chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient said she had severe and violent chills the night of the day she got the flu shot. She also had pain all over her body and muscle. violent chills
second dose: fever; second dose: chills; second dose: sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 18:30 (Lot number: 30155BA) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Pfizer COVID First dose: 10Sep2021, LOT: FD08CG, states she doesn't understand the writing, because the letters are all together, Expiry Date: Unknown, NDC: Unknown, Injection, left arm, unknown dosage, injection), administration date: 10Sep2021, when the patient was 18 years old, for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset 02Oct2021, outcome "recovered" (02Oct2021), described as "second dose: fever"; CHILLS (non-serious) with onset 02Oct2021, outcome "recovered" (02Oct2021), described as "second dose: chills"; OROPHARYNGEAL PAIN (non-serious) with onset 02Oct2021, outcome "recovered" (02Oct2021), described as "second dose: sore throat".   Additional information: She states he got the, well they all got the second dose of the vaccine on Friday, but he got fever, chills, sore throat, fever; chills; sore throat: Confirms began about 6 hours after getting the shot. He got it about 5:30 in the afternoon and started feeling that way over night, so confirms began 02Oct2021 and was just a one day thing and confirms recovered completely 02Oct2021. Pfizer COVID 19 Vaccine: Indication: They all decided to because they have a 7-year-old at home and he works so hopefully it will help protect him better from it. She confirms the product the patient received is the Pfizer COVID 19 Vaccine.   No follow-up attempts are possible. No further information is expected.
IN RELATION TO THE PENTACEL ADMINISTRATION, ONLY VIAL 1 OF 2 WAS ADMINISTERED. PT WAS ONLY IMMUNIZED FOR DTAP AND IPV. ADMINISTRATOR DID NOT USE VIAL 1 DTAP/IPV AS DILUENT TO VIAL 2 HIB. PT IS STILL DUE FOR HIB. PT NEEDS TO BE SCHEDULED TO COME BACK TO GET HIB ONLY VACCINE.
Red mark on her arm (half dollar in size)/it is burning and is hot to touch; Red mark on her arm (half dollar in size)/it is burning and is hot to touch; Red mark on her arm (half dollar in size)/it is burning and is hot to touch; Itching; This spontaneous case was received on 17-Sep-2020 from a pharmacist via agency (reference number: SEQW20-01866) and concerned a female patient of an unknown age.  The patient's medical history and concomitant medications were not reported.  On 14-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number reported was P100240196 and expiry date was 19-May-2021.   On the same day, after vaccination, the patient developed a red mark on her arm which was half dollar in size. It was burning and hot to touch and the patient also experienced itching. The patient did not receive any treatment associated with events.  The outcome for the events was not reported.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: The developed erythema, skin burning sensation, skin warm and pruritus on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. No information about concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The developed erythema, skin burning sensation, skin warm and pruritus on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is suggestive. No information about concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
For the first day or two after the shot, I had a slight fever and a slight headache.  My arm was a little swollen.  These symptoms cleared up but approx. 9 days after vaccination, a large red blotch appeared at the injection site on my upper left arm.  At first, I thought it was an insect bite but there were no obvious indications of a bite.  A few days later, after the red area got bigger and more itchy, I contacted my internist, and he told me to put betamethazone cream on that spot.  Over the next 5 days, it got larger and larger--up to about 3x5 inches--but the redness faded.   Today (about 6 days after it sppeared) the blotch is less red. When I looked up "red blotch after vaccine" on the internet, I found several postings entitled "covid arm."  The  descriptions and photos matched my symptoms and I now assume this is what I had.
Felt a little nauseous and a little headache started on December 31st 2020 @ 9:00pm and lasted  until January 1st 2021 @ 12:00am.  Pain, tenderness, swelling(I have a big bump) and redness of the injection site started December 31st 2020 @ 8:00am until present it?s still going on January 1st 2021.  At one point felt like my heart was beating fast started on December 31st 2020 @ 10:00pm until December 31st 2020 @ 10:30pm.  Not sure where this falls into might not even have to do with the vaccine sorry if I guy is reading this but I bled all day on December 31st 2020 and I am currently on Birth Control and have been on for 3 years now and haven?t had a female menstrual cycle in about 3  years.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/08/21Lot#EL3248 2nd dose01/29/21 ,lot#EN5318 Diagnosed covid positive:08/11/21 Symptom onset:08/11/21 Exposure: Symptoms:Cough, fatigue
C/O Left arm heaviness/tingling after recieving shot.  C/O heaviness/tingling in lower legs/feet.  C/O tingling sensation left side of head/face.  BP 118/82; HR 124.  Taken to Emergency Room for evaluation.
My left arm began to hurt at the injection site and slowly spread down to my fingers.  I felt very tired and fell into a sound sleep.  I woke up to moderate swelling throughout right arm down to finger tips and up to left side of neck.  Joint  pain and stiffness throughout the body and more intense on the left side of my body. Mild headache.  Concreted pain at injection site.
Vomiting, diarrhea, fainting, tingling in arms and fingers, severe chills (uncontrollable shaking), intense muscle and body, intense headache
I just couldn't take a deep breath and made the mistake it and told the physician that it felt like someone was sitting on my chest and my lungs burned and I could not take a deep breath. I just knew I could not breath. Physician prescribed Advair, Prednisone, Benzonatate, Albuterol. Went to the physician at the end of August of 2021 and they prescribed another round of Prednisone and Albuterol and I was not any better and they sent me to get a chest x-ray and the radiologist thought it might be COPD and she went to the hospital and had breathing measured and she was done with this and requested a pulmonologist and was diagnosed with Brachialgias. She is still on Albuterol sulfate on a nebulizer every day with a Albuterol inhaler.
The day of the first dose of the COVID 19 Moderna vaccine I experienced tinnitus in my right ear for about 2 hours. Thereafter, I started feeling my heartbeat in my ear every time I laid down and intermittent tinnitus . In early June, I started feeling pain in the same affected ear. At that time I went to my primary care  physician who prescribed me antibiotics(Amoxilin)  infection. After completing the five day treatment of antibiotics symptoms did not improve so I made an appointment with an ENT and went to an urgent care clinic where they prescribed me an antibiotic and steroid drop but that medication did not improve my symptoms. At the appointment with the ENT on June 9th I was diagnosed with a bulging ear drum and ear infection. More oral antibiotics were prescribed with a steroid to reduce swelling. Pain in the ear seemed to subside but I still had ear fullness and redness.  At the follow up appointment on 6/30 a hearing test was done where it was discovered that I lost about 50 percent of my hearing on right ear.  I still have tinnitus and hearing loss today.
Patient c/o an increase in asthma related symptoms after receiving FluMist.  Her parent reported the symptoms to the clinic on 11/26/08.  She was scheduled for an appointment, examined, and treated for allergy and asthma related symptoms on the same day.
Bell's palsy; Firm red swollen arm; Firm red swollen arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed firm red (erythema), swollen arm (peripheral swelling) and bell's palsy.    The patient's medical history was not provided. No relevant concomitant medications were reported.     On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011J20A) for prophylaxis of COVID-19 infection.    On 05 Jan 2021, the patient developed firm red swollen arm. On 22 Jan 2021, the patient experienced medically significant event of symptoms of bell's palsy.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events developed firm red (erythema), swollen arm (peripheral swelling) and Bell's palsy was not reported.  The outcome of the event firm red (erythema) and swollen arm (peripheral swelling) was resolved on an unspecified date. The outcome of the event bell's palsy was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
excruciating headaches; Itchy injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (excruciating headaches) and VACCINATION SITE PRURITUS (Itchy injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (excruciating headaches) and VACCINATION SITE PRURITUS (Itchy injection site). At the time of the report, HEADACHE (excruciating headaches) and VACCINATION SITE PRURITUS (Itchy injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       lot of patients who received the Moderna COVID 19 vaccine has reported similar side effects.  Treatment information in response to events was not provided.
Flu like symptoms: headache, fatigue, night sweats, muscle and joint pain. That is, a big increase in Chronic Fatigue Syndrome
10 pmish 3/27/21 onset of body shivering.  Took temperature in early am 3/28/21 -- > 100 degrees F.  Upon wakening later in am 3/28/21 middle - lower back pain 2-3/10 pain level "at worst" relieved temporarily with Aleve.  Does not recall activity to irritate musculo-skeletal systme.    Individual has not sought medical assessment/evaluation, care or treatment as of this report.
Loss of eye contact, loss of speech, Autism. Caused by two doses of MMR vaccine on 02/02/2018 & 08/03/2018.
Headache, Arthralgia, Fever, CoughWheeze, FATIGUE, CHILLS, SORE THROAT Narrative:
This spontaneous report was received from an administrator and refers to an adult patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with pediatric dose of VAQTA lot # N023953, expiration date 05-NOV-2018 (route of administration was not reported) for prophylaxis. No adverse effects were reported.
(pt had a previous hosp stay; was dx'd positive for COVID and bilateral pneumonia; O2 supplementation; DNR/DNI; dc'd to home with O2 and Hospice Care; per death certificate, pt died in the home with COVID 19 being the cause of death
administered PENTACEL without the ACT-HIB component with no reported adverse event; Initial information received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA210789.  This case involves a 4 months old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] without the act-hib component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5V (Rotateq) and pneumococcal vaccine CONJ 15V (CRM197) (Vaxneuvance) both for prophylactic vaccination (Immunisation).  On 06-Jul-2023, the patient received a dose of 0.5 ml (dose 2) once of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UJ868AA; expiry date: 30-Mar-2024; strength: standard) via intramuscular route in the right thigh for Immunization.  On 06-Jul-2023 the patient was administered pentacel without the act-hib component with no reported adverse event (single component of a two-component product administered) (latency: same day).  It was reported, "HCP already know what to do but they have not administered the ACT-HIB component since they don't have the diluent for the vaccine. HCP was warm transferred to the Pasteur Customer Service for their order of the ACT-HIB diluent."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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.
Approximately 6-8 hours after injection I began experiencing rapid onset of extreme left shoulder pain and dysfunction with weakness persisting and increasing in severity over the next 2 days.  The pain feels peri-articular, as if I tore my rotator cuff, making it difficult to raise my left arm.  No rubbing or manipulation of the shoulder, deltoid area makes the pain any better. There was and is no injection site redness, erythema or other evidence of injection site reaction.  (I am a non-practicing MD,  know the difference. ) In looking through the literature this seems like SIRVA (shoulder injury related to vaccine administration) but am not certain.  I am wondering if the injection was administered too high? maybe into the capsule?
Blurry vision; This is a spontaneous report from a contactable nurse (reported for himself). A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot number EL3247), via an unspecified route of administration in left arm on 15Jan2021 13:00 as single dose for COVID-19 immunization. The patient medical history included Hypertension, ADHD, hyperlipidemia and COVID-19. The patient concomitant drugs included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), olmesartan medoxomil (BENICAR), atorvastatin (LIPITOR) and pantoprazole sodium sesquihydrate (PROTONIX). The patient was no known allergy to medications, food, and other products. The facility where the most recent COVID-19 vaccine was administered was hospital. On 15Jan2021 13:00 the patient experienced with Blurry vision. Treatment received was reported as no. Outcome of event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
aches; Chills; Headache; tight muscles; Hot flashes; Next 2 days: soreness in left arm; This is a spontaneous report from a contactable Other HCP (patient). This 30-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK5730) intramuscular at left arm on 03Jan2021 at 10:30 AM at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications included cyclobenzaprine, levothyroxine and drospirenone/ethinylestradiol (NIKKI). The patient experienced aches and chills, headache and tight muscles on 03Jan2021 at 13:00. Then the patient had hot flashes and soreness in left arm from 03Jan2021 next 2 days. No treatment was received. The patient had no allergies to medications, food, or other products. The patient was no pregnant. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of all events was recovered.
On September 4, 2021 I was admitted to the hospital for chest pain and shortness of breath. After battery of test a CAT scan showed that I had a blood clots in my right lung. I do not have risk factors for any type of blood clots. My first vaccine was on August 13, 2021. My second vaccine is scheduled for September 7, 2021. I was in the hospital for two days with two separate IVs going. One had A blood thinner and the other one was iron. I will be on blood thinners for six months to one year. During that entire time I will also have blood test taken every six weeks. The doctors and the cardiologist cannot explain how or why I got blood clots. My lifestyle is not conducive to the risk factors of it.
Two weeks after receiving my second Moderna vaccination shot I started to have pain in my cervical spine with loud pulsating tinnitus in my left ear, the next day a began to have migraine headaches and eye pain. I have now been suffering from the neck pain, tinnitus, migraines and eye pain for 5 weeks. I also have been having some sort of twitch or spasam in my head. Please help me if you can.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer or other non-health care professional.   A 19 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EP6955 and expiration date: not reported), via intramuscular, in Left Arm, on 19Mar2021 (at the age of 18-year-old) as DOSE 1, SINGLE and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EP6955 and expiration date: not reported), via intramuscular, in Left Arm, on 09Apr2021 (at the age of 18-year-old) as DOSE 2, SINGLE  both for covid-19 immunization. Medical history included allergy to Some adhesives. There were no concomitant medications. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. The patient tested positive for covid-19 on 13Oct2021 at 10:30. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Oct2021, sars-cov-2 test: negative on 08Oct2021, sars-cov-2 test: positive   on 13Oct2021.No treatment was received for the events. The outcome of the events was recovering at time of report.  No follow-up attempts are needed. No further information is expected.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might have been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment medication was provided.
Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Medium, Systemic: Fever-Medium, Systemic: Tachycardia-Mild, Additional Details: Chest pains (sharp, severe) from about 2-5am on 10/16/21. Currently on 10/16/21, fever/chills and elevated HR.
Information has been received from a registered pharmacist concerning a patient who on an unknown date was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed an injection site reaction that was described as the PNEUMOVAX 23 vaccine site swelling up to the size of a baseball. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.