chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Crohn's disease; Rheumatoid arthritis flare up; thyroid eye disease; Psoriasis flare up; breast reduction; diabetes; Hip replacement; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (not available). The reporter is the patient. Other Case identifier(s): 22K-163-4421982-00 (AbbVie).  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIP ARTHROPLASTY (non-serious) with onset 2021, outcome "recovered", described as "Hip replacement"; DIABETES MELLITUS (medically significant) with onset 2021, outcome "not recovered", described as "diabetes"; MAMMOPLASTY (non-serious) with onset Mar2022, outcome "recovered", described as "breast reduction"; CROHN'S DISEASE (medically significant), outcome "not recovered"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "not recovered", described as "thyroid eye disease"; PSORIASIS (non-serious), outcome "not recovered", described as "Psoriasis flare up". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "hip replacement" and "breast reduction" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events and the suspect drug BNT162b2   cannot be excluded. 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
The next day after administration patient developed soreness in arm from shoulder to elbow. This has continued for over 30 days.  Patient also had flu like symptoms for 24 hours after vaccine administration.
One hour after shot patient passed out on side of road someone woke her up and she drove to sister (friends) house and passed out again. They took her to ER she was flushed had hives BP 60/30 unconscious.
Patient received the Pfizer COVID vaccine at 1745. Patient states he didn't feel right but stood up to go to the observation area and lost consciousness causing him to fall backwards to the floor where he was witnessed hitting  his head on the gym floor.  Patient was unresponsive for approximately one minute and was then alert and oriented but c/o dizziness.  VS at 1756 BP 137/63 HR 85 and O2 Sat 98%.  Patient remained in the supine position for approximately 10 minutes and was then aided into a sitting position on the floor and then assisted into a chair.  Patient was then observed for 30 minutes by staff where he continued to c/o lightheadedness and dizziness.  VS at 1806 BP 115/68 HR 84 O2 Sat 97%.  EMS was then called to assess patient for continued dizziness.  VS by EMS sitting BP 122/77 and standing 117/70.  Patient was offered to be taken by EMS for further assessment but patient and grandfather both declined further care at this time.  Patient and grandfather were instructed to call 911 immediately for any change in mental status, nausea/vomiting, or any other reaction symptoms with verbalization of understanding and agreement.  Patient was advised upon discharge to stay hydrated and rest for the remainder of the evening.  Patient and grandfather were also encouraged to discuss reaction with patient's PCP prior to receiving second dose.
The patient received the booster shot in the afternoon and was found by the nurse unresponsive at 9:05pm. Her vitals were strong but she could not move or speak. She did respond to pain. She was taken to the ER where a chest x-ray and brain CT came back clear. She did have elevated white blood cells and tested positive for a UTI. She recovered the ability to speak and move after 3 hours while on IV fluids with a broad  spectrum antibiotic added.
Unable to move legs and roll over in bed. Difficulty in breathing. Had to be seen in ER Dept.of hospital.
Early October 2021 started with daily water diarrhea, lower abdominal pain 5-8 loose stools daily after years of recurring constipation.  Have since had colonoscopy w/ biopsy reporting 'lymphocytic gastritis'.
Received H1N1 vac 11-4-09. On 11-5-09 when mother picked him up at daycare she noticed a fine red rash starting to appear on son's abd. and back. This rash cont. to cover a larger area of his abd and back up until 11-7-09. There has been no change in the rash since 11-7-09. Patient had 4 diarrhea stools on 11-8-09. Patient has been afebrile since vac. Referred to Dr.
I am the patient and am reporting the following adverse reactions: after receiving this vaccine on November 17, I had no ill effects until the morning of December 1, 2017. I awoke with crushing chest pains and a rapid heartbeat - my physician husband and I proceeded to the ER, thinking I was having a heart attack. Extensive stay and tests in the ER resulted in determination of no heart attack, no elevated BnP or cardiac enzymes. I was discharged to home that day. I continued to have the following systemic symptoms: chills, cough, rapid heartbeat, sneezing,sore throat, tightness in chest, decreased urine output, painful and burning urination and general feeling of malaise for the next three days. By December 3, I had recovered as these very strange and multiple symptoms seemed to have worked their way out of my body. I made appointments with my cardiologist and gyn doctors to continue checking for causes. Lengthy cardiac workup (stress test, PET scan, etc) all proved negative. Tests for UTI was negative. I strongly feel that the vaccine and recent multiple cortisone treatments had interacted, as reported in recent literature.   This report has been delayed as I experienced a serious fall which results in a total knee replacement with complications (and my husband had serious health issues). But I wanted to get this information to you - apologies for the delay.
2 days after receiving Flu Mist, pt began to have itchy, red rash on lower legs and lower back.  Since then, rash is lighter, but still with itching.  On exam today, faint macular, papular, & in some places vesicular rash on lower legs, lower back, abd, chest, neck & head.  Also had HA chills & body aches which lasted 2 days.
Extreme and morose emotionality; crushing depression, onslaught of thoughts of self mutilation and ocassionally suicide. Anxious and fearful dreams.   Also, body aches, lethargy, fatigue, headaches. No fever.  This is ongoing as of day six following the vaccine. Tomorrow will be one week.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX (lot# and route unknown) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
cough; itchiness on her throat; This is a spontaneous report from contactable consumer (patient) from a sponsored program SUPPORT.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration on 18Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient got her first dose last 18Mar2021 and her next dose will be today on 09Apr2021 and she was asking if it was okay to take the second dose even if she had experienced itchiness on her throat as well as cough on an unspecified date. She stated that she will also have a Colonoscopy on Wednesday and she provided number and hours of operation. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
arm bruising, 'a little blue and red'; tenderness in arm; This spontaneous report was received from a pharmacist and the patient referring to a 72 years old patient of unknown gender. Concomitant therapy included warfarin. The patient's pertinent medical history and concurrent condition were not provided.     On 14-SEP-2020 (on Monday), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose detail, strength, route, lot# and expiration date were not provided) for prophylaxis. On 14-SEP-2020, the patient experienced arm bruising, which was a little blue and red. The patient also reported tenderness in arm. No infection was present as confirmed by the pharmacist. No treatment was given to the patient. The outcome of the events was unknown.    The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
The pt's left deltoid area was red, very swollen and warm to touch. Looks similar to a tetanus reaction.
Right leg swollen, red and hot to touch, mom called with symptom at 3:50 on 8-24-06.  Was seen at 4:30 by provider and had 24 by 13 centimeter area of erythema with warmth.  Placed on KEFLEX 250/5 2 teaspoons twice a day for 7 days.  99.6 temperature at office at 4:30.
Patient received vaccine on Thursday, July 15th. On Saturday, July 17th, the patient began having chest pains. This resolved itself with a few hours. Patient did not go to the doctor or hospital and she reported it to us on Monday, July 19th.  She was also advised to go see her primary physician for further assessment.
Patient presented to the pharmacy stating that the day after his vaccination all the fingers on both of his hands began swelling. He was in a lot of pain. His fingers began bleeding and oozing during the course of the past month. Patient reports that symptoms have recently improved.
Developed urticaria (diffuse) late on 2/5/11, received immunizations 2/4/11.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (slight fever 5 days after vaccination) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (slight fever 5 days after vaccination). At the time of the report, pyrexia (slight fever 5 days after vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
Ringing in ears Headache Muscle aches Joint aches Dizziness  Cannot sleep good  Memory loss brain fog
Seven days after the injection, I developed a very red, hot,swollen, painful, and itchy area encompassing the upper outer part of my left arm surrounding the injection site, approximately 8-10 cm in diameter.
I had loss of appetite. I had depression. I went to my doctor about this. I had a abnormal ultrasound done. I am still waiting on the results for that.
Stiff neck and sore, achy muscles and joints lasting until 10/21/2014. Extreme weakness in legs, feet and arms and numbness and tingling all over.  Also, trouble with walking and balance beginning 10/29/2014 an ongoing.
Shot administered on Friday.  Was required to stay 1 hour after shot, approx 10 minutes after leaving itching on hair began, progressed to ears and throat tickle.  Took 1 Benadryl which stopped any progression of itching.  Approximately 5pm, had aching, took temp which was 102.4.  Temp remained in 102 range throughout night and all day on Saturday.  Had aches and headache Friday evening and all day on Saturday to migraine level.  Felt like I had been hit by a train.  Temp stayed in the 99-101 range Sunday and 99 range Monday but began to feel better.  Temp ceased Monday evening.  Throughout week was exhausted but no additional headache or temp.
pt recv vax 21JAN99 & on 23JAn99 all day & 23JAn99 pt was crying incessantly w/high pitch cry (6hr crying then rest then crying again);24JAN99 diffuse rash appeared all over body;23JAN99 T102.2 given APAP & DPH w/relief;
Patient received PPSV23 vaccination on 08/14/19.  Since then, he has had painful, expanding area of erythema on the left upper arm.  No fevers.  No nausea, no vomiting.  He otherwise feels well.  The arm is sore to touch.  He has not taken any medication for it. Assessment/Plan:  Diagnoses and all orders for this visit:  Postimmunization reaction, initial encounter  Left upper arm pain  Patient has an exaggerated, but likely normal reaction to the pneumococcal vaccine.  Doubt cellulitis.  Recommended cool compresses to the arm and over-the-counter acetaminophen as needed for pain.  Return precautions were discussed.
Patient admitted after a fall at memory care unit in his assisted Care Facility.  He had been weak, had 5 day history of diarrhea, cough, SOB, and increased confusion.  Currently still hospitalized.  TX: Dexamethasone, azithromycin, rocephin, decadron, and Oxygen (up to 0.5LPM)
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-JAN-2015 the patient was vaccinated with an improperly stored dose of VAQTA 50 unit/ml (lot # J001396, expiration date 02-AUG-2015, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 8 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the highest recorded temperature of 9 Fahrenheit degree. The total cumulative excursion time of the third time was 48 hours with the lowest recorded temperature of 1 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Moderna Covid-19 vaccine expired on 19-Mar-2022 was initially stored in the refrigerator on 27-May-2022; expired booster dose given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired booster dose given) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 19-Mar-2022 was initially stored in the refrigerator on 27-May-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired booster dose given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 19-Mar-2022 was initially stored in the refrigerator on 27-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired booster dose given) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine expired on 19-Mar-2022 was initially stored in the refrigerator on 27-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported Number of doses/vials reported was 1 dose (0.25 ml) The vial did not undergo any temperature excursions.
Red and swollen - patient was given diphenhydramine 15 minutes after immunization was  given.
Left arm where shot was inserted has a large red welt and is hot and itchy. Appeared one day after injection. Has not gotten better two weeks after injection.
Starting in evening pain at injection site. Also including pain in elbow & shoulder joints. VICODIN needed to reduce pain level. Injection site is not hot or discolored. VICODIN only taking the edge off the pain. Patients major complaint elbow joint pain.
5/16- symptoms started- cough, fever body aches. admitted 5/19 with SOB in addition. COVID pnuemonitis, 5/23-sudden decrease in saturation - placed on BiPAP and transferred to the ICU. further decline and arrested on 5/27. PEA and agonal breathing.  intubated and ACLS meds given. Coded a second time and family elected to halt heroic measures.
Shingles rash developed within a few hours of receiving an H1N1 flu shot on November 1, 2009.
Developed a rash going from right arm where shot was given across the back to the left arm.
Patient's left arm experienced redness, swelling, tenderness, and a softball-sized knot near the injection site
trace bogginess noted in 3 small joints of the hands; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from an unspecified date at 11 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. Per clinical notes, reporter stated that she has received both doses of Covid vaccination. She held tofacitinib citrate for 7 days after the first vaccination. She was currently holding after the second dose. Also stated that she was doing well on tofacitinib citrate monotherapy. There was trace bogginess noted in 3 small joints of the hands on an unspecified date. The action taken in response to the event for tofacitinib citrate was post-therapy. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Starting from 2/8-2/9 I noticed itchiness on both my arms and started scratching without thinking too much of it. A few days later I noticed quite a few spots on both arms but mostly on the one where I had my shot (I have pictures to show, if needed). The itchiness continues through now (2/23/2021) and it is almost painful. It also spread to some areas around the neck, upper back and chest. Is it possible that I developed a minor form of chicken pox? I had it already when I was a child. I am wondering: is there something I can use as a relief for the itchiness to help me avoid scratching. Can it be contagious? Could the second dose cause the same side effect? How long do I need to wait to do the Covid test? If given the opportunity, could I take the Covid test in between the two Shingrix doses? Anything else I should know? Thank you in advance for your response.
Patient presented to a local emergency department with fever, intermittent chills, chest and back pain. The pain was worse when lying flat and relieved by leaning forward. Patient reported the onset of symptoms around two weeks after he received his second dose of COVID-19 vaccine .An initial laboratory workup showed mild leukocytosis with white blood cell (WBC) count of  15,000/ cells/mm3, and elevated inflammatory markers of C reactive protein (CRP) was 247?mg/L (normal <5?mg/L). . CT chest with IV contrast ordered to rule out pulmonary embolism which revealed new pericardial effusion. Transthoracic echocardiography showed a large circumferential pericardial effusion without tamponade physiology .Pericardiocentesis and drainage were performed, draining 560 mL of bloody effusion in total. The pericardial fluid was sent for culture, cell analysis, and cytology. Both bacterial and fungal cultures remained negative. A16S rRNA gene amplification and sequencing test was also negative. Cytological examination did not show malignant cells.An intensive work-up for a cause was performed. A computed tomography scan of chest, abdomen and pelvis ruled out tumor masses. Autoimmunity study, quantiferon, antineutrophil cytoplasmic antibody (ANCA), serum angiotensin converting enzyme (ACE) and Lyme serology were all negative. Antibody test for coxcackievirus, CMV, EBV, B19, HHV6, HIV, HCV were negative.Patient was doing well for a week after discharge from the hospital, until he started to have back pain, intermittent fever and chills again. He was admitted again to the hospital and repeated thoracic echocardiogram showed a small precordial effusion. Treatment with ibuprofen  and colchicine started. On a 4-week follow-up, our patient reported a resolution of chest pain. Both colchicine and ibuprofen were discontinued.. Cardiovascular magnetic resonance imaging (CMR) was conducted to exclude possible infiltrative etiology of myopericarditis. The exam revealed no signs of active inflammation  but did show a small area of epicardial enhancement characteristic of prior myocarditis
Received 2nd moderna vaccine 2/12/21. Left arm a bit sore that night at injection site. Woke up 2am with chills, whole arm and left shoulder blade very painful, fatigue. Sunday felt a bit better. Monday improved. Now use arm to hold the phone. Would just hang at the side, very painful. Laryngitis started yesterday, has chronic PND and allergies. Still have some chills, fatigue overall improved. Took tylenol, mindful of transaminitis