chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had an unusual menstrual cycle beginning March 24. I just started another cycle a few days ago, which is far earlier than normal (about 20 days difference vs. my normal 28 days). Further, this is a far more painful period with cramping, a lot of blood, quite a bit of acne and very tender breasts. The vaccine is the only X factor.   I did have other side effects from the second dose, though they all seem to be what was listed ? chills, extreme fatigue and headache.
has developed chills and fever over 101F and some change; has developed chills and fever over 101F and some change; His arm was unbelievably sore yesterday, and useless today.; His arm was unbelievably sore yesterday, and useless today.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose:, He had the Pfizer BioNtech vaccine both shots earlier in the year.), administration date: 2021, for COVID-19 immunization; Bnt162b2 (2nd Dose:, He had the Pfizer BioNtech vaccine both shots earlier in the year.), administration date: 2021, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious) all with onset 29Sep2021, outcome "unknown" and all described as "has developed chills and fever over 101F and some change"; PAIN IN EXTREMITY (non-serious) with onset 28Sep2021, outcome "not recovered", LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 29Sep2021, outcome "unknown" and all described as "His arm was unbelievably sore yesterday, and useless today.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller said that his arm is unbelievably sore, and has developed chills and fever over 101F and some change. Caller is asking if he can take ibuprofen for his fever. The patient underwent lab data for Body temperature was 101.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Was sick all night; Abdominal burning; Shaking; Fever; Muscle pain; Joint pain; severe headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever) and MYALGIA (Muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (severe headache) and CHILLS (Chills). At the time of the report, ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (severe headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were  provided No treatment drugs were provided
patient experienced pain across the ribs & chest.  Was diagnosed as possible pericarditis at hospital & will follow up with cardiology
Aching; Strong chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching), CHILLS (Strong chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aching), CHILLS (Strong chills) and PYREXIA (Fever). At the time of the report, PAIN (Aching), CHILLS (Strong chills) and PYREXIA (Fever) had not resolved.            Patient received 2nd Moderna covid19 vaccine booster dose.   Concomitant medications were not reported. Treatment medications were not reported.
Low grade fever. Sores in mouth - painful - 48 hours after vaccine. - mild flu like symptoms. Treatment - Magic mouthwash.
Admitted on 4/5/2021 with severe life threatening COVID 19 pneumonia. Still currently hospitalized.
Developed seizure 24 hours after 4 month immunizations (DTaP, IPV, PCV, Hib). Developed seizure 24 hours after 6 month shot - only DT given that day.
THE PATIENT AND MOTHER  CAME INTO PHARMACY AS A WALK IN AND ASKED FOR MODERNA 2ND DOSE. PHARMACIST DID NOT SEE DOB OF THE SON WHO IS 16 YEARS OLD. PATIENT LOOKED MUCH OLDER AND WAS GIVEN MODERNA DOSE THAT WAS DOCUMENTED ON VARS, AND CARD.  WE NOTICED THE ERROR WHEN INPUTING VACCINE INTO COMPURTER SYSTEM. THE PATIENT IS DOING FINE WITH NO ISSUES TO REPORT.
approx 1wk p/vax pt devel large red blotches on both forearms;1yr post vax pt cont to have faint blotches;
Bad gas pains- 1 week Menses arrived 9 days earlier than expected- heavier flow, much more painful After that, 2 days of migraines Followed by perpetual nausea(even with ZOFRAN), diarrhea- unable to remain hydrated Ended up going to the ER to get fluids, more meds
Headache and dizziness began 1 hour after injection and lasted for 30 minutes.  8 days after injection, redness/swelling/itching/lumps developed at injection site. Axillary lymph node swelling in arm injection was given.
pt recv vax 21OCT96 & 15JUN97 pt devel lesions mostly on lt side of chest, w/a few lesions scattered throughout body;MD is sure that the lesions are not zoster;MD felt that the lesions devel on lt side;dx follicular eczema;
Redness and induration of left thigh within 24 hours after vaccines given. No fever or drainage from injection sites. Treated initially as cellulitis, but was not responsive to antibiotics.
Patient received GARDASIL vaccine in addition to MVC4. Pt sat in room and talked with mom and siblings for a short time. Pt left room, walked to check out station, fainted and  hit her head on the wall and floor.She did not respond appropriately when answering question. Ambulance called and was transported to hospital where she was diagnosed with a concussion. Pt went home and was rechecked in our office 2 days later.
After administration of the last vaccine (HPV) I placed the needle and syringe in the sharps container and began applying bandages to the right arm. Before I could apply the bandage to the last injection site, the patient's eyes rolled back in his head and he lost consciousness. I called for help and opened a dose of ammonia inhalant. When the other nurse entered the treatment area, she noted that the patient's hands were balled up in fists. The patient began thrashing his arms and legs and exhibited seizure-like activity. Approximately 30-45 seconds after he lost consciousness, the patient awoke. He could not remember what had happened and did not remember receiving his vaccines. A cold compress was applied to his head. He then vomited once. His blood pressure was 110/60 and pulse was 88. He denied dizziness but reported feeling very tired. He and his father denied a history of similar symptoms. He was observed for approximately a half hour after the episode. A second blood pressure was 104/70.  It was recommended that the patient go to the emergency room but the father refused. It was then recommended that they contact the child's primary care physician. The patient was able to independently ambulate out of the clinic.
Interchange of vaccine products; Rash scaly/scaly rash in groin region; Psoriasis/POSSIBLE PSORIASIS; Pustular rash; This spontaneous case was reported by a consumer and describes the occurrence of EXFOLIATIVE RASH (Rash scaly/scaly rash in groin region), PSORIASIS (Psoriasis/POSSIBLE PSORIASIS), RASH PUSTULAR (Pustular rash) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 01-Jun-2022, the patient experienced EXFOLIATIVE RASH (Rash scaly/scaly rash in groin region), PSORIASIS (Psoriasis/POSSIBLE PSORIASIS) and RASH PUSTULAR (Pustular rash). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, EXFOLIATIVE RASH (Rash scaly/scaly rash in groin region), PSORIASIS (Psoriasis/POSSIBLE PSORIASIS) and RASH PUSTULAR (Pustular rash) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.            No concomitant medication was reported. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Company comment- This is a spontaneous case of interchange of vaccine products (received a dose of TOZINAMERAN vaccine, reported as co-suspect) concerning a 20-year-old male patient treated with Adalimumab (reported as co-suspect) for an unknown indication, who experienced the unexpected non-serious  exfoliative rash.  A dose of mRNA-1273 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Vaccination date was not provided; hence, latency cannot be assessed. It was reported patient had scaly rash in groin region, possible psoriasis and pustular type rash which looks like pimple. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case of interchange of vaccine products (received a dose of TOZINAMERAN vaccine, reported as co-suspect) concerning a 20-year-old male patient treated with Adalimumab (reported as co-suspect) for an unknown indication, who experienced the unexpected non-serious  exfoliative rash.  A dose of mRNA-1273 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Vaccination date was not provided; hence, latency cannot be assessed. It was reported patient had scaly rash in groin region, possible psoriasis and pustular type rash which looks like pimple. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
rash started 11/2/21, improving by 11/7/21, after peeling, feeling burned and sensitive, and having significant R>L leg edema. Patient has history of psoriasis on feet and this was reminiscent of flare of that, but resolved quickly with just emollients
A report was received from a healthcare professional in the USA on 7/5/04 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/29/03. This report was received as follow up and involves a group of 10 children under the age of 4 years who inadvertently received Fluvirin instead of the product approved for pediatric use in the USA. None of the vaccinees experienced any adverse effects. No further information is expected.
This medically confirmed spontaneous report (initial receipt: 12-Nov-2012) concerns an 11-year-old male patient, who had no pertinent medical history or drug allergies. He was not taking any concomitant medication at the time of the event. On 09-Nov-2012 the patient received AFLURIA (batch number was not provided). On the same day he also received Tdp vaccine and his first dose of GARDASIL injection. The patient also had blood drawn for unspecified blood work when vaccines were administered. On 09-Nov-2012, after receiving vaccination, the patient felt dizzy and nauseated. He had an episode of 'explosive diarrhoea' and fainted on toilet. No injuries incurred. At that time, the patient had no wheezing, no injuries and no hypotension, but the patient was 'clammy and pale'. After leaving the office, the patient had another syncopal episode and diarrhoea in the parking lot. No injuries reported from the fall. The mother called the physician this weekend to report that the patient continued to have vomiting, diarrhoea and severe headache and that she was taking him to the ER (Emergency Room).
pt recv vax in winter of 1989 & 1 day later died; mail requesting f/u fr reporter was returned marked "moved-left no address-unable to forward-return to sender".
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) to obtain permanent prevention and protection against shingles and zoster related injuries. In 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Swollen left under eye noted at 0500 the morning after the vaccine where fillers are in.  Prednisone and zyrtec started and swelling has improved however 1 more day left of medications.
have only had like one dose of DTaP / HCP didn´t have information about which vaccine it was administered to the patient; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 8-year-old male patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included Tdap (received 1st dose of Boostrix on unknown date).   On an unknown date, the patient received the 2nd dose of Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Tdap vaccine, which led to incomplete course of vaccination. The patient received 1st dose of series in foreign country and healthcare professional (HCP) did not had information about which vaccine was administered. The HCP was not agreeable to recontact as she couldn´t provide more information about the 1st dose that patient received in the foreign country. The reporter did not consent to follow up.
KIDNEY STONES; EYES WERE TURNING YELLOW; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date the patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced kidney stones, and eyes were turning yellow (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the eyes were turning yellow and kidney stones was not reported. On an unspecified date, the patient received mrna 1273 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No adverse events were reported following administration of  mrna 1273 (dose number in series 2). This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220114730 and 20220136407.; Sender's Comments: V0: 20220137233- Covid-19 vaccine ad26.cov2.s- Kidney stones. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Discrepancy Noted:  Five (5) vials that was supposed to contain (10) doses per vial contained only (9) doses.   Clinic received 250, 5ML (10) dose vials in a shipment received 12/22/2020.  At onset of vaccinations, the Immunizations Clinic noted five of the vials did not contain the appropriate amount of vaccine as stated per the manufacturer.  No adverse impact.  No mission degradation.  Inquiry is submitted to address this discrepancy on current and future vaccine shipments.
pt stated that the morning after the covid vax she felt nauseated, fatigued, had chills, racing heart beat, strange taste in her mouth.  One week after getting the vax she still has all of these symptoms and has an appt w/ her PCP on 3/11/2021.  She states she feels like she did when she had carbon monoxide poisoning 3 years ago.
A 5-year-old patient received Pfizer 6M-4 year old vaccine incorrectly.
Client spoke with PHN on 8/6/21. Reports having "tight jaw" and the taste of metal in his mouth that started when returned to work after completing 30 minute observation period. Client reports symptoms lasted 2 hours. Denied rashes, shortness of breath, denies tingling or numbness at the time. Reports 24 hours after receiving vaccination side effect started of "chilld, headache, bodyache, fatigue" that lasted for 2 days. Client denies s/s illness today. PHN edu to follow up with PMD.
Pain at the injection site. Shoulder pain since the date of shot. MD gave prescription for anti-inflammatory. MD told patient it may be tendinitis from injection.
Classic Anxity attack with upset stomach.  Blood pressure spiked, and heart raced.  No pain, only terror feeling.  Spoke with NP and seh recommended 2 Benardyrl.  If things got worse to go to ER.   They did get better.  Next day foggy head and still upset stomach,  Yesterday was better, stomach still huts but better.
PT EXPRIENCED VASOVAGAL RESPONSE/SYNCOPE AND VOMITING 20 MINUTES AFTER ADMINISTRATION
Information has been received from a certified medical assistant (CMA) and a registered nurse (RN) concerning a 72 yr old retired Caucasian adult male (also reported as over 65) with CAD, HTN, cardiomyopathy, NIDDM, and hypercholesterolemia who on 20Oct05 at 13:30 (also reported as the second week of October and a couple weeks ago) was vaccinated IM with a second dose of 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot649697/1038P). On 20Oct05 (also reported as the day after the injection), the pt experienced swelling, redness, warmth, induration and pain at the injection site. The swelling was described as almost like cellulitis. Unspecified medical attention was sought and the pt was treated with prednisone 23mg every day for 5 days and cephalexin (Keflex) 500mg, TID for 5 days. It was reported that the pt recovered as of 24Oct05. The reporter also noted that the pt received the first dose of pneumococcal 23v polysaccharide vaccine five years prior. No product quality complaint was involved. Additional information is not expected.
I was getting dressed and all of a sudden this wave came over me. I felt like I was going to pass out, I put my head down between my knees sat back up and started sweating from my head and completely short of breath. I left out one room and sat down. I got up to go and was panting for my breath. The ambulance came and felt as if I was dehydrated. I opted out of going to hospital. I called my doctor on and was sent to another HCF and had DC of chest. I was told the results showed I had a pulmonary embolism. I was admitted to the hospital that Thursday that week and placed on bed rest and heparin drip. I had a Saddle Pulmonary embolism. I was discharged and that following Monday, I am now taking ELIQUIS for the rest of my life. Health wise now I am doing great.
He received his day three dose, a day late and his day seven dose on 16sep2021, with no adverse event; nitial information received on 17-Sep-2021 regarding an unsolicited valid non-serious case from pharmacist and consumer/ non healthcare professional via Information (under reference 00774476).  This case involves a male patient (unknown age) who received his day three dose of RABIES VACCINE (IMOVAX RABIES), a day late and his day seven dose on 16sep2021(inappropriate schedule of product administration).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  The patient received first, second and third dose of the suspect IMOVAX RABIES (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination on 09-Sep-2021, 13-Sep-2021 and 16sep2021 respectively.  It was a case of an actual medication error due to Inappropriate schedule of product administered.  It was reported "Pharmacist reports a male patient, receiving post-exposure vaccination, was administered his day 0 dose on 09sep2021, he then received his day 3 dose, a day late, on 13sep2021. He came in for his day 7 dose on 16sep2021, which would have been the day it was due, if he hadn't received his day 3 dose late, but is now a day early, per interval guidelines.. The dose was administered and they have now received an order for him to receive his day 14 dose on 23sep2021. Pharmacist is asking if these interval irregularities will affect efficacy."  At time of reporting, no adverse event reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on the batch number for this case.