chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After I administered the flu vaccine, the patient stood up and I told her we were still processing her significant other's vaccination at the other counter. I told her she can "relax and hang out in flu shot area" while we get his flu shot ready. After we processed his vaccine, I was preparing it at the counter in front of the flu shot station. Her significant other called for my attention and his arms were wrapped around her head and shoulders. This was approximately 5 minutes after administering her flu shot. She was becoming unconscious and she started urinating on herself. Immediately, I called for my technician to dial 911 and a team member. I declared to her significant other that I was going to administer the EpiPen and then administered it to her left thigh. She then regained consciousness and was able to speak to us. Her significant other questioned how much she ate that day and she only ate one meal. While we were waiting for EMS to arrive, I was monitoring her heart rate and breathing. When EMS arrived, she said she had a history of fainting in the past with a nose piercing and has become light-headed when getting blood drawn. On the vaccine screening and consent form, question #3 states. "Do you have a history of fainting, particularly with vaccines?" - she marked no as her answer. She was able to speak, eat, drink, and to stand up to be placed on the stretcher to be assessed by EMS. I called within 24 hours to follow-up with the patient but she did not pick up and I was only able to leave a message.
Soreness; feeling stiff; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-089449), for BNT162B2. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on unspecified date as a dose number unknown, single for COVID-19 immunization. The patient medical history included C55 uterine cancer, Shingles (she has been on Gabapentin since her Shingles outbreak). The patient started taking other medication on 25Feb2021 which included lenvatinib mesylate (LENVIMA) and pembrolizumab (KEYTRUDA). On an unspecified date the patient advised that she had been feeling stiff and sore the last few days. Patient got the COVID shot from Pfizer a few days ago. Soreness appeared after that. Patient advised some of the discomfort follows the same areas as she shingles outbreak, she had last year. Patient had been on gabapentin since her Shingles outbreak. Patient receive the treatment of tylenol and occasional a tramadol for soreness and stiffness. Patient was advised to seek healthcare care professional guidance on what to do for this issue. Patient believed that it was a combination of lenvima, keytruda, and the COVID shot that are causing patient's issues. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
1325: complain of itching to face and upper back. small hive noted on front of neck and small rash on upper back.  HR 89. Bp 125/83. RR 16. oxygen saturation 95% at 1325 Benadrly 25mg IM given. 1336: Dr had patient stay an additional 30 minutes.  1350: VS- BP 114/79. HR 73. RR 18. Oxygen 96%.  1355:itching improved. patient feeling tired from Benadryl. rash is lighter. VS- Bp 109/77. HR 72. Oxygen 96%. RR 18.  1400: patient discharged to home.
Large hive-like rash covering injection site (about 2.5 in wide and 3.5 in long) which appeared about 2 weeks (16 days) after vaccine. Rash is raised, red, mildly itchy and mildly tender. Upper arm is weak and sore, much like it felt for the 2 days post vaccine. I am treating with cold compress and bendadryl.
Patient was born a normal healthy baby. He spoke at least 5 words and hit all his major milestones. He had a lot of ear infections in that 1st year, but we always were able to heal them using antibiotics. On his 1st birthday, he received 5 shots, I told the Dr. he was not feeling well and she didn't act at all concerned. We left and about 2 hours after the shots, he spiked a fever of 102. We called and the Dr. said it was normal, to give him Tylenol. We moved the next day. When we arrived, he was quite ill. We saw my mothers Dr. since we had just arrived and hadn't picked a pediatrician yet. They put him on antibiotics for an ear infection. It didn't work. They put him on another antibiotic and it seemed to start working then he fell ill again. His behavior was becoming different and he wasn't sleeping well at this point. We went to a different Dr. and they did the same thing, yet another antibiotic. After about 6 different rounds of antibiotics he finally stopped having fevers. But there was still something wrong. He had begun to flap his hands wildly at the TV. I recall thinking I hadn't heard his voice in a while. We wrote it off to him not feeling well during the antibiotic-fest, but he wasn't sick anymore. I knew he had stopped talking. Then he turned yellow, not his eyes, but the bottoms of his feet and the palms of his hands, and a hue of yellow all over his skin. We went to the Dr. and he said it was due to overeating carrots and other yellow veggies. This was not possible because patient was fixated lately on nothing but spinach and pudding. That's about all he would eat. The yellow began to fade a bit but he still wasn't right. The behaviors were getting worse by the minute. He started smearing his feces all over the walls and floors. He also ate it. He ate everything he wasn't supposed to. Not like a baby mouths things but obsessively eating everything. He was fixated on the floor. He would make these odd noises (which he still does to this day) and flap at the floor. He was throwing things, knocking things over, biting himself, and others, he pooped 5-8 times a day. On patient's 2nd birthday, he was diagnosed as severely autistic. I couldn't understand. I hadn't read a word about vaccines and autism at this point and always attributed the illnesses he had for the last year to his shots.
remote sudden mesenteric ischemia 2 1/2 months after vaccination with subsequent gangrenous colon and hemicolectomy
I experienced photosensitivity, pain, and eye redness in my left eye on 4/7/21. I was diagnosed with anterior uveitis on 4/8/21, then a week following treatment (with steroid eye drops) was experiencing worsening symptoms including blind spots, greater photosensitivity, and headaches, this time in both eyes. I followed up with my eye doctor on 4/23/21, who directed me to go to Hospital . There, I had an X-Ray, MRI, and multiple blood tests. Nothing impressive resulted, so I was discharged from the hospital with instructions to see the retina specialist, steroid eye drops and atropine eye drops to keep my eyes dilated. The retina specialist saw me on 4/29/21 and diagnosed me with bilateral panuveitis, and instructions to follow up with a rheumatologist to rule out autoimmune disease. I was treated with 50mg of Prednisone for 4 weeks with a 4 week taper and steroid eye drops 6 times a day for 4 weeks with a 6 week taper. We agreed to discontinue the use of the atropine drops because it was difficult for me to work with dilated eyes. About 2 weeks into tapering the eye drops, I noticed that my left eye became dilated as well as a continuing scotoma in my left eye. I followed-up with the retina specialist, who directed me to the neuro-ophthalmologist. The neuro-ophthalmologist said that the dilated pupil was idiopathic and I did not exhibit anything that could have contributed to it. However, to be safe, I received a lumbar puncture on 6/16/21. Those results were also not impressive. Multiple follow-up appointments have shown that the inflammation in my eyes has subsided. I followed-up with a rheumatologist who has told me there is no autoimmune cause to this (I had bloodwork done to back this up).
Unable to give full details of adverse event, patient died on Hospice.  Tested for Covid-19 on 09/09/2021, with positive results.
Arm was really sore; The spot of the injection was raised feverish; The spot of the injection was raised and bumpy; The spot of the injection was red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was really sore), VACCINATION SITE WARMTH (The spot of the injection was raised feverish), VACCINATION SITE SWELLING (The spot of the injection was raised and bumpy) and VACCINATION SITE ERYTHEMA (The spot of the injection was red) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was really sore), VACCINATION SITE WARMTH (The spot of the injection was raised feverish), VACCINATION SITE SWELLING (The spot of the injection was raised and bumpy) and VACCINATION SITE ERYTHEMA (The spot of the injection was red). At the time of the report, PAIN IN EXTREMITY (Arm was really sore), VACCINATION SITE WARMTH (The spot of the injection was raised feverish), VACCINATION SITE SWELLING (The spot of the injection was raised and bumpy) and VACCINATION SITE ERYTHEMA (The spot of the injection was red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication were provided. No Treatment Medication were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant FU - event outcome was updated from unknown to resolved .
This spontaneous report as received from a pharmacist refers to a 25 years old female patient. No information on the patient's pertinent medical history, current conditions, drug reactions and allergies was provided. On 10-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (lot# N022704, expiry date: 27-FEB-2019), dose was not reported, subcutaneously, to prevent pneumonia. Concomitant therapies included influenza virus vaccine inactivated (unspecified). On the same day (reported as "later that evening"), the patient developed: fever, hot sweats, injection site redness, swelling, pain and it was hot to touch. The patient sought medical attention and went to the doctor's office. She was treated with unspecified antibiotics and was instructed to stay home from work for an unspecified time. She was scheduled for a future appointment on an unspecified date, to be tested for methicillin-resistant Staphylococcus aureus (MRSA). Product quality complaint (PQC) was not involved.  At the moment of reporting, the patient had not recovered from the events. The causality assessment was not reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA007624: US-009507513-1710USA007828: US-009507513-1710USA008051:
shingles rash appeared bi-laterally on the patients face; This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 12th February 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2020, 7 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The shingles rash appeared bi-laterally on the patients face a week after receiving the vaccine. The reporter consented to follow up.
Rash consistent with chickenpox on face, trunk, legs - onset 1/17/2006.  Diagnosis 1/19/2006. Caladryl to rash PRN.
not sleeping well /can hardly sleep for 5 to 10 minutes/cannot go back to sleep for few hours; back ache from neck down area; knot in the arm; feeling of no energy,did not get her cycle for 5 weeks; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back ache from neck down area), SKIN MASS (knot in the arm), SLEEP DISORDER (not sleeping well /can hardly sleep for 5 to 10 minutes/cannot go back to sleep for few hours) and FATIGUE (feeling of no energy,did not get her cycle for 5 weeks) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced BACK PAIN (back ache from neck down area), SKIN MASS (knot in the arm), SLEEP DISORDER (not sleeping well /can hardly sleep for 5 to 10 minutes/cannot go back to sleep for few hours) and FATIGUE (feeling of no energy,did not get her cycle for 5 weeks). At the time of the report, BACK PAIN (back ache from neck down area), SLEEP DISORDER (not sleeping well /can hardly sleep for 5 to 10 minutes/cannot go back to sleep for few hours) and FATIGUE (feeling of no energy,did not get her cycle for 5 weeks) outcome was unknown and SKIN MASS (knot in the arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Unconscious; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Unconscious) in a patient of an unknown age and gender 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 LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Unconscious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.  Company Comment: Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.
Child awake in the am on 09/15/01 with am intense red rash on abdominal, face, arm and legs. No other symptoms of illness. Just rash, Mom stated child has had heat rash before but this is different from what she has seen. Mom was required  to take child to doctor or 09/17/01. 11/20/01 mom reached, said rash went away 1 day later. Doctor agreed it was vaccine related.
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: sleepy the night of injection-Mild, Systemic: Nausea-Mild, Additional Details: pt contacted  to report adverse rxn . pt is familiar and would like to report it.
Received SPV on 23 Jul '14 and 14 days later developed acral papulovesicular eruptions on knees and elbows which are painful and pruritic. On 8 Aug pt went to ER and the VHC Call Center was contacted. Pictures were sent and a short history taken on pt. This patient was given steroid cream for his lesions and told to F/U with his PCP on Monday. Today, patient was called and his cream is gone - applying clobetasol 0.05% cream tid - and is very uncomfortable. Consulted with Dr and it is agreed that patient should go to local ER and receive oral prednisone 50mg po qd x 10 ds, then 40mg x 2ds and decreasing doses by 10 mg until weaned.
Pt recvd vax & w/in 1 hr devel chest tightness, lip tingling & became flushed;
Within 2 days baby had a seizure, stiffened body and seen in ER. Basic labs CBC, U/A, BMP, CXR - WNL.
Evening of vaccination felt fine, arm a little sore at injection site. Morning after vaccination had flu-like symptoms, e.g., headache, slight fever, body aches, sleepy. Sept most of the day. Morning of second day after vaccination felt good (normal) but notice rash and felt soreness in upper left arm. No change in rash over the course of the day.  Prescriptions (continued): Xarelto 20mg
Arm sore; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030NE0A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer and Shoulder prosthesis user.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (Arm sore) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Triggered adrenal crisis/event (identical to same I usually experience every 3-4 months) Hot flashes, tremors, headache, nausea/vomiting, diarrhea, erratic heart rate, passing out.  Lasted approx 3 days
3 values in heart not working. Aorta stenosis and trouble with lungs. Constant cough and choking murmur.  Fevers on and off sleeping sweats and chills.  Pressure in chest and back.
Patient received Rabies Post Exposure Vaccine (Imovax) for Dose #2/Day 3, on 6/18/2009 at 10:00 a.m.  At 1:35 am, patient was transported to hospital.  Patient had fallen and was unconscious.  Patient remains hospitalized in ICU.  Cause of fall and current diagnosis unknown. Rabies post exposure vaccine will be continued in hospital, per protocol.  8/26/09 Hospital records received 6/19/09 to 7/8/09. Assessment: Acute and chronic alcoholism, status post fall, bilateral deep venous thrombosis both lower extremities, status post enterococcus upper respiratory infection. Rabies series initiated after a skunk bite. Patient admitted for complications of his fall. Closed head trauma, left occipital contusion, cerebral concussion. Alcohol and opiate withdrawal. Admitted to psychiatry for evaluation and recommendations regarding the patient's history of drug and alcohol dependence and depression. While in the hospital the patient had his rabies vaccine series, which had been started outpatient, completed.
a raised lesion appeared near injection site/Raised skin lesions appeared all over my legs, arms and torso; Lichen Planus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 11:45 (Lot number: EN6205) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VENLAFAXINE; LOSARTAN. The following information was reported: SKIN LESION (non-serious) with onset 18Mar2021 15:00, outcome "recovering", described as "a raised lesion appeared near injection site/Raised skin lesions appeared all over my legs, arms and torso"; LICHEN PLANUS (non-serious) with onset 18Mar2021 15:00, outcome "recovering", described as "Lichen Planus". The events "a raised lesion appeared near injection site/raised skin lesions appeared all over my legs, arms and torso" and "lichen planus" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin lesion, lichen planus.  Additional information:The patient was not diagnosed with COVID-19,Prior to vaccination. The patient had not been tested for COVID-19,Since the vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Product: COVID 19 Brand: Pfizer ;Brand unknown: False;Lot number: ER8727,Lot unknown: False;Administration date: 07Apr2021;Administration time: 02:00 PM;Dose number: 2 Vaccine Location: Left arm  No follow-up attempts are possible. No further information is expected.
Parent noted a lump and redness at vaccine site left thigh. No fever. Has rash over chest, abdomen and neck. Cool compress to area. TYLENOL for discomfort. F/U if symptoms worsen.
6 days after receiving vaccine - pt called to say she had severe itching/pain starting in arm pits - traveling around bacK and turso.
Incident details: Per Dr. (medical director) email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (pfizer) in error as patients are now only supposed to receive the bivalent booster per Dr. email. Pt was due for booster at the time they received it, however the bivlalent booster was not yet stocked at company. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation  of monovalent covid boosters until company receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also ?monovalent? and ?bivalent? are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Vancouver Clinic receives the bivalent vaccines. Staff and providers were notified via email, social media, and verbally. Incident reported to VAERS.
Pt vax w/ 3 doses; 05Dec90 titer indicated non-responder.  Booster dose from diff lot given 8Jan91 & titer done 25Feb91 revealed the pt seroconverted.
3 weeks after shot, numbness and tingling in right hand  3 weeks after that speech problems, trouble swallowing, loss of use of hand,  went to the ER on May 18 with a blood clot in brain causing stroke.
Patient reports painful left arm since day of injection. States she cannot sleep on her arm and her arm is painful to the point of her being unable to complete exercises for a chronic back injury. Feels like she has been punched in her arm and the feeling has not gone away.