chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She may have shrunk a little; Arm soreness at injection site; Extreme tiredness; Headache; Nausea; General unwell feeling; Didn't feel steady on her legs; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 74-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 08Feb2021 at 10:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. Historical vaccine included Flu Shot for immunization on an unspecified date and experienced mild sore arm; first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. It was reported that reporter attempted to clarify which lot number was for the second dose of COVID-19 Vaccine. Provided two lot numbers from her patient card of EM9810 and EL3249. Caller was unable to determine which lot number coincided with her second COVID-19 Vaccine. No additional vaccines administered on same date of Pfizer suspect; no prior vaccinations received within 4 weeks. On 09Feb2021, the patient experienced arm soreness at injection site, extreme tiredness, headache, nausea, general unwell feeling, didn't feel steady on her legs, on an unspecified date, the patient experienced she may have shrunk a little. Reported that arm soreness at injection site was mild pain, extreme tiredness only lasted a day to a day and a half, mild nausea made her not want to eat. Didn't feel steady on her legs as she did not have wobble legs, just didn't feel steady. Had no fever and no joint pain. The patient underwent lab tests and procedures which included body height which resulted as she may have shrunk a little. Patient received treatment for headache with aspirin and it took care of the headache immediately. The outcomes of events (Arm soreness at injection site, Headache, Nausea, Didn't feel steady on her legs) were recovered on an unspecified date in Feb2021, the outcomes of events (Extreme tiredness, General unwell feeling) were recovering, the outcome of event (She may have shrunk a little) was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Fainted.  He was leaning against a wall and said he felt sick, then 30 seconds later he said he felt funny and started to faint.  As he was going down his eyes rolled in the back of his head, a nurse caught him and laid him gently on the floor.  His left hand seemed to seize up and he started to shake a bit.  Another nurse came to hold his head, I told another nurse to get the Dr., and the nurse who caught him monitored his condition.  Patient came out of it in about 30 seconds and had no memory of fainting.  The Dr. & Nurses checked his vitals and they were within Normal range.  Nicolaus had just come from school and had not eaten since lunch.  The nurse game him a granola bar & water.
Patient experienced chills, nausea, vomiting, dizziness and headache.  These symptoms started the following morning after the administration and lasted for a couple of days.
Approx 24 - 30 hrs after receiving PPV23, pt developed fever of 101 po, chills.  Injection site red, swollen, tender, approx 3 inches in diameter.  Area of swelling continued to enlarge to about 6 inches the next day.  Was seen by M.D. on 10/17/08.   Per M.D., "possible viral/bacterial infection beginning in airway before injections which cross react with strep pneumo antigen or only strep pneumo vaccine local reaction, esp. if had high titer previously."  Temp at MD 99.1 on 10/17/08.  Treated for cellulitis with Dicloxacillin X 10 days.  Phone call to pt on 10/23/08, injection site improving on antibiotics, feeling better.
Patient's arm was a little swollen at the deltoids and bruised. Arm is throbbing with pain slightly.
Early Fall I had gotten new contact lenses and was comfortably wearing them 10-11 hrs per day; Dr. saw me for f/u and said that they fit well and were being tolerated well.  In December I started to have burning when I put them in and had to wear them less time.  I tried drops or took them out to rewet.  By the end of December I had excruciating burning that made me cry from pain.  I stopped wearing them until I could be seen for f/u on 1/5.  I was told that my eyes were very dry and that  I "can't wear contact lenses"; there was no explanation about the change in my condition.  I was told that perhaps I could wear them 1-2 hrs on special occasions; I tried one more time and the burning was excruciating causing me to cry from discomfort. Only recently did I begin to question if this could be an adverse effect from the vaccine since no other professional could state anything except that I now have exceptionally dry eyes and need to use drops multiple times daily.
This literature marketed report was received from the authors of the literature article. The authors conducted a retrospective cohort study among the patients of unknown age (reported as "older"), with autoimmune or inflammatory (AI) diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), inflammatory bowel disease (IBD), psoriasis, and psoriatic arthritis (PsA), using 2006-2013 insurance data. The aim of the study was to evaluate the duration of herpes zoster (HZ) vaccine (manufacturer unknown) effectiveness. The vaccinated cohort consisted of 59627 patients. 53.1% of the patients had RA, 1.4% had AS, 20.9% had IBD, 31.6% had psoriasis and 4.7% had PsA. 11.0% of the patients used biological drugs prior to index date, 46.1% used disease-modifying antirheumatic drugs (DMARD). 14.0% used unspecified glucocorticoids at the dose lower than 7.5 mg/day, 2.5% used them at the dose higher or equal to 7.5 mg/day and 83.5% of the patients did not use them at all. Upon evaluation of potential confounders, 26.7% of the patients had diabetes, 24.9% had chronic obstructive pulmonary disease (COPD), 10.4% had renal disease, 11.3% and heart failure, 44.8% had outpatient infection during baseline, 50.7% used narcotics, 27.7% used unspecified antidepressants and 21.8% used unspecified nonsteroidal antiinflammatory drugs (NSAID). On unknown dates, the patients were vaccinated with a dose of  zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiry date were not reported) for prophylaxis. To understand long term effectiveness and avoid misclassification related to healthcare associated with vaccine administration, follow-up started from 30 days after the vaccination date or corresponding calendar date in the matched cohort, and ended at the earliest of first HZ, death, loss of coverage, or 31-DEC-2013. Matched patients were censored if they were subsequently vaccinated, and then included in the vaccination group and re-matched. The maximum follow up time was 7 years post-vaccination. HZ was diagnosed using an International Classification of Diseases, 9th (ICD-9) inpatient diagnosis code alone or an outpatient diagnosis code plus antiviral medication (famciclovir, acyclovir, valacyclovir) within 7 days of HZ diagnosis. This report refers to 169 patients who, on unknown dates, developed HZ in the 4th year after the vaccination (considered as lack of efficacy). The authors concluded that the duration of HZ vaccine (manufacturer unknown) effectiveness waned over about 5 years among older patients with AI conditions, many of whom were treated with immunosuppressive and immunomodulatory agents. This is one of several reports from the same literature article (cross-referenced with MARRS # 1703USA010321, 1703USA010592, 1703USA010593, 1703USA010595, 1703USA010596, 1703USA010597). Additional information has been requested. Sender's Comments:  US-009507513-1703USA010321.
Red, swollen, sore, got infected and was put on antibiotics, steroids and took Benadryl for the itching.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure." (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: COVID 19 Treatment; (Jul2022) negative; (19Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
NAUSEA; SORE THROAT; SWALLOWING DIFFICULTY; FATIGUE; BODY ACHES; FEVER; RECURRENT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805122, and batch number: 1805122 expiry: unknown) dose was not reported, administered on 13-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced sore throat. On 20-MAR-2021, the subject experienced swallowing difficulty. On 20-MAR-2021, the subject experienced headaches. On 23-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 14-MAR-2021, and fatigue on 15-MAR-2021, and had not recovered from fever, headaches, sore throat, nausea, and swallowing difficulty. This report was non-serious.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On the night of 19-OCT-2015, the PNEUMOVAX 23 was improperly exposed to 48F for 8 hours. On 20-OCT-2015, the patient was vaccinated intramuscularly with a dose of this improperly exposed PNEUMOVAX 23 (lot number L021367 and expiration date 05-NOV-2016; dose was not reported). Concomitant therapy was not reported. There was no adverse effects reported. Additional information has been requested.
The patient received immunizations then 12-24 hours later started having pain and swelling. Two days after the immunizations, he went to his doctor and was diagnosed with cellulitis. He was given an antibiotic to treat the infection.
Received dose #1 on 3/3/00; #2 on 4/7/00. Pt phoned in on 9/8/00 to report that 1-2 weeks after receiving dose #2, she developed petit mal seizures, mostly at night and 1 grand mal seizure. She reports she had a mild fever for 1-2 days after vaccination; no other adverse reactions. Is still undergoing neurological testing at this time.
Hospitalization: 5/17/2023 - 5/20/2023 (3 days) Presentation to the ED: weakness and AMS COVID + date: 5/17/2023 Treatment: antiviral remdesivir, bronchodilator therapy and oxygen therapy Discharge to: SNF.   011J20A 1/12/2021 028L20A 2/9/2021 066F21A 11/12/2021
The event was that the patient received a COVID vaccine on 12/3/2021, and then mistakenly received another vaccine today, 12/10/21. There were no observable signs or symptoms. Provider was not aware until parent called the clinic to inform provider that patient had received a dose on 12/3/21 and did not inform the provider at the time of the injection.
Patient was given an undiluted dose of Covid-19 vaccine, Pfizer, Age 6m-4y. Vial was not diluted prior to administration. Nursing supervisor was notified on 10/31/23. Provider was notified on 11/1/23. Family was notified on 11/1/23 and confirmed patient had no symptoms of adverse reaction.
Pt received vax 3rd dose 3Jan90, Titer ck on 6Apr90 indicated nonresponder. 16Apr90 admin Engerix & Heptatitis B & titer testing showed borderline
an eighteen month old male child was vaccinated with KINRIX; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 20-JUL-2023, the patient received Kinrix (left thigh) .5 mg. On 20-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: an eighteen month old male child was vaccinated with KINRIX).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 25-SEP-2023 A reporter reported that an eighteen month old child was vaccinated with Kinrix which led to inappropriate age at vaccine administration. The reporter Consented to follow up.
Patient was given tdap vaccine in left deltoid 11-26-14 on evening of vaccine - patient felt pain while lying on injection site - patient spike fever to 103 11/28/14 was sent to ER. 67 y/o female s/p tetanus shot in (L) deltoid region 3 days ago, that evening she developed pain in the left arm, swelling, chills. The course of the next 2 days the swelling became gradually increased and she developed more chills, yesterday with shaking chills and teeth chattering though no objective fever. Swelling has starting to decrease since yesterday, actually says it is substantially improved today with less pain, left swelling, still some redness, no fevers or chills today. She has been taking TYLENOL with some relief.
My arm hurt after first dose..  But after 2nd dose I am sick body aches all over Head hurts arm fill like I'm lifting a ten pound hammer.throat hurts some some coughing
patient called 911 with shortness of breath and chest pain. When squad arrived, he was still oriented and awake and told squad he had Pfizer vaccine the previous day.  Thought was a pulmonary embolism had occurred. Then he lost consciousness and pulses. EMS started CPR.  Despite aggressive ACLS maneuvers, the patient ultimately died.
At 2:54 pm, the patient received her first dose of Pfizer (lot number EW0179, expires on 08/2021) on left deltoid. Patient walked with a steady, balanced gait to EMT observation area. At 3:20 pm, patient notified EMT that she was feeling unwell. Patient became diaphoretic. EMT assisted patient to anti-gravity chair. Patient remained A&Ox4 and talking to EMT. Patient complained of chills in back of neck and numbness in hands bilaterally. Lead RN was notified of reaction. RN requested vitals Q5 minutes for 30 minutes. At 3:24 pm: BP of 120/80, HR 107, SPO2 99% and respirations of 17/min. Patient's husband was notified and he sat with patient. Patient consumed 16 oz of water. At 3:29 pm, patient reports no longer experiencing numbness in hands. At 3:30 pm: 130/80, SPO2 99%, HR 92, RR 17. Patient no longer diaphoretic. Patient states she is "feeling better" and requested to leave facility. Patient was A&Ox4 with no reports of dizziness and lightheadedness. Lead RN provided patient with education concerning when to call 9-1-1, including worsening of symptoms and trouble breathing. Patient was instructed to follow up with PCP. At 3:35 pm, patient stood up from chair, denied lightheadedness and dizziness. Patient walked to car with steady, balanced gait.
I had a scratchy throat, congestion, and tightness in the chest. I also had a mild cough. I completed an at home COVID-19 Test on November 21, 2022. I called the doctor who prescribed Paxlovid which I began to take on the 22nd.  The symptoms gradually improved over a weeks' time to completely feel better.
Information has been received from a consumer concerning her approximately 16 month old son with no known allergies or past medical history who in approximately August 200, at "14-16 months old" was vaccinated with a first 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no concomitant medication. In approximately September 2002, "a month after the shot" the patient was "only saying three words" though he was speaking "normally" prior to vaccination. The patient was diagnosed with a mild form of autism "called PPD". The patient was hospitalized once to have an EEG done. It was also reported that the patient had blood tests, an MRI, an EKG, an MRA, and "MRS" performed, all results unspecified. At the time of the report that patient was five years old and he has "improved". He can now speak, dress himself, and go to the bathroom properly although he may have "future problems". There was no product quality complaint involved. Additional information has been requested.
Shortly after receiving immunization, watching siblings get their shots, fell backwards having what appeared to be a seizure with stiffness, rolling eyes backwards.  Recovered soon.  Mom denies seizure disorder.  EMTs called, they said that he was ok.   Mom said that she would take him to the hospital to be checked out.
Information has been received from a physician and a nurse.  It was reported that a 62 year old female with type II diabetes, hypertension, congenital heart disease, dyslipidemia, hypothyroidism and penicillin allergy (AMOXIL caused gastrointestinal upset), and a history of chickenpox who on 05-FEB-2009 was vaccinated SQ into left arm with a 0.65ml ZOSTAVAX (Oka/Merck) (lot # 662997/1619X).  Concomitant medication included AVALIDE, TOPROL XL, PRAVACHOL, METFORMIN, LEVOTHYROXINE SODIUM, aspirin and CHOLECALCIFEROL.  The female did not experience any symptoms.  Subsequently, the female's husband developed shingles.  On 08-FEB-2009 symptoms began in his mouth as a sensation of cold sores.  The patient called an unspecified dentist who did some X-rays.  The patient had blisters on the left side of the tongue and left side of the lips and outside on the chin on the left side.  There was a pain that shot up to the left ear to the tip of the forehead on the left side.  The patient was in a lot of pain and also had a headache.  The patient was given VALTREX.  As of 10-FEB-2009 the patient's outcome was unknown.  Follow-up information was received from the licensed nurse (L.N.) on 12-FEB-2009 which reported that the 61 year old male experienced 7 vesicles on the mandibular branch of 5th cranial nerve then to the mouth.  His maximum temperature was unknown.  Other systemic symptoms included headache, difficulty swallowing and itching pain.  He was in the office twice for his shingles.  As of 12-FEB-2009, the patient still symptomatic pending, he was not recovered.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of the lesion was collected on 12-FEB-2009.  The sample was taken from 2 vesicular lesions one in patient's mouth and the other on his chin.  The PCR results for the specimen from 2 vesicular lesions one in patient's mouth and the other on his chin identified the presence of WT VZV.  Additional information has been requested.
I experienced a red welt about three inches in length and two inches wide at the injection site. There was also a sign of a hive/blister in the same area. The whole area was extremely hot to the tough. This lasted for almost six days. I had experienced welts from immunotherapy shots in the past, and the recommendation was to take extra does of antihistamine and to use hydrocortisone and/or antihistamine cream. I did this for about a week, and the welt finally subsided. As it started to subside after six days, I started experiencing itchiness and still had two small bumps as of day 10. Since I am familiar with adverse reactions due to my immunotherapy treatment, I did not seek medical help as I was not having a reaction elsewhere on my body (i.e. hives/rashes in other places, anaphylactic).
On 08/29/01, mom indicating she and the doctor questioning a reaction to immunizations given 08/08/01. Eight days after he was lying in bed and started shaking (trembling-like), was crying. He could not sit or stand, he was taken to the ER, he was walking okay and then he stopped. He started shaking and fell over again later while in the ER. No further problems since. Having EEG 08/30/01.
Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. The physician reported that the pt completed the varicella virus vaccine live series and still had a negative titer. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Headache, Myalgia & NauseaVomiting Narrative: Day 1 of vacc: minor arm pain Symptoms Day 2 and Day 3 post vac: severe arm pain, HA, severe generalized myalgia, chills, nausea.
Baby had 2-3 episodes of turning blue during a feeding on the evening that the vaccination was given.
Pt developed symptoms 10/13/17 and came to our pharmacy at 10/18/17. Pt had rash left upper eyelid area and left forehead and head. Pt also had pain. We suggested to go to urgent care or ER. She went to a few urgent care but she wasn't treated because her insurance was not accepted. She made an appointment with her PCP at 10/24/17 instead.
Aches; Chills; Fatigue; Has missed the window to get her  second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (Has missed the window to get her  second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (Has missed the window to get her  second dose). At the time of the report, PAIN (Aches), CHILLS (Chills), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (Has missed the window to get her  second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
A little over 24 hours after receiving my second COVID19 vaccine, I noticed stiffness in my neck and a headache.  Within another hour, I took my temperature and was running a low grade fever between 99.5 and 100.3.  I also experienced tiredness, achey muscles and joints, headache and fatigue.  I laid in bed for several hours and subsequently slept from about 10pm on April 6th to 10am on April 7th, 2021.  when I got out of bed on April 7th, I noticed i was feeling better and was not running a fever.  Throughout the day, my energy level improved and all other symptoms receded.
I started experiencing extreme nausea roughly for about 2 weeks before receiving the vaccine. It has been almost a year and I am still feeling nauseous daily. My symptoms are beginning to improve daily.
Patient requested Moderna Bivalent vaccine. Patient was in the same room as sons, who were also getting their COVID boosters. Patient was accidentally given the Pfizer Bivalent dose that was meant for her son, instead of the Moderna vaccine that had been drawn up for her.