chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant and a nurse practitioner, for the pregnancy registry for GARDASIL, concerning a 23 year old female patient with Glioblastoma multiforme in 2007, cholecystectomy in 2001, history of smoking and asthma, and with a history of 4 pregnancies and a 4 full term deliveries, who on 08-NOV-2007 was vaccinated the first 0.5 ml dose of with GARDASIL (Lot #654540/1209U).  The patient became pregnant after receiving the vaccination.  Her LMP was 18-DEC-2007. Estimated conception date was 15-DEC-2007 and EDD was 26-SEP-2008.  Other medications used during pregnancy included MONISTAT on 11-apr-2008 for yeast and prenatal vitamins 7 tablets once a day on 11-APR-2008.  Prenatal care panel were performed.  On 07-FEB-2008 ultrasound was performed for SGA with the result of pregnancy 5 week 6/7 day; on 25-APR-2008 amniocentesis was performed for SGA with the result of pregnancy 5 week 6/7 day;  on 25-APR-2008 amniocentesis was performed for SGA with the result of pregnancy 17 week 2/7 day, and MSAFP was performed for screening with the result of Neg x4.  On 24-SEP-2008 the patient had a normal female infant (6 pounds, 10 ounces) with no congenital anomalies.  Other complication was choroid plexus cyst.  There was not complication during pregnancy and labor/delivery, and not infections or illness during pregnancy for the patient.  BS monitoring per 6 AM was performed during pregnancy.  Follow up information was received from a nurse practitioner.  She reported that the fetal choroid plexus cyst was noted only prenatally on a mid-trimester ultrasound.  On 10-JUN-2008, at 25 weeks EGA, the patient had a  follow up sonogram with a perinatologist who said the cyst had resolved.  No further testing was done or needed.  The reporter also noted that the baby was fine with no problems and no anomalies.  Additional information is not expected.
Pain to lateral superior deltoid m. Received flu shot on 10/15/14 and states she is unable to raise Lt arm above shoulder since then.
Patient experienced syncope w/a vasovagal reaction.  Patient awoke after 10 seconds.  Juice given.  Patient observed for 30 minutes.  symptoms resolved, patient discharged.
Chest tightening and redness around arm the size of a half dollar. Very hot to touch and painful.
Moderna COVID-19 Vaccine EUA  Sore arm (before 1pm) Sensitive skin (around 8pm) skin more sensitive (like a cold/flu coming on, ~9:30pm)
21AUG97 PM fever, chills, irritable & drowsy;22AUG97 AM fever, chills, irritable, & drowsy;PM better went to aunt's house w/no further sx;23AUG97 PM aunt reported hives on knees & calves relieved w/DPH;
Myalgia, Fever,  Chills, Flu-like Symptoms Narrative:  Symptoms lasted for 3 days
Child was cramping and diarrhea initially..then red foam from his mouth and lungs.
Tdap given IM Lt deltoid on 8-12-08.  That night she noticed dime size sore knot to Lt neck, below skull (lymph node?), also c/o joint pain, tiredness, aches.  Today, 8-14-08, continues to c/o sore, dime size knot to Lt neck.  Referred to MD for evaluation.
Information has been received from a 69 year old female patient referring to herself. The patient's concurrent condition included asthmatic bronchitis about 2 or 3 years ago. The patient's concomitant medication included fluticasone, rosuvastatin, loratadine and VENTOLIN. The patient had no drug reactions/allergies. On 15-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (.5ml once, route was reported as injection (unspecified); strength, lot# and expiration date were not reported) for prophylaxis. On the same day, 5 to 6 hours after receiving the vaccination the patient experienced pain, swelling and redness in the arm she received the vaccination in. The patent also stated that she later "came down with extreme chills and uncontrollable shakes and had trouble moving, walking and speaking (significant disability or incapacity was reported on 17-DEC-2018)." The following morning (16-DEC-2018) the patient woke up with a fever, a headache and lethargy. The following Monday the patient spoke with a pharmacist and was told that the PNEUMOVAX 23 probably gave the patient a mild case of pneumonia. The patient also stated that she had seen another patient indicate on social media that the other patient experienced the same AE after getting PNEUMOVAX 23 but it lasted for about a week. The patient did not want to provide any additional AE information for this other patient (captured in MARRS# 1901USA002740). The patient spoke with a pharmacist to seek medical attention. No treatment was given. No lab test was performed. The patient also stated that she at the reporting time took 5mg of generic ezetimibe (manufacturer unknown) daily because she "can't handle" a 10mg dose. The patient also stated that she was "sensitive" to many unspecified medications and often need to take a smaller dose of these other unspecified medications than "other people." The patient did not specify which medications she was sensitive to or what she meant by "sensitive". Action taken with of ezetimibe (manufacturer unknown) was unknown. The outcome of the events was reported as recovered. The causality between the events and PNEUMOVAX 23 and ezetimibe (manufacturer unknown) was not reported. Upon internal review, pneumonia was determined to be medically significant. This is one of two reports which have the same reporter. Sender's Comments: US-009507513-1901USA002740.
Pt recvd vax & exp extremely itchy, red & hot inflamed deltoid associated w/dizzy strange feeling & nausea;
I broke out in a rash in several different areas of my body. I had some allergy testing done at the dermatologist and was treated with cetirizine and famotidine.
Patient said she developed bursitis in both arms that required a cortisone shot from her doctor.  She said it developed about a week after she had the vaccine.
Client was screened as per CDC guidelines and had no contraindications for receiving the vaccine on 4/14/2021. LCHD had no notice of any adverse issues. He did not present to the 2nd dose clinic and follow up phone calls revealed that he had died on 4/28/2021.
grandmother's who is legal guardian stated pt had rash, blisters over entire body to ER. diarrhea; took pt to ER & was treated w/DPH;
Pt received Moderna Covid vaccine Lot #010A21A in R deltoid on 2/26/21 and developed itching of arms and legs in first 15min of observation. Pt sat an additional 15 minutes and developed redness on right arm and continued itching in both arms and legs.  Pt felt it was a similar reaction that she had previously to contrast dye.  Pt was offered Benadryl and declined but then was getting ready to leave and changed her mind.  She was given 50mg IM Diphenhydramine and asked to wait an additional 15 minutes.  She said symptoms were improving at that time and was allowed to leave.
Patient who is 11 years old and 10 months received Pfizer covid shot that is approved only for 12 years or older
I had adverse event to both vaccines, The second was and second dose EL 8982  Both times I had a slight fever. Painful enlarged lymph node in left armpit. Body aches that kept me up at night. And feeling mentally cloudy. Symptoms lasted for 203 days. I called my oncologist on the phone.
This spontaneous case was reported by a physician and describes the occurrence of VOMITING (vomited 3 times in 7 days) and FATIGUE (still feels tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomited 3 times in 7 days) and FATIGUE (still feels tired). At the time of the report, VOMITING (vomited 3 times in 7 days) outcome was unknown and FATIGUE (still feels tired) had not resolved. 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 concomitant drugs and treatment medications were reported.
Initial misuse report received from health care professional on 20 Sep 2013. A dose of FLUZONE ID was administered to greater than to 65 years old patient on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Father states patient wasn't feeling well 5-10 minutes after receiving the 3rd pfizer covid vaccine. He states she looked like she was going to fall over. He caught her and we placed on the floor to sit while the dad was fanning her. We offered to call the paramedics, but patient declined. Gave her water and candy which she drank and ate. She felt better afterwards. She stayed another 30 minutes and left on her recognizance. She states she feels better and went home with her dad.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015, concerning a patient of an unknown age and gender who on 30-JUN-2015 was vaccinated with a dose of ROTATEQ (lot # K016313, expiration date was not reported) (dose and route not reported) that was 87 hours temperature excursion. The lot was received on 08-APR-2015. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Within a few days of the vaccine, the patient developed an unusual pain syndrome in the upper and lower parts of the left arm.  There was a mass in the distal tricep (remote from the injection site) with intense pain with any flexion or extension of the elbow, hyperalgesia noted in the skin of the left arm, no visible sweating, redness or swelling of the arm.  strength was  normal.  There were no signs of systemic infection such as fevers or chills. The rest of the body  was normal. There was no fall or trauma to incite the injury.
Rash that is spreading slowly each day. It began in the armpit of the vaccinated arm and then spread from bilateral armpits down lateral trunk to inguinal area and back.
I felt fine after the shot. About four hours later, there was pain in the area around the shot. In the middle of the night, around 3 a.m. I woke up feeling chilled, somewhat generally achy, and quite "bad." At 5:30 a.m. I took my temp, and it was 4-5 degrees above my normal temperature. About three hours later, my temp reverted to normal, and I felt worn but better. It is now 1 p.m., my temp is normal, but not surprisingly I feel rather worn after doing an hour of errands and work.
Fatigue, (R) lung collapse necessitating mechanical ventilation thought possibly due to Guillain-Barre Syndrome, although no LP done, MRI not conclusive. Still under investigation at hospital. 1/13/09-records received for DOS 11/5-12/20/08-DC DX: Pneumonia and pleural effusion. Neuromuscular disorder.  Presented with 3 week history of jerking movements as well as weakness of legs. Required mechanical ventilation. Video swallowing studies showed pooling of fluid in vallecula with incomplete emptying. TachycardicTreated with IVIG and plasmapheresis.
This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 16th January 2019, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). The patient was treated with neomycin. On an unknown date, the outcome of the cellulitis was recovering/resolving. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the patient experienced streak and cellulitis. On 18th January 2019, the cellulitis went tore. The outcome of the event was improved 2 to 3 days after. The reporter was agreed to follow up from GlaxoSmithKline.
A report was received from a state department immunization co-ordination on 10/20/03 concerning a 75 year old male vaccinee who experienced respiratory failure and was hospitalized an unspecified length of time after receiving Fluvirin on an unspecified date. The vaccinee has a history of chronic obstructive pulmonary disease and cardiac failure. On an unspecified date the vaccinee experienced respiratory failure. The outcome of the event was unknown at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Pertinent medical history was unspecified. The patient had no drug allergies. On 28-NOV-2014, the patient was vaccinated with ZOSTAVAX (strength and route not reported, lot #K012923, expiration date: 29-NOV-2015). On an unknown date the patient experienced lump and redness at the injection site and redness that spread from the injection site "all the way to their armpit" on an unspecified date in 2014. The patient also developed malaise and nausea on an unspecified date in 2014. No treatment was given. The patient sought medical attention by calling the pharmacist. The patient's wife received ZOSTAVAX on the same date and experienced the same adverse event which was captured in MARRS # 1412USA001968. The outcome of adverse events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 09-JUN-2014, the patient was vaccinated with a dose of ZOSTAVAX (strength reported as 19400 PFU) lot # J013138, expiration date 17-JAN-2015, 0.65 ml, subcutaneous. Co-suspect and concomitant therapies were not reported. The pharmacist reported that ZOSTAVAX was stored at 40F for 90 days and was administered to a patient on 09-JUN-2014. No adverse effects reported. Additional information has been requested. These is one (1) of two (2) reports from the same reporter (MARRS 1406USA007864 and 1406USA007871).
patient felt vaccine dripping down her arm, patient felt hat she did not receive the full dose, patient is checking with her doctor if she should get revaccinated  as we offered her that option since we are not sure if she received the full dose.
The individual received the Pfizer vaccine on January 6th and January 27th and tested positive for Covid this week (exact date unknown).; The individual received the Pfizer vaccine on January 6th and January 27th and tested positive for Covid this week (exact date unknown).; This is a spontaneous report from a contactable other hcp.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ), dose 1 via an unspecified route of administration on 06Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The clincal curse was reported as follows: the individual received the pfizer vaccine on january 6th and january 27th and tested positive for covid in Mar2021 (reported as : this week (exact date unknown) .The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Mar2021  .      No follow-up attempts are needed. No further information is expected. .; Sender's Comments: Based on information provided, the events of "tested positive for covid in Mar2021" is related to bnt162b2 inherent to the therapy.
muscle pain; joint pain; shivering; tiredness; headache; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2022, the patient received the 2nd dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced muscle pain, joint pain, shivering, tiredness and headache. On an unknown date, the outcome of the muscle pain, joint pain, shivering, tiredness and headache were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, joint pain, shivering, tiredness and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received Shingrix and experienced muscle and joint pain, shivering, tiredness and headache.  The patient wanted to know what he/she should take. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Right after vaccine injection, patient started having tingling in her face and feeling sob.  Episode last about 5 mins.  Afterwards, pt felt fine.  Denies chest pain, rash, itching or dizzy. RR 18 BP 120/73 HR 74 and oxygenation of 99%.
i HAD MY SHOT ON THE 5TH I STARTED TO HAVE ITCHY HANDS AND FEET ON THE 13TH.  I HAD EATEN SHRIMP FROM RESTAURANT AND USED THEIR HAND SANTIZERS SO I THOUGHT IT WAS THAT.   OVER THE NEXT THREE DAYS I STARTED TO SWELL AND ITCH ALL OVER AND HIVES FROM HEAD TO TOE. I WENT TO MY PRIMARY CARE AND THEY HAD ME GO ON PREDISONE AND BENADRYL  THEN I HAS A DAY OF CALM AND THEN ON THURSDAY THE  21ST IT GOT WORSE MY FACE THROAT WHOLE BODY SWELLED WAS ITCHING FROM HEAD TO TOE DIFFICULTING BREATHING AND CHEST PAINS.  I WAS TAKEN TO THE ER AT HOSPITAL AND WAS TREATED WITH   A WHAT THEY CALL A POWER PACK.  THEY THOUGHT THAT I MAY BE ALLERGIC TO THE SHRIMP NOW,  THEY PUT ME ON PREDISONE AND BENADRYL WITH A  PLAN TO WEAN OFF THE PREDISONE.  MY REACTIONS CONTINUED TO GET WORSE.  JANUARY 21ST I SAW AN ALLERGIST A FULL BLOWN ATTACK..tHEY HAVE INFORMED ME THAT BELIEVE THIS IS DUE TO THE COVID SHOT  THEY CHANGED MY MEDS TO ZYRTEC, BENDADRYL, PRESISONE AND ALLEGRA.  THE NEXT DAY I WAS EVEN WORSE SO THEY INCREASED THE DOSAGE WHICH AT FIRST I WAS COMFORTABLE BUT AS I HAVE BEEN WHEENING OFF THE PREDISONE THE SYMPTOMS HAVE INCREASED AGAIN,  I WAS SEEN AT THE WALK IN CLINIC ON SATURDAY THE 30TH IN WHICH THEY RECOMMENDED A NEW ANTIHISTAMIN,  I WAS THERE BECAUSE I WAS HAVING THE CHEST PAIN AND SHORTNESS OF BREATH AND FULL BODY RASH I HAVE BEEN IN COMMUNCIATION WITH MY PRIMARY DOCTOR AND HE HAS PUT ME ON HYDROXYZINE HCL 25 MG AFTER TRYING THIS FOR ONE NIGHT IT DID NOT HELP I HAD TO TAKE BENDADRYL IN THE NIGHT NAD THEN ZYRTEC JUST TO CALM THE ITCHING TO WHERE I COULD TOLERATE IT,  I HAVE BEEN USING OATMEAL BATHS AND COLD COMPRESSES ON MY HANDS AND FEET AS THEY CONTINUE TO SWELL ITCH AND HURT TO THE POINT WHERE IS HURTS TO WALK ON THEM.  IN TALKING WITH MY DOCTOR AGAIN TODAY THEY HAVE PUT ME BACK ON 50 MG PRESDISONE
12/20/21, sore throat, fever, nausea, diarrhea, coughing, cold. Test done on 12/21/22 Covid 19 detected. Test done at a mobile clinic. I went to work on 12/27. They sated that immune-compromised doctors could go to work after 7 days. By Thursday, I was not feeling well. I was sick again but this time no fever, cough, cold, sore throat, sob, pO2 (documented with pic) down to 91. Arrhythmia, extreme fatigue, chest pain. insomnia. Contacted a ER doc at Hospital. He recommended  monoclonal antibodies (in my chart). I decided against as per reports 2 didnt work for Omicron  and 1 was difficult to find. I used just some palliative care. I have been seen by my pneumologist and contacted my cardiologist. I recovered in 3 weeks. Some residual symptoms now. I am
24 hrs after my second shot I got a fever that lasted through the night. Two days after receiving my second shot I began getting chest pains (pressure, fluttering, sharp pain that radiated from my heart up my neck). They became more severe and I was worried that I was having a heart attack. Went to my regular doctor. Had an EKG that looked normal, was sent for a chest x-ray, and blood work. As well as prescribed a ZioPatch heart monitor for 2 weeks. Lab work came back normal and ZioPatch recorded one instance of Ventricular Tachycardia so I was referred to a cardiologist. Symptoms continued for about 3 weeks slowly becoming less intense but including lightheadedness and constant feeling of pressure with occasional (daily) pains that felt like a side ache in my heart.  Strong Symptoms reappeared in the beginning of June. Cadiologist ordered a stress echo. This came back normal as well.  I was given a Clinical Diagnosis of Pericarditis and told to take Ibuprofen. Symptoms continued through the second week of July and then diminished again.