chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 3 AM I woke up and couldn't breathe. It was very difficult to breathe and I thought I was having an asthma attack so I took my rescue inhaler and it didn't work so I waited about 10 minutes and tried again and it still didn't work. I called my husband and he took me to the ER and they put me on 12 liters of oxygen because oxygen was down so low, and then they tested me for covid (negative) and they did an X-ray of lungs and said it was pneumonia, and they put me in a room and I stayed there for 5 days so my oxygen gradually came down and I was able to get off oxygen by the fifth day. During that time I had multiple breathing treatments (2x a day in hospital) and then I also got antibiotics and my regular medicine as well and then I was able to go completely off of the oxygen the 4th afternoon. They kept me for the 24 hours to evaluate and make sure everything was clear and I was able to get out the next day and then I was given instructions to follow up with my PCP which I did the next week and he diagnosed me with Bronchitis. He gave me Levaquin and put me on a steroid pack (meprednisone pack 4 mg) and codeine for the deep cough, and levofloxacin 500 mg (antibiotics) and so I finished that up and it took me awhile. I notice sometimes my chest is tighter than normal but that's it.
Hive rash on back.  Generalized paresthesias and hyperesthesia.  Subjective shortness of breath.  Confounded by anxiety flare.  Tearful.  Mildly tachypneic.  Lungs clear to auscultation.  No respiratory distress.
Nurse administered meningococcal B vaccine instead of meningococcal conjugate.  No adverse reaction reported by parent or patient
This spontaneous report was received from a vaccine site coordinator and refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M034437 with an expiration date of 03-FEB-2019 (doses, route of administration and anatomical location were not reported). Administered doses of vaccine underwent a temperature excursion of -1 degree Celsius or colder -0.5 degree Celsius for 2 hours and 30 minutes which was detected by a data logger. There was previous excursion between 0 degree Celsius to 1 degree Celsius for 4 hours reported. No adverse effects were reported. Additional information has been requested.
Medical Assistant, mistakenly diluted the pfizer vaccine at 2:00pm, January 27th, 2022. The new Pfizer formula is not to be diluted. It was our 1st shipment of the new pfizer tris-sucrose formula. I made the mistake out of the habit of previously having to dilute pfizer vaccine formula. There were no adverse reactions following the 15 minute observation time with the patient.  I was reading through information on the CDC about what to do in this situation. The information took some time to find so I let the patient leave the office after the 15 minute observation time since they were not experiencing any adverse reactions. I explained to them that the administration of this particular vaccination was more than likely invalid because it was diluted. I told the patient we would call to reschedule as soon as we knew more information. We are attempting to reach the patient now to reschedule a pfizer booster shot as soon as possible.
approx 3-4 hrs p/vax pt had red, warm rash on face, neck & both arms w/swelling of face, eyelids, & throat; pts given DPH; 4 days p/vax pt seen in ER w/same sx;
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 13-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J000495 (exp: 14-APR-2014), 0.65 ml, subcutaneous in the left arm. A few weeks later, approximately in 2013 the patient had a "bad reaction" to ZOSTAVAX in the injection arm. The reaction included pain and weakness in the arm and a thumb that can no longer move properly. The patient sought medical attention either from her physician or from an unspecified emergency room. At time of report, the patient was not recovered. Additional information has been requested.
Shoulder pain; swelling, hot and red-swelling radiating down arm to hand and fingers.
after the first dose I just have like slight nausea sort of that for couple of hours; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 39-year-old) as dose 1, single for COVID-19 immunization. Medical history was none provided. Concomitant medication(s) included omeprazole (PROTONIX [OMEPRAZOLE]); quetiapine fumarate (SEROQUEL); bupropion hydrochloride (WELLBUTRIN); meloxicam; budesonide (NASOCORT); diphenhydramine hydrochloride (BENADRYL); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and propranolol taken for an unspecified indication, start and stop date were not reported; metoprolol taken for heart medication, start and stop date were not reported and that's like a longer acting one so she only take either one or the other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported that family medical history related to adverse event was no reported. Patient reported that she did not remember when she received the first one but the second dose, she received on 09Apr and we have received that one at work. Reported that date of first shot she was trying to find. On an unspecified date, patient experienced after the first dose I just have like slight nausea sort of that for couple of hours. Therapeutic measures (antibiotic) were taken as a result of after the first dose I just have like slight nausea sort of that for couple of hours. The clinical outcome of event was unknown.  Information about lot/batch number has been requested.
2.5 days of high pitched screaming and generalized irritability, low grade fever (temperature not taken by parents), uneventful recovery. Seen in office 04/24, symptoms resolved by then.
I started having (on Sunday - after midnight, actually) started vomiting all the rest of the morning long. Husband administered Phenergan to me - I have it on hand for Migraines. The rest of the day, I had achiness, headache, fever (got to 101 for awhile then to 9.6). I had those symptoms until Tuesday. I couldn't go to work on Monday. I don't remember if I took migraine medicine or not during that time. I have had brain fog - there are things I can't remember. I was prescribed Omeprazole - the Saturday following the week I got the shot. Because I started getting a burning sensation up esophagus and a sharp pain up in the center underneath my breast bone - felt like someone was stabbing me with a knife) - I went to the Walk-in Clinic (same doctor's office that I go to - Family Medicine) on that Saturday after I had the symptoms. The doctor thought my gastritis had a flare up again. I have had this sensation since I've had the shot. Omeprazole - haven't been having the sharp pains that I was having but I still feel a lump in my throat. She told me to watch the foods I eat - it's eating a lot a bland food which is hard to do when I am working outside the home. Still have the stomach issues.
Initial information received on 05-Jul-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves, diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] vaccine that had expired was accidentally administered to 1 year old, 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 hepatitis A vaccine for Prophylactic vaccination.  On 23-Jun-2023, the patient received a 0.5 ml total dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength: unknown) (lot: C5893AA, expiry date: 21-Jun-2023) via unknown route in left thigh for Immunization and vaccine that had expired was accidentally administered to 1 year old, with no reported adverse event (expired product administered) (latency: same day).  It was unknown if any lab data/tests available.  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was not applicable.  Outcome: unknown.    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.
I tested positive for COVID-19 on 12/10/22. I had severe muscle and joint pain, sneezing, congestion, fatigue, and a cough. I never had a fever though. We were out of town, and I had to go to a clinic that I am unfamiliar with. They prescribed 5 days' worth of Paxlovid. A week after the symptoms started, I was feeling better. Then, all of the sudden I started feeling bad again. I am just now starting to feel better again. I am still testing positive for COVID-19.
father called clinic stating pt recvd vax 15APR92 & had gotten the mumps; says it was verified @ hosp ER on 25APR92; Now pt has measles; MD question measles but pt did have a red, petechial rash;
Redness, possible "fluid", pt rec'd KEFLEX rx (500 mg 4x daily x 10 days) on 3/15/14. Pt was seen by family dr 3/17/14, rx for BACTROBAN crm AA TID. Dx cellulitis.
This spontaneous report as received from a pharmacist, via a company representative, refers to a 60 years old female patient. No information on her medical history, concurrent conditions or concomitant drugs was provided. On 20-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX one vial (route and site of administration, dose number, lot # and expiration date not reported). On an unknown date in May 2015, the patient got a rash near the injection site, which hurt and became warm. The outcome of vaccination site rash, vaccination site warmth and vaccination site pain was unknown. The relationship between use of ZOSTAVAX and the adverse events was not reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 29-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX (strength, site of administration, dose, dose number, lot number and expiration date were not reported), which was inadvertently administered intramuscularly instead of the recommended subcutaneous route. On 29-MAR-2016 (also reported as the same day the injection was given), following ZOSTAVAX administration (reported as following that administration), the patient experienced a localized reddened area at the injection site. The patient sought medical attention (type was unknown). Product quality complaint was not involved. No further information was reported. The outcome of localized reddened area at the injection site and the relatedness between this event and ZOSTAVAX were not reported. Additional information has been requested.
Medical Assistant administerted  Pfizer Covid-19 Vaccine mg/0,9 ml, instead of 3 mg/0.3 ml
I had a terrible cough, which shredded my throat. I did not get any body aches & I took three days of of work to rest. I got through it within a week minus my cough lingering behind. I also caught a sinus infection a few days after. I messaged my doctor's office Monday morning 12/05/2022, and I was provided an anti-viral treatment called Molnupirovir. They also provided me with a prescription for Zithromax to help clear the sinus infection.
pass away recently due to blood clots; This is a spontaneous report from a contactable nurse (parent) and consumer. The nurse reported similar events for three patients. This is the first of three reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient pass away recently due to blood clots on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. It was reported that even though the event was outside of reporting timelines & deemed by the PI to be unrelated to study drug.  Information on batch and lot number is requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of thrombosis with fatal outcome due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including vascular imaging studies, coagulation panel and autopsy results, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021688670 same reporter, event and suspect drug; different patient; PFIZER INC-2021688671 same reporter, event and suspect drug; different patient; Reported Cause(s) of Death: blood clots
Fussy, tired, rapid heartbeat, induration at sight of injection, red & swollen on legs (at injection site) the swelling was over 2 inches, & fever - symptoms begin that day & continued on till early morning of the 16th, was taken to the ER 6/13/01 for her legs (the swelling). They said it could of been an allergic reaction to the shots or cellulitis. Show was given a prescription for Cephalexin and Children's benadryl. Her fever was 101.5F consistently til the morning of 06/16/01 tylenol helped some.
Saturday around 2pm I developed intense body aches, progressed to chills, nausea and severe headache by 8pm. Next day improved but still had myalgias.  Had some mild pleurisy and congestion starting on Tuesday. This would only be in an and resolve by evening time.
Information has been received from a 74 year old female patient with high blood pressure, arthritis, reflex sympathetic dystrophy and no known drug allergies who about 10 years ago in approximately 1999 and on 11-SEP-2009 was vaccinated with the first and second doses of PNEUMOVAX 23 (dose, route, and lot # not reported).  Concomitant therapy included TOPROL XL TABLETS, guanidine, NORVASC and BENICAR.  On approximately 11-SEP-2009 after her second vaccination, the patient developed an area that was "really red which travelled from the injection site to elbow".  The area was swollen, painful and hot.  She was prescribed with KEFLEX.  The patient had no adverse event at the time of receiving her first dose of PNEUMOVAX 23.  The patient sought medical attention through an office visit.  No lab diagnostic study was performed.  The patient recovered about 7 days after starting KEFLEX.  Follow up information from the consumer indicated that she developed a rash on her legs shortly after she recovered from her injection site reaction with PNEUMOVAX.  She went to a dermatologist who "tested" her and determined the rash was from PNEUMOVAX.  The consumer was currently using an unspecified ointment for the rash.  The rash was not itchy.  The consumer was recovering.  No further information is available.
On Oct. 7th 2021 I was given a shot too high and too deep on my shoulder. The pain was intense and immediate. The lady that wounded me apologized and said that it will stop hurting soon.  On Jan. 31st 2021 Dr. finally agreed to see me. After an examination he realized that I had been inured and order a MRI.  I had the MRI on Feb. 9th. 2021 The next day, Feb. 10th, Dr. ordered a urgent referral to an orthopedic surgeon.  On Feb. 23rd 2021 I saw the surgeon and he scheduled me for rotator cuff surgery as soon as he could. On March 24th 2021 I Finally had surgery to repair the crippling damage done to me by the lady that gave me the shot improperly. On Oct. 7th 2021 I was given a shot too high and too deep on my shoulder. The pain was intense and immediate. The lady that wounded me apologized and said that it will stop hurting soon. I sent my primary care doctor. Several messages and he kept telling me that it should stop hurting soon. On Dec. 3rd 2021 I saw my orthopedist for cortisone shots in my knees and I told him what happened. He told me to keep using my arm so it wouldn't lose range of motion and that it should stop hurting soon. On Dec. 24th 2021 I saw my dermatologist for a routine check up. By this time the pain had become much worse, I couldn't sleep more then a few hours at a time and I was gaining a lot of weight. She advised me to demand Dr. order a MRI and persist until he did. On Jan. 31st 2021 Dr. finally agreed to see me. After an examination he realized that I had been inured and order a MRI. I had the MRI on Feb. 9th. 2021 The next day, Feb. 10th, Dr. ordered a urgent referral to an orthopedic surgeon. On Feb. 23rd 2021 I saw the surgeon and he scheduled me for rotator cuff surgery as soon as he could. On March 24th 2021 I Finally had surgery to repair the crippling damage done to me by the lady that gave me the shot improperly. My M.D. successfully preformed Orthopedic Surgery to repair my rotator cuff, Labral, SLAP repair. ( LEFT SHOULDER ARTHROSCOPIC ROTATOR CUFF REPAIR, SUBACROMIAL DECOMPRESSION, BICEPS TENODESIS ) On Friday May 6, 2022 I started physical therapy and have been going twice a week for sessions to improve range of motion and increase strength. I still can not rise my hand more then half way up or lift more then 5 pounds. I have had almost a year of intense and content pain, I have spent hundreds of dollars and my life has been miserable.
Patient received Monkeypox vaccine ~ 2 weeks ago at Hospital. Patient traveled to for an event and presented to  our ED  (transfer from outside facility) with complaints of chest pain and diagnosed with acute inferior wall myocardial infarction with elevated cardiac enzymes. Patient underwent PCI which was negative. No alternative cause yet identified.
felt sick; fever; raising heart rate; red; swollen and itchy arm; swollen and itchy arm; dizziness/light-headedness; nausea; headache; body aches; she is currently breastfeeding her 4-week-old baby; she is currently breastfeeding her 4-week-old baby; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 37-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8737, Expiration date: unknown, NDC number: Unknown), via an unspecified route of administration on 26Mar2021 (at age of 37-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, patient had fever, raising heart rate, red, swollen and itchy arm, dizziness, light-headedness, nausea, headache and body aches. She also said that she felt sick. She also mentioned that it had only been a few weeks after she went on labor when she received the 1st dose, and that she is currently breastfeeding her 4-week-old baby. Patient had a hard time telling the difference between allergy and side effects. She did not have an anaphylactic reaction; she didn't need any help like that, but she had fever, her arm swelled up. It was red like sunburn; she had itching and she was sick for a few days and had dizziness for a few days. Also mentions she was breastfeeding and now her baby is almost three weeks old. she had the shot right after the birth. She was scheduled to receive the second dose of the vaccine 16Apr2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021442055 mother-baby case
one patient was administered improperly stored PROQUAD; No adverse event; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 18-MAR-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA(PROQUAD) injection, lot number: S022913, expiration date: 19-JAN-2021 for prophylaxis (exact dose and route of administration were not provided) reconstituted with properly stored sterile diluent. No additional adverse effects were reported.   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) experienced temperature excursion of 6 degree Fahrenheit to 14 degree Fahrenheit and 12 degree Fahrenheit for 3 hours and 59 minutes. The previous temperature excursion was 6 degree Fahrenheit to 14 degree Fahrenheit and 9 degree Fahrenheit for 8 hours and 51 minutes. The digital data logger was involved.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases: A0756483A - A0756512A, A0756514A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.