chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on 23Feb2021, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient was scheduled for knee surgery. Prior to having knee surgery, the patient had to get a COVID test. The patient got the COVID test and on 08Mar2021 he tested positive for COVID. Therefore, they had to cancel the knee surgery. The patient was scheduled to have the next COVID shot on 16Mar2021 and they are calling to get advice. They want to know what they should do about the next vaccine and if they should reschedule. Outcome was unknown.  Information about Batch/Lot number has been requested.
patient came in for flu shot and was accidentally given daughters covid 19 pfizer booster. Patient has already completed a moderna series with a moderna booster about 3 weeks ago (per daughter). As of now no adverse reactions/symptoms etc.
This spontaneous report had been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. It was reported that on unspecified dates, multiple unspecified patients could have inadvertently received improperly stored unspecified doses of ROTATEQ orally for prophylaxis, lot numbers: N030152 (expiration date: 01-SEP-2019), N034400 (expiration date: 10-MAY-2019) and N013989 (expiration date: 30-JAN-2019); (dosage schedule, route and anatomical location  were not reported); GARDASIL 9 for prophylaxis Lot number: N032284 (expiration date: 22-SEP-2020) (dosage schedule was not reported); and PEDVAXHIB for prophylaxis lot number: R000875 (expiration date: 26-SEP-2020) (dosage schedule, route and  anatomical location  were not reported). The temperature was from 9 Celsius (C) to 25 C for a timeframe of 96 hours. There was no previous temperature excursion. The call was because a data logger. No adverse effects were reporter. No further information was provided.
Pt came in 2 days after receiving the vaccination with a large, red engorgement on her arm where she was injected. About 3 inches in diameter, she said it itches but does not hurt.
egg sized lump and hot rash on arm. Patient thinks the rash has stopped spreading and is going to resolve by its self.  No treatment necessary unless no resolution with time
Frozen shoulder. First tenderness at injection site followed by increased area of pain and then shoulder stiffness and limited range of motion. Orthopedic eval, followed by PT.
fatigue (04/11), sore arm (04/11), raised welt that is warm to touch on left deltoid (04/13), HA (04/11)
Headache, high fever (102+) for first 24 hours, 99-100 temp following, fatigue, severe pain in arm, aches, hot arm where shot was administered, everything hurts.
A nurse reported that a pt received vaccine 1/6/00, several days post vaccine pt developed an injection site reaction characterized by redness and induration. Pt recovered.
Immediately after receiving GARDASIL - fainted - went pale - last less than one minute.  Had her elevate feet and rest til no longer faint.
2nd day :fever of 2, then 3 degrees. Chills, aches, headache, sensitive to light. 3rd day okay. 4th and fifth day (22 & 23), large reddish welt middle of upper arm, below injection site.  Measures 8" x 3". Raised and swollen. No itching, no fever.
off label use; 6 yo female had fever and 24hra post first dose of Covid 19 vaccine; 6 yo female had fever and 24hra post first dose of Covid 19 vaccine; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "off label use"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), PYREXIA (non-serious), outcome "unknown" and all described as "6 yo female had fever and 24hra post first dose of Covid 19 vaccine".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt spiked temp of 101.3 and had seizure; was taken to ER
The patient was administered Pentacel instead of Diphtheria, Tetanus and Acellular Pertussis (DTAP), No AE; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 23 months and 4 days old male patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination instead of just DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) on an unknown date (wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to wrong vaccine administered.  At the time of report, no adverse event was 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 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 lot number.
swelling of the lymph nodes on her neck and stuff; This is a spontaneous report from a contactable other Health Professional (parent).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included nodules in both breasts and got markers put in. There were no concomitant medications. On an unspecified date, the patient experienced swelling of the lymph nodes on her neck and stuff, the reporter stated that it was not a big thing not really turn into any things. The outcome of event was unknown.    Follow-up (04Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Mild throat swelling, not enough to obscure airway, went home and took Benadryl and went to sleep. Symptoms gone post nap (also had fatigue and mailase both gone after nap)
Fever of 103.1, body aches, headache for x1 day, symptoms resolved after 1 day course of OTC Tyelnol prn.
DISCOMFORT OF THE JAW; DISCOMFORT OF THE TEETH; ABDOMINAL PAIN; MODERATE HEADACHE; This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no any medical history and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced moderate headache. On 31-MAR-2021, the subject experienced abdominal pain. On 12-APR-2021, the subject experienced discomfort of the jaw. On 12-APR-2021, the subject experienced discomfort of the teeth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain, was recovering from moderate headache, and the outcome of discomfort of the jaw and discomfort of the teeth was not reported. This report was non-serious. This case, from the same reporter is linked to 20210445480.
No known adverse events were noted. The patient was administered his first Moderna dose while being 17 years old.
Information has been received from a physician concerning a 16 year old female patient with epilepsy who on unspecified dates was vaccinated with two doses of GARDASIL, 0.5 ml, IM. Concomitant therapy included hormonal contraceptives (unspecified), started "about the same time as the first dose of GARDASIL". The dosage of the birth control pill was increased due to the patient also taking LAMICTAL. The physician reported that the patient had experienced an increase in frequency of seizures since her first dose of GARDASIL. The physician reported that the patient was under the care of an unspecified neurologist due to her known history of epilepsy. At the time of the report the patient's outcome was not specified. The patient sought medical attention by an office visit. No diagnostic tests were performed. Upon internal review increase in frequency of seizures was determined to be an other important medical event. Additional information has been requested.
Fever (100.7), swelling  and redness and warm to touch at injection site, vomiting, nausea, diarrhea, weekness. More combative.
CK levels were elevated; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BLOOD CREATINE PHOSPHOKINASE INCREASED (CK levels were elevated) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced BLOOD CREATINE PHOSPHOKINASE INCREASED (CK levels were elevated). At the time of the report, BLOOD CREATINE PHOSPHOKINASE INCREASED (CK levels were elevated) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  No concomitant medication information was provided.  The patient saw their general practitioner and went to emergency room (ER) to be examined. No treatment product information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-218897 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a consumer concerning her/his 67 year old female cousin with a history of back problems who on approximately 05-JUL-2010 (also reported a during the second week in July 2010) was vaccinated SC with a 0.6 ml ZOSTAVAX (Merck). On 26-AUG-2010 the patient began experiencing a burning pain in her back beneath her shoulder blade. The pain had moved under her breast. No medical attention was sought. At the time of the report the patient had not recovered. No further information is available.
Pt experienced fever minutes post vax. Pt developed rhinitis, red watery eyes sneezing, red itchy face. Pt was taken to ER.
4 in X 45 in red/warm area @ shot site of DTaP, 4 prior DTaP-Lederle vaccine
approx. 20 min. after injection-She returned -> light bruise at injection site to Lt deltoid-Lt. hand moist, Lt. arm cold, stated fingertips numb, nailbeds dusky-full sensation and ROM, grips equal; circulation improved while resting on table-ice packs to site, escorted by friends to obtain Benadryl (50 mg, P.O./F/U call at 1300-she returned to work as symptoms subsided.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer, Case MOD22-013894. The manufacturer tested the lot number 084J21A. Data revealed that the vaccine administered on April 1 to April 8, 2022 from lot number 084J21A likely maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. The vaccine administered on April 9 to May 11, 2022 from lot number 084J21A likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration. We are working on contacting the patient and recommending re-vaccination. No ill effect post.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 71 year old. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (first dose) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on 15-MAR-2021 for prophylactic vaccination. Patient did not experience any adverse events following vaccination (dose number in series 1). The patient received second dose of covid-19 vaccine ad26. cov2.s (dose number in series 2) (booster dose) (suspension for injection, route of admin and batch number were not reported) dose was not reported, 1 total, administered on 16-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. The patient received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 18-MAR-2022 at left deltoid for prophylactic vaccination which was off label use (without adverse event), and inappropriate schedule of vaccine administered (dose number in series 2).  The nurse explained that patient came in to get Janssen Covid 19 booster shot. Her vaccination card had the initial shot (given 15-MAR-2021) on one side of card and the first booster (second dose) of Janssen Covid 19 vaccine (given 16-NOV-2021) on other side of card. This led to confusion about the booster shot and a third dose was given. The nurse stated, they asked patient if she was here for her second and she said yes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
1 of 3 pts vaxed from the same DTP lot# (same vial) who exp fever & crying; pt also recvd HIBTITER & had t101.6;
This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N017700, expiration date: 09-JUN-2019, dose, strength, frequency and route of administration were not provided ) for prophylaxis. The vaccine was diluted with properly stored dose of sterile diluent (manufacturer unknown). The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes prior to administration. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The call was because of digital data logger. No adverse events were reported. Product quality complaint was not involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1711USA002012:
Female received 2nd dose of moderna covid 19 vaccine on 4/8/21 and 1st dose of moderna covid 19 vaccine on 3/11/21.  She did not inform staff that she had received 1st dose of pfizer moderna covid 19 vaccine on 3/24/21.
The patient did not experience any adverse reactions to the extra immunization. I gave the Proquad that contains both the MMR and Varicella. Then also to that, I gave a Varicella.
Developed chest pain <24 hours post vaccine. Cardiologist thinks it may be mild pericarditis, but not related to immunizations.
This spontaneous report was received from a nurse refers to a 9 weeks old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 04-OCT-2017, the patient was vaccinated with improperly stored  ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054:
Kinrix administered to a 4-month-old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th December 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 10-Jan-2023  Reporter's Comments: The nurse reported that a 4-month-old patient accidently administered a dose of Kinrix.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional supportive information: The 4-month-old patient accidently received a dose of Kinrix, which led to inappropriate age at vaccine administration.
This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient might have been vaccinated with improperly stored VAQTA injection, lot # M027879, expiration date: 24-JAN-2018, lot# M047658, expiration date: 28-OCT-2017 (dose and route of administration were not reported). Temperature excursion ranged from 47 to 77 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. Digital data logger was used. No adverse effect was reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012509: US-009507513-1703USA012508:
Injection site turned red and swelling, was hot to touch. As of Monday AM, 10/9/17, redness going away - no longer hot and swelling has gone down.
Developed a rash on both of legs; Rash showed up on her arm at the "location that I got the vaccine as well"; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient (at 40 years ) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) via an unspecified route of administration, administered on arm on 12Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Apr2021, at night, the patient developed a rash on both of legs. She also stated that the rash showed up on her arm at the location that she got the vaccine as well, but she stated that the rash has already gone away. she did take pictures of it. The patient was due for her second dose on 03May2021 and would like to know if she was still okay to get it despite the side effects she experienced. Response was the patient knows the contraindications to receiving a dose of the vaccine. Also let her know that rash had been reported as a non-severe allergic reaction to the vaccine. The outcome of the events was reported as recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Localized redness, soreness, itching, swelling and muscle stiffness at shot site on arm.
Got shingles vaccine, got shingles/Suspected vaccination failure; Got a bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-NOV-2022 Reporter's Comment: The reporter reported this case via interactive digital media. The reporter stated that one of his/her friend got Shingles vaccine, it didn't work well and she got a bad case of Shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available. This case had been linked with case US2022AMR131302, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR131302:Same reporter.
Took shot and have flu like symptoms for 19 days so far have run up to 102 fever for19 days have taken ibuprofen to help keep fever down but when it wears off fever comes back and now she has developed pneumonia in one lung. She is very fatigued this has gone on for 19 days I fear we may lose her if something is not done.