chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After 1st dose, noticed soreness; arm pain at injection site along with minor breathing difficulties.; arm pain at injection site along with minor breathing difficulties.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Mar2021 11:30 (at the age of 50-years-old) as dose 1, single for covid-19 immunization at church. The patient medical history included MGUS, known allergies: penicillin (Known allergies: Penicillin and Macrobid). Concomitant medications included levothyroxine, liothyronine (NP THYROID), epinephrine (ADRENAL), estradiol, famotidine. Other medications patient received in two weeks included NP Thyroid, Adrenal, Estradiol, Famotidine. The patient previously took macrobid [clarithromycin] and experienced known allergies: penicillin. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that after 1st dose, on 16Mar2021 the patient noticed soreness and arm pain at injection site along with minor breathing difficulties. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
11/30/21 pt brought to ED via EMS; pt in respiratory distress with O2 saturations in 60s% on RA; fever and chills x 1 wk; EMS administered Solu-medrol and DuoNeb; pt admitted to ICU; found to be positive for COVID; COVID pneumonia; given Decadron and Tocalizumab; alternating between BiPAP and Vapotherm; pt's O2 needs increased requiring intubation; developed progress hypotension; given Levophed; concern of pulmonary embolism; developed changes in QRS complex eventually widening and pt with asystole; pt expired in the hospital
Joint pain in hands and ankles. Hands lock and stiffen. Ankles very sore.
10/10 pain to injection site in left arm, muscle aches all over body, fever, headache
Information has been received from a consumer concerning her son with no medical history or drug allergies who was vaccinated with the booster dose of MMR II on an unspecified date. Subsequently the patient started to lose all language, made no eye contact, and was not social. At ten years old when autism research was more know and then the patient was diagnosed with autism. It was also reported that about two years ago, the patient had a titer test done to check the measles, mumps and rubella titers and the patient's rubella titers was very high. The patient did not seek medical attention. The patient was considered to be permanently disabled and was not able to live alone. Additional information has been requested.
After he had the first vaccine he tested positive with the Covid; I was officially diagnosed with corona virus; he got sick, 02Jul; This is a spontaneous report from Pfizer-sponsored program . A contactable consumer (mother) and male consumer reported that a 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0176), via an unspecified route of administration on 24Jun2021 (at the age of 26 years old) as single for covid-19 immunisation. There was no medical history. There were no concomitant medications. Reporter stated that her 26-year-old son got his first vaccine and then he tested, after he had the first vaccine he tested positive with the Covid on 02Jul2021. He got sick on 02Jul2021 So, he do not know when can he get the vaccine again. He waited 10 days and he went to go another test and he was supposed to get the second dose on 15Jul2021, thursday. On 02Jul2021, he was officially diagnosed with corona virus and he went just now to get an additional test just because he had not had any symptom in the last few days so he wanted to confirm that he was ok at this point and he was wondering if he could still get the second vaccine on the 15Jul2021. He wanted to know if he should get that second dose now because he tested positive or if he should do both series again? Consumer stated that he went to go get the PCR test today and he was just now waiting for the results that are supposed to be in by Thursday morning but he was just want to confirm whether or not if he come out as negative if he can just proceed to go ahead and just take the second dose of vaccine. The patient underwent lab tests and procedures which included polymerase chain reaction: unknown result on 13Jul2021, sars-cov-2 test: unknown result on 02Jul2021. Consumer was informed that a product complaint was filed. The outcome of events was unknown.
Information has been received from a nurse practioner concerning a 70 year old female, with an allergy to penicillin, who on 04-APR-2007 was vaccinated subcutaneously in the right arm with a dose of Zostavax (lot#656861/0329U). There was no illness at the time of the vaccination. On approximately 04-APR-2007 the patient experienced right arm pain, difficulty moving arm, redness at site and knot at site. The patient was treated with ADVIL, ALEVE and darvocet, with heat and ice. Unspecified medical attention was sought. No product quality complaint. The outcome is unknown. No further information is available.
Patient received a vaccine dose for the 5-<12 year old age group and not for the 6 month to 5 year age group. Error was not noted until 3 hours after patient received the vaccine.  Parents were phoned on 5 separate times and voice messages left for parents to call clinic and still have not heard from them.
Pt had fever 13MAY92 (day of vax) through 16MAY when fever broke;  pt then broke out w/a rash behind ears & it spread to entire body similar to heat rash; loss of appetite; pt not seen by MD; CHN suggested that be done; 18MAY92 pt well;
Client waited 15 minutes in waiting room after receiving her shots & exited via the elevator.  T.C. returned from security in the lobby that the client passed out as exiting the elevator.
This spontaneous case reported by a consumer, describes the occurrence of pleural effusion (lungs filling up with fluid), diarrhea (uncontrolled diarrhea), abdominal discomfort (uncontrolled bowel movements), decreased mobility (cannot move) and vomiting in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history information reported. On Mar 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 16, 2021, patient experienced pleural effusion (lungs filling up with fluid), diarrhea (uncontrolled diarrhea), abdominal discomfort (uncontrolled bowel movements), decreased mobility (cannot move) and vomiting. At the time of the report, pleural effusion (lungs filling up with fluid), diarrhea (uncontrolled diarrhea), abdominal discomfort (uncontrolled bowel movements), decreased mobility (cannot move) and vomiting outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessment, concomitant medication or treatment information. This case linked to MOD-2021-048046 (patient link).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 14-FEB-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
5 minutes post injection, I felt tingling in my jaw. By the next day, the tingling had turned to numbness in my left side of my face. I experienced numbness in my left face for several days followed by numbness in my left leg and then numbness in my left arm. Symptoms come and go now, one month later.
Vaccination did not work / Doesn't have antibodies for Covid-19; Swollen arm with a big red dot the size of a tennis ball; Swollen arm with a big red dot the size of a tennis ball; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Vaccination did not work / Doesn't have antibodies for Covid-19), VACCINATION SITE SWELLING (Swollen arm with a big red dot the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Swollen arm with a big red dot the size of a tennis ball) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062G20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm with a big red dot the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Swollen arm with a big red dot the size of a tennis ball). On 24-Mar-2021, the patient experienced ANTIBODY TEST NEGATIVE (Vaccination did not work / Doesn't have antibodies for Covid-19). On 12-Feb-2021, VACCINATION SITE SWELLING (Swollen arm with a big red dot the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Swollen arm with a big red dot the size of a tennis ball) had resolved. At the time of the report, ANTIBODY TEST NEGATIVE (Vaccination did not work / Doesn't have antibodies for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.         No treatment information was provided. No relevant concomitant medications were reported. The patient did not receive any treatment.  Based on the current available information and temporal association between the use of the product and the start date of the events (vaccination site swelling, vaccination site erythema) a causal relationship cannot be excluded. Very limited information has been provided for the event (antibody test negative) at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (vaccination site swelling, vaccination site erythema) a causal relationship cannot be excluded. Very limited information has been provided for the event (antibody test negative) at this time.
?During the first 48 hours post-vaccination: severe/disabling body aches concentrated in the pelvic region, legs, and lower back; muscle weakness/fatigue - inability to stand for a period >60seconds without collapsing or losing consciousness; mental confusion, disorganized thinking;  ?17 days post-vaccination: disrupted menstrual cycle, unusually long and heavy - previous cycle ended on 7/05, most recent began on 7/20 and ended on 7/29
This literature marketed report was received from the authors of a published literature article, concerning 22 female patients who had a positive high-risk human papillomavirus (HR HPV) result after vaccination with GARDASIL injection (dates of vaccination, dose, route of administration, lot# and expiry date were not reported). Data was collected on a series of 297 consecutive women with HPV immunization. The following parameters were gathered: age, date(s) of immunization(s), type(s) of vaccine, cytology results, and surgical biopsy results, if available. The presence of pre-vaccination HPV infection was also noted wherever possible. Specimens with abnormal cytologic results (as defined by an abnormal Papanicolaou smear result, including atypical cells of undetermined significance (ASCUS) with a positive reflex high-risk HPV) subsequently underwent molecular screening of high-risk HPV (HR HPV). All samples were then reflexed to the line probe assay for specific genotyping. Of the 297 women, 27 patients (9.1%) had an abnormal cytological result. Two specimens had insufficient material remaining for molecular testing, and one specimen failed to run due to excessive clotting. Of the remaining 24 specimens, 21 (87.5%) showed a positive HR HPV result on initial screening. Twenty-three samples were then successfully genotyped. The frequencies for the genotypes covered by HPV vaccination (HPV types 16, 18, 6 and 11) were 17.4%, 4.3%, 4.3% and 0%, respectively. Of note, one patient with HPV 18 infection had received an incomplete vaccination series, and one of the patients with HPV 16 had definite pre-existing cervical dysplasia before immunization. The most common HR HPV genotypes were HPV 39, 59 and 66 (17.4% each). The average number of HPV strains per patient was 2.6. The authors concluded that immunized women were not exempt from HR HPV infection and although their data supported the efficacy GARDASIL against HPV 16 and 18 infection, the current vaccination scheme offered only limited protection against cervical cancer. The outcome of the event was not reported. The authors considered the event of HPV infection in HPV-vaccinated women to be related to the vaccination with GARDASIL. Additional information has been requested.
NUMB TONGUE, NUMB TOES, THREW UP ONCE, SLIGHT FEVER  NO TREATMENT, SYMPTOMS SUBSIDED AROUND 10:00 PM
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.; Sender's Comments: This report concerns a male patient of unknown age who experienced an unexpected non-serious event of COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. The report states that the patient was vaccinated with 2 doses of mRNA-1273. Re-challenge was not applicable as the events happened after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273  is not affected by this report.
Pt reported to the pharmacy with redness, swelling, and slight pain on the arm - the injection was given (right). It extended down to the forearm & was warm to the touch. Counseled pt to f/u with Dr. if worsened & take BENADRYL for symptoms. No fever, SOB or add'l swelling present.
10AUG98 diarrhea & severe abd pain;14AUG98 rash uper legs arms, & around eyes w/itching, swollen eyes;20AUG98 pain in hands & feet for 2 days can't walk;
Left anterior shoulder pain that is not improved with NSAID's.  Began a few hours after administration of vaccine and has persisted since
This spontaneous report as received from a consumer as part of a marketing research program refers to a 14 year old female patient who is her daughter. No pertinent medical history and concurrent conditions reported. On an unknown date the patient was vaccinated with GARDASIL (dose not reported). No other concomitant therapies reported. Consumer stated that this vaccine was safe and effective which the consumer did not believe that it was. The consumer's child had become very sick (hospitalization) because of this vaccine and her life has been altered in a negative way because of this 'safe' vaccine. The patient experienced psoriatic arthritis (hospitalization) that was not present before she received the vaccine. The consumer reported that the healthy daughter spent 4 months laying in bed, barely able to eat because she suffered from severe fatigue (disability, hospitalization) (days after receiving her vaccine). The consumer stated that the child went from healthy and active to sleeping 22 hours a day (hospitalization), not able to eat (hospitalization) and having to withdraw from school. The consumer stated that after 3 hospital stays, months of testing and finally fighting with the physician that something was wrong (as they said no even with 4 negative Epstein-Barr virus (EBV) tests), she was referred to a rheumatologist who had seen causes like this a lot lately. The consumer further stated that the patient was now suffering from arthritis in her back which was not there at her last well check at the end of 2013. The consumer had blindly allowed the doctor to talk the consumer into allowing the child to receive this vaccine without researching it. If the consumer had known that there are high risks for this vaccine and the fact that people with a family history of autoimmune based disorders (lupus, thyroid, RA, psoriasis, etc) should not receive this vaccine because of the increased risk of developing an AI (Autoimmune) disorder that can alter the child's life forever. The consumer would speak out and let everyone know not to vaccinate their child with this GARDASIL or anything like it. The outcome of the events was unknown. The causality of the events was unspecified. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a licensed vocational nurse refers to a 65 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 31-OCT-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB lot number M036156, expiration date 23-FEB-2019, for prophylaxis (route of administration was not reported). No adverse effects were reported.
Pt recvd vax & exp sniffling, sneezing & extremely swollen eyes & face 15 mins p/vax;
This initial spontaneous case, received on 02-Nov-2017, reported by other non-health professional and concerns a 12-year-old female patient of weight: 48.3 kg, height: 148 cm. The patient's historical condition included stomach pain throughout the years. The patient's concomitant medications were not reported. On an unspecified date, the patient received Influenza vaccine (dose, route, anatomical location, trade name and manufacturer was not reported). On 20-Oct-2017, the patient was also received ILARIS (300 mg, subcutaneous, once a (as reported)) for TRAPS (tumor necrosis factor receptor associated periodic syndrome). On an unspecified date, after receiving INN flu vaccine seasonal (reported as two and half weeks ago) and ILARIS injection on 20-Oct-2017, the patient had bad injection site reactions. She used topical BENADRYL but it had no effect, hence it was replaced with oral BENADRYL which helped, but one of the reaction sites returned about in 10 days. On 29-Oct-2017, as soon as BENADRYL was stopped, since then she had bad stomach pain, was tired, appetite lost and was not going to school. It was also reported that, the site reaction that returned was  noticeable, burned and itched, but not as large as it originally was. The patient was not eating and sleeping all the time. She had an intense feet pain (pain level: 5.5). It was reported that, the patient had reoccurring stomach pain throughout the years, she was on ILARIS but not to the intensity that it  did not go away like it was then. She also felt like she was being punched in the stomach. The reporter also reported that, ILARIS reduced length of flare and blood work looked good a month ago, for the first time and had normal sedimentation rate. The outcome of the event injection site reaction was recovering and for events stomach pain, loss of appetite, tiredness and intense foot pain was not recovered (ongoing). The outcome of the other events was not reported.
pt says she developed a severe headache, nausea and was shivering.  When she laid down she could feel her heart beating.  She took Tylenol.  She woke up feeling like she had the flu.  She was very fatigued.  Her lack of motility symptoms have intensified.  She had these symptoms for several days so went to her PCP which told her to monitor her symptoms.   A week after taking the vax she started feeling very cold, had shivers, body aches, and developed a cough.  She took Tylenol and went to bed.  She woke up with a debilitating headache.  She was weak and dizzy so took more Tylenol.  She continued to be dizzy, felt fatigued and had brain fog.  She called the vax nurse help line and was instructed to go to the ER.  She went to the University.  She had blood test, EKG,  and Brain CT which were normal.  She was dehydrated and was given IV fluids.  She was monitored and sent for Covid and Sars testing which were normal.  She still has shivers, chills, body aches and feels very tired and feels like this has interrupted her cognition.
This spontaneous report was received from a healthcare provider regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On unknown dates in January 2016 (also reported as since 11-JAN-2016) unknown number of patients were administered with improperly stored doses of M-M-R II (lot # K022285, expiry date 12-NOV-2016 and lot # L012482, expiry date 10-APR-2017) dose, route unknown. Concomitant medications were not reported. It was reported that there were no previous temperature excursion to the product. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Immediately after the vaccination was given, patient appeared to have passed out.  Regained consciousness within a minute, became responsive.  Within the next 5 minutes, had another episode of unconsciousness that lasted almost a minute.  I alerted the staff at that time to call 911.  While on the phone with 911, patient regained consciousness but did not feel well at all.  Patient then proceeded to throw up while waiting on EMS to arrive.  Patient was transported to the hospital for evaluation.