chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lump; it's uncomfortable; At the injection site, it's like a hard knot that's there; rise of swelling near the place where they got the shot; It does not hurt but it itching a little bit/It doesn't hurt, just itches/where she got the injection there's itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump), FEELING ABNORMAL (it's uncomfortable), VACCINATION SITE INDURATION (At the injection site, it's like a hard knot that's there), VACCINATION SITE SWELLING (rise of swelling near the place where they got the shot) and VACCINATION SITE PRURITUS (It does not hurt but it itching a little bit/It doesn't hurt, just itches/where she got the injection there's itches) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 032M20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE MASS (lump), FEELING ABNORMAL (it's uncomfortable), VACCINATION SITE INDURATION (At the injection site, it's like a hard knot that's there), VACCINATION SITE SWELLING (rise of swelling near the place where they got the shot) and VACCINATION SITE PRURITUS (It does not hurt but it itching a little bit/It doesn't hurt, just itches/where she got the injection there's itches). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and CORTISONE for Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (lump), FEELING ABNORMAL (it's uncomfortable), VACCINATION SITE INDURATION (At the injection site, it's like a hard knot that's there), VACCINATION SITE SWELLING (rise of swelling near the place where they got the shot) and VACCINATION SITE PRURITUS (It does not hurt but it itching a little bit/It doesn't hurt, just itches/where she got the injection there's itches) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient went to the emergency on 23-Nov-2021. In the emergency, the patient was put a circle on the area and told her if it got any bigger to come back. The patient reported that, this was the first bad experience she had. The patient didn't have anything after the first two doses.  Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Reporter's alternative phone number was added. Event description was updated. On 24-Nov-2021: Reporter, patient and suspect drug details along with additional events and treatment details were added.
Ten days after my second COVID vaccine, I woke up one morning and could barely walk.  My feet were very painful.  My calves, ankles, forearms, wrists and base of my skull were experiencing "charlie horse" like sensations.  Prior to this occurrence, nine days after my first COVID vaccine,  I experienced what appeared to be an infection in my right index finger, no explanation how it happened.  There was no incident leading up to it.  My finger bled on the top side for no known reason and then a discolored painful bump appeared near the fingertip (on the palm side of my hand).  I could not bend my finger.  It was extremely swollen and painful.   I visited the doctor about this on 1/15/21 and was prescribed a 10 day anti-biotic.  I completed the regimen.  The swelling and pain went away.  The discolored raised bump did not.  The spot which bled healed with no problem.   This report is difficult to navigate.  To make sure the dates of my COVID vaccines are clear and the onsets of my symptoms--- 1st Pfizer shot was given on Tuesday, January 5, 2021 in my right arm.  The onset of first symptoms occurred on Thursday afternoon, January 14.  I visited the doctor for this the following day (January 15).   2nd Pfizer shot was given on Tuesday, January 26, 2021 in my left arm.  The onset of symptoms as described below began early morning 10 days after the second shot was administered.  I woke up with these symptoms (as described below).
On the anterior and lateral left upper thigh there is an area of blotchy erythema approx. 5.5 cm in diameter with central induration at the site of his previous induration and distinct edge and fluctuance advised cool compress to area, Tylenol/motrin
Patient developed a half-dollar size red area at the injection site, the site was observed in the pharmacy 2 days after vaccination, patient stated it did not seem to be growing/getting worse, but was sore. Was given some hydrocortisone cream to help with the reaction.
Post vax the patient developed a blister on her left arm and her left arm was swollen. There was no evidence of cellulitis.
She's been diagnosed with small fiber neuropathy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 Immunization. The following information was reported: SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "She's been diagnosed with small fiber neuropathy". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 06-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route of administration were not provided) lot # L012479, expiry date 10-APR-2017. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Nausea, severe pain all over body, particularly in joints, swelling and itching at shot site, severe headache, congestion, extreme fatigue, no appetite, fever of 100.9, Chills and sweats., swollen and painful lymph nodes on neck.  Popping feelings and then pain that spread.
I had a mild reaction to the second dose of Moderna with symptoms including tingling at the injection site, as well as my head, throat/mouth, and legs. I also experienced swelling and prolonged pain where I received the shot.  About 7 hours after I developed a fever that remained over 100 degrees Fahrenheit for about 2 weeks. I went to urgent care after the migraines got worse and I couldn?t shake this illness. I went to see my doctors/primary care physicians and basically since then I?ve been continually Ill, in may being diagnosed with Lupus (SLE) and limited systemic sclerosis/Scleroderma. And in June, I was so sick I had to resign from my job in finance at a biotech firm, to move home to live with my parents so they could help care for me. And to be close to specialists and doctors helping me through this life change.    I received the booster about 2 months ago now and just tested positive for Covid and am continually getting worse for the fourth day now.
adverse effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse effect). At the time of the report, VACCINATION COMPLICATION (adverse effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
Patients father, called today 08/20/18 and stated the child had a half dollar sized knot on right arm. Father stated the child complained of numbness in right arm the night of the injection. The father called the child's primary care provider and was told to call the place of administration. The father denies redness or heat at the site. The father states the area is tender to the touch and child still complains of pain when lifting arm
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2014, GARDASIL underwent a temperature excursion. On 05-AUG-2014, the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. No adverse effect reported. This is one report from the same source. Additional information has been requested.
No additional AE information; HCP called to report TE of GARDASIL 9 in which the vaccine was administered to a patient; This spontaneous report has been received from a medical assistant referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 22-JUN-2023, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot# W015188, expiration date 06-JAN-2025, strength, route and anatomical location were unknown) for prophylaxis. The vaccine was administered by the reporter as an experienced user. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) had multiple previous excursions (product storage error) and was not able to be evaluated during the call. No additional adverse event information could be provided.
Swelling of all joints, pain in joints, severe migraine on left side, went to ER and diagnosed with infection and was referred to the neurologist and given antibiotics.
Chicken pox on right arm, abdomen, and bottom of left foot Severe muscle stiffness in thoracic spine and neck Lightheadedness, brain fog, weakness, and difficulty standing due to weakness Warmth, pain, and swelling to injection site 8 days after injection Migraine headache
a little arm soreness after her first shot.; headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a little arm soreness after her first shot."; HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: The patient was eligible for her second dose of the Comirnaty vaccine tomorrow. She had a headache on that day and wanted to know if its ok if she could take Ibuprofen. She also reported that she only had a little arm soreness after her first dose of the Pfizer BioNtech covid 19 vaccine and wanted to know whether this happened because her body did not build antibodies. The patient also wanted to know about the Comirnaty vaccine still effective in people who have no side effects and how long does the spike protein for the Comirnaty vaccine stay in the body after vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
BURNING PAIN DOWN LEFT ARM FOR APPROX 5 HRS, FEVER 101.2 NOTED APPROX 6.5 HRS POST VACCINE TOOK 400MG IBUPROFEN, 45 MIN LATER ANOTHER 200MG TO REDUCE PAIN. FLULIKE SYMPTOMS OF LETHARGY, FEVER AND PAIN DOWN ARM, ACROSS SHOULDER, (TO INCLUDE LEFT SHOULDER BLADE) AND UP NECK TO LOWER HEAD LASTING 3DAYS. LETHARGY APPROX 7 DAYS. PAIN PERSISTED FOR NEXT 3 WEEKS AT HIGH LEVEL. DOSED BETWEEN 400-600MG OF IBUPROFEN AT PRESCRIBED INTERVAL 3 WEEKS FOR PAIN.  STAYED WITH 400MG OF IBUPROFEN FOR NEXT 2 WEEKS AT PRESCRIBED INTERVALS. I CONTINUE TO HAVE CONSISTANT SHOULDER AND ARM PAIN WITH LIMITED MOBILITY IN MY LEFT ARM. CURRENTLY SEEING ORTHOPEDIC MD FOR PERSISTANT PROBLEM.
At site of injection, patient reports a red spot that is itchy, swollen and warm to the touch
9/16/21 presents to the ED with SOB and testes positive for COVID 19, despite being vaccinated (3 doses of Pfizer) 9/22/21 pt discharged, "Completion of 5 days of remdesivir, Rocephin, and Zithromax To continue Decadron until 9/25"
BRIEF OVERVIEW: Admission Date: 7/22/2023 Discharge Date: Jul 24, 2023 Discharge Disposition:  home or self care  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Encephalopathy [G93.40] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 73-year-old female with PMH significant hypertension, anxiety disorder, depression, ADHD, alcohol use disorder presents to the hospital on  7/22 with concerns for altered mental status.  Patient had developed symptoms including fever, cough, rhinorrhea, headache, sneezing, fatigue, diarrhea and myalgias about 6 days prior to presentation.  After testing positive for COVID-19, patient was started on Paxlovid on 07/22, of which she may have taken 1-2 doses.  Shortly thereafter, patient was noted to have progressive confusion and hence brought to the hospital. Patient was admitted, suspicion for Paxlovid related altered mental status.  CT head was negative for acute process, chest x-ray, urinalysis, ammonia, lactic acid were all reassuring.  Patient's mental status changes quickly improved, however persisted to have difficulty following commands, understanding information etc..  Out of abundance of caution, MRI brain was done to evaluate for stroke, however was negative. Her mental status changes were likely related to interaction between BuSpar and Paxlovid, with latter being a enzyme inhibitor, likely increased her available BuSpar in her system. She was discharged home on 07/24. Incidentally she was also noted to have asymptomatic bradycardia, EKG showing sinus bradycardia, with good chronotropic effect during daytime.  Bradycardia was mostly noted during nighttime.  Patient denied any lightheadedness or dizziness or syncope. She also has history of alcohol use disorder, quit drinking about 2 weeks prior to presentation, plans to stay quit.  She was given a 10 day course of thiamine. As far as COVID-19 infection, patient was significantly feeling better from her symptomatology, she is nearly 7 days after her symptoms had started, needs no further isolation.  Per her request, BuSpar dose was changed to 15 mg twice daily (patient was supposed to be on 30 mg twice daily, however is only taking 30 mg once daily.  I suggested to take 15 mg twice daily instead).  Adderall was discontinued-she no longer takes it.
failure to provide adequate ATB is reported in pt who recvd flu vax; pt recvd vax OCT92 & devel influenza MAR93; no other details known; This case was reported by a MD in the US
Experienced 20 second tonic seizure w/ loss of consciousness. No prior history of seizures.
red marks around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 97C2S, expiry date 14th May 2022) for prophylaxis.   On 22nd December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details provided as follows: The age at vaccination was not reported but could be 65 or 66 years. The patient was not immunocompromised. Till the time of reporting, the patient still had red marks around injection site. The reporter consented to follow-up.
p/vax around 730PM started feeling achy & very sore muscles & joints became nauseated for a few hours;was achy & sore until Thurs.;
patient complained of joints aching in shoulder and then redness spread to left elbow where elbow was enlarged.  she went to clinic and they said it was probably due to vaccine
Persistent right shoulder since receiving flu vaccine in January 2015. Has been seen twice times for follow up. Had right shoulder X-ray and blood work which was normal. Later received a steroid injection and sent to physical therapy.
This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (swollen lymph node above collar bone) and VACCINATION SITE PAIN (arm was sore and tender just above the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore and tender just above the injection site). On 29-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node above collar bone). At the time of the report, LYMPHADENOPATHY (swollen lymph node above collar bone) and VACCINATION SITE PAIN (arm was sore and tender just above the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I experienced fever, joint pain, body aches from 12-36 hours after the injection. I experienced a swollen lymph node under the arm injected with the vaccine.  Tylenol used for pain and fever.
After immunization, patient left the room walking and started wobbling and lost balance. MA and MD caught patient prior to falling. Patient was taken back to a room and laid down, vitals within normal limits, and gave patient apple juice. After lying down for a few minutes patient was feeling better. Patient did not loose consciousness or have a allergic reaction, MD states patient had a vaso-vagal/anxiety response after immunization.
I was very cold for about 3 hours, which is unusual for me, followed by several hours of fever.
This spontaneous report as received from a registered pharmacist refers to many unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with a doses of ZOSTAVAX (doses, routes and lot numbers were not reported). The pharmacist reported that over the past several months (in 2014), she had been aware that many unspecified patients who received ZOSTAVAX on unspecified dates experienced injection site reactions described as a little knot surrounded by a big red circle. At the time of the report the patients' outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
When it was administered, the person stuck the needle in and poked and moved it around.  It wasn't fluid and she was nervous  headache within 5 minutes and pain like a needle between my eyes and nose. Felt crappy for 2 weeks - lethargic developed flooters, bright light, enlarged heart, irregular heartbeat, and vision problems. The vision changed within the same day and saw my ophthalmologist.  Dull pain on shoulder blade on the left chest went to the doctor.
Pt reports she had a sore arm for a month and was unable to raise her arm during that time.  Symptom self resolved
Headache. Severe, crippling muscle pain and weakness throughout entire body. Started about 11:30 pm Friday 10/22/2021 lasted until Monday 10/25/2021.
Information has been received from a health professional, a female receptionist, who on 12-FEB-2007 was vaccinated with the first dose of Gardasil (Lot #654885/1424F). Concomitant therapy included hormonal contraceptives (unspecified). Following the vaccination, on 12-FEB-2007, the patient developed a red bumpy rash that was in the shape of the latex-free band-aid that she had used, and was painful to the touch. On approximately 26-FEB-2007 ("two weeks" later), the patient recovered from the events. On 13-APR-2007, the patient was vaccinated with the second dose of Gardasil (Lot #654885/1424F). Once again, on the day of vaccination, the patient experienced the red bumpy rash, painful to the touch, and in the shape of the band aid she had used. As with the first occurrence, on approximately 27-APR-2007 ("two weeks" later), the patient recovered from the rash. The patient sought unspecified medical attention. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a 25 year old female, with no prior history of a band aid reaction, who on 12-FEB-2007, was vaccinated with the first dose of GARDASIL (Lot #654885/1424F). Concomitant therapy included hormonal contraceptives (unspecified). There was no illness at the time of vaccination. Following the vaccination, on 12-FEB-2007, the patient developed a red bumpy rash that was in the shape of the latex-free band-aid that she had used, and was painful to the touch. On approximately 26-FEB-2007 ("two weeks later"), the patient recovered from the events. On 13-APR-2007, the patient was vaccinated in the left deltoid, at 1:30pm, with the second dose of GARDASIL (Lot #654885/1424F). Once again, on 14-APR-2007 (previously reported as the day of vaccination), the patient experienced the red bumpy rash, painful to the touch, and in the shape of the band aid she had used. Treatment included a topical cream (unspecified). As with the first occurrence, on approximately 27-APR-2007 ("two weeks later"), the patient recovered from the rash. The patient sought unspecified medical attention. No further information was expected.