chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the night I got the vaccine it caused an erection all night.  I woke every 2 hours or so and it was uncomfortable.
Large,  (4cmx4cm), mildly itchy, raised, welt at injection site one week after initial dose that resolved spontaneously in one week.  This was followed by a large (8cmx10 cm) non raised,  red area that resolved spontaneously in 72 hours
Staff tended to the patient after they verbalized not feeling well after receiving their COVID-19 vaccine. Vitals (sitting) were taken at 4:02pm and staff called a Code at around 4:05pm. A second set of vitals (laying down) were taken. Dr., along with the code team, arrived and recent vitals were reported. Patient was instructed to continue being observed for 30 minutes. Patient was assessed by Dr., who asked to check blood glucose levels (97). A 3rd set of vitals (sitting, feet dangle) were taken. The final set of vitals were taken at 4:22pm. Dr. returned and said that the patient could leave if he felt asymptomatic. Patient denied dizziness when standing up and left around 4:30pm.
TAKING BACTRIM DS WHILE ON VIVOTIF; UTI; This spontaneous case report (PVX2019-2682) was received from a nurse on 28-Oct-2019. Additional information was received on 29-Oct-2019. It described a female consumer who developed UTI (Urinary tract infection) (PT: Urinary tract infection), while being on Vivotif capsule for travelling. She started "taking Bactrim DS while on Vivotif" (PT: Labelled drug-drug interaction medication error) for UTI.  Case report: The consumer started taking Vivotif from 23-Oct-2019. After her third dose of Vivotif, she developed UTI on 27-Oct-2019. Thus, she started Bactrim DS on 28-Oct-2019.  Action taken with Vivotif with respect to event UTI was vaccine discontinued, while with respect to the event "taking Bactrim DS while on Vivotif" was not applicable.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, the patient developed a urinary tract infection (UTI) following administration of Vivotif vaccine. Since UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "taking Bactrim DS while on Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, the patient developed an urinary tract infection (UTI) following administration of Vivotif vaccine. Since UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "taking Bactrim DS while on Vivotif" was considered as not applicable.
shortness of breath; hot flashes; body aches; uncontrollable shakes; low blood pressure; fever of 104.4 degrees Farenheight; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes) and HYPOTENSION (low blood pressure) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00813212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes), HYPOTENSION (low blood pressure), PYREXIA (fever of 104.4 degrees Farenheight), VOMITING (vomiting) and CHILLS (chills). The patient was treated with POTASSIUM for Adverse event, at an unspecified dose and frequency and MAGNESIUM for Adverse event, at an unspecified dose and frequency. On 31-Mar-2021, DYSPNOEA (shortness of breath), HOT FLUSH (hot flashes), MYALGIA (body aches), TREMOR (uncontrollable shakes), HYPOTENSION (low blood pressure), PYREXIA (fever of 104.4 degrees Farenheight), VOMITING (vomiting) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 104.4 degree farhanite (High) High. On 30-Mar-2021, COVID-19: negative (Negative) negative. On 30-Mar-2021, Epstein-Barr virus test: negative for mononucleosis (Negative) negative for Mononucleosis.         No concomitant medications were reported. The patient had no adverse events after dose 2.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Vaccine dose 2 details added. Event outcome updated.
Booster received 4 Months and 5 days earlier; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster received 4 Months and 5 days earlier) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster received 4 Months and 5 days earlier). On 08-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster received 4 Months and 5 days earlier) had resolved.            No concomitant medication was provided by the reporter No treatment medication was provided by the reporter.  It was reported that pharmacist administered the booster dose to patient only in three months.
2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the 1st dose of adjuvant suspension only, and came back 2 months later and only administered the lyophilized powder mixed with normal saline. No adverse events reported by patient. This was 9 of 9 linked cases reported by same reporter for different patients. The reporter consented to follow up.   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138558:Same reporter US-GLAXOSMITHKLINE-US2021AMR138555:Same reporter US-GLAXOSMITHKLINE-US2021AMR138557:Same reporter US-GLAXOSMITHKLINE-US2021AMR138556:Same reporter US-GLAXOSMITHKLINE-US2021AMR138546:Same reporter US-GLAXOSMITHKLINE-US2021AMR138554:Same reporter US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1 - deleted.
I had begun to have intestinal pain after my first covid shot but the second made it quickly unbearable. Following my 4/20 second Pfizer shot I felt unable to eat and vomited the liquids I consumed. By 5/2 I was debating going to a hospital.   I began to have uncontrollable diarrhea throughout the day. I developed a fever and was unable to leave the bathroom for long. The pain got so bad that I was unable to sit up or sleep through the night.  I was hospitalized on 5/13.  There was blood and protein in my urine, my liver was enlarged, I was anemic, and my CRP was astoundingly high at 84.2. My calprotectin, a measure of intestinal inflammation, was over the limit of the test at >3,000. Calprotectin should be below 50. All tests for parasites and pathogens came back negative.   I developed uveitis in my eyes from the autoimmune attack that was happening in my body.   A colonoscopy was performed on 5/28 which showed autoimmune disease in my intestines. It was determined that the findings were similar to Crohn's Disease, which I did not have prior to vaccination.   I now have an autoimmune disease that will remain with me for the rest of my life and will be on immune suppressing medication for the rest of my life.
01/27/22 presents to ED for "Abdominal pain". PMHx of "CAD status post stents, paroxysmal A. fib on Eliquis, heart failure with reduced ejection fraction"
Red lesion where I got the shot and arm sore. Stuffy nose, sneezing, chills, feet cold, tired
Patient was given an intramuscular pneumococcal vaccine in the right arm via a student nurse while in the hospital. Patient was in good health at time of discharge, when the patient arrived home she had a temperature of 104 F, pain, immobility of the right arm, and was delusional. The patient's husband called an ambulance and the patient was taken to a local hospital. Orthopedic surgeon consult felt the vaccine was injected into the patient's bursa (too high).
headache, chills, chest tightness, weakness, tingling in legs, sweating, decreased appetite.
pt recv 1JUL97 & pt presents next day w/swelling & heat in area that vaccine was injected;pt states maximum swelling was last PM w/grapefruit size edema;edema is now less than last noc, but still visible;
Patient indicated that injection site became itchy around approximately 8:30 PM on 10/16/2014. Patient relayed that she took 25 mg Benadryl at the time she first noticed symptoms.  Patient stated that the injection site was still itchy in the morning (on 10/17/2014) and that she experienced increasing itchiness that spread into her shoulder around 3:00 PM. Patient sought attention from medical staff at the facility around 4 PM at which time medical staff noted mild redness around the injection site approximately 1 inch in diameter. Medical staff also noted warmth at the site and on superior aspect of lateral shoulder on the ipsilateral side.
This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A female patient, of an unspecified age, received the 2nd dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient medical history and concomitant medications not reported. Historical vaccine included the 1st dose of BNT162B2 (Comirnaty, solution for injection), via unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. On an unspecified date, patient experienced shoulder pain, inflammation and a lump down her armpit. She wanted to know if the side effects are reported with vaccination; and if swollen lymph nodes is a reported side effect of the vaccination. Referred to her physician for diagnosis and treatment recommendations. The outcome of the events: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Redness at the injection site, swelling and warmth spreading lower on the arm towards the elbow. She was advised to take ibuprofen and use cold packs. She is still within the 2 day window of receiving vaccine and symptoms apear better than they were yesterday.
Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L004466 with expired date 02-AUG-2016, oral, dose was unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
administered a dose of Fluzone High-Dose that was expired; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 69 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that administered a dose of Fluzone High-dose that was expired (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 18-Oct-2019, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ044AA and expiry date 04-Jun-2019 via intramuscular route in the left arm.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  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 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.
Smallpox vaccination given 2/11/03. PT developed temp about 1 hr. post vaccination (tactile). Had a recorded temp of 101.8 at 4 p.m. Took 2 doses of Tylenol and temp resolved by 3 a.m. No other Symptoms. Now feeling well.
Vaccine error. Pt was administered Dose 2 of Tdap when first Tdap vaccination had already been received on 11/30/2021. Medical assistant notified physician and parent right away. Documentation completed.
Pt was given the Tdap vaccine and then the GARDASIL and as soon as she had the GARDASIL vaccine she fell back into the chair. Her eyes rolled back, had some jerking moments only a few seconds. No seizure activity. Was alert in a few minutes and able to speak. Skin was pale BP 106/70, BS-98. Had not eaten breakfast. Color was better after 30 min. able to sit up and left under her own power.
Pt. returned to clinic on 12/12/03. Left Deltoid where pt. received flu vaccine was a 2 1/2 in.reddened area.  Pt. reports only slight soreness at needle site.  No edema or pain.  Robust reaction to vaccine.  No treatment necessary.  Told to return to clinic with any S/S of infection or seek medical attention at ED or PMD.
ED Note: This is a 43-year-old female with history of asthma who presents for evaluation of chest tightness. The patient is an employee and received her COVID-19 vaccine, first dose 20 minutes prior to ED arrival. She subsequently developed chest tightness and wheezing. She used he albuterol r inhaler and now feels improved. She says that she has been having increased asthma exacerbations lately because of the change in weather. She has had no prior allergic reaction to any vaccine. She denies any hives. Denies any throat tightness. Her symptoms at this point have resolved.  Monitored in ED x 4 hrs.  No treatment.
Within a few days of receiving Menactra vaccine, patient developed toe numbness then headache, nausea, followed by foot dragging, impaired joint position sense leading to ataxia.  He was admitted to Hospital.  Neurologist treated him with IVIG after diagnosing Chronic Inflammatory Demyelinating Polyneuropathy. His spinal fluid had Protein of 222 and WBC of 13. MRI is normal.  He had decreased appetite and required IV fluids.  After treatment with IVIG he was dischared on IV fluids at home (his mother is a doctor), a walker for balance.  7/1/09 Hospital records received DOS 4/30/09 to 5/22/09. Assessment: Guillain-Barre Syndrome/CIDP. Presented with paresthesias in both lower extremities, abnormal gait, headaches, vomiting. Dysautonomia, pseudotumor cerebri. IVIG. Hemolytic anemia. Pale, knees buckling, not feeling good. Nystagmus. Altered perception to touch, deep tendon refexes reduced. Unable to tolerate oral intake. Placed on total parenteral nutrition.
pt recvd vax; macular rash & fever 102;2 wks later mild pharyngitis; no urticaria or oth allergic manifestation;
started itching immediately p/vax & devel rash w/blisters starting on face then to neck then scalp then axilla; spoke w/clin who recommended DPH;
Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Additional Details: patient recieved the first covid vaccine, he lost color in his body and his body was cold, he was shaking and nervous, He didnt faint or lose consciousness. 911 was called, and all his vitals were normal. he stated he gets this reaction after every injection/needle poke.
Patient was given Moderna instead of Pfizer for her Booster.  Patient is 16.
VACCINE ADMINISTERED TO 16 YEAR OLD INDIVIDUAL; This spontaneous report received from a health care professional concerned a 16 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination. The drug was associated with Off label use. Age at time of vaccination 16 years old. No concomitant medications were reported. On 09-NOV-2021, the patient experienced vaccine administered to 16 year old individual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered to 16 year old individual was not reported. This report was non-serious. This case, from the same reporter is linked to 20220649370, 20220649804, 20220649704, 20220650014, 20220649045, 20220649488, 20220649137, 20220649421, 20220649626, 20220649803, 20220649884, 20220649915 and 20220650111. This report was associated with product quality complaint: 90000237034.
Swollen lymph nodes in left armpit; This is a spontaneous report from a contactable consumer (patient).  A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ELI283, via an unspecified route of administration on Left Arm from 07Jan2021 14:45 to 07Jan2021 14:45 as SINGLE DOSE for COVID-19 immunisation.  Medical history included none.  The patient's concomitant medications were not reported.  The patient experienced Swollen lymph nodes in left armpit on 08Jan2021 12:00 with outcome of not recovered. The patient is not pregnant. Patient was not tested for COVID prior and post vaccination.  No treatment was received for the event.
Information has been received from a registered nurse concerning a 19 year old female with hypersensitivity to pineapple and to amoxicillin, and a history of urticaria 5 years ago to a tetanus toxoid, who on 23-AUG-2007 was vaccinated IM with a 0.5ml first dose of Gardasil (lot # 658488/0930U). Concomitant therapy included SYNTHROID, ORTHO TRI-CYCLEN LO, albuterol, ADVAIR, CLARITIN and ZANTAC. On 23-AUG-2007 the patient experienced hives all over her body and had no trouble breathing. The patient telephoned the office and BENADRYL was prescribed. The patient's hives all over her body persisted. No laboratory or diagnostic tests were performed. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a registered nurse concerning a 19 year old female patient with hypersensitivity to pineapple and to amoxicillin, and a history of urticaria 5 years ago to a tetanus toxoid who on 23-AUG-2007 was vaccinated IM with a first 0.5ml dose of GARDASIL (lot # 658488/0930U). Concomitant therapy included SYNTHROID, ORTHO TRI-CYCLEN LO, albuterol, ADVAIR, CLARITIN and ZANTAC. On 23-AUG-2007, the patient developed hives all over her body but had no trouble breathing. The patient telephoned the office and BENADRYL was prescribed. No laboratory or diagnostic tests were performed. The patient's hives all over her body persisited. Follow up information states that this reaction was not related to the immunization. No product quality complaint was involved. Additional information is not expected.
Patient reported on day 7 at the pharmacy. Mentioned that she has swelling on right temporal area. I (pharmacist) touched the area and it was inflamed. About less than an inch in diameter. Patient reports that its painful to touch. Took ibuprofen to help with pain.
Pt's mother states that pt had fever for 24hrs, stopped breathing and was rushed to Hospital, but was deceased on arrival. Coroner contacted mother and informed her that pt appeared to have had meningitis (H. Flu), but death listed as non-conclusive.
Worker stated that left arm started swelling and hurting last night 9/25/14 inform nurse staff this evening on 9/26/14 4 inch in size warm to touch very red in color.
Covid-19 I tested positive for Covid 19 on February 2, 2023 and I experienced runny nose, slight fever, cough,  I was prescribed Paxlovid for my symptoms.
Malaise and injection site pain within hours. Fever/chills within 12 hours that cleared up after 2nd night.  Muscle cramping followed injection for at least a week, along with significant joint pain persisting for several weeks.  Woke up with severely numb right arm on 3rd night and this recurred a few nights over the next 2 months.  Arm was so numb the muscles below the shoulder did not want to move.  Encountered tingling/neuropathy and muscular weakness in both arms within 48 hours of injection, with tingling/weakness just above and below the elbows persisting to date.  Tingling in arms at one point progressed down the right arm as a cold burning sensation for first few months going all the way to the fingers.  Was not easily fatigued nor having any sleep disturbances prior to the injection.  Began having less restful sleep, encountering periods of very low energy (occurring each afternoon for first several months, but now improving).  All of these symptoms began immediately after vaccination.  Energy levels have improved, but not to pre-vaccination levels.  Neuropathy still being experienced near the elbows, with occasional tingling/cold sensations in right arm at and below injection site.
p/vax pt reported has felt progressively worse since;thick tongue (slurred speech & spaceyness);lt arm tenderness & motor coordination changes;speech slurred;
PATIENT DEVELOPED A SMALL LOCALIZED REACTION IMMEDIATELY UPON RECEIVING THE VACCINE (SWELLING).  ADVISED HER TO WAIT FOR 15 MINUTES AND INFORM ME IF SHE FELT ANY ADDITIONAL SYMPTOMS.  WITHIN 2 MINUTES SHE STATED WHE WAS FEELING WARM AND LIGHTHEADED.  SHORTLY AFTERWARDS, THE PATIENT DID FAINT IN HER CHAIR AND REGAINED CONCIOUSNESS WITHIN 10-15 SECONDS.  SHE CONTINUED TO FEEL WARM AND CLAMMY.  WE PROVIDED THE PATIENT WITH DIPHENHYDRAMINE 50MG.