chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 2 weeks post 2nd vaccine, I presented to PCP after dealing  with hives and no known reason. I was prescribed a Prednisone titer which resolved this event. This cycle of ideopathic uricaria, unspecified is still occurring despite multiple prescriptions for Prednisone and Hydroxyzine even now. I was referred to an allergist for testing, which was accomplished on June 24th; no specific enviromental allergen; so labs were ordered with same result. PCP and allergist suggested Xolair as an option if nothing else gave a longer or lessening of symptoms since traditional pathways have had minimal effect.
Patient came into pharmacy on June 22nd, 2021 stating she had swelling underneath her left armpit after receiving her second COVID vaccination on June 19th, 2021. The swelling began on June 20th, 2021 and has gradually decreased in size over time. The pharmacist, counseled the patient that there have been reports of lymphoedema following COVID vaccination. She recommended the patient follow-up with her primary care provider for further evaluation.
At about 7 p.m., roughly seven hours after the shot, I started feeling a burning sensation in my right arm that I figured was probably a normal reaction so I didn't think much of it. By 9 p.m. the same burning sensation was occurring in my left arm. I took an Advil PM and went to bed but the burning continued to spread. By midnight, both arms, my thighs, feet, hands and abdomen were all on fire. I had a splitting headache as well, but that may have been from the stress of not being able to stop the burning all over my body. This continued throughout the night. My plan was to go to the emergency room if it continued to the morning. But sometime between 5 and 7 a.m. it stopped. Thank God!!
11.5 x 13cm Local reaction noted: warm to touch but do not feel cellulitis noted by Dr.
Information has been received from a physician concerning a 11 year old Caucasian female with no relevant medical Hx who on 05/08/1999 was vaccinated SC in the arm with a 0.5ml first dose  of varicella virus vaccine, live. There was no concomitant medication. There was no illness at the time of vaccination. On 04/13/04, the pt presented to the office with chicken pox (about 100 lesions), also described at typical chickenpox presentation which lasted 1 week, with fever. There were no relevant laboratory or diagnostic tests performed. The pt sought medical attention but no medications or treatments were given. Subsequently, the pt recovered on 04/21/04. No product quality complaint was involved. No further information has been requested.
This spontaneous report was received from a medical assistant refers to unspecified 13 patients of unknown age and gender. This report pertains to the patient who on 01-JUL-2013 was vaccinated with VARIVAX (Merck), (lot # H014074, expiry date 20-JUL-2014) 0.5 milliliter (ml), subcutaneous. The medical assistant reported that improperly stored VARIVAX (Merck) that was exposed to unsupported temperature conditions was administered to an unspecified patient. No adverse effect reported. No further information was available. This case is linked to 1312USA009865, 1312USA009866, 1312USA009867, 1312USA009868, 1312USA009869, 1312USA009870, 1312USA009871, 1312USA009872, 1312USA009873, 1312USA009874, 1312USA009875 (Same reporter link). Additional information has been requested.
Tingling Below Chin; Tingling Eye; Tingling Nose; Tingling Upper Lip; Tingling Chin; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling Eye), PARAESTHESIA (Tingling Nose), PARAESTHESIA ORAL (Tingling Upper Lip), PARAESTHESIA (Tingling Chin) and PARAESTHESIA (Tingling Below Chin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 23M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PARAESTHESIA (Tingling Eye), PARAESTHESIA (Tingling Nose), PARAESTHESIA ORAL (Tingling Upper Lip) and PARAESTHESIA (Tingling Chin). On an unknown date, the patient experienced PARAESTHESIA (Tingling Below Chin). At the time of the report, PARAESTHESIA (Tingling Eye), PARAESTHESIA (Tingling Nose), PARAESTHESIA ORAL (Tingling Upper Lip), PARAESTHESIA (Tingling Chin) and PARAESTHESIA (Tingling Below Chin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had been taking Benadryl. The patient went to ER where she was ruled out with a stroke and heart attack.   Reporter did not allow further contact
left Cranial Nerve VI palsy with diplopia which has not resolved/is permanent. a few months later, I also developed left Cranial Nerve III palsy with ptosis which has not resolved/is permanent. On 9/9/2022 I received a 4th Covid vaccine (Moderna bivalent) at Pharmacy.  The next day I had a severe outbreak of pityriasis rosea, and over the next few weeks the left cranial nerve III palsy worsened. Medical work up including MRI of brain, lab work, coagulation studies, consultation with ophthalmologist, neurologist and rheumatologist has been negative for other etiologies.
TTP-HUS (Thrombotic Thrombocytopenic Purpura - Hemolytic Uremic Syndrome) treated with plasmapheresis and blood transfusions. 4 days in ICU.
With erythema, redness to (L) lateral/posterior forearm. No fever, no SOB, received ZOSTAVAX 8/27/09.
rash all over her body; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number L9F99, expiry date 10th May 2022) for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient suffered of rash all over her body after Shingrix first dose. The pharmacist was looking for common adverse reactions after Shingrix. The reporter consented to follow up.
flu like symtoms with fever, chills, achy, tired for about 2.5 days For first shot, rash appeared on arm about 9 days later, this time it was 24 hours later, it has been there for 2 days so far. I am watching it. Noticed lumps in right breast with tenderness as well. will follow up with a doctor on Monday.
Tenderness in left armpit- onset 5 days after injection  Redness, swelling, itching, warm to the touch injection site- onset 7 days after injection
Shingles approximately 2 weeks after first moderna vaccination.  And Shingles again after second moderna vaccination.  A friend also developed Shingles approximately 2 weeks after receiving the first Pfizer vaccination.  A co-worker of my real estate also developed shingles after receiving the covid19 vaccination.
Patient received moderna vaccine on 2/13/21, 3/13/21 and 10/30/21. COVID positive on 5/4/22. Presented to ER on 4/30/22. Patient presented to ED with R sided flank pain going on for more than a week. Upon evaluation patient found to have pulse oxygen of 64% on room air.  Patient was started on nasal cannula oxygen and subsequently on BiPAP.  Throughout the course in the ED patient remained alert and orientation, patient was also found to have hypertension and received 1 L of normal saline in the ED, x-ray chest and CTA chest did suggest ground glass opacities on the right side of lung which were suspicious for infectious process/chronic pulmonary disease.  CT abdomen pelvis was also performed.When he arrived to the IMC on 4/30/22 requiring 10 L of high-flow oxygen. Admitted due to resp failure and STEMI.  It was noted that he was on ventilator initially, extubated and then reintubated.  Pt last extubated on 5/15/22.  Pt's breathing has progressively improved.  Pt completed antibiotics for pneumonia. treated with steroid and remdesivir and meropenem. Discharged on 6/3/22
this is one of four patients who devel fever, redness & tenderness @ the inj site;no further details known at present;
Information has been received from the mother of an 8 year old male, with no known allergies, who in August 2001, was vaccinated with varicella vaccine live. There was no concomitant medication. In February 2002, the pt experienced a seizure. On 06/02/2002 the pt developed a rash. On 06/03/2002, the pt developed breakthrough chicken pox and had less than 50 lesions. The pt did seek medical attention.  Upon medical review seizure was considered an other medical event. Additional info has been requested. Initial info has been received from the mother of an 8 yea rold male and follow-up info has been received from the registered nurse and physician regarding the male pt, with no known allergies, who in 08/24/00, at age 5, was vaccinated with varicella virus vaccine live, SC in the left arm (lot 635459/0759K). There was no concomitant medication. In February 2002, the pt experienced a seizure. On 06/02/02 the pt developed a rash. On 06/03/2002 the pt developed breakthrough chickenpox and had less than 50 lesions. Also on 06/03/02 the pt was seen in the physician's office and the pt's body temp measurement was 101 degrees F. The pt had red marks on the face and chest. There were no vesicles or blisters noted. The pt also developed mild tonsillitis. The pt had possible early chickenpox. "Later on," the mother reported that the pt developed 40 chickenpox lesions and the pt was not treated with any medication. The pt did recovere from chickenpox and tonsillitis. The pt did seek medical attention. Upon internal review seizure was considered an other medical event. Additional info is not expected.
Initial information received on 18/Sep/2006 from a consumer.  It was reported that a 49-year-old female patient received a first dose of YF-VAX, lot number UE888AA, administered in the left arm, a dose of Hepatitis B vaccine (manufacturer unknown) and a dose of oral Typhoid vaccine (manufacturer not reported) on 05/Sep/2006.  Two days later, the patient developed double vision in her left eye.  She also experienced numbness and tingling on the left side of her face and in her left arm.  A computerized axial tomography scan was performed on 16/Sep/2006 but no results were provided.  The patient was scheduled to see an opthoneurologist on 18/Sep/2006.  At the time of this report she had not recovered from the events.
Immediately after completion of vaccine administration, pt became rigid and unresponsive for aproximately 2-3 minutes per administering LPN and pt's mother.  Immediately following rigidity, patient vomited.  After vomiting, patient became alert and oriented x 3.
Pain at the injection site for the first couple of days which affected my sleep quality. Slight chest pain starting September 16 that lasted until September 22. On September 22, I saw a doctor virtually and they advised me to avoid intense exercise, take over the counter pain killers like advil, and monitor symptoms but didn't prescribe me any medicine.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received a dose of Moderna vaccine from a vial punctured and used for more than 12 hours) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037F21A) for COVID-19 immunization. No medical history reported. On Oct 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Oct 4, 2021, patient administered expired product (patient received a dose of Moderna vaccine from a vial punctured and used for more than 12 hours). At the time of the report, administered expired product (patient received a dose of Moderna vaccine from a vial punctured and used for more than 12 hours): resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Prolonged screaming, crying s/p immunizations (6-8 hours) duraiton.
Muscle soreness in bottom going down legs, almost like did 100 squats day before. Ok when walking, but difficult to sit down. Started day after shot, has not gotten better.
pressure mainly at her right ear; hives; mild heart pounding; fast heartbeat; nausea; pressure headache: 6/10; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (pressure mainly at her right ear), URTICARIA (hives), PALPITATIONS (mild heart pounding), HEART RATE INCREASED (fast heartbeat) and NAUSEA (nausea) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (pressure mainly at her right ear), URTICARIA (hives), PALPITATIONS (mild heart pounding), HEART RATE INCREASED (fast heartbeat), NAUSEA (nausea) and HEADACHE (pressure headache: 6/10). At the time of the report, EAR PAIN (pressure mainly at her right ear), URTICARIA (hives), PALPITATIONS (mild heart pounding), HEART RATE INCREASED (fast heartbeat), NAUSEA (nausea) and HEADACHE (pressure headache: 6/10) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
no additional information available or provided; VARlVAX underwent a temperature excursion and was then administered to a patient; This spontaneous report was received from a reporter with an unspecified qualification (reported as "administrator") and refers to 7-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 05-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, lot # U022732was confirmed to be valid, expiration date 20-JUL-2023, for prophylaxis (route and site of administration were not reported).  The administered dose was exposed to the temperature of 12 degrees Fahrenheit (F) for 9 hours and 38 minutes. There were also previous temperature excursions reported as follows: 9.7 F for 2 hours and 41 minutes; 10.8 F for 2 hours and 45 minutes; 10.6 F for 4 hours and 16 minutes; 11.1 F for 3 hours and 14 minutes; 10.9 F for 4 hours and 43 minutes; 10.8 F for 2 hours and 17 minutes; 18.3 F for 2 hours and 36 minutes; 18.7 F for 3 hours and 4 minutes; 12.4 F for 9 hours and 43 minutes; 17. 4 F for 24 hours and 0 minutes; 19.9 F for 10 hours and 57 minutes. No additional information was available or provided.
Shingrix given 6/10, rash began evening of 6/11. On 6/12 rash spread over entire body seen in clinic 6/12 - antihistamine prescribed
no advesre effect; patient received her first dose of gardasil 9 on an unspecified date about a year ago and was in the office on 6/10/2019 to receive second dose; This spontaneous report was received from a medical assistant refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date in approximately 2018 (reported as about a year ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# and expiry date were not reported) for prophylaxis and the patient was in the office on 10-JUN-2019 to receive the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration). It was reported that there was no adverse affects reported (no adverse event). No PQC was involved.
Severe pain in injection site. Coughing progressed to wheezing and extreme difficulty breathing. Fluid expelled from the lungs. Heart rate elevated.Was given medication and breathing treatments at Hospital ER. Had two more episodes after medication was given.  11/18/08 Reviewed hospital medical records of 11/13/2008. FINAL DX: allergic reaction to flu shot Records reveal patient experienced SOB, wheezing, coughing, nausea, vomiting x 1 day.  In ER was hypertensive, tachycardic w/O2 sat of 86% on RA.  Tx w/antihistamine, steroids, nebs.  Admitted overnight for observation.  Responded well to treatment & d/c to home on continued oral antihistamine, inhaler, antiibotics & steroid taper.
Rash started on face then turned to lesions around eye as well as face and nose that will not heal. Headaches, brain fog and inflammation as well. Been to Dr. Office over 10 times, dermatologists 3 times, ER two times and Psych Ward for 2 weeks all related to lesions on face that will not heal and have strange black discharge.
Seen in clinic 10/21/09 with cough, congestion, and "feels hot". Prescribed TAMIFLU on 10/21/09 and given intranasal H1N1 vaccine on 10/21. Subsequently apparently had flu-like symptoms and tiredness for unspecified period of time and apparently found unresponsive in home. Resuscitation unsuccessful.
Child received Infanrix and Havrix IM on 10/30/19 IM in Right Vastus Lateralis around 9AM. He started with a low-grade fever around 4pm of 99 degrees. It did elevate to 101.6 per ear thermometer later Wednesday night. Mom gave him Tylenol throughout the night. On 10/31 the fever remained around 99 degrees. He was not himself. No real appetite. By 2pm, the child started having a seizure. EMS was called and he was taken by ambulance to the ER. His seizure lasted a total of 90 minutes from start to finish. The ER doctor felt this was a Grand Mal type seizure. He had an MRI, chest x-ray and spinal tap to rule out infectious nature for seizure. All were negative and no meningitis was noted. Genetic testing has been done and results are pending. Child is on anti-seizure medication and being followed by a Pediatric Neurologist- Dr. No further seizure activity for the child when mom called on 11/5/2019. Child's activity was back to normal.
I felt pretty fatigue and my leg was aching a couple of weeks after receiving my booster. My leg was hurting pretty bad to the point where over the weekend I couldn't get the pain out of my mind. The following Monday morning, I called my doctor to try to get an appointment to be seen, but they couldn't take me in that day and my doctor urged me to go to the emergency room. So I went to the ER and they took blood and completed an ultrasound; they noticed a blood clot in my right leg and gave me some blood thinners there to take as well as prescribed me to some blood thinners to take for the next 3 weeks. I was told to take it very light for the next couple of weeks as I'm taking the blood thinners. So now I'm taking these pills until I'm cleared.
Information has been received from an unspecified reporter referring to an 11 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003650.
PT REPORTS WAKING WITH HEAD ACHE, NAUSEA, FEELING EXHAUSTED. THURSDAY 7/2 PT REPORTS FEELING OF HEART POUNDING, RACING, HEART PAIN. STATES IT REMINDS HER OF WHAT SHE FELT WHEN SHE HAD THE SHINGLES YRS AGO. DESCRIBES SITE AT WHICH VACCINE ADMINISTERED, PUFFY, RED, WARM TO TOUCH. AREA OF REDNESS IS A RECTANGULAR SHAPE PT STATES. PT FELT BETTER OVER WEEKEND 7/4 & 7/5 THEN STATES MONDAY 7/6 FELT HEART POUNDING FOR ABOUT 1 HR. AND SLIGHT NAUSEA, BUT FEELING BETTER THAN BEFORE. PT DID NOT REPORT REACTION UNTIL 7/6/09 AFTERNOON. PT INSTRUCT TO SEE DOCTOR IF SYMPTOMS WORSEN. PT WAS NOT SEEN BY DR AND NO TREATMENT FOR REACTION.
(L) arm (site of the injection) (+) localized erythema, swelling - large wheals - (-) lymph nodes. RRR. ENT: normal. LCTA.
acute myopericarditis which occurred 2 months after  administration of 2nd dose of  Pfizer Covid-19 mrna  vaccine
increase in blood sugar; grogginess; sweats; chills all night; pain at injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (increase in blood sugar), SOMNOLENCE (grogginess), HYPERHIDROSIS (sweats), CHILLS (chills all night) and VACCINATION SITE PAIN (pain at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (chills all night), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (headache). On 13-Feb-2021, the patient experienced SOMNOLENCE (grogginess) and HYPERHIDROSIS (sweats). On 16-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (increase in blood sugar). At the time of the report, BLOOD GLUCOSE INCREASED (increase in blood sugar), SOMNOLENCE (grogginess), HYPERHIDROSIS (sweats), CHILLS (chills all night), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: increase (High) unknown.         No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: NNI
I continue to have nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (I continue to have nausea) 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 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced NAUSEA (I continue to have nausea). At the time of the report, NAUSEA (I continue to have nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: decreased (Low) lost 14 pounds.         No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # R013565, expiry date 13-MAY-2020 (exact dose and route of administration were not reported) for prophylaxis, reconstituted with properly stored sterile diluent. The doses of vaccine were stored between 6 degrees Fahrenheit (F) to 14F (10.6F) for 96 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1810USA002750.