chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Over the past 10 years I have occasionally experienced bouts of epischleritis which last approximately two days and responds well to ibuprofen.  One week after receiving the vaccine I experienced the most severe flare up to date.  My left eye was completely red, swollen and painful.  Two days later my right eye also flared up.  This episode has lasted 8 days and counting.  There has been minimal refief using ibuprofen and I have had to add ice packs to help relieve the swelling and pain.   As this condition is caused by inflammation I believe there may be a connection.
Redness and swelling at injection site. Doctor wrote the patient prescriptions for medrol pack, benadryl, and pepcid.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Medium, Additional Details: patient broke out in hives on the arm the vaccine administered
Lymphadenitis in armpit of same side as injection site, no treatment necessary, patient doing well
1hr after shot felt hot & nauseous progressing to 102 F, body aches, stomach ache, chills, weak. Weak next day & then fine.
Patient had a tonic-clonic seizure approximately five minutes after receiving the first dose of the Moderna covid-19 vaccination. Post seizure the patient reported feeling a fever leading up to seizure. Patient had no history of seizure but has experienced fainting in the past. 911 was called immediately and paramedics cared for her.
expired on 23-Mar-2022 and administered on 25-Mar-2022 (2 days after expiration).; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired on 23-Mar-2022 and administered on 25-Mar-2022 (2 days after expiration).) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Concomitant products included ASA for Anticoagulant therapy.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022 at 10:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Mar-2022 at 10:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired on 23-Mar-2022 and administered on 25-Mar-2022 (2 days after expiration).). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired on 23-Mar-2022 and administered on 25-Mar-2022 (2 days after expiration).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking ASA as a blood thinner. No further details was provided about the medical history of the patient.  It was reported that they administered 8 doses of Moderna COVID 19 Vaccine (7 boosters and 1 full dose second vaccine) 2 days after the vaccine expired.  Treatment information was not provided.
Information has been received from a physician concerning a 4 year old white male weighing 43 lbs and 41 inches in height who on 06-FEB-2007 was vaccinated subcutaneously with the second dose of varicella virus vaccine live (Oka/Merck) (lot# 654030/0913F). There was no concomitant medication. On 25-JUN-2007 the patient developed moderate to severe case of chicken pox. The patient sought unspecified medical attention. The patient was treated with acyclovir. The patient was recovering. There was no product quality complaint. Additional information has been requested.
Patient received 2nd dose of Pfizer vaccine on 04/02/2021. Then was exposed to his mother who tested positive for Covid-19. He was tested for Covid-19 on 08/02/2021 and received positive results on 08/02/2021. He is currently asymptomatic.
MMRV was given in error. Should have gotten MMR. No adverse reactions noted at this time.
psychiatric issues; This case was reported by a nurse via sales rep and described the occurrence of psychiatric symptom in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced psychiatric symptom (serious criteria hospitalization). On an unknown date, the outcome of the psychiatric symptom was unknown.   It was unknown if the reporter considered the psychiatric symptom to be related to Meningococcal B vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a Men B vaccination unsure if Bexsero or Tumenba and soon after the patient had psychiatric issues and was admitted to a hospital for those.  That was all the information that the reporter had but did speak to MSL about this. The reporter did not consent to follow up.
Frequent urination; Ear ache; Incapacitated; Sore throat; Weakness; Swelling of the face and throat; Swelling of the face and throat; Exhaustion; Headache; Muscle pain; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Sep2021 at 10:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Aug2021 at 16:00 as a single dose for COVID-19 immunisation. On 03Sep2021 at 14:00, the patient experienced swelling of the face and throat, weakness, exhaustion, head ache, muscle pain, chills, fever, sore throat, ear ache, frequent urination and incapacitated. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events swelling of face and throat, weakness, exhaustion, headache, muscle pain, chills, fever, sore throat, ear ache, frequency urination and incapacitated were resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/29/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE J96.00 ACUTE RESPIRATORY FAILURE 3/7/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/17/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE R09.02 HYPOXIA 5/1/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE G47.33 OBSTRUCTIVE SLEEP APNEA 4/29/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 3/7/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/17/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 5/1/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE G47.33 OBSTRUCTIVE SLEEP APNEA 4/29/2022 ADENOCARCINOMA METASTATIC TO RIGHT LUNG J96.00 ACUTE RESPIRATORY FAILURE 3/7/2022 ADENOCARCINOMA METASTATIC TO RIGHT LUNG J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/17/2022 ADENOCARCINOMA METASTATIC TO RIGHT LUNG R09.02 HYPOXIA 5/1/2022 ADENOCARCINOMA METASTATIC TO RIGHT LUNG G47.33 OBSTRUCTIVE SLEEP APNEA 4/29/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE J96.00 ACUTE RESPIRATORY FAILURE 3/7/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/17/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE R09.02 HYPOXIA 5/1/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE
Within 5 minutes of receiving vaccine patient complained to wife of feeling lightheaded, became awake but not responsive for about 5 minutes, slurring words not getting any communication out, clammy/muggy, pale, refused to move onto the floor, was dead weight when trying to move. Blood pressure was 100/50 HR 60.  Wife said he was not anxious walking in, later he said he has "white coat syndrome".  Paramedics were called, was evaluated by paramedics and they attributed it as a vasovagal response. Patient finally after 10 minutes came around.
This case was reported by a nurse via sales rep and described the occurrence of rash in an elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 22nd January 2019, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash and blister. On an unknown date, the outcome of the rash and blister were unknown. It was unknown if the reporter considered the rash and blister to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and experienced rash and blistering. The reporter did agree to follow up from GlaxoSmithKline.
Child received Proquad 11/09/06.  Child came in with varicella rash on 11/20/06.
Magenta-pink raised purulent rash 1 x 3 inches at and around injection site. No blisters.
I received the second dose of the Pfizer vaccine.  Similar to my first shot, around 5-10 minutes after the shot I felt lightheaded, sweaty, and flush.  I lied down and that issue subsided after about 20 minutes (my doctor noted that it was likely a vagal response).  I had minor aches and tiredness the next couple of days, which I was expecting.  I have also had periodic chest tightness, dizziness, numbness in arms, and a fast heartbeat / palpitations.  These symptoms come and go in waves and last about 20-30 minutes at a time.  They seem to be worse in the early evening.  My most concerning episode was on Aug 18 when they did not seem to go away.  I went to the ER and had tests, no major issues were noted.  I followed up with a doctor visit on Aug 20, no major issues were noted and I was referred to a cardiologist.  These issues are persisting but do not appear to be getting worse.  I have seen online on forums on website where other people have reported side effects very similar to mine.  I would like to get information on what is causing these issues and how to best treat them.  Everything I have been told is that my issues are not life threatening but I would like information on what is happening.  That information should be readily available for vaccines that are being rolled out for general use.
High fever (102+) even with Motrin, chills, extreme pain in arm, spreading to surrounding muscles. Cellulitis onset morning of 3/12/14, continued to spread until 3/15/14 after over 48 hours on antibiotics. Flu like symptoms associated with cellulitis, including continued fever, chills, body aches.
Day 1: Chills, severe pain in injection site arm including muscular and joint pain. Pain down entire arm radiating up neck. Day 2: fatigue, dizzy, lightheaded  Day 3: vomiting Day 4: vomiting and severe headaches
22JUL crying, went limp & eyes rolled back;went to ER turned blue-eyes rolled back; adm on 23JUL96 for 24hr observation;
Fever of 101; flush face; sick to my stomach; achy; Sore arm; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 67-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: 3N6201), via an unspecified route of administration (at the age of 67-years), administered in arm right on 02Mar2021 at 12:30 as dose 2, single for COVID-19 immunization. Medical history included migraines from and known allergies- yes lots mostly sulfa based from an unknown date and unknown if ongoing. Concomitant medications included topiramate (TOPIRAMATE) taken as 50 mg x 3, amitriptyline hydrochloride (AMITRIPTYL.HCL BRISTOL MYERS) and levothyroxine sodium (THYROXINE) taken as 112 mcg for an unspecified indication, start and stop date were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265), via an unspecified route of administration (at the age of 67-years), administered in arm right on 10Feb2021 at 12:15 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient does not have covid prior vaccination and had not been tested for covid post vaccination. On 03Mar2021 at 18:00, the patient experienced fever of 101, flush face, sick to my stomach, achy and sore arm. The treatment was received for all the adverse events with advil. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The facility type was reported as hospital. The clinical outcome for all the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Fever, chills severe tiredness for one day then headaches lasted 7 full days with dizzyness and tiredness.  Today is day 8 and headaches seem to have dulled but still exist.
The day after vaccines, child seemed very tired. 10 days later child has muscle spasms which turned into seizures. Medical doctors used Phenobarbital (did not work). Child is now seeing a Natural Health Practitioner.  04/23/2007 MR received for a 6 day hospitalization 02/15-21/2007 for h/o spells which began on 1/18/2007 consisting of leftward eye deviation, flexion and stiffening of arms and legs and redness of the face with a gasp, lasting 5-10 seconds. The infant had them every 20 minutes or so, never during sleep.  She then began having R eyelid twitching, and rhythmic clonic activity of the RUEs and RLEs.  She was brought to the local ED at that time where she had 3 more episodes.  She was txd with phenobarb and admitted. Admitted 02/01-03/2007. Seizures stopped for several days but recurred and been having ~5/day until this admission.  PE shows plagiocephaly and microcephaly.  Left ear posteriorly rotated.  Sacral Hair tuft.  Infant did not make eye contact or track.  Full EOM.  Hair loss sides of head. Otherwise WNL.  Final DX:  Infant-onset partial epilepsy.  Severe developmental delay and growth failure. 04/27/2007 MR received for initial hospitalization (02/2-3/2007) for c/o multiple minor staring episodes where the infant looks off to the left and becomes unresponsive for a few seconds.  They have increased in frequency over the prior 2 weeks.  Infant had 2 grand mal seizures in the ER with eye deviation to the left. PMH: none.  PE: WNL except esotropia noted on the left. Final DX: Infantile seizures.
The Moderna 6-11 year old Lot:AR4504B 0.5 mml dose was given to the patient that is an adult in error.
Acid reflux; Has been experiencing on going bloating sensation; Achy feeling in the stomach/stomach pain; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Apr2021 (Lot number: EW0161) as dose 2, single and administered in arm left, administration date 22Mar2021 10:00 (Lot number: ER8730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "breaking out in hives", start date: Aug2019 (unspecified if ongoing), notes: Started breaking out in hives; "immune system concentration" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; VALSARTAN taken for hypertension; ROSUVASTATIN taken for blood cholesterol increased. The following information was reported: ABDOMINAL DISTENSION (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Has been experiencing on going bloating sensation"; ABDOMINAL PAIN UPPER (non-serious) with onset 22Mar2021, outcome "recovering", described as "Achy feeling in the stomach/stomach pain"; NAUSEA (non-serious) with onset 22Mar2021, outcome "recovering", described as "Nausea"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "Acid reflux". The event "acid reflux" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastrooesophageal reflux disease.  Additional information: The patient reported that This week the cardiologist also put him on Ezetimibe 10mg. They wanted to give him more cholesterol medication, but he did not want to because of the cramps. He would get leg cramps on 20mg of the Rosuvastatin occasionally. He just assumed it would be worse if they doubled it. It made him feel uncomfortable, so they prescribed the Ezetimibe to take along with the 20mg Rosuvastatin.The manufacturer of the Rosuvastatin is Aurobindo, Lot OF2021022-A, Expiration Jun2023. They said the Ezetimibe would also help lower bad cholesterol. They put him on 20mg Prilosec, which has done nothing and then they doubled the dose. He then stated it is not Prilosec, but a form of Prilosec, which he named as Omeprazole, and that is the only thing they gave him. They are 20mg capsules. The manufacturer is Xiromed, LLC, Lot and expiration are unknown as it is in a pharmacy vial. The count size is, this is his 2nd fill, of 90. The doctor said to double his dose this week and he did two days ago, and it was not doing anything.  No follow-up attempts are possible. No further information is expected.
Allergic reaction; Rash in arm, legs, trunk, face and hair; This spontaneous case from was received on 02-Nov-2023 from other non-healthcare professional via Agency (reference number SEQW23-03981) and concernes a 76-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 11-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 mL, route of administration and anatomical location: not reported) for influenza immunization. The batch number reported was 371635.  On the same date, the patient was also vaccinated with non-company co-suspect Covid-19 vaccine (manufacturer unknown; dose, route of administration and indication: not reported). The batch number was not reported.  On an unspecified date (15-Oct-2023 or 16-Oct-2023), four or five days after receiving the vaccines, as reported, the patient developed a rash in the arm, legs, trunk, face, and hair. The patient also reported that she thought she might have had an allergic reaction to Fluad vaccine. The patient used calamine lotion and Benadryl (diphenhydramine hydrochloride) as a treatment.  The outcome of the events 'allergic reaction' and 'rash all over' was not reported.   The reporter considered the event 'allergic reaction' as related to Fluad Quadrivalent. The reporter did not provide a causality assessment for the event 'rash all over'.   The case was assessed as non-serious.
Patient returned to the pharmacy on 11/14/2019 and told the pharmacist he was experiencing continued muscle pain in the right deltoid that originated after receiving the flu shot on 10/8/2019. He struggles lifting his arm past shoulder height. He also complained of congestion and fatigue that has hindered his ability to leave his house. He denies any pain in his shoulder joint.
This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. On an unknown date in last flu season, 2013 the unspecified patient was vaccinated with a dose of ZOSTAVAX in the arm (dose, dose number, route and lot# not reported). On an unknown date in 2013, the patient's whole arm "blew up", and the patient was diagnosed by the primary care provider as having an allergic reaction to the ZOSTAVAX. The outcome of event was unknown. This is one of several reports received from the same source. Additional information has been requested.
PATIENT DOES NOT CALL OR REFER ANY ADVERSE PROBLEM VACCINE NOT VIABLE.
45 minutes after immunization Pt experienced headache, chills, nausea,. Pt woke up at 2:30 AM with total body shaking/tremors, aches, pain, continued headache, flushing. Pt fell back asleep and woke up at 6:30 AM with worsened symptoms. Went to urgent care and received Ondansetron and Ketorolac. All vitals were good! Per patient, MD thought it was an immunological response to the Fluzone HD.
Pain around the injection site following vaccination.  Approximately 2 days later, patient began experiencing pain, tightness, and slight tingling in forearm.  Patient also experiencing episodes of sweating only in the hands with no relief.  Patient has received ibuprofen 800mg which has helped somewhat with the hands but not the forearm.
This is a spontaneous report by a contactable physician. This physician reported that a 6-week-old female baby received the first dose of PREVNAR 13 (Batch/Lot # G75073) at 0.5 ml single dose intramuscularly in the left thigh, and HIB in the left thigh, both on 17Oct2013. Relevant medical history and concomitant were reported as none. On 17Oct2013 the baby experienced lots of discomfort, and reaction at the administratoin site such as skin got swollen, redness and warmth. Therapeutic measures taken in response to above mentioned events included ice and TYLENOL. The baby fully recovered on 18Oct02013. Follow-up attempts completed. No further information expected. Follow-up (05Nov2013): New information from a contactable physician includes: vaccination date and Batch/Lot, concomitant vaccine, patient's demographics, outcome. Follow-up (26Nov2013): New information from the same contactable physician includes: details on administered vaccines, and, details on medical history and concomitant medications.
Nausea and vomiting at school. Continued through sunday, child was with father.  Returned to mothers house on Sunday 11/22/09, evening with report ill all weekend. Not eating or drinking.  Temperature checked at that time 104 degrees.  Unknown how long fever elevated to this level due to poor reporting by father. Given Motrin and tylenol after temperature taken.  He vomited this up so taken to Emergency room.  Treated with Zofran in ER.  Taken home and continued on Motrin and Tylenol and  forced fluids. Reports feeling better at this time. Tolerating foods/fluids.