chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I began jerking cause I was cold, chills and breathing bad. Sweating Didn't take temp. Dr told me to go to Urgent care. Gave me prednisone and Benadryl 5-1-12, on Saturday 5/5/12 noticed a yellow spot around shot site hard and swollen tennis ball size. Called Dr. Sent us to Urgent care but went to ER. ER lance the site bloody watery drainage. Admitted to hospital for dressing changes and vancomycin until Tuesday. Skin dying around site. MD told me I might need a skin graft. Shot given in wrong spot 4 inch lower than other shot I have received in arm. Continue seeing my family doctor. Admitted to hospital.
Wrong immunizations given to pt/ ER visit 7/14/2011 urticaria and itching to bilateral forearms. Treated with ADRENALIN 0.3cc/SC BENADRYL 50 mg/po prednisone 40 mg/po; PEPCID 40 po continued BENADRYL, PEPCID and prednisone at home.
rash started on legs and feet, following week routine blood work resulted in kidney failure, rash getting worse and worse
I began to get a severe hives reaction located on both hips, upper thigh on right leg, behind my neck and all across upper pubic bone. Very itchy and red rash. Do not recall this delayed reaction after the first vaccine.   I did a virtual visit with ED. I do not tolerate Benadryl  so was prescribed Vistaril and use hydrocortisone cream. I do have many pictures as documentation.
sick; fever; body aches; sinus; lymph nodes swelled; joint pain; headaches; This is a spontaneous report from a contactable nurse reported for self (patient). This 44-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: E51685), intramuscular on 21Dec2020 at 07:30 at single dose on left arm for COVID-19 immunisation. There was no medical history or allergies to medications, food, or other products.  The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After first dose on 21Dec2020, the patient had sick, fever, body aches, sinus, lymph nodes swelled, joint pain, headaches. All of the events considered as non-serious and no treatment was received. The outcome of the events was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the second dose of BNT162B2 (lot: Ek9231) on 11Jan2021 on the left arm.
Patient reported blisters around site of ZOSTAVAX injection. Patient was instructed to keep the blisters covered and contact her doctor or pharmacy if reaction worsens.
Itching; Rash that peeled; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced pruritus and rash desquamating. The patient was treated with antihistamine and medication unknown (Unknown Topical Medication). On an unknown date, the outcome of the pruritus and rash desquamating were unknown.   It was unknown if the reporter considered the pruritus and rash desquamating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date of Shingrix was unknown. The pharmacist reported that, the patient complaint that, after injection experienced itching and rash that kind peeled. The reporter reported that, this was happened more than 6 months ago. The reporter consented to follow up. This case was 1 of the 2 linked cases, reported by same reporter.
Seen at ER on 3/1/18. 9 x 10 cm erythema on upper Rt arm. Smooth, no induration.
Patient arrived at Health Department today to receive her second dose of  Moderna vaccine.  Patient was inadvertently administered vaccine at age 17 on April 12, 2021.  Original medical records indicates vaccine administered by a new volunteer nurse.  Dr. notified, verbal order to administer Covid vaccine for off label use.   Follow up with employees include: Education to volunteers regarding age limitations with MODERNA vaccine Ask patient age prior to vaccine Signs present in vaccination area with age limits listed  VAERS and ARIA to be competed.
This spontaneous report was received from a registered nurse via a company representative and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications and drug reactions or allergies were not known to reporter. On an unspecified date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unspecified date, the patient developed rash after receiving ZOSTAVAX. No further information regarding the patient and the adverse event was known to the reporter. No Product Quality Complaint (PQC) was involved. The information regarding the outcome of the reported adverse event was not provided. The relatedness between the event of rash and the suspect therapy was not reported. Additional information is not expected as the reporter did not wish any further contact.
Vaccination site erythema; Vaccination site pruritus; Vaccination site swelling; Vaccination site rash; Vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE WARMTH (Vaccination site warmth) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040AZA) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    The patient's past medical history included Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site rash and Vaccination site warmth.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE WARMTH (Vaccination site warmth). At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE PRURITUS (Vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown.            Reporter did not allow further contact
Patient came to me 2 days after the shot with her arm red and warm. but not at the injection site, but around the arm.  I told her to go to doctor that it looked like cellulitis, an infection.
sick; Initial information was received on 28-Sep-2021 regarding an unsolicited valid non-serious social media case from a consumer/non-healthcare professional.  This case involves a patient of unknown age and gender who got sick (illness), after receiving INFLUENZA VACCINE.  The patient's past vaccination included Influenza vaccine (lot number and expiration date and other dosing details were not reported) after which patient got sick for 8 to 10 days.   It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) 8 to 10 days after the administration of INFLUENZA VACCINE.  It was reported "Yup. Gets me sick every year, 8 to 10 days after receiving that vax. None for me, thank you."  It was unknown if the patient experienced any additional symptoms/events.   There were no laboratory data/results available.  It was not reported if the patient received any corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
After receiving the first COVID vaccine, patient reported being extremely dizzy and lightheaded. The patient was given orange juice from her boyfriend and stated she began to feel better. After an additional 5 minutes patient began to lay down on chair reporting feeling extremely dizzy again. The store manager, called 911. Patient was examined but did not go with EMT. She left the store with her boyfriend. Patient did report to the EMTs a history of anxiety and also reported that she was nervous to get the shot.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA lot # R002086, expiration date: 22-APR-2019 (exact dose, route and site of administration were not reported) for prophylaxis. The vaccine was exposed to temperature in the range of 47 degrees Fahrenheit to 77 degrees Fahrenheit (47.9 degrees Fahrenheit) for 10 minutes. Temperature excursion was detected by a data logger. There was no previous temperature excursion. No adverse events were reported. This is one of three reports from the same reporter. Sender's Comments: US-009507513-1808USA009171: US-009507513-1809USA001769.
patient recieved a booster shot and is 15yo .  no adverse reaction to submit. just noting  booster shot was inadvertently given since cdc has not approved the booster for this age group yet.
Information has been received from a physician concerning a 11-year-old female who was vaccinated with Varivax; date not provided. In December 2006, the patient experienced "breakthrough." The number of lesions was not specified. Unspecified medical attention was sought. There was no additional information available. There was no product quality complaint involved. Additional information has been requested.
ended up in bed for days; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves female patient (age unspecified) who ended up in bed for days (bedridden), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination twice.  On an unknown date, the patient ended up in bed for days (bedridden) (unknown latency) following the administration of INFLUENZA VACCINE. This happened both times after taking vaccine  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, outcome of event was unknown.  There will be no information available on the batch number for this case.
Developed vesicular papules and fever, characteristic of varicella, 4 years, post vax.
This case was reported by a consumer via call center representative and described the occurrence of arthritis in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of adverse event. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced arthritis, shoulder pain, neck pain, ear pain and pain in elbow. The patient was treated with ADVIL. On an unknown date, the outcome of the arthritis and ear pain were unknown and the outcome of the shoulder pain and pain in elbow were not recovered/not resolved and the outcome of the neck pain was recovered/resolved. It was unknown if the reporter considered the arthritis, shoulder pain, neck pain, ear pain and pain in elbow to be related to SHINGRIX. Additional details were provided as follows: The patient had tendency to have reactions to vaccines and always had a weird reaction to the flu vaccine. She did not provide any further details regarding that. In mid of August 2018, the patient received her dose of SHINGRIX in her right arm.  The next morning, the patient woke up with pain in her shoulder that traveled up her neck and behind her ear and down top her elbow, all on the right side. The neck pain resolved after a month of taking ADVIL 3 times a day. The pain in her shoulder down to her elbow was still present. The patient had an x-ray and was told she had slight arthritis. The patient did not consent to follow-up. This case was linked with US2018GSK230613, reported for the same patient.
Information has been received from a healthcare worker (immunization official) referring to a 21 month old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-JUNJ-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIBVAX, lot # K010440 (expiration date, dose and route not reported) which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Started 15 min post vaccine injection. Dizzy, fainting, low blood pressure. Numbness in hands/feet. Took an hour to recover.
VOMITING; LOOSE STOOLS; RESTLESSNESS/EXCESSIVE FUSSINESS; RASH OVER FACE, NECK AND FEET; MUCUS IN STOOLS; VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned an 8 week old female. The patient's weight was 6.8 kilograms, and height was 25 inches. The patient's concurrent conditions included non-alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug use. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: 21-JUN-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced vaccine exposure via breast milk. On APR-2021, the subject experienced mucus in stools. On 03-APR-2021, the subject experienced rash over face, neck and feet. On 04-APR-2021, the subject experienced loose stools. On 04-APR-2021, the subject experienced restlessness/excessive fussiness. On 05-APR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 05-APR-2021, was recovering from restlessness/excessive fussiness, had not recovered from loose stools, and rash over face, neck and feet, and the outcome of vaccine exposure via breast milk and mucus in stools was not reported. This report was non-serious. This parent/child case is linked to 20210411086.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
red, circumferential, blotchy rash at injection site.  Not itchy, not raised, not hardened, no drainage, no skin peeling
Unable to use legs, extreme pain on both hip joints, nausea, very sore left arm, very weak left arm, needed assistance in and out of bed
It was the worst flu symptoms I've ever had in my life; my wife and I would check my oxygen pulse levels once an hour for 48 hours to make sure it didn't drop. I had flu symptoms, fever, and a light cough. I took Advil, nasal spray, and vitamins as well as Sudafed to help reduce my flu-like symptoms. I had a PCR test taken at the clinic on 03/09/2022, and it was confirmed on 03/11/2022 that I was positive for COVID-19; within a few days of OTC medications, I was feeling pretty better.
pt recvd vax & devel swelling of the arm; No further details were provided;
Information has been received from a nurse concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL.  Subsequently, the patient developed paralysis in the arm.  It was unknown if the paralysis occurred in the injection site arm.  The patient recovered on an unknown date.  There was no product quality complaint.  Upon internal review, the patient's paralysis in the arm was considered an other important medical event.  Additional information is expected.
Healthy 4 month. 2pm received 4 month vaccinations on 3-20-07. Within 12 hours patient developed high fever 102, cranky, difficult to console, staring spells. Require ER visit 3-21-07 and follow up primary care physician visit 3-23-07.
Injection site and surrounding area was sore only after waking up the morning after booster. About 22 hours after injection, my left arm (injection arm) was swollen - noticeably my hand/fingers and forearm. Not vastly swollen, but I could definitely feel it - the tight and tingly/cooling feeling is what allerted me to the issue.  I did do some light labor the night before - roughly 7 hours after the injection, but nothing extreme.  No heat in the injection area, just the swelling.  I am filling this out while its happening. We're keeping a close eye on it, since I can't find anything that's detailed about the whole arm swelling after injection.
Vaccine administered and temperature exposure > 24 hours; Vaccine administered and temperature exposure > 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered and temperature exposure > 24 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered and temperature exposure > 24 hours) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021 at 10:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered and temperature exposure > 24 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered and temperature exposure > 24 hours). On 20-Aug-2021, PRODUCT STORAGE ERROR (Vaccine administered and temperature exposure > 24 hours) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered and temperature exposure > 24 hours) 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 product use was not provided by the reporter.   Reporter explained the events as the opened vial of Moderna COVID-19 Vaccine was sitting in the refrigerator for 9 days. The vial was punctured on 11AUG2021and supposed to be thrown out, but it was accidentally put back in the fridge.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up document was received on 26-AUG-2021 and contains reporters email address. On 04-Sep-2021: Additional information received on 04 Sep 2021 contains new significant information. Reporter details updated, Product details updated and onset date updated.
Ankle redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Ankle redness) in a 75-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Ankle redness). At the time of the report, ERYTHEMA (Ankle redness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant was reported. No Treatment medication was reported.   This case was linked to MOD-2021-374741, MOD-2021-374892 (Patient Link).
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received anti-viral medication Paxlovid (Lot number: GD7763) via oral route from 07Sep2022 for the treatment of COVID-19. Known allergies was reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information in the case the reported events DRUG INEFFECTIVE and Covid 19 are assessed as related to suspect drug .
This spontaneous prospective pregnancy report was received from a 41 year old female patient referring herself. Concomitant therapy included low dose aspirin. The patient had no medical history or drug reactions/allergies. On 12-NOV-2018, the patient was accidently vaccinated with GARDASIL 9 injection (strength, dose, route of administration, lot # and expiry date were not reported) in upper arm instead of a flu vaccine (unspecified) for prophylaxis (wrong product administered, exposure during pregnancy). The patient became pregnant with last menstrual period (LMP) of 13-AUG-2018 (reported as 17 weeks) and estimated due date (EDD) of 20-MAY-2019. Initial exposure to GARDASIL 9 was at 13 week(s). The pregnancy outcome was outcome pending. No lab diagnostics/studies was performed. The patient sought medical attention and spoke with physician. No treatment was given. The patient was not hospitalized. There was no product quality complaint (PQC) reported.
Can't lift left arm fully or extend it all the way back; Pain in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Can't lift left arm fully or extend it all the way back) and VACCINATION SITE PAIN (Pain in injection arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02521A and 04C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MOBILITY DECREASED (Can't lift left arm fully or extend it all the way back) and VACCINATION SITE PAIN (Pain in injection arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Can't lift left arm fully or extend it all the way back) and VACCINATION SITE PAIN (Pain in injection arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information reported also included heating pad and exercise.  No concomitant medication was reported.