3 DAYS LATER - PAIN IN LOWER RIGHT ABDOMEN SIDE MUSCLE 3 ADDITIONAL DAYS  WAS DIAGNOSED  WITH SHINGLES
Information has been received from a physician via a field representative concerning a female patient of unknown age. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route not reported) for preventing HPV. The patient received the GARDASIL 9 as the first dose of the scheduled 3 doses. On an unspecified date, the patient experienced hives. The outcome of hives was unknown. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning a female patient of unknown age and race. Concurrent conditions, medical history, concomitant medication and drug reactions/allergies were not reported. It was reported that on 28-AUG-2018, the patient was administered the first dose of VAQTA lot number: N020689 (expiration date: 22-OCT-2018) (strength, dose and route were not reported) for prophylaxis; and on 03-OCT-2018, she received the second dose of VAQTA. No adverse effects were reported. There was no product quality complaint (PQC) reported.
Client had eye exam on 10/13/03 and received new glasses with 20/20 vision. However sometime shortly (1 month) after pt experienced double vision-shortly thereafter physician ordered a MRI (1/20/04) of head,results negative. To primary physician (1/20/04) did blood work-negative. Then to neurologist (1/23/04) who diagnosed myasthenia gravis. She then saw a physician also confirmed (EMG)-confirming the diagnosis. Presently takes Prednisone 10mg QOD, Pyridostigmine 60mg TID, Zantac 150ng BID, benicar 20mg QD. Per this client-she will need to continue on these medications for life time. The medical record received on 3/23/04 fatigue, dizziness, balance difficulty, joint pain, joint stiffness and heartburn.
This case was reported by a physician and described the occurrence of fever in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 10th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, 12 hrs after receiving SHINGRIX, the patient experienced fever, chills and myalgia. The patient was treated with TYLENOL. On 12th March 2019, the outcome of the fever, chills and myalgia were recovered/resolved. The reporter considered the fever, chills and myalgia to be probably related to SHINGRIX. Additional details were provided as follows: Medicine of doctor received SHINGRIX at retail pharmacy on Sunday and on 11th March 2019, Monday morning he developed a fever of 102 degree F, shivering and myalgia over the course of the day. The suspect drug course for vaccines was not discontinued. The events did not cause the patient to be admitted to the hospital overnight or prolong an existing hospitalization. The reporting health care professional did not consider the events to be life threatening. The reporting health care professional did not consider the events to result in persistent or significant disability or incapacity. The patient did not die. The events did not require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect.
Severe swelling and pain/tenderness in left arm, armpit, wrist, left side of my neck, left shoulder,  left ribcage (front and back), left knee , left ankle. Fatigue. Swelling and fatigue have been decreasing over the past days but are still present.
Pt had 3 series, after 2nd, patient constantly had leg cramps, after 3rd, she started having seizures, in the time we have been to hospital on several emergencies, We have done our research, We were on 3 medicines at one time to control seizures, She has been in Hospital for a week in testings, monitors to watch night seizures, She is now under the care of neurologist, she has to continue to go up in doses of medicine after seizures. She now has symtoms of menopause, which I have seen is another adverse effect. My daughter was a runner, she loved swimming, but had to stop all, because she has no warnings of the seizures. She has fell out at school several times resulting in concussions. She is
Patient brought to the ED by EMS on 9/26 for recent falls, weakness, and mild confusion. Since 9/21, patient notes she has been feeling increasingly weak and fatigued with decreased appetite. On 9/25 she was found on the floor by her son. On 9/26 the patient's son attempted to call the patient but when she didn't pick up he went to check on her and found her on the floor again so called EMS. In the ED, the provider noted the patient was mildly confused and had a mildly elevated temperature of 99.7 F. The patient tested positive for COVID in the ED. She was admitted on 9/26 due to her recurrent falls, generalized weakness, and COVID-19 infection. At time of report (9/30), patient is still admitted. Additionally, patient has received the COVID vaccine and one booster.
Fever to 101F for about 15 hours, site pain for about 24 hours, headache for about 15 hours, shortness of breath ongoing, took 400mg ibuprofen every four hours
I developed a rash at the injection site one week following my injection.  The rash started that evening.  It was a small, hard,  red bump, pea size in diameter, and itched.   The next morning it was still red and hard.  It was the size of a nickel and continued to itch.  I went to see my primary care physician that afternoon.  He diagnosed it as a reaction to the vaccine.  Now,  48 hour plus, it has continued to grow and itch.  It has remained red and hard.  I have been putting ice one the areay, Advil a couple of times a day, and I take allergy medicine daily.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 01-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Woke up the day after vax was given with a temperature that lasted for 2 days. Screaming started shortly after and lasted for 5 days non-stop. Called physician two times after hours and had one visit to the physician during those 5 days.
started to feel like I was going to pass out  about 5 minutes after getting 2nd dose. I went back to the pharmacy area where it was administered and sat down in one of the chairs and tried to recline as much as I could to prevent from passing out. It took about 45 minutes before I could get up without feeling faint.   Later that evening I started to get a fever and muscle aches. When I woke up around 3 am my fever was just under 101.  I had a fever the following day and unable to eat due to nausea until evening time.  I was unable to do my normal exercises due to weakness until that Sat Sept 4th, in which I was able to do about 30% of what I normally do. By Sunday morning I started having bouts of chest pain and tight chest. The pain would go away if I sat down and tried to relax my breathing to resting state. On Monday the chest pain got worse going in to my jaw and R ear area.  By Tues it got worse with chest pain, and sharp pains into my back
Initial unsolicited report received from a non-healthcare professional (office staff) on 25-Jul-2018. This case involves a four-month-old patient (gender not reported) who was inadvertently vaccinated with an expired dose of 0.5 mL PENTACEL batch number: C5402AA, expiry date: 24-Jun-2018 via intramuscular route in left leg on 02-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 for and ROTATEQ for Immunisation. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any harm or not. 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.
My husband started having symptoms and I was fine then I started having symptoms. I had a terrible headache, diarrhea. My husband and I both went in and got the monoclonal antibodies. I never got short of breath, but my oxygen dropped to 80 and then I spiked a fever and went to ER, they admitted me and had me on oxygen, I had COVID pneumonia, I lost my appetite completely, I was in the hospital for 8 days and when they sent me home, they had me on 4 liters of oxygen. I'm still really fatigued.
Cough  Shortness of Breath  Headache  New loss of taste or smell
I have hives on my feet, hands, arms, body.  The red patches come and go.  They are very itchy.  This started last night around 6PM on 11-16-2021 and continue as of this writing, at 1:00AM on 11-18-2021.
This spontaneous report was received from a registered nurse referring a 15 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 13-FEB-2015, the patient was vaccinated with a dose of GARDASIL for prophylaxis (dose, route, lot # and expiration date were not reported) and on 04-DEC-2015 was vaccinated with a dose of GARDASIL 9 for prophylaxis (dose, route, lot # and expiration date were not reported). No adverse effects were reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
PSA (PROSTATIC SPECIFIC ANTIGEN) NUMBERS WENT UP; TIRED BY THE END OF THE DAY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 83.45 kilograms, and height was not reported. The patient's concurrent conditions included: prostate cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: enzalutamide (tablet, oral, batch number: EJ6677 expiry: 31-MAY-2024, batch number: 1861177 expiry: 31-AUG-2024) dose was not reported, 1 time every 1 day, from 17-AUG-2021, and dose was not reported, 1 time every 1 day, therapy dates were not reported for prostate cancer. Concomitant medications included leuprorelin acetate. On an unspecified date, the patient experienced psa (prostatic specific antigen) numbers went up, and tired by the end of the day. Laboratory data (dates unspecified) included: Prostatic specific antigen went up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with enzalutamide was not reported. The patient had not recovered from psa (prostatic specific antigen) numbers went up, and tired by the end of the day. This report was non-serious.
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, since 05-SEP-2014, the patients were vaccinated with M-M-R II (dose, lot# were not reported) which were exposed to an unsupported temperature excursion of 59F for a cumulative total of 132 hours. On 05-SEP-2014, total excursion time was 63 hours. On 16-SEp-2014, total excursion time was 15 hours. On 18-SEP-2014, total excursion time was 24 hours. On 23-SEP-2014, total excursion was 15 hours. On 29-SEP-2014, total excursion time was 15 hours. No Product Quality Complaint (PQC) was involved. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Screaming crying to the point he would be dripping sweat and not breathing while crying for hours at a time. Not drinking his bottles and screaming during feedings. It has been 5 days since his shots and they want to blame his thrush but he ate just fine when it was covering his mouth he now only has a few little spots on one side of his cheeks I cant imagine it being because of the thrush. Inconsolable for hours at a time before finally giving up and just going to sleep.
Left  Bell's palsy  (unable to close eyelid all the away, tearing, left facial drooping)
pt recvd measles vax on 2NOV92 & on 4NOV92 devel double vision; pt was seen by neurologist & an ophthamologist; no further details were provided;