chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 61 year old male patient without any pertinent medical history. On an unknown date of June 2014, the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dose, strength, route and lot number were not reported). Secondary therapies were not reported. There was no concomitant medications.  Physician reported that a patient received ZOSTAVAX and developed dizziness that did not felt like spinning, but the patient stated that it felt like he was always on a boat, in 2014 (onset date reported as "about three weeks" after ZOSTAVAX. Physician stated that an unspecified neurologist diagnosed the patient with vestibular migraine, and referred him to an unspecified physical therapist. Physician stated that the unspecified physical therapist disagreed with the diagnosis. The physician stated that the patient had been referred to her for evaluation of a possible psycho-somatic cause of the dizziness. The outcome of vestibular migraine was reported as not recovered/not resolved.  Patient has performed a Magnetic Resonance Imaging (MRI) which was negative. Patient had received many unspecified treatments but none had relieved the symptoms. The physician stated that although the intensity varies, the patient had constant dizziness. Additional information has been requested.
Patient fainted, syncopal event during the post-vaccination monitoring period. Patient states they did not eat today. The patient was caught by EMS before reaching the floor. Did not hit head. Vitals, sinus bradycardic, HR 38, BP 120-70, 18 RR, blood glucose 103. Pt says his HR usually runs in the 50's. After the patient's observation period ended, HR was 60, BP 136/81, RR 16. Patient refused further treatment and refused transportation to the ER. Patient denies dizziness and pain/discomfort. Patient signed refusal to treat form.
Severe headache developed on evening of vaccine. The next morning, patient developed an itchy bumpy raised red rash on her Right forearm while at school.  Benadryl helped a little.  A worsening headache, cough and wheeze started evening 4/27/21.  She took Tylenol and used her Albuterol inhaler.  She slept poorly due to itch, headache, bad cough & wheezing. On 4/29/21, 4 hrs after taking Benadryl, she developed an urticarial rash on her Left forearm (right arm improved by then). A pruritic, extensive petechial Left-sided facial rash began that evening which worsened the next am and spread to right side of face. Headache comes and goes. Rash spread to upper arms 5/3/21 despite daily Claritin. Facial rash is fading
Patient presented on 6/19/2021 with cardiogenic shock that quickly progressed and ultimately required heart transplant.  Pathology from explanted heart showed lymphocytic myocarditis
Severe headache,  extreme fatigue, warm sensation in chest for about an hour,  numbness in hands, dizziness and extreme irritability.  This lasted until day 3 after the shot. Then, all of the sudden, like someone turned on a light,  8 was better.  It was instant.  The strangest thing I've ever experienced!
Beginning around 4pm on December 27th, I experienced itches around the back and scalp. These continued throughout the night and into the 28th. Ice helped to distract from the itching and alleviate symptoms for the time. Around 3pm on the 28th my thumbs began to feel sore and by 7pm both had swelled. The wrist and other fingers began to feel sore around this time too and by 9 there was slight tightness in my chest. Around 9:30 I took two aspirin. The itching persisted although it felt less severe than earlier. Around 10:30 pm I took a shower and took one tab of Benadryl. The next morning the swelling had not subsided in the thumbs and some swelling appeared in the feet. At the advice of a nurse I am taking Benadryl every four hours and Claritin every twelve. I am still monitoring the swelling as well as the chest tightness. For the most part the itching has subsided, though hives have appeared on the hands and feet.
Severe myalgias, fatigue, headache, chills began 6 hrs post vaccine; by the next afternoon, fever to 103.1, extreme fatigue, headache, myalgias,  altered mentation, right arm pain, swelling, redness; sought medical attention - prescribed prednisone 20 mg daily; fever defervesced late afternoon , but returned the next morning to 101.2, with improving headache, fatigue, myalgias; by 1/24/21, most symptoms except fatigue and local injection site pain had resolved; now still mild fatigue and mild arm pain
Mostly sore upper arm. Some tingling and numbness of left wrist and hand. 2 quick, slight feelings of dizziness a few hours after injection.
After influenza shot on Friday experienced symptoms late Saturday and throughout Sunday. Ringing in ears, auditory sensitivity, echoing, light headedness for about 28 hours
Called our office 10/15, had had a localized reaction started 2 inches below injection site down arm about 9 inches red, very painful, hot to touch, no fever.  Wife gave Tylenol, resolved after 3 days.
First, complete loss of hearing in left ear within one week of first vaccine - Initially visited urgent care- prescribed Cefdinir and methylPrednisolone - Then went to see Dr., ENT - After the antibiotics and Prednisolone, my hearing loss returned - Dr. did hearing assessment  Second, extreme inflamation of sinuses developed within one week of first vaccine - Not clear up with antibiotics - Dr.  then performed Resect Inferior Turbinate procedure to open nasal and sinus passages on both sides of my noise - I have never had hearing issues or extreme sinus inflamation until I received this first Pfizer vaccine
fatigue, body aches, migraine (behind my eyes hurt), chills (my hands in particular were cold despite having heat on me), and it feel like there was a weight on my chest
(Left arm) arm irritation, large red spot that is itchy on spot and surrounding area. Erythematous. Referred to MD to be seen.
Redness/ swelling warm to right deltoid area. Pt seen by doctor. Treated with Benadryl 12.5mg, tylenol 160 mg/ 5ml.
MIGRAINE; NUMB TO FINGERS; ARM SWOLLEN; PRESSURE IN ARM/ARM TIGHTNESS; CHILLS; HEADACHE; FELT FEVERISH; INJECTION SITE TINGLING (DOWN THE ARMS TO THE FINGERS AND UP TO THE SHOULDER BLADE); FELT HOT; DIZZINESS; This spontaneous report received from a patient concerned a 32 year old female. 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 admin not reported, batch number: Unk) dose was not reported, administered on 28-JUN-2021 for prophylactic vaccination. The batch number was not provided and has been requested. No concomitant medications were reported. On 28-JUN-2021, the subject experienced injection site tingling (down the arms to the fingers and up to the shoulder blade). On 28-JUN-2021, the subject experienced felt hot. On 28-JUN-2021, the subject experienced dizziness. On 28-JUN-2021, the subject experienced numb to fingers. On 28-JUN-2021, the subject experienced arm swollen. On 28-JUN-2021, the subject experienced pressure in arm/arm tightness. On 28-JUN-2021, the subject experienced chills. On 28-JUN-2021, the subject experienced headache. On 28-JUN-2021, the subject experienced felt feverish. On 29-JUN-2021, the subject experienced migraine. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt hot, dizziness, chills, and felt feverish on 30-JUN-2021, was recovering from headache, had not recovered from injection site tingling (down the arms to the fingers and up to the shoulder blade), pressure in arm/arm tightness, numb to fingers, and arm swollen, and the outcome of migraine was not reported. This report was non-serious.
The wrong vaccine was given to a patient while she was due for Tdap and IPV, she was given KINRIX which is DTAP and IPV combined. She is out of the age range for this vaccine at 17, where this is only used for 6 years and under. The lead CMA in this office reached out to agency and it was discussed with their education department on what steps to follow in this error. This was documented in agency in the patient's chart as received. Agency let us know that the patient will need to return in 4 weeks in order to be adequately protected against tetanus.
PATIENT HAD A SEIZURE AND FELL. SHE DID HIT HER HEAD. FALL WAS NOT WITNESSED BY THE RESPONDERS. VITAL SIGNS WERE TAKEN: BP 142/88, PULSE 98, O2 SATS 100%, RESPIRATIONS 20, BLOOD SUGAR LEVEL 84. HELPED PATIENT TO WHEELCHAIR AND SECURED HER TO THE FIRST AID AREA. AMBULANCE WAS CALLED AND SHE WAS TRANSPORTED TO THE ER.
Blood shot eyes. Face was flushed red. Aches in back. Slight headache and neck ache.
Itchy, red, warm, slightly raised injection site on day 8 after vaccine. Symptoms resolved completely within 48 hours,
6/19/21 patient awoke with non-bloody, bright green emesis and abdominal pain. She endorses several episodes of nonbloody diarrhea with continued abdominal pain.  She endorses starting her menstrual period 3 days ago. Mom endorses fever at this time, T-max 102.9.  Presented to an urgent care for further evaluation where they obtained a rapid strep test and COVID-19 swab that were both negative. 6/21/21 she presented to an ED for continued and worsening symptoms.  She received a dose of antibiotics and saline boluses during transfer to another hospital.  In route, she became hypotensive with minimal response to fluid resuscitation. She required vasopressors to maintain blood pressure. A CT of the abdomen showed nonspecific findings for enterocolitis.  A urinalysis had 5-15 RBCs and 51-100 WBCs. She was started on antibiotics. She required ICU admission initially, but improved and became hemodynamically stable after about 16 hours in the PICU. Her urine culture grew 3 different organisms with low colony counts so antibiotics were discontinued on 6/22/21. An ECHO demonstrated normal biventricular size and systolic function (LFEF 62%), mild tricuspid regurgitation estimating mildly elevated RV pressure (30-40% systemic), mild flow accelration across normal appearing trileaflet aortic valve and borderline small aortic root and sinotubular junction, normal ascending aorta, no pericardial effusion, normal right, left main, and LAD coronary artery diameter z-score, and mild outpouching in the left main coronary artery that may represent an early appearance of an aneurysm. A repeat ECHO the following day revealed normal biventricular size and systolic function, mild tricuspid regurgitation estimating RV systolic pressure of 30mmHg, left main coronary artery appears slightly prominent but measures within normal limits. LMCA measurement is similar to previous, normal measurement of the proximal RCA and LAD, and trivial pericardial effusion. The patient also had an elevated CRP of 18.8 mg/dL, fibrinogen of 408 mg/dL, d-dimer of 0.98, and nt-pro BNP of 309. SARS CoV2 IgG was positive and IgM was negative. She received IVIG 100 gm on 6/23/21 and was started on rivaroxaban. CRP decreased to 8.2 mg/dL on 6/23/21.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was fully vaccinated and just had a case of Shingles. This case was considered as suspected vaccination failure since the 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.
Severe debilitating chills. Worse than any previous infection experienced. Unable to move. Mildly improved with Motrin. Had low grade 100.3 F fever. Weakness aches lymphadenopathy. Severity of symptoms of reduced from severe to mild in just over 48 hours.
pt recvd vax; pt devel flu manifested by nausea, vomiting, headache & ache all over;
This spontaneous report as received from a licensed practical nurse refers to an 8 year old female patient. On 19-JUL-2013, the patient was vaccinated by a staff error with a 0.5 ml dose of GARDASIL (lot # J003727, expiration date 07-NOV-2015) intramuscularly in the left deltoid. No adverse effects were reported. Additional information has been requested.
Patient received 0.2ml of a concentrated vial. Pediatric Pfizer (PEDS) Covid-19 vial not reconstituted before administration of the shot. We did not know of the fact until several hours later. We are unable at this time to reach the parent so we are not aware of any adverse reactions.
Patient has had persistent arm pain since administration of Gardasil.  She also may have a cellulitis at the site of administration, but this far out it is difficult to tell if that's where it was given.  She had arm pain immediately after it was given, however.
Information has been received from a Medical Assistant (M.A.) concerning an 18 year old female patient who on 04-NOV-2007 was vaccinated in deltoid with a dose of Gardasil lot #656049/0187U. Concomitant therapy included Depo-Provera in the other arm. The patient developed hives about four hours after receiving Gardasil. Benadryl was ordered. The patient's outcome was unknown. Additional information has been requested.
Upon second dose of Maderna: cold chills and low grade fevers throughout the night , body aches and pain in joins. Body aches and join pain still occurring after over 2 weeks of vaccine administration.
Dizziness; Weakness; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Low grade fever; nausea; she did not feel well; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 67-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVI-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 22Feb2021 (Age a vaccination: 67-years-old) as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. historical vaccine included first dose of BNT162B2 (Lot/batch number: EL9262) for covid-19 immunization and got sick. patient and her husband received second injection on Monday afternoon. They have both been sick since then. He has been worse than her but getting better they did not expect it to take this long to get over it. She has had injection site pain, tiredness, headache, muscle pain, chills, joint pain, low grade fever, neither of them got a very high temperature but they checked both of their temperatures and they were right under 100, but she got chills, she was nauseated but she did not throw up, she did not feel well, they both felt unwell, she had dizziness and weakness. She still has the headache and the nausea is off and on. She still has dizziness, weakness all of that is still going on today but it is getting all getting better. She confirms ongoing but improved. She says the injection site pain, muscle pain, joint pain, and low grade fever have all resolved. The tiredness is ongoing, she groups that with the weakness. The outcome for the events chills, did not feel well was unknown, dizziness, weakness was resolving, Tiredness, Headache, nausea was not resolved and for remaining events outcome was reported as resolved on an unspecified date.  No follow up attempts are possible. No further information is expected.
Evening of shot, pt had 3 x 6 cm zoster like rash with surrounding erythematous ----, also had SOB, joint/muscle pain and tactile fever, and honey crusted lesions of abdomen. All sx.
Hives all over my body every single day.; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old female patient received second dose of bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Mar2021 (Batch/Lot Number: EN9266), single for covid-19 immunization. The patient did not had any medical history. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID or any other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL6208) via an unspecified route of administration on 13Feb2021 as dose 1, single dose for covid-19 immunization and experienced hives all over her body a week after first dose of vaccine and she would get them about 2-3 times a week. In Mar2021, after receiving the second dose of vaccine the patient experienced hives all over her body every single day. The adverse event resulted in doctor or other healthcare professional office/clinic visit. She visited an allergist, but she cannot diagnose her. The patient knew that the event was from the vaccine. The patient was advised to take Allegra twice a day and Zyrtec as therapeutic measure for event. The outcome of the event was unknown.; Sender's Comments: As per the information provided in the narrative, the causal association between the suspect drug and the event cannot be excluded.
Rash around injection site within 5 days Rashes on my hands around and on my knuckles and on my feet closer to and on my toes
10/08/2016 - started experiencing swelling left hand and joints. 10/10/2016 - started experiencing several episodes of numbness in separate limbs through the night while sleeping. 12/11/2016 - seen in hospital ER Diagnosis - Parasthesias - Steroid MEDROL dose pack ordered. Follow-up with Dr. 10/12/2016 for diagnosis of Parasthesia. Deltasone 10 mgm ordered, 4 tabs po qd X 3 days, 3 tabs po qd X 3 days, 2 tabs po qd X 3 days, 1 tab qd X 3 days.
The patient was  given expired J&J vaccine doses. The vial was punctured at 9:40AM and expired correspondingly at 3:40PM. The respective time the shot was given outside this window was 4:51 PM.
Patient claimed she has been breaking out into rash and eruptions on her skin since the covid vaccine.
little bit sore; possible Bell's Palsy; left side of his face was swollen; Couldn't open his mouth; A Spontaneous case report was received from a consumer concerning a 67 year old male patient ,who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced swelling face, facial paralysis, couldn't open his mouth and pain.  The patient medical history, as provided by the reporter, included hypertension and type 2 diabetes.  On 13-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Lot number:024M20A)  in the left arm for prophylaxis of COVID-19 infection.  On 13-FEB-2021, the patient felt his left side of his face was swollen, and he couldn't open his mouth. On 17-FEB-2021 he went to emergency room and diagnosed with possible Bells palsy. Lab tests was done: x-ray and imaging and couldn't find anything. On 26-FEB-2021 he also felt little bit sore.  No treatment was given for the events.  Action taken with mRNA-1273 in response to the events was unknown.   The events ,swelling face, facial paralysis, couldn't open his mouth were considered resolving on 26-FEB-2021 and pain was considered as not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
After 15 minutes, but before 30 minutes I felt a rush of lightness fill my body and I became extremely dizzy, weak and lightheaded. I felt a little bit of tingling throughout my body. The medics at the facility had me drink water and wait there a while longer. I was told this was a normal reaction. I left the facility around 2:30 still feeling a bit dizzy and weak.  The feeling subsided after drinking more water and eating.
vaccination site pain; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 44-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.    The patient's past medical history included Miscarriage in November 2017 and Allergy (decrease injections) since 01-Jan-2017. Concomitant products included COLECALCIFEROL, MENAQUINONE-7, PHYTOMENADIONE, RETINOL PALMITATE, TOCOPHEROL, TOCOTRIENOLS NOS (VITAMIN D COMPLEX) for Deficiency vitamin, PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] for Pregnancy.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 22-May-2021. On 27-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 27-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Ultrasound scan: normal (normal) healthy. On 27-Feb-2021, COVID-19: positive (Positive) Tested positive. In 2021, Blood glucose: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported 3 previous pregnancies included first on 16-Sep-2016 with outcome of live full- term birth, for second miscarriage had happened in Nov-2017 and third on 09-Aug-2019 with the outcome of live full-term birth.  Estimated date of conception reported was 15-Aug-2020. Date of positive pregnancy test was 15-Oct-2020.  No treatment information was provided.
On 9/25 she got FLUZONE and PNEUMOVAX 23 vaccine both on the right arm. THE SYMPTOMS STARTED 9/25/17 AT NIGHT.  SYMPTOMS: FEVER  (103 F) PAIN AND SWELLING IN THE RIGHT ARM. Next day she couldn't stand up, her muscles wouldn't work. She has neuropathy. Pharmacist called Dr.  to report the incident. She took ibuprofen and Tylenol and she put lidocaine in the area. Dr. diagnosed the patient with cellulitis and prescribed medrol pack, keflex and recommended to put ice pack in the area.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient. She had no relevant history. On 31-AUG-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 1 injection, right arm, lot # 0653AE, exp. date 10-FEB-2014 (dose was not reported) for prevention. Her concomitant medications and past drug history were unknown. On 01-SEP-2013, the patient reported swelling that just started in her right arm. It was unknown if there was any relevant laboratory data. As of 01-SEP-2013 it was unknown if the patient would have another PNEUMOVAX 23 and she continued to have swelling in her right arm. The relatedness between therapy with PNEUMOVAX 23 and swelling that just started in her right arm was not reported. Additional information has been requested.