chrisvoncsefalvay/vaers-outcomes huggingface dataset:
prostate cancer; This is a spontaneous report from a contactable consumer reporting for himself. A 65-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on an unspecified date, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none.  The patient experienced prostate cancer (medically significant) on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of the event and included treatment with Lasix (not clarified over the call, reported as for his urine). Patient reported he had to underwent a surgery.  The information on the lot/batch number has been requested.
10Nov89, 13Dec90, 14May90, pt vax w/ hepta B.  21Jul90 titer indicated non repsonder.  10-Oct90 recv booster vax. titer to be done Nov90.
The sickest she has ever been; This case was reported by a other health professional via call center representative and described the occurrence of sickness in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The medical assistant reported that the patient was the sickest she had ever been following dose one of Shingrix. The reporter consented to follow up.
Vomiting; Diarrhea; Swollen lymph nodes; Muscle spasms; Migraine; Migraine; Fungal infection; Pelvic pain; Breast pain; Numbness & tingling in extremities and face; Numbness & tingling in extremities and face; Vaginal discharge; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0181), via an unspecified route of administration, administered in Arm Left on 21Jun2021 12:00 at the age of 60-year-old as dose 1, single for covid-19 immunisation. Medical history included migraines, breast cancer (in remission for 13 years), Inflammatory bowel disease and patient had allergies to dilaudid, toradol, fiorocet. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced vomiting, diarrhea, migraine, swollen lymph nodes, fungal infection, pelvic pain, breast pain, numbness and tingling in extremities and face, muscle spasms and vaginal discharge. all beginning the same day or within two days of the injection and recurring ever since; sometimes with severity on 21Jun2021 18:00. The events result in emergency room/department or urgent care visit/ hospitalization prolonged and patient did not receive any treatment in response to the events. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Injection site redness - hot to touch - swollen - hot to touch - a little itchy but not bad Just showed the morning of my 8th day after the shot It about 8cm in diameter and doesn't seem to be growing larger.
This case was reported by a healthcare professional via a sales representative and described the occurrence of a subject of unspecified age and gender not responding to therapy following vaccination with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject completed the Engerix B series.  At an unspecified time after completion of the Engerix B series, the subject was tested and found to have not responded to therapy.  The result of the test was indeterminate.  A subject was given a second Engerix B series and still did not respond.  Again, the result of a titer test was indeterminate.  At the time of reporting the outcome of the event was unspecified.
Long term Headache; Slight chest pain; Tiredness; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 11:00 as dose 1, single for covid-19 immunisation. Medical history included Type 2 Diabetes, High Cholesterol from an unknown date and unknown if ongoing. Concomitant medications included empagliflozin (JARDIANCE) and rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported. Not known allergies. On 27Jan2021 08:00 AM patient experienced long-term Headache, Slight Chest pain, tiredness. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not received treatment. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Case number PHEH2012US025571 is an initial spontaneous report received from a healthcare professional on 13 Nov 2012. This report refers to a unspecified age and gender patient. The patient was vaccinated with FLUVIRIN (batch number: 12245P and expiry date: May 2013) on an unspecified date. The reporter reported that, two separate times after attaching safety needle to prefilled syringe (PFS), an employee got glass in the eye once the syringe broke at the hub. No information on person/employee. No additional information provided by reporter.
Headache, Arthralgia, Diarrhea, NauseaVomiting, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, Narrative:
The soreness in the arm in which the shot was administered is unbearable.  I couldn't sleep on it, can't lift it without feeling sharp pain and I am afraid to move it.
Initial report was received on 08 June 2014 from a consumer. An unidentified High School student patient, gender and date of birth not reported, was vaccinated on an unknown date with TDAP, manufacturer unknown and was diagnosed on 05 June 2014 with Whooping cough. The patient's medical history, concomitant medications and vaccination history were not reported. Laboratory tests were not reported. Treatments were not reported. The patient outcome was not reported. No further details were available at the time of this report. Documents held by sender: None.
Report 2001018374-1 describes lightheadedness in a pt who rec'd hepatitis B vaccine recombinant (Engerix-B). This report was rec'd from a person of unspecified professional identity and had not been verified by a physician or other HCP. Allergies, medical history, and concomitant medications were unknown. On 7/23/01, the pt rec'd her first L deltoid dose of Engerix-B, 20 minutes later, she was lightheaded, flushed, and nauseous. She experienced flu-like symptoms and was not feeling with it. As of 7/25/01, the pt's symptoms were resolving.
Pt received their initial COVID series with the Pfizer vaccination and was seeking the booster dose with Pfizer.  Pt received Moderna instead of Pfizer for their booster dose. Event was a vaccine administration error.
This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (1st dose received in 2018). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional details were provided as follows: The age at vaccination was not applicable to this report. The pharmacist reported late dose of Shingrix. The patient did not receive the 2nd dose till the time of reporting, which led to incomplete course of vaccination. No further information reported. The reporter consented to follow-up. This case has been linked with case US2021251174, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021251174:Same reporter.
I received my second covid vaccine on 1/26.   On 1/27 I had severe body aches, headache, burning dry eyes, debilitating fatigue, and could barely move my arm.  I had these same symptoms on 1/28
Pt c/o flushing/sweating and trouble breathing/SOB (resolved with the removal of her mask).  Pt was also thirsty, nauseated, and had blurred vision that started 10mins after vaccination.  BP 123/72, HR 63, RR 16.  Pt given water and apple juice.  Symptoms resolved in ~30mins.  Pt stable and released from the vaccination site.
Patient felt immediate pain upon injection and had trouble  moving arm. Doctor performed x-ray but could not find abnormal markings. Patient diagnosed with bursitis. Prescribed Tramadol for pain.
Sore shoulder where flu shot was given that has persisted over a month later.  Pain in deltoid muscles, especially when raising arm or moving arm across chest.  Pain is strong when doing this.
Real fatigue; Light headache; Cold; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the left arm on 15Sep2021 at 12:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (reported as HBP) and asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took promethazine (PHENERGAN), for an unknown indication, from an unspecified date and experienced drug allergy. On 16Sep2021, at 07:00 the patient experienced real fatigue, light headache and cold. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events real fatigue, light headache and cold was not recovered, at the time of this report.
At injection site on right arm, area is red, swollen, warm to touch, area is 3 - 4 inch size down arm. Painful to touch and closer to the middle of injection is hard to touch. Was since the next day at office and checked by a nurse practitoner. The course of treatment that was given afterwords was Keflex 250mg/5ml 3 tsp po bid for 10 days.
A non-serious spontaneous report of H1N1 LAIV inadvertently administered to 52-year old was received from a health professional concerning a patient of unknown gender. The patient's medical history was not provided. On an unknown date in 2009, the patient received H1N1, intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Sluggish while playing basketball - very tired. Slept Sunday evening/night Monday, 2-3-14, began running low grade fever 99-100 degrees/mom.  States he has normal appetite when awake, but sleeping so soundly he slept through meal times.  Left school Tues early-came home to nap - couldn't wake him up. "had an upset stomach Wednesday - no N/V. When she got home from work"  remained sluggish this weekend as well. Doesn't think it's serious enough to see the Dr., but very abnormal for him.
Redness at injection site; decreased mobility in left arm; Weakness in left arm; Soreness in left arm; left arm "feel fatigued"; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site erythema, injected limb mobility decreased, weakness of arms, pain in arm and muscle fatigue. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injected limb mobility decreased, weakness of arms, pain in arm and muscle fatigue were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injected limb mobility decreased, weakness of arms, pain in arm and muscle fatigue to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received first dose of Shingrix in the left arm. The patient experienced redness at the injection site for a couple of days after receiving dose, redness had resolved. The patient experienced weakness, soreness and decreased mobility in the left arm approximately 2 weeks before reporting, the muscles and tissues in her left arm felt fatigue. The patient stated that, weakness, soreness, decreased mobility were ongoing at the time of reporting. The reporter did not consent to follow-up.
Herpes simplex 1 (cold sore) outbreak on lip started 22 hours after 2nd vaccine. No signs or symptoms prior to vaccine. I have not had a cold sore in 2+ years prior to getting vaccine.
received Boostrix instead of Flu vaccine; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9ZK5T, expiry date 7th October 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th November 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 14th November 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: The medical assistant reported that a colleague received a dose of Boostrix instead of an unnamed flu vaccine, and wished to know how to proceed, initials, and gender were given for the patient, but specific age was withheld.  The vaccine administration facility was the same as primary reporter The reporter consent to follow-up. Additional Supportive information:The patient received Boostrix instead of an unnamed flu vaccine, which led to wrong vaccine administered. This case has been linked to the cases US2022168196 and US2022168197reported by the same reporter .; Sender's Comments:  US-GSK-US2022168196:same reporter US-GSK-US2022168197:same reporter
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 24-APR-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion of 72 hours. This is one of several reports from the same reporter (MARRS 1507USA000441). Additional information is not expected as all correspondence was received.
Patient received immunization on 8/10/2016 at 2:26 PM. Came in next day with redness and swelling around the injection site. Never had reaction in the past to flu shot. Was told to take antihistamine and ibuprofen. Will follow up.
Pt received PNEUMOVAX23 - that evening he described severe tenderness of arm & progressed to involve aching pain of entire, not red or swelling. No respiratory symptoms next am generalized rash.
Friday: 3/12/2021: 4:30 PM mild headache and right arm pain, 6:30 PM no headache but then body aches, 8:00 PM chills, all over severe joint and body aches, temperature, chills, nausea, and no sleep due to symptoms that 3/12 Friday night.   Saturday: 3/13/2021: Friday PM severe symptoms continued (reasonable left arm pain from injection, severe joint and body aches, temperature, chills, nausea, no sleep due to pain) all day.  Sunday: 3/14/2021   (milder systems of those I experienced on 3/13/2021)  All symptoms eased up around 8:00 PM  Left corner of upper and lower lip numbness and left tip of tongue numbness started at ~5:00 PM)  Was able to sleep. Monday: 3/15/2021  tired, left side of upper and lower lip numbness and left tip of lounge numbness continued but went away by 5:00 PM
pt recv vax while was pregnant;first dose given @ about time of conception;@ about 7 to 8 wk pregnant;pt elected to terminate the pregnancy in part because of the concerns about the vax but also for personal reasons;
VACCINE WAS GIVEN ON 10/8/2022, 8 DAYS AFTER ITS EXPIRATION
Approximately 9 hours post vax pt experienced a mild local reaction, which developed into a large red area, 4 inches in diameter.
Friday, I received the shot at 3:30pm. I got home around 5:00pm and I started to not feel not feel well at all around 8:00pm. I woke up Saturday feeling dizzy and weak just like the night before. Saturday evening I let my dog out and when I turned around to go inside I fainted and feel on my face.
Information has been received from a registered nurse concerning a female patient who was vaccinated with her second dose of GARDSIL (lot # not provided). The patient fainted after getting her second dose of GARDASIL. There was no adverse event after the patient received her first and third dose of GARDASIL. The patient had sought unspecified medical attention. On an unspecified date the patient recovered from an adverse event. Additional information has been requested.
Information has been received from a registered nurse (RN) concerning an 8-month-old infant who on 12-APR-2006, was vaccinated PO with the 1st dose of ROTATEQ. Unspecified medical attention was sought, but no adverse events were reported. Additional information has been requested.
I was having a colonoscopy and was asleep. They said they couldnt do it because it was something wrong with my heart. I went home and I was still feeling tired. I called my doctor and went in and explained what happened. She ordered a stress test and a halter monitor and that would not be completed until November. She also did an EKG and she indicated that there was something odd that she would like to have someone else review and she would 3get back with me. I do not feel any different but its unknown whether the issue still exist.
Vaccine with 34F temperature administered to patient; two doses has been given to two; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) and EXPIRED PRODUCT ADMINISTERED (two doses has been given to two) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical information was reported.).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) and EXPIRED PRODUCT ADMINISTERED (two doses has been given to two). On 05-Apr-2021, PRODUCT STORAGE ERROR (Vaccine with 34F temperature administered to patient) and EXPIRED PRODUCT ADMINISTERED (two doses has been given to two) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  Treatment information was not provided.; Sender's Comments: This report refers to a case of Product storage error and Expired product administered, for mRNA-1273, lot # 027B21A, with no associated AEs.
No adverse event; Doses were administered after the 30 day BUD; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses were administered after the 30 day BUD).    No treatment and concomitant medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-711736 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-711736:Master case (Patient: D-Y)
nausea, loss of appetite, itchiness, red swollen hives, light headedness
Throat tightness, dry throat; BP 116/64, HR 53. O2 sat, 100%. One hour later, throat tightness resolved.