chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient administered Hep A and HPV vaccine. Sat in clinic room 10-15 minutes. Stated felt fine, color good. released to check out. stood 1-2 minutes and fell, possibly fainting, hitting head  9/22/09 ED and medical records received DOS 4/20/09 to 9/03/09. Assessment: Skull fracture and intracranial hemorrhage secondary to vasovagal syncope. Patient presents with headache and vomiting after syncope and a fall. Had felt light headed and lost consciousness, struck back of head on ground. Occipital skull fracture. Anterior intraparenchymal bleed and small subdural hemorrhage, occipital fracture, hematemesis. Pain left buttock and posterior left leg. Off balance gait. 10/2/09 Received ICD9 codes: 80121; 7802.
Pt recieved second pfizer bivalent dosage on 11/25/22. No adverse reactions noted, Pt has no questions or concerns.
rash on back of body calf and thigh; severe burning pain on body; symptoms/developed shingles; severe burning sensation as fire on body and ankle; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2022, the patient received the 1st dose of Shingrix. In June 2022, 7 days after receiving Shingrix, the patient experienced shingles, burning sensation and pain burning. In July 2022, the patient experienced rash. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)), methylprednisolone and valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, burning sensation, rash and pain burning were recovered/resolved.   It was unknown if the reporter considered the shingles, burning sensation, rash and pain burning to be related to Shingrix.     Additional Information: GSK Receipt Date: 6-DEC-2022. Reporter's Comment: The reporter was the patient.  The patient received his Shingrix dose and seven days later he experienced developed symptoms of shingles burning in the left side of my body severe burning sensation was on "fire" going towards my ankle left side only.  The reporter stated fourteen days after vaccination, he developed a rash on the back of his left calf and thigh.  The patient saw his primary physician who prescribed methylprednisolone dose pack.  The patient then saw a dermatologist who diagnosed the rash as shingles and prescribed valacyclovir for 7 days.  Physician said to go ahead and get the 2nd dose, worried if it would be worse than the first one. Dermatologist prescribed antiviral on 6th July 2022 and in 14 days the rash was gone. Nothing else was reported.  The reporter did not to consent to follow-up. Additional supportive information: The case US2022182839 was identified as duplicate of US2022182844. The case US2022182844 would be voided, and all the future correspondence would be added in this case US2022182839 which stands as a case of record for this patient.
Narrative: COVID infection following COVID vaccine series 04/14, Moderna ,  dose #1 05/12, Moderna , dose #2 1/3 COVID swab, result: detected 01/02 pt cc: cough, fever, headache, myalgias, rhinorrhea, sore throat exposure: unknown  01/03 pt admit ED cc: Dry cough sore throat and general malaise dx: COVID  infection LOS: 1day
Benign Uterine Polyp: I have no idea if this is related to the COVID vaccine, but I was seeing articles about vaccinated women experiencing menstrual irregularities when I experienced some unexpected vaginal bleeding after being menopausal with no bleeding for over a decade.  May 3, 2021 vaginal bleeding after menopause May 10, 2021 OB/GYN Dr. appointment May 20, 2021 Vaginal ultrasound - hemoragic appearing mass in uterus found June 21. 2021 Pre-Op Dr. appointment June 30, 2021 Hysteroscopy - Uterine Polyp found and removed July 6, 2021 Notified of Lab results: Polyp was benign
Individual stated he felt shaky, could feel heart racing.  Had similar reaction following first injection followed by rash on both lower extremities and forearms requiring him to call his PCP Doctor who advised him to take Benadryl for 48hours with complete resolution of symptoms.  No report of chest pain or SOB.  3:55Pm: BP 157/74, HR 124, SaO2 96, FSBS 84; IM Benadryl administered, EMS called: :  4:00pm: BP 150/90, HR 144, SaO2 96%
Patient reported weakness, fatigue, and lethargy. Symptoms started about 3-4 hours after shot and continued into the night when he woke up with fever and sweats. I asked him how he was feeling the next day when all was reported and he stated he felt better but was still somewhat weak. I told him to report back to us or to Dr if symptoms continued and also shared side effects listed on VIS again with patient.
Pt received Pfizer vaccine.  In observation, developed a rash on lower extremities (feet and calf).  Called provider over, gave patient 50 mg Benadryl.  Vital signs are stable.  Pt complains of itchy throat, O2 sat 100%.  No s/s of wheezing or SOB.  30 minutes passes by and rash starting to develop on thighs.  Provider advised to give epinephrine IM.  Educated patient regarding medication.  Ambulance called.
During patient's 15 minute wait time after vaccination, patient reported to have some numbness in right arm and leg. Patient also said that they felt some tightness in chest. Patient was breathing and said can breath. Patient requested that we call 911 and we did. EMS came and asked if patient wanted to go to hospital. Patient requested to go.
This spontaneous report as received form a nurse refers to a patient of unknown demographics. The nurse reported that an expired dose of VARIVAX (0.5 ml, subcutaneous) (lot number reported as 1632AA/expiry date: 18-OCT-2013) was administered to a patient on 04-NOV-2013. No adverse effects reported. Additional information has been requested.
Information has been received from an MA concerning a 67 year old male who on 11/12/01 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 637487/1071K) in the arm. Concomitant therapy that day, in the opposite arm, included a flu vaccine. At the pneumococcal vaccine 23 polyvalent injection site, the pt had pain, bruising and a nodule about 20 minutes after being vaccinated. The pt sought unspecified medical attention. Additional information has been requested.
Arm pain, fatigue, cold chills and fever (100.8), dizziness, migraine, nausea, "brain fog"
2 FLUZONE Quadrivalent Np vaccines were given to an 11 year old patient/ patient was to get both the flu and Pneumococcal but got two flu vaccines instead with no reported adverse event; 2 FLUZONE Quadrivalent Np vaccines were given to an 11 year old patient/ patient was to get both the flu and Pneumococcal but got two flu vaccines instead with no reported adverse event; Initial information received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11-years-old male patient who received 2 doses of influenza quadrival A-B vaccine [Fluzone Quadrivalent] as patient was to get both the flu and Pneumococcal Vaccine but got two flu vaccines instead with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Oct-2023, the patient received 2 doses of 0.5 mL dose of suspect influenza quadrival A-B vaccine, suspension for injection (batch number and expiry date unknown) (Strength: standard) via intramuscular route in unknown administration site for immunization as patient was to get both the flu and Pneumococcal Vaccine not produced by Sanofi Pasteur (unknown formulation) but got two flu vaccines instead with no reported adverse event (extra dose administered) (wrong product administered) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
36 yo female received J&J COVID-19 vaccine on 3/10. Minimal information found in chart. Rapid nasopharyngeal test was done on 3/31 at 07:31 and resulted back positive later that day.
Approximately 12 hours after vaccine dose: fever that lasted for 48 hours, fatigue, and extreme swelling of lymph nodes in throat, armpit, and groin. Swelling in lymph nodes of arm that received vaccine was so severe that I could not let my arm rest down by my side without throbbing pain. Pain went away after about 48-72 hours but swelling persisted for 1 week.
Patient stated that she got a rash on the side of her body a week after getting the IM Fluzone vaccination.  Patient stated that the rash was unresponsive to OTC Benadryl and hydrocortisone.  She also reported tingling in her fingers a week later.
DIZZINESS; EQUILIBRIUM OFF WHENEVER STANDING FOR PROLONGED PERIOD; BACK OF LEG DISCOMFORT; SORENESS AND PAIN IN MUSCLES; SORENESS AND PAIN IN JOINTS; HAIR LOSS; SORE ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non alcoholic, non smoker, bouts of irritable bowels syndrome, and fibromyalgia. The patient experienced drug allergy when treated with hydrocodone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced hair loss. On 24-JUN-2021, the subject experienced sore arm. On 25-JUN-2021, the subject experienced soreness and pain in joints. On 25-JUN-2021, the subject experienced soreness and pain in muscles. On 26-JUN-2021, the subject experienced dizziness. On 26-JUN-2021, the subject experienced equilibrium off whenever standing for prolonged period. On 26-JUN-2021, the subject experienced back of leg discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, soreness and pain in joints, dizziness, back of leg discomfort, hair loss, soreness and pain in muscles, and equilibrium off whenever standing for prolonged period. This report was non-serious.
Patient was here with her mother for her first covid 19 vaccine. Patient stated that she got nervous when when got shots and felt a little nauseous during the administration. immediately after the immunization the patient became pale and sweaty. she placed her head on the table in front of her and stated she just needed to rest. She then tried to sit up and seemed to loose consciousness for just a moment. the patient never fell or hit anything. She was weak, pale, and sweaty. We provided water, orange juice, and candy to the patient. We provided an ice pack and towels for comfort. She felt better within 30 minutes and went home.
joints were hurting (9/10 rating); This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joints were hurting (9/10 rating)) in a female 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.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ARTHRALGIA (joints were hurting (9/10 rating)). At the time of the report, ARTHRALGIA (joints were hurting (9/10 rating)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
swelling, erythema, warmth and pain 5 days after moderna covid-19 vaccine administration
Had the two injections, still getting outbreaks/suspected vaccination failure; Shingles many times; Had the blisters biopsied; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient had the two injections of Shingrix and still got the shingles many times. The patient had shingles before the shots and still getting outbreaks.  The patient did blisters biopsied. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Pt. c/o "a little dizziness". Pt had blood drawn in the morning and did not eat. Snack and water provided. Pt. also reports he has anxiety and this feels similar. Pt. waited additional 15 minutes and reports symptoms resolved. Pt. dc' d home.
Case number PHHY2011US65897 is an initial spontaneous report received from a health care professional (physician assistant) on 21 Jul 2011. This report refers to a 20 year old female patient. She was vaccinated with MENVEO (batch number: X10034) intramuscularly on 10 Jul 2011. But, the patient received only the Men CYW-135 liquid conjugate component without reconstituting it with Men A lyophilized powder component. No adverse reaction was reported following this drug administration error.
Pt seen 5/6/19 for c/o left shoulder pain at rest and worse with any movement.  Pain is severe with movement- Pt is crying with physical exam/range of motion.  No skin abnormalities, erythema, swelling, or fever.
Jul2021 I received my first Pfizer Covid vaccine/ In August the second dose/ Today I received my Pfizer Covid booster; stomach ballooned by 5 inches/ bloating and stomach distention for 6 months/ 3 pant sizes up in a week. Still up 3 due to the bloat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 20Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, so much worse), administration date: Aug2021, for Covid-19 immunization, reaction(s): "so much worse"; Bnt162b2 (Dose 2, 3 pant sizes up in a week. Still up 3 due to the bloat), administration date: Aug2021, for Covid-19 immunization, reaction(s): "3 pant sizes up in a week. Still up 3 due to the bloat"; Bnt162b2 (Dose 1, severe bloating), administration date: Jul2021, for Covid-19 immunization, reaction(s): "severe bloating"; Bnt162b2 (Dose 1, stomach distention), administration date: Jul2021, for Covid-19 immunization, reaction(s): "stomach distention". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 20Jan2022, outcome "unknown", described as "Jul2021 I received my first Pfizer Covid vaccine/ In August the second dose/ Today I received my Pfizer Covid booster"; ABDOMINAL DISTENSION (non-serious) with onset 20Jan2022, outcome "not recovered", described as "stomach ballooned by 5 inches/ bloating and stomach distention for 6 months/ 3 pant sizes up in a week. Still up 3 due to the bloat".  The lot number for bnt162b2 was not provided and will be requested during follow up.
A little anxiety; This is a spontaneous report from a contactable other hcp (patient). A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included bipolar disorder, known allergies and covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. It was reported that after receiving first Pfizer's vaccine the patient got a little anxiety. But after receiving a second one of Pfizer's vaccine since 05May2021 started to have a severe anxiety until now today. Some medications will not help out as enough. The patient underwent lab tests and procedures which included Nasal Swab: positive on 11Dec2020. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Batch number ER8733, given intramuscularly on arm. Dose 0.3 ml) on 26-Mar-2021, Pfizer (Batch number EW0165 and given intramuscularly on arm. Dose 0.3 ml) on 23-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (Allergy to Sulfa drug), Anxiety, Thyroid cyst and Hyperlipidemia. Concomitant products included PAROXETINE and LORAZEPAM for Anxiety, ATORVASTATIN for Hyperlipidaemia.    On 24-Jan-2022 at 12:59 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jan-2022 at 12:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022 at 12:59 PM, EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (The patient was disclosed of an event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date) to be not related.    It was reported that as per Moderna, the vaccine would maintain the necessary effectiveness against COVID 19. The patient did not need to seek medical care for the event.
2nd dose of Moderna lot 103M20A. Beginning in March continuing through the beginning of August I began having episodes of Bradycardia approximately 2-3 weeks apart for a total of 21 episodes. Have not experienced an episode since mid August.
Both legs feeling numb; like if they dont have oxygen going through them, I feel like the blood circulation in my legs is not the same .; heavy at times; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 15May2021 at 12:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was allergic to penicillin. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021, the patient experienced both legs felt numb, like if they did not have oxygen going through them, she felt like the blood circulation in her legs was not the same and heavy at times and she had to be constantly moving them. It was hard to explain and she did not want to get the second dose and scared as it could make it worse. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events both legs felt numb, like if they did not have oxygen going through them and blood circulation in legs was not the same and heavy at times were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient complaining that he was not feeling well, feeling shakey during vaccination. After vaccination patient complained of feeling dizzy, patient was given some water to drink, took a few small sips and began vomiting. No hives or rash present, patient denied difficulty breathing/swallowing. Single vomiting episode, continued to monitor patient for a additional 20 minutes. Strong radial pulse - regular with a rate in the 80's. Talked to mother/guardian about transporting to ED for further evaluation, mom did  not want an emergency room evaluation, was comfortable taking him home and following up with PCP/Cardiologist. Directed her to call emergency if another incident occurred, if he developed a rash, or if he contd p2 began complaining of difficulty breathing/swallowing. This information was relayed using a translator on site, mom is primarily Spanish speaking. Mom understood the instructions, declined further evaluation. Patient remained for observation where he was able to drink water without nausea/vomiting. Patient denied dizziness prior to leaving clinic with mom.
About 2 hours after the second dose of the Pfizer vaccine I felt a warm, flushed feeling in my left foot, not unlike stepping in a bucket of warm water. The sensation lasted about 5 seconds and disappeared on its own. Since then, about once per hour I have had the same symptom, with a warm, flushed feeling in my left foot. There is no pain, slight numbness and tingling, but no loss of function or coordination. I can sense that the symptom is about to begin approximately 10 seconds before it starts, because my foot begins to feel swollen. This has occurred about 40-50 times since the injection, and has only gone down slightly in frequency over the past 72 hours, currently it is happening about once every 1.5-2 hours.