chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist on 28-Nov-2017. This case involves a 13-year-old male patient, who was vaccinated with 0.5 ml dose of FLUBLOK QUADRIVALENT batch number: QFAA1703 expiry date: 26-Mar-2018 (dose in series was not reported) via intramuscular route in left deltoid on 25-Nov-2017. Patient medical history and concomitant medications were not reported. On 27-Nov-2017, two days following the vaccination, the patient experienced general body pain, fever, headache and sore throat. It was an actual medication error due to Inappropriate age at vaccine administration. A 13-year-old male patient was administered FLUBLOK. Lab data was not reported. No corrective treatment was given. Outcome of the events was unknown for all the events at the time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Follow up information received from a pharmacist on 23-Dec-2018. Event updated. List of documents held by sender: none.
PERICARDITIS; This spontaneous report received from a patient via a company representative through social media  concerned a patient of unspecified age, sex, race and ethnic origin.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient stated that experienced pericarditis after got the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pericarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211114655- COVID-19 VACCINE AD26.COV2.S- Pericarditis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pt arrives to the observation are after his injection feeling a little dizzy and experiencing scratchiness in his throat.  He arrives via wheelchair eating gold fish and drinking water. 1338 BP 144/97 HR 78 Oxygen room air 98% 1345 pt states he is feeling better "back to normal" 1350 pt released from observation to exit with wheelchair
It started on 02/13/2023, I have a problem with my eyes from Graves Diseases. My right pupil was constricted, and my left pupil was dilated. I called the ophthalmologist and they had me come in immediately. They could not dilate my pupils, and I was checked and diagnosed with Uvulitis. They sent me to see the retina specialist. They said I have an auto immune syndrome and not due to my disease. They had done a scraping and forced dilated my eye. It came up negative and just an inflammatory response. The started in the left eye and now has spread into the right eye. My doctor has says she has seen this happening in patients after the vaccine. This was out of the blue and they feel that I am one of the many to have this happen to me. I see a doctor retina specialist and ophthalmologist twice a week and it started to clear quite quickly using a gel. Now I have a Prednisolone eye drop. My vision has gotten better, I go in to see him in another week to see how to get off of the eye drops for the inflammation. My case those unusual cause it?s mostly happened to people in one eye, but I have it in both. It was very difficult for a while it's looking like I am watching the world through a dirty window.  I am a professional and this was interfering with my work and driving in was blinding. I am now seeing improvement in the inflammation; I am seeing improvement. Three years ago, on March of 202 I had COVID-19.  I had a headache and a very different kind it was in the back of my head. I had no taste no smell and no appetitive. It was a little bit of cough. I did have GI issues and was out of work for three weeks.  The lack of smell and taste lasted for about six weeks or so. I wonder could this be in relation.
Low grade headache within 10 minutes (3:30pm) of getting shot. Arm sore after about 1 hour. Headache worsened. Took Ibuprofen.  Whole body aches by 8pm. Chills and fever through night. Fever like symptoms Saturday morning. Cough developed around 9am.  Persistent headache.
VACCINE GIVEN >24 HOURS AFTER MDV PUNCTURED.  PATIENT SCHEDULED TO BE RE-VACCINATED
PT via wheelchair to ER c/o dizziness after he received second dose of covid vaccine today at noon. Pt's son stated he had no issues with the first dose. The patient had a syncopal episode in the ED lobby while waiting for a room. Upon review in the ED, patient with Hgb of 6.5. Prior history of Crohns and GI issues/bleeding.
Patient presented at observation with complains of lightheadedness, nausea, and vomited three times during the course of 15 mins. Patient had solid vomit (digested beans). Patient monitored for additional 45minutes. Vital signs were within his normal limits. Patient expressed not have been drinking water the whole day, water was provided during the observation time. Patient expressed feeling better and being in stable condition. Nurses ambulated the patient, gait was assessed and patient was able to walk by themselves. Patient left the observation area after being observed for a total amount of 1 hour.
Two hours after the shot was administered, I was unable to lift my left arm (the shot was given in upper left arm near the shoulder). The muscular pain continued to get worse and make my arm more unusable. By the end of the night, 9/29/17, I was unable to use the arm at all. I could not brush my hair, wash my hair, sleep on my left side, or, most importantly, hold my infant baby. The pain lasted for about two weeks and then started to subside. The pain never completely dissipated. It was always lingering, making me unable to use the arm to full capacity. The pain returned, full strength, on 10/28/17. It is much worse that it was when the shot was first administered. It is a muscular pain making me unable to lift my arm over my head, or out to the side of my body, without aid.
13may97 pt recv vax; 03jul97 pt recv positive urine pregnancy test & LMP was 23may97; pt had an elective abortion "unrelated to MMR vax;
18cm x 15cm redness, heat, swelling at site of DTaP and Varicella vaccines.
Lead RN was notified about a patient being ill in the parking lot after her vaccination. 3 RN's met the patient in the parking. The Site Officer was with the patient and called EMS. The patient stated she was nauseous and dizzy. She stated she "threw up" and she had a smoothie for breakfast. The patient vitals were stable but her B/P was elevated. Vital Signs: B/P 146/102, Pulse 88, Temp 97, RR 16. The EMS suggested to take her to the ER, but the patient refused. After assessing the patient, she refused to go to the ER and stated she is fine now. Also, she stated she became anxious and now she's calm now. No anaphylaxis was noted and no respiratory distress. EMS had the patient sign a "Against Medical Advice" refusal because she did not want to go to the ER. Lead RN informed the patient to call her PCP about her blood pressure
after the vaccine patient's cough got worse/It was a very strong cough with phlegm; after the vaccine patient's cough got worse/It was a very strong cough with phlegm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (after the vaccine patient's cough got worse/It was a very strong cough with phlegm) and PRODUCTIVE COUGH (after the vaccine patient's cough got worse/It was a very strong cough with phlegm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COUGH (after the vaccine patient's cough got worse/It was a very strong cough with phlegm) and PRODUCTIVE COUGH (after the vaccine patient's cough got worse/It was a very strong cough with phlegm). At the time of the report, COUGH (after the vaccine patient's cough got worse/It was a very strong cough with phlegm) and PRODUCTIVE COUGH (after the vaccine patient's cough got worse/It was a very strong cough with phlegm) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-079291, US-MODERNATX, INC.-MOD-2021-079392, US-MODERNATX, INC.-MOD-2021-079429, US-MODERNATX, INC.-MOD-2021-079441 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079291:1st dose US-MODERNATX, INC.-MOD-2021-079392: US-MODERNATX, INC.-MOD-2021-079429: US-MODERNATX, INC.-MOD-2021-079441:
Redness and swelling radiating to the side of the injection site in an area the size of a rectangle about 3 1/2 x 4 1/2 inches. Called pharmacy on next date (not in pain or irritated); instructed to watch and if it did not subside consider seeing md. stopped by pharmacy and decided w/ pharmacist (me) to seek medical attention w/ Dr. who diagnosed as an allergic reaction and prescribed prednisone.
No adverse events reported at this time. Patient advised to repeat dose of Prevnar 20 as soon as possible.
Patient claimed to have a rash that started the day after the reaction and progressed. Patient finally saw the doctor on 1/3/2019 and was prescribed a steroid shot and a steroid dose pack. Patient was given the shot again on 2/20/2019 and given ranitidine 150mg, cetirizine 10mg and hydroxyzine 10mg for the reaction.
Information has been received from a consumer concerning her 20 year old daughter, with no pertinent medical history who on 14-MAY-2008 was vaccinated with a first 0.5 ml dose of GARDASIL. There was no concomitant medication. In May 2008, a few days after vaccination, the patient experienced aches and pain, fatigue, mental confusion and headaches. It was also reported that the patient fainted while standing in line at a store. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Blood sugar spiked to 265 mg/dL during normal side effect period. All other side effects struck me as normal: aching, chills, very low grade fever, tiredness.  Outcome: all good now.
6JUL92 several hrs p/vax pt devel itching @ inject site; 48 hrs later devel full blown inject site itching, swelling & rash; exhibited no airway obstruction or other allergic type reacts;
Information has been received for a case in litigation from information obtained from a published article concerning a female patient who was vaccinated with MMR II, HEP B, DTAP, and HIB. Subsequently the patient experienced symptoms of mercury toxicity, such as speech delay and gross motor deficiencies/autism. The patient's parents alleged that as a result of receiving the MMR II, and thimerosal containing vaccines, including hepatitis B, DTAP, and HIB, the patient sustained symptoms of mercury toxicity such as speech delay and gross motor deficiencies. At the time of the report, the patient's outcome was unknown. Upon internal review symptoms of mercury toxicity, such as speech delay and gross motor deficiencies/autism was considered an other important medical event. No further information is available.
Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 09-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE's reported; M-M-R II was administered intramuscular Instead of subcutaneous; This spontaneous report as received from pharmacist referring to a 24-year-old female patient. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 03-JAN-2022, the patient was mistakenly vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA)(M-M-R II) (lot # T016197 and expiration date 11-MAY-2022), 0.5 ml, intramuscular (Instead of SC) in left deltoid muscle for prophylaxis (incorrect route of product administration). No additional AEs reported. No PQC.
C/O difficulty breathing receiving Bicillin. Wheezing all lobes, Benadryl and Epi administered. IV Normal saline started. Transported to medical center via EMS.
Expired vaccine given. Expiration was 9/30/2022  and vaccine was given on 10/26/2022.
This spontaneous report was received from a nurse practitioner who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot# M040141 and expiration date: 27-MAR-2018 and lot# M034692 and expiration date: 24-JAN-2018; albumin status therapy type, dose and route of administration were not reported) as prophylaxis. The vaccines were stored in the temperature between 6 degrees Fahrenheit (F) to 14F (9.1F) for 2 hours, with a previous temperature excursion of more than 6F and less than 14F (9.9F) for 15 hours. Data logger was not involved. It was reported that sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000248: US-009507513-1707USA001313.
Chills, body ache, stomach ache, diarrhea, headache, vomiting, ears ringing.  Severe abdominal pain.
moderate pain at time of injection at location injection increasing dramatically over the next 12 hours.  Severe shoulder pain, lack of joint mobility.  Gradually lessening over 72 hours, but still with restricted movement and ongoing pain.
Vertigo and loss of balance.  When remaining seated became dizzy until vomiting.  Remained in bed the rest of the day and as long as I was lay on left side was ok.  Next day vertigo was gone however, remained light headed with light dizziness.  Has remained for the past week.
Injection site reaction, large red area to right deltoid muscle where vaccine was administered; pain to site.
I tested positive for Covid on 18May2022; I tested positive for Covid on 18May2022.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN5318), in left arm, on 23Mar2021 as dose 2, single (Lot number: EN5318), in left arm and on 17May2022 as dose 3 (booster), single (Lot number: FJ5683) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 18May2022, outcome "unknown", described as "I tested positive for Covid on 18May2022"; COVID-19 (medically significant) with onset 18May2022, outcome "unknown", described as "I tested positive for Covid on 18May2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Nasal Swab.  No follow-up attempts are possible. No further information is expected.
Cardiac Arrest Narrative:  Pt went into cardiac arrest 2/13 when he was being taking off dialysis machine. Per wife, he was unresponsive, but they were able to revive him with CPR and then called 911 who took pt to Hospital. Pt ultimately died at Hospital 2/26/21. Pt received second dose COVID-19 vaccine 2/12/21 (day prior to cardiac arrest)
Immediate muscle pain at the injection site, which quickly spread down my right arm and to my right shoulder, and has since limited my ability to use my right arm.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE ACUTE DVT OF LEFT POPLITEAL VEIN
10 by 12 cm area of swelling and erythema and tenderness at (L) lateral upper arm. Pt has more BENADRYL and ice and symptoms are resolving.
Arm hurt really bad when Med went in. Woke me up during my sleep if I moved. This morning every muscle hurts including my tongue. Headache. I know fibromyalgia pain. This pain burns and is very uncomfortable. I seem to have fluid built up in my hands. I feel absolutely horrible!!!
pt recv vax; lt upper arm pain and burning immediately after inject w/ progressive worsening;burning distal upper arm and into hand; dec ROM and pain; referred to neurologist;
Information has been received from a certified medical assistant concerning a 15 year old female patient with no medical history or allergies who on 19-JUL-2007, was vaccinated IM into the left deltoid with a dose of Gardasil (Lot# 657621/0387U). Suspect concomitant therapy included VAQTA administered into the left arm, at a separate site MENACTRA and MMR II, both administered into the right arm. On 19-JUL-2007 immediately after the vaccination, the patient experience3d pain at the injection site of the Gardasil vaccine. Then the patient experienced numbness of the left arm and dizziness at home about one hour after the vaccination. It was reported that the patient returned to the office and was observed for 30 to 45 minutes. Laboratory diagnostic studies performed included a blood pressure measurement which was normal. After observation in the office, the patient's symptoms resolved and have not returned as of 23-JUL-2007. No product quality complaint was involved. Additional information has been requested.
Initial case received on 10 October 2014 from a consumer who is the patient. A 23 year old female patient with a history of wheat, gluten and latex allergy was vaccinated intramuscularly on 17 September 2014 with Influenza Quadrival A-B vaccine, batch number UI172AA into the left arm. On 09 September 2014, 30 minutes after the vaccination she experienced numbness and tingling in left side of her face and approximately 2 hours later also had numbness and tingling in her left arm. Two hours later it spread to right arm also and by midnight she called the Pharmacist because her entire torso was numb and tingly. She was advised to take two BENADRYL and a TYLENOL. She slept until 4 pm the next day. When she woke up, she had numbness and tingling in her arms and face and her tongue was numb. She was taken by her grandmother to an urgent care facility where she was given epinephrine. Her throat became tight and so she was sent to the emergency department next door. She was treated with SOLU MEDROL and was seen by a Neurologist. She was evaluated and had "left sided deficient" with a diagnosis of "possible GBS". She was placed on a 2-week neuro watch. The numbness and tingling started to fade away. The patient was treated with a Prednisone regime. She was seen by a primary care physician and a neuro evaluation was done on an unreported date. She was improving but was still very tired, sleeping 16 hours a day. On September 29, 2014 she developed a migraine headache and again was seen by the primary care physician on September 30, 2014. She was told to take IMITREX when she got home. About 30 minutes after taking IMITREX she experienced crushing chest pain and was "diaphoric". This lasted about 10 minutes, then went away. She was seen again by the physician on October 2, 2014 and was given TORADOL IV. She had numbness and tingling to left side of face and hand. She was sent to the ER and was given Dexamethasone, BENADRYL, and REGLAN IV. After about one hour, the treatment didn't help so she was given Morphine IV. The numbness and tingling were gone but the headache continued. She was seen by a neurologist on October 7, 2014. The reporter stated that the doctor "suspects something in the Flu shot triggered the nervous system to react against her own body". Her right optic nerve was inflamed- (occipital neuralgia) and she was given an unspecified nerve block for the migraine. She was in Dexamethasone orally and still has a few seconds of numbness in her face. At the time of the report she was still experiencing electrical shocks throughout her body which lasted a few seconds. She also had blurred vision. Laboratory tests were not reported. The patient outcome was unknown. Documents held by sender: None.
COVID positive on 11/9/2021. D dimer 11/9 374,  11/9 Troponin I is elevated in acute coronary syndromes with myocardial necrosis as well as ST elevation MI. 91-year-old female who presented with shortness of breath, cough, nausea, vomiting, diarrhea.  The patient was residing at a local nursing facility.  The patient also was saturating at 90% on room air.  She improved after being put on a non-rebreather. The patient was found to have COVID-19.  The patient unfortunately required intubation. She improved throughout the stay with treatment and was able to be extubated.  The patient speaking well on discharge and wanted to go home.  The patient also did have anemia, which was likely secondary to iron deficiency.  However, the patient did not have dark stool or bloody stools.  Her hemoglobin stabilized after getting transfusion.  She is to follow up closely with her gastroenterologist as an outpatient and to do and repeat CBC on the 19th. The patient was discharge in stable condition.COVID-19 with associated pneumonitis. IV Dexamethasone. Remdesivir as per ID. Anticoagulation per protocol.
Fully vaccinated and tested positive (experiencing symptoms); Fully vaccinated and tested positive (experiencing symptoms); This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for four patients. This is the second of the four reports (reporter's mother). re A female patient of an unspecified age received the first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was fully vaccinated, and then had tested positive on rapid test in Mar2021. The patient was experiencing symptoms. The outcome of the events was unknown.  Information about lot/batch number is requested.; Sender's Comments: Linked Report(s) : report number 2021308848 same reporter/product/events, different patient
Temperature spiked from 97.2 to 102. Fever broke 45 hours after shot, but left with bad headache and cough. Took another 24 hours for headache to go away. Cough still exists. Still little appetite. Things that I normally would like, I don't want or don't taste just right. Having to force myself to eat. It was worse than when I actually had Covid-19 in March 2020.