chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spontaneous report received on 11/16/00 from a medical assistant in a dermatologist's office regarding an adverse event possibly related to administration of Fluvirin. On 10/6/00, this 83 year old female received a Fluvirin injection. Shortly after receiving the injection, she developed a temperature of 102 degrees F, chills, and general malaise. These symptoms lasted approximately four days. In mid-Octiber, she developed lesions on her hands and in her mouth. She was treated with an unspecified course of Prednisone, with symptom abatement. After completion of the Prednisone therapy, the symptoms reappeared. She was then treated with an injection of Kenalog and topical use of Orabase and Kenalog ointments; lesions remain at the time of this report. The diagnosis of Stevens-Johnson Syndrome has been made. The reporter stated that the dermatologist's office has treated this patient for over ten years. She indicates that patient is normally very mentally there, but that the patient hasn't been herself. She describes the patient as being easily confused and forgetful. Patient has a history of hypertension, pharyngitis, hypothyroidism, unidentified gastrointestinal problems, and increased weight loss. Additional information has been requested from the physician. Follow up information from PCP received on 10/11/01: The additional adverse events of sore throat and swollen lips were identified. Patient has resolution of symptoms by November 20, 2000. Dosages and therapy dates of concomitant medications were clarified.
Nurse administered the pentacel along with the others listed above. She went to document it and realized, she did not reconstitute the Act Hib. There was no adverse event. Patients mother was notified of the error. No treatment  neccessary. Dtap & IPV count in the series. Will receive the Act hib at next visit.
DIFFICULTY BREATHING, ALUBUTEROL INHALER, EMS TOOK PT TO HOSPITAL
Clent states," startred with a headache and dizziness, with a temperature of 99.7 the same night the shots were administered. Started wheezing shortly after other symptoms started."  "I have a history of asthma, but I have not wheezed for 6 yrs.  I started using my albuterol and my nebulizer, also got Mucinex from store to help bring up cold in my chest."  Client told if symptoms persist and not relieved by albuterol inhaler to proceed to nearest ER or to see family physican.  Client denied having a Family physician told to proceed to nearest ER if symptoms persist.
Patient presented with shortness of breath, progressive fatigue, pre-syncope and leg numbness. The workup revealed severe aortic stenosis, nonobstructive CAD, an ascending aortic aneurysm and normal left ventricular function. On November 17 the patient underwent AVR and ascending aortic aneurysm repair. The patient was discharged on ASA, statin and beta blocker therapy. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pt came back today 7/13/2021 and mentioned that he was having some kind of steady tingling sensation on the vaccinated arm (left) that started around July 2nd. He heard about the recently reported side effect Guillain Barre Syndrome on the news so he tried to seek out  how he can report this and came back to our pharmacy. Told him we need to report thru VAERS and will reach out to him if more info is needed.  He was also advised to sign up thru Vsafe for monitoring.
Per mom on 4/16/11 pt. had fever of 103 degrees F and "weakness in legs". Offered appt. but declined.
joint pain leading to disablement of joint function; could not walk during day; knees, ankles, wrist & hand joint did not affect shoulders, hips & elbows; joint pain in feet; stiffness, h/a;
Mom stated "on Friday night I noticed her leg getting red." I looked at leg on Saturday a.m. and right leg is swollen, warm and redness the size of a softball around injection site. Mom called on 4-23-07 and site was back to normal.
Pericarditis Sharp pain behind ribs left side of sternum treated w/ a gout medication which reduced symptoms by ~ 80% but couldn't continue using it due to toxicity Ibuprofren and Aspirin have no effect As of today 1/15/23, symptoms are as intense if not more than when they originated. spend every day anxiety ridden wondering what damage has been done and if I'll develop worse ailments as a result.
Sinus infection; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was due to get her second dose of BNT162b2 the day after the report. She was on an antibiotic for sinus infection. The reporter asked if it was okay for her to take it. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Pt recvd MMR vax 14SEP90; Following vax pt devel a rash; No further details were provided;
Arms were sore; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE PAIN (Arms were sore) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.     On 12-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (Arms were sore). On 13-Jan-2021, INJECTION SITE PAIN (Arms were sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Jan-2021 and was forwarded to Moderna on 18-Jan-2021.    This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE PAIN (Arms were sore) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical History Information was reported.     On 12-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INJECTION SITE PAIN (Arms were sore). On 13-Jan-2021, INJECTION SITE PAIN (Arms were sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
patient fainted; hit his head; This spontaneous report was received from a physician referring to an adolescent male patient. Pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  In approximately 2017 to 2018 (4-5 years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (strength, dose, lot #, expiry date and route of administration were not provided); meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA)  (strength, formulation, dose, lot #, expiry date, route of administration and indication were not provided); and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (strength, formulation, dose, lot #, expiry date, route of administration, and indication were not provided). After vaccination, the patient experienced fainted when he was getting up from the exam table and hit his head. The patient was followed concussion protocol (details of protocol were unknown) and received treatment by the physician. The outcome of the events was reported as recovered.   The causality between the events and suspect vaccines was not reported.  Upon internal review, the event of syncope was determined to be medically significant.
Pt currently has Covid 19  Vaccine #1 Pfizer given 03/07/2021 Lot # EP6955
Extreme Hives, trouble breathing / problems have continued since first injection / she breaks out in hives when there is a change of temperature (outside to inside / inside to outside) / has trouble breathing when exerting (cross country runner / basketball player) / has continued with sports but pushes through discomfort / very frustrating  1/23/09 Received PCP medical records of 3/24/08 FINAL DX: hives Records reveal patient w/daily hives since 2/15/08.  Referred to specialist & declined further in series.  No further records available.
24 hours after threw up, headache, nausea, fever, intense stomach discomfort for 48 hours. Increased fever 24 hours after symptoms began at 102.9 degrees Fahrenheit. Watery loose stool after fever broke with cramping and nausea. No appetite.
Patient was given vaccines on 9/26/16 we were not notified of any reaction until 10/06/2016. He came in with what looked to be a rash (poison ivy) or bug bites on his arm and said it was a reaction to the vaccines he received.
Peeing blood; they were able to see the stone; Pain; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 27Apr2021 16:00 (age at vaccination 53 Years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection) dose 1 on 30Mar2021 for covid-19 immunisation. The patient experienced peeing blood in Apr2021, they were able to see the stone in May2021 in a Scan report. The patient developed pain in Apr2021. The patient was hospitalized for peeing blood on 30Apr2021. She didn't have pain for three weeks except for an occasional sharp stab here and there. After three weeks it got really bad again. She went to her primary care provider and got another scan. The pain has not stopped this time. She is in constant pain from this. She states she was very healthy before this, she takes no medications, and was biking, kayaking and scuba diving. She knows the Pfizer vaccine caused these kidney stones, there was no way it wasn't from the vaccine- it was too coincidental. She wanted to know if this is a side effect of the vaccine. The patient underwent lab tests and procedures which included scan was did not see any stones on Apr2021 (but the doctor believed it was a kidney stone because there was no UTI), scan was they were able to see the stone on May2021. She was given antibiotics and pain medication. She stated she took the antibiotics but not the pain medication because she doesn't like to take them, and only took Tylenol. On this scan they were able to see the stone. She was started on another antibiotic which she finished last Saturday. The outcome of events peeing blood, pain was not recovered, while for kidney stone, the outcome was unknown.  Information on the lot/batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Can't step down on left foot and doesn't use his left arm.  Not as alert.  Tired and spacy. 60 day follow up on 07/28/03 reports:  Vaccine was a TD manufacturer.  Was not Aventis.  No lot number was listed on the report.  The patient did not recover from adverse event.  Patient's personality is back to normal.  He is walking better on his left foot, but still does not put his heel down first.  He still continues to not use his left arm when needed.  Patient used to read constantly.  Four or five books a week was not unusual.  This reading has been constant since he learned to read.  Since April, patient has read one book.  Patient has seen a neurologist and a pediatrician.  He had an MRI.  He saw a physical therapist and an acupuncturist.  Now he is seeing a neuropsychologist.  Accupuncture and time seem to be healing slowly."
Extreme headache, foggy vision back spasms, bone pain, chest heaviness, swollen neck and throat Spent 6 hours in hospital after 3 EKG's came back abnormal. I was 100% fine and healthy before this. Was put on intravenous Benedryl, Tramadol and one other drug and observation. ER Dr. wanted to keep me overnight for observation and follow-up with my medical Dr.
sick; very fatigued (has no energy to do anything); nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 (Lot number: ER8731) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure", start date: 2006 (ongoing); "thyroid issues Stated that the medication is working and he still has thyroid issues.", start date: 2006 (ongoing); "Diabetes Type II", start date: 2006 (ongoing). The patient took concomitant medications. The following information was reported: ILLNESS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "sick"; FATIGUE (non-serious) with onset 14Apr2021, outcome "recovered" (15Apr2021), described as "very fatigued (has no energy to do anything)"; NAUSEA (non-serious) with onset 14Apr2021, outcome "unknown", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea.  Additional information: Caller stated that he got a couple of things about the vaccine. Stated that he took the first and second shot. Stated that the first one made him sick within a little over an hour after taking it and that he was sick for 4-5 days. Stated that he took the second shot 2.5-3 weeks later and got sick immediately after it. Stated that he had walked outside to his car and had nausea, did not feel good and was very fatigued. Stated that the nausea lasted a day or two but the no energy has been getting worst since. Stated that he took the second shot May2021. Stated that it is to the point that he has no energy to do anything. Stated that the timeframe of all this happening goes right up to the shot. Stated that the doctors do not know how to treat it. Wanted advice as to how to treat it or what to do. Stated that his bloodwork comes back normal and everything. Clarified that this is for the Pfizer vaccine. Stated that Pfizer made the vaccine and he is sure other people called. Stated that he wanted to know if they have any advice on what to do. Stated that he is getting worst and worst. Wanted to know what is going on.  No follow-up attempts are possible. No further information is expected.  Follow-up (28Mar2022): This is a follow up spontaneous report from a contactable consumer. This male consumer (patient) reported for himself that: Updated information: Reporter's address, RMH, vaccine administration date, lot number, outcome of the event and lab test captured.
Passenger received the vaccine after the 30 day window for storage in a refrigerator(not in freezer) had ended.
No adverse event occured.We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given.
Very swollen at injection site. Pain. Inability to move arm . Full body muscle aches. Headache. Eyes hurt. Exhaustion. Urinated in bed while sleeping- 1st time.
6x7 cm erythema at injection site left arm.  No temperature, swelling at injection site.
Upon the delivery of Pfizer gray cap vaccine on 2/15/2022, pharmacy has kept the vaccine in the freezer (average temperature at -23.9 C) for 27 days before the administration. There were no adverse reactions reported after the administration.
Case number PHHY2011US69557 is an initial spontaneous report received from health care professional on 29 Jul 2011. This case refers to an 11 year old female patient. She was vaccinated with MENVEO (batch number: M10034) 0.5ml intramuscularly on 28 Jul 2011. But, she was given only Men A conjugate conjugated vaccine reconstituted with a sterile diluent instead of Men CYW-135 liquid conjugate. No adverse reaction had occurred following this drug administration error.
Client was inadvertantly given her first dose on 4/16/2021 although she was not 16. Given permission by our medical director, Dr to receive the second.
9/17/21 SEEN IN THE ER WITH INCREASING SOB. ADMITTED TO HOSPITAL WITH ACUTE HYPOXIC REP FAILURE BILAT. PNEUMONIA FROM COVI D19.  9/26/21 DISCHARGE HOME WITH HOME OXYGEN WHICH IS NEW.   ADDITIONAL INFORMATION RELATED TO PATIENT CONDITION POST DISCHARGE WILL NEED TO BE OBTAINED FROM PATIENT.
After 2nd COVID-19 vaccine began having Malaise, chills, fever, polyarthralgias, myalgias Joint pain, stiffness, inflammation and tenderness in multiple Joint, tendon ruputure, DVT.
RED CIRCLE ABOUT 2 INCHES WIDE AROUND INJECTION SITE STARTED 10 DAYS AFTER 1ST SHOT STARTED FRI 4-23 & IS STILL THERE MONDAY 4-26 & ITCHES & BURNS
Pfizer COVID-19 Bivalent Booster 12+ dose given to child under 12. Side effects began 12 hours later - fever, headache, fatigue, weakness, nausea - and mainly resolved around 48 hours later.
back of arm where the MMR was given is red & swollen as large as an egg mom states;inj was given on 4FEB98 @ about 2PM;
Severe vomitting and diarrhea, redness and swelling at the injection site. Inconsolable crying lasting on and off for about 48+ hours. Severely lethargic and trembly. 04/10/07-records received from PCP. Records document frequent otitis media, bilateral myringotomies on 9/2/05. DX autism vs speech delay 7/27/05-
Woke up in middle of the night feeling cold for body, fever 102 degrees detected in the next morning. Patient is going to take acetaminophen for fever.
Mother noticed papules on body on 10/3/00. Seen in MD's office on 10/4/00, with scattered papules over body. Brother has chickenpox.
sick; fever; back pains; This is a spontaneous report from a Pfizer sponsored Program. A contactable female consumer reported that:  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 16Mar2021 as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The caller stated received first CoVax yesterday and experienced sick, fever, back pains on an unspecified date . Caller asked if that was normal. Medical Information: No unaddressed medical questions referred or forwarded to Medical Information. The outcome of event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
On April 26, 2021, he experienced a horrible headache and spent two weeks in bed. On the third week, we contacted the doctor and had a virtual appointment. He was prescribed medication, but that medicine made him even more sick. He ended up in the ER and he received some medication. He felt good for 24 hours. But the headache came back. He ended up in the ER again and he was hospitalized for one night. When he was released from the hospital, he was given Topamax, which helped slightly. He's been given additional medication. He has been seeing a neurologist.
Raised, red area from deltoid to elbow, approx. 2" across and 4" down. Hot to touch and tender to touch. Mother applied cold compresses on 3/2/01, 3/3/01 and gave Tylenol every 6 hours.
3 months after receiving the Johnson and Johnson vaccine in my right arm, I noticed a lump in my right breast. After scheduling an appointment with my OBGYN, he was unable to determine the type of lump and suggested I get a mammogram. The mammogram showed a mass that was examined closer on ultra-sound; these images presented a need for a biopsy and that result proved I had invasive lobular breast cancer. I was diagnosed on 6/21 and I have been receiving treatments for HER2+ since August 10, 2021.
Admitted to acute hospital after a fall at home 9/24/13. Pt fell out of her wheelchair. She had recently seen a neurologist for increased weakness. Pt has received inpatient skilled care for this weakness and is still all inpatient. Neurologist saw pt 11/4/13. Diagnosed Guillain Barre.
While getting second dose noticed that a blood stream was going down the arm; Not receiving the full dose; A spontaneous report was received from a consumer concerning a 79-years-old, male  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood stream was going down patient's arm /vaccination site haemorrhage, not receiving the full dose/ accidental underdose.  The patient's medical history was not provided. Concomitant medications included were ezetimibe, simvastatin and metformin.  On 03 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 030L20A) in the left arm for prophylaxis of COVID-19 infection. On 03 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 026A10A) in the left arm for prophylaxis of COVID-19 infection.  On 03 Mar 2021, while getting the second dose the patient noticed that a blood stream was going down his arm and was worried that the blood was mixed with the vaccine and not receiving the full dose.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   The outcome of the events, blood stream was going down patient's arm and not receiving the full dose was resolved on 03 Mar 2021.; Reporter's Comments: This report refers to a case of vaccine underdose for mRNA-1273, lot# 026A10A  with associated AE of vaccination site bleeding. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
HIVE LIKE RASH ON CHEST BACK AND ARMS, TOOK TWO BENADRYL, APPLIED HYDROCORTISONE CREAM FOR ITCHING AND WENT TO BED.
Very fatigued. (4 days) Low Grade Fever (2 days) Bone aches (1 day)
Patient experienced seizure activity after receiving 2nd dose of pfizer vaccine. Sx started approximately 5 mins after receiving injection.  fell and hit head.  B/L upper extremity contractures noted that did not resolve and was associated with extreme pain and muscle rigidity.
i was tested in November and December of 2020 and my eyes were good, no macular degenertion, in May i was checked for a follow up and the fact that i was having vision problems.  i had bad macular degeneration in my left eye and the start of it in my right eye, plus PED, whatever that is., the Macular degeneration is in the center vision area of the retina so vision is really bad.
Extremely reddened, swollen, warm area on left arm. Only presented today 1/17/21. Took Benadryl and applied ice to area.
Sore throat/pharyngitis, fever, neck pain cervical lymphadenopathy.